Human immunodeficiency virus (HIV) infection is a significant problem among female sex workers (FSWs) in Nagaland, India. Place of solicitation and sex vary considerably in this context. The aim of this study was to investigate the relationship between categories of sex work and HIV risks.In 2009 a survey was undertaken among 417 FSWs in Dimapur, Nagaland using an interviewer-administered questionnaire and blood and urine samples. Using this data, we constructed a typology of sex work by combining usual place of solicitation and place of sex, and examined variations in demographics, sex work patterns, sexually transmitted infections (STIs) and HIV prevalence across typology categories. Binary logistic regression analyses were done to examine the association between category of sex work and HIV, STIs, and condom use.By combining place of solicitation with place of sex, seven distinct categories of sex work emerged. The largest category were women who usually solicited in a public place and had sex in a rented room or lodge . One-tenth of participants were HIV positive (10.3%) and 35.4% had at least one STI . FSWs who both solicited and entertained in a rented room or lodge  and those who solicited by phone and had sex in a rented room or lodge  were more likely to be HIV positive compared to home-based FSWs. Women who both solicited and entertained in public  and who solicited in public and entertained in a rented room or lodge  were more likely to test positive for an STI compared to home-based FSWs.The results indicate that different categories of sex work are associated with different HIV and STI risk profiles. Local contextual understanding of the different types of sex work and the associated levels of risk assist NGOs to target their interventions more effectively and efficiently in order to reduce STI and HIV prevalence among FSWs and their clients. Human immunodeficiency virus (HIV) is a major public health challenge in India, which is experiencing a concentrated epidemic affecting high-risk groups including female sex workers (FSWs) ,2. NagalDimapur is Nagaland’s main business centre and a hub for commercial sex work, hosting an estimated 1 800 to 3 500 FSWs ,7. AccorThe Bill & Melinda Gates Foundation-funded Avahan HIV prevention program in India undertook a large cross-sectional survey among high-risk groups in six states, including FSWs in Nagaland . The IntTwo other Indian studies had investigated FSW typologies by combining place of solicitation with place of sex, both of which came from southern India ,13. SubsJain & Saggurti  identifiThe relationship between women’s STI and HIV vulnerability and the type of sex work they engage with is likely to be an interdependent one. It is probable that the socio-economic vulnerability of a woman influences the type of sex work she engages with, and some types of sex work are more likely to place her at risk of STIs and HIV infection than others. Sex work categories are generally differentiated by where the solicitation and/or sex takes place i.e. the physical and social environment surrounding the sex work, be it public place, home, brothel, rented room etc. Gieryn (2000) argues that place mediates our social lives in a number of important ways i.e. it is not just a setting for activities, or even an independent variable that needs to be controlled for; rather place is an ‘agentic player in the game – a force with detectable and independent effects on social life . Some environments are inherently more unsafe than others, and thereby place women engaging in sex work at greater risk of stigmatisation, harassment, violence, and HIV and STI infection.As the earlier analysis of the syphilis prevalence among FSWs in Dimapur indicated that combining place of solicitation with place of sex may provide a more nuanced understanding of HIV and STI profiles and risks, we decided to analyse the most recent data from the 2009 IBBA  in orderThis paper presents analyses of cross-sectional IBBA Round 2 survey data collected from 417 FSWs in Dimapur in 2009 using an interviewer-administered questionnaire and the collection of blood and urine samples. A detailed description of the IBBA methods, questionnaire and approach to biological testing can be found elsewhere ,14. The Respondent driven sampling was used to recruit FSW participants to the IBBA survey. Respondent-driven sampling is a sampling method based on social network theory that can be used to recruit hard-to-reach populations, such as FSWs . RespondFor this study, recruitment of participants began with seven purposively recruited ‘seeds’. All seed participants were given three uniquely coded coupons to recruit three eligible participants from their personal networks. The new recruits were invited to attend a nominated RDS site, taking along their coded coupons. These new participants were in turn provided with recruitment coupons to share within their networks. This peer-to-peer participant recruitment process continued until the desired sample size was achieved. All participants were paid a compensation of Rs100 (approximately 2 USD) and another Rs50 per newly recruited participant.Women, aged 18 years or over, who had sex with men for cash payment at least once in the past month and who had given informed verbal consent were eligible to participate. The IBBA survey has two components: 1) demographic and behavioural data collected by an interviewer-administered questionnaire covering socio-demographics, sex work practice, condom use, and exposure to NGO-delivered HIV prevention interventions, and 2) collection of blood and urine samples for HIV and STI testing ,14.Blood samples were tested for HIV and syphilis antibodies, and urine samples were tested for N. gonorrhoea (NG) and C. trachomatis (CT). Serum samples were tested for HIV by Microelisa , and positive tests were confirmed by Genedia HIV 1/2 ELISA 3.0 . Serum samples were also tested for syphilis by rapid plasma reagin (RPR) test and confirmed by Treponema pallidum haemagglutination assay (TPHA). Urine samples were tested with nucleic acid amplification assay (Gen-Probe Aptima) for the detection of NG and CT.Participants were asked “where do you generally solicit/pick-up most of your clients?” and “where do you generally entertain most of your clients?” . Participants were able to give only one answer to each question, which was recorded against pre-coded response options. Their responses were used to generate two key variables: usual place of solicitation and usual place of sex.With this data, we constructed a new variable based on a combination of usual place of solicitation and usual place of sex. This new variable generated a typology of sex work that collapses two characteristics of sex work into one, and permits comparisons of FSWs who solicit and have sex in the same place, and those who move between places. For example, FSWs who solicit in a public place and also entertain clients in a public place were grouped into one category (i.e. public-to-public). An “other” category was created that groups together all participants who identified either their usual places of solicitation and or their usual place of sex as other than home, phone, public place, or rented room/lodge (RRL).Mother tongue was collapsed into a binary variable separating those participants whose mother tongue was Naga from those whose mother tongue was non-Naga; this variable acts as a proxy indicator for migration to Nagaland. Duration in sex work was defined as the number of years since the participant first sold sex. Regular clients were those who the participant knew well and who repeatedly visited them for sex. Occasional clients were those the participant did not know well and who only visited the participant for sex on one or a few occasions. Consistent condom use was defined as generally using a condom every time. Program exposure was defined as having ever been exposed to at least one of the following three core program services: 1) contacted by peer educators/staff of NGOs, 2) received condoms, and/or 3) visited the program clinic. This approach to defining program exposure is consistent with analyses of program exposure among FSWs in other parts of India ,17. OtheData obtained by the respondent-driven sampling approach is typically analysed with a statistical software package called RDSAT. However, RDSAT is limited to generating adjusted estimates of proportions, and is not suited for cross-tabulation or multivariate analysis as required for the objectives of this paper. RDSAT is capable of generating individualised weights that can be used in multivariate analyses, however, there is divided opinion regarding the utility of these weights and findings generated with them are to be treated with caution . Thus, aLogistic regression analyses were conducted to estimate the strength of the association between the sex work categories and HIV status, STI status , and condom use with regular clients; similar analyses on condom use with occasional clients were not conducted due to the small size of the sub-group reporting such clients. Due to the small sample size in some categories of the typology, parsimonious models were generated with a small number of purposively selected control variables to account for differences in relevant socio-demographic characteristics and sex work practices. This approach has been used in previous socio-epidemiological surveys of FSWs where the main objective was to examine the relationship between one independent variable and one dependent variable, while adjusting for a range of control variables ,16. The There were 417 FSWs recruited into the study. The usual places of solicitation and sex reported by the participants are shown in Table The largest sex work typology category was comprised of those who usually solicited in a public place and had sex in a RRL (31.7%), followed by home-to-home (16.1%) and phone-to-RRL (15.3%). A smaller number of participants comprised the categories RRL-to-RRL (8.6%), public-to-home (7.4%), public-to-public (4.8%), and phone-to-home (3.8%).Data on socio-demographics Table  and sex The women in the public-to-RRL category were more likely to be illiterate (82.6%); be married (57.6%); have experienced sex before the age of 16 years (60.3%); and have been beaten in the past six months (53.4%). These women had been in sex work longest (35.5% for 5 years or more) and were most likely to have occasional clients (87.9%).Women in this category were least likely to have been beaten in the past six months (19.4%), had less exposure to HIV prevention program services (25.4%), and only 50.8% said that they have occasional clients.Women in the phone-to-RRL category were the most literate (79.7%). A high proportion reported a Naga language as their mother tongue (84.4%) and being unmarried (48.4%). They earned the most money; 77.7% were paid more than 200 Indian rupees (≈US$3.3) by their last client.Women in the RRL-to-RRL category were the youngest (mean age of 23.3 years) and had been in sex work for the shortest time .The women in the public-to-home category were the equal oldest (mean age of 29.3 years), along with women from the public-to-public category. They were paid the least (71.0% were paid less than 200 Indian rupees by their last client), and were least exposed to the program (22.6% reported receiving at least one of the core NGO-delivered HIV prevention services).The women in this category were illiterate (80.0%), had the highest proportion reporting a non-Naga language as their mother tongue (90.0%), and were very likely to be widowed (35.0%). They were poorly paid (66.7% received less than 200 Indian rupees from their last client) and were less exposed to the program (25.0%).This category had the highest proportion of women who reported a Naga language as their mother tongue (87.5%), were the most likely to live alone (75.0%), and be unmarried (56.3%). They were least likely to report having occasional clients (37.5%), had sex with the lowest number of clients  and had the lowest prevalence of STIs (21.4%).Only 63.4% (n = 243) of participants had used a condom at last sex with a regular client, and 74.8% (n = 214) with an occasional client. Consistent condom use  was very low with both regular  and occasional clients . Over one-third of participants  tested positive for an STI  and 10.3% (n = 43) tested positive for HIV.Table One other covariate associated with HIV status was literacy; women who could read and write were less likely to be seropositive (OR = 0.4). Every additional year of age was associated with a reduced likelihood of condom use at last sex with regular clients (OR = 0.95) and a reduced likelihood of consistent condom use with regular clients (OR = 0.94). Every additional year since having first started sex work was associated with an increased likelihood of using condoms at last sex with a regular client (OR = 1.09). Those who were married (OR = 2.7) or widowed (OR = 4.9) were more likely to use condoms consistently with regular clients. FSWs who were paid more (i.e. greater than 200 INR) by their last client were more likely to have used condoms as last sex with a regular client (OR = 1.8) and more likely to consistently use condoms with regular clients (OR = 2.5).By combining usual place of solicitation with usual place of sex we generated a typology of female sex work that consists of seven distinct categories. The number of categories highlights the diversity of sex work in this setting where there is no legal sex industry. We examined variations across the categories in relation to a range of factors including HIV and STI prevalence and condom use, and found differences across categories that have relevance to the design and implementation of HIV prevention programs. The results also suggest that a combination of usual place of solicitation and usual place of sex provides more detailed information about HIV risks compared to place of solicitation or place of sex alone.The IBBA survey of FSWs in Dimapur, Nagaland, revealed a high prevalence of STIs  and HIV (10.3%) and that condom use with both regular and occasional clients was relatively low. The HIV prevalence is comparable to that found among FSWs in the southern states of India (9.3% in 2011); however, the prevalence of STIs in the southern states was substantially lower (reactive syphilis was 4% in 2011) and condom use with both regular and paying partners was above 90% , highligImportantly, the prevalence of STIs was highest among women in the public-to-public (50.0%) and public-to-RRL (47.1%) categories, and condom use was lowest in the public-to-public category (8.3%) reflecting the risky context for FSWs soliciting in public. Public places were the most commonly reported place of solicitation, and were linked with characteristics of vulnerability including older age, illiteracy, experiences of violence and being paid less by their clients. Public place solicitation was also associated with having a non-Naga mother tongue, suggesting that some women in this category have migrated to Nagaland; migrant sex workers are typically more vulnerable to HIV/STIs due to inconsistent access to preventative services, a lack of control over their sex work environment, and a diminished ability to negotiate safe sex practices ,21.There were important differences between FSWs who usually entertained their clients at a RRL, depending on where they usually solicited their clients. Those who solicited their clients in public places had a high STI prevalence (47.1%), and those both soliciting and entertaining at a RRL had the highest HIV prevalence (22.2%). The high prevalence of HIV among the RRL-to-RRL category is concerning given they were one of the youngest groups and had the shortest average duration in sex work. The explanation for this is unclear and needs further investigation, but the low level of consistent condom use by these young women may be a contributing factor, which could be due to their dependence on managers of lodges and rented rooms who may act as middlemen/women. Such findings indicate that women entertaining at RRL are a diverse group (depending on place of solicitation) and are not the same in terms of their risks or prevention needs.Interestingly, the phone was identified as the second most common method of solicitation in Dimapur. Elsewhere in India, cell phones are increasingly being used by FSWs for solicitation and are replacing the need for middlemen and reducing the need to solicit in open spaces ,23. In DAs in our study, the other two studies of sex work typology in Southern India found that public places were the most common sites for solicitation, and for place of sex it was rented room, lodge or home ,12. WhenExplanations for the observed relationships between categories of sex work and HIV and STI prevalence and risks are likely to be complex and reflect the interdependent connections between sex workers and the environments they work in. For example, FSWs who are illiterate, widows and non-Naga speaking report earning less money, and are more commonly soliciting in public places. Soliciting in public places means they are more likely to be victims of violence and harassment by police and local gangsters, and arguably have less control over their environment compared to those who are working from their own home. These factors influence their capacity to manage risk, including the consistent use of condoms. So the most vulnerable women end up engaging in sex work in the more unsafe environments, which in turn compounds their vulnerability. Gieryn (2000) notes that ‘public places provide the circumstances for the most degrading forms of informal social control; on-the-street harassment of women… is surely one way to keep disadvantage groups in their place’ .It is not clear why there is such a difference in condom use and HIV prevalence among FSWs who have sex in a rented room or lodge depending on where they solicit their clients. Those women who both solicit and have sex in a rented room or lodge are much more likely to have HIV and less likely to have used a condom with last regular client than those who solicited in a public place or by phone (but had sex in a rented room or lodge). Qualitative field-based studies that seek to better understand these differences would yield a more nuanced understanding of HIV vulnerability among FSWs in Dimapur, and the findings are likely to have implications for the effective delivery of HIV prevention programs.There are several limitations associated with this study that should be considered when interpreting the findings. The sex work categories identified are a direct function of the sex work patterns of the women who were recruited into the study, and the extent to which they represents sex work in Dimapur more broadly is difficult to determine. However, we did conduct a dissemination meeting with local NGOs who provide harm reduction services for FSWs in Dimapur, and the identified sex work categories and related risk profiles resonated with them. Women were asked about their usual place of solicitation and their usual place of sex; however, this information alone does not capture the fluidity of sex work patterns. As highlighted by Jain & Saggurti , many seTo better explore variation in risks for different FSW groups we generated a typology of female sex work by combining usual place of solicitation with usual place of sex.The process yielded seven distinct categories of sex work, reflecting the diversity of sex work in this setting, and the largest group were comprised of FSWs soliciting in public and entertaining in a RRL. There was considerable variation in HIV and STI prevalence and other characteristics across the categories of the typology. FSWs from the public-to-public, public-to-RRL, phone-RRL and RRL-to-RRL categories were the most vulnerable to HIV and STI infections and would benefit from programs that specifically target their profile. Compared to place of solicitation and place of sex alone, combining place of solicitation and place of sex more effectively highlighted the most vulnerable women. Local contextual understanding of the different types of sex work and the associated levels of risk are necessary for NGOs to target their interventions more effectively and efficiently in order to reduce STI and HIV prevalence among FSWs and their clients.


Electrostatic gates are of paramount importance for the physics of devices based on high-mobility two-dimensional electron gas (2DEG) since they allow depletion of electrons in selected areas. This field-effect gating enables the fabrication of a wide range of devices such as, for example, quantum point contacts (QPC), electron interferometers and quantum dots. To fabricate these gates, processing is usually performed on the 2DEG material, which is in many cases detrimental to its electron mobility. Here we propose an alternative process which does not require any processing of the 2DEG material other than for the ohmic contacts. This approach relies on processing a separate wafer that is then mechanically mounted on the 2DEG material in a flip-chip fashion. This technique proved successful to fabricate quantum point contacts on both GaAs/AlGaAs materials with both moderate and ultra-high electron mobility. The use of QPCs has generated an enormous body of work regarding ballistic quantum transportElectrostatic gates fabricated on the sample surface are routinely used to locally deplete the two-dimensional electron gas 2DEG) in semiconductor heterostructures, in order to study the electronic behaviour in further confined geometries. The realization of the split gate in 1981DEG in sefractional effective charges, quantum statistics and quantum numbers, all driven by electron-electron interactions. This is in stark contrast with the Integer Quantum Hall Effect (IQHE) whose emergence does not involve any interactions and consequently is much more robust against disorder. While detrimental to the electronic mobility of its 2DEG, split gates fabricated on high-mobility GaAs/AlGaAs heterostructures have led to important insights. For instance, shot noisetour de force experiments performed on the 5/2 FQH state11When the electron mobility in a 2DEG surpasses - It avoids contamination by chemicals during the fabrication process. Usually, the gate fabrication process uses several steps in which polymer resists are deposited on the surface of the 2DEG and chemicals are used to develop and remove these resists. Even when an appropriate solvent is used, these resist residues are hard to remove and doing so often involves a cleaning process that can damage the 2DEG (e.g. an oxygen plasma). Resist residues can also trap charges and generate undesirable fluctuations in the density of the 2DEG.- It avoids degradation of the electron mobility during lithography. Radiation damage can arise from heating, electrostatic charging, ionization damages (radiolysis), displacement damage, sputtering and hydrocarbon contamination. In our approach, the 2DEG is never exposed to any electron beam or optical lithography.- It avoids additional strain induced by differential thermal contractions. At room temperature, GaAs has a thermal expansion coefficient of μm during the first 150 K, whereas GaAs will shrink by less than 2 μm. This is likely to induce strain in the material and to affect the electron mobility at low temperatures, particularly in the case of a narrow constriction with a width of only 500 nm.- It makes it possible to re-use the 2DEG material. The technique is non-destructive and enables the re-use of the 2DEG material at will. In addition, for the highest mobility GaAs/AlGaAs 2DEGs with mobility in excess of μm2 only, should the need arise, our approach allows for the device to easily be remounted on a slightly different part of the wafer. This technique also allows one to swap gates so as to measure different devices (or designs) on the exact same piece of material. Finally, it avoids wasting precious material during low-yield processes, which is common when fabricating complex devices.In order to circumvent the problem of degradation of the electronic mobility, we have developed a flip-chip technique where all processing steps required to fabricate the electrostatic gates are performed on a separate substrate that is then mounted on the surface of the 2DEG. This approach has previously been used to fabricate resonators on 2DEGse-beam lithography process, with 50 nm of chromium first deposited to allow charge evacuation during the e-beam exposure followed by a spinning of MAA/PMMA resist. After exposure and development, 5/150 nm Ti/Au is deposited by e-beam evaporation followed by lift-off and chromium etching. Extreme care is taken to obtain a near perfect lift-off so as to prevent residual metal standing up along the edge, which could cause gate leakage or introduce an undesirable buffer space between the flip-chip gates and the 2DEG. A layer of aluminum oxide (30 to 100 nm thick) is then deposited to further prevent potential gate leakages. The ohmic contacts are fabricated directly on the GaAs/AlGaAs either by indium diffusion, or by evaporation of Ge/Au/Ni/Au using shadow mask to avoid lithography. The 2DEG wafer is placed on a sample holder and the ohmic contacts are connected to the contacts of the holder by indium-soldered gold wires. Then, the flip-chip is placed on top of the 2DEG together with an additional sapphire top plate, which is itself held in place by four BeCu springs that apply very gentle mechanical pressure. The optical interference fringes between the top plate and the flip-chip allow a fine tuning in the alignment of the flip-chip device. All fabrication and assembly steps are performed in a class-100 cleanroom to avoid contamination of the critical interfacing surfaces.In 2 in area and not perfectly flat; this could easily be improved by reducing the contact area between the two mechanical parts of the device.We have fabricated both 1 μm long QPC and Fabry-Pérot gates on sapphire and tested the technique on GaAs/AlGaAs wafers grown at Sandia National Laboratories (Sample A) as well as Princeton University (Sample B). We have chosen to compare the flip-chip devices with the best conventional QPC fabricated out of 20; in many cases, the conductance quantization were not as good as for the flip-chip devices. For the flip-chips mounted on sample A, several QPCs showed pinch-off with a success rate of ~80%. In total, more than 20 devices were tested and a pinch-off voltage ranging from −6 V to −40 V was determined. For comparison, conventional QPCs (CQPCs) made on a similar wafer to sample A showed a pinch-off voltage ranging from −1.7 to −3 V, and thus had a superior gate efficiency by a factor ranging from ~3 to 13. We attribute the lower gate efficiency of the Flip chip QPC (FCQPC) to the ‘air’ (vacuum) gap between the flip-chip and the 2DEG. A rough calculation that assumes a pinch-off voltage scaling linearly with the distance between gates and the 2DEGs estimates this gap to be in the range from 50 to 200 nm. This gap most likely occurs because the contact area between the 2DEG and the flip-chip gates is over 3.6 × 2 mm6 cm2/V · s . For both devices, the quantization of the conductance is clearly observed. While the CQPC shows better-defined and more precise conductance plateaus , this likely arises from the shape of the QPCs that were not identical, and because of both the air gap present in the FCQPC and shallowness of the 2DEG modifying the gate-induced electric field profile. We also note that in the metallic regime at conductance below ~50 e2/h, the slopes of the FCQPC and CQPC are strikingly similar. Importantly, we have not observed a pronounced hysteresis in the pinch-off curve of the FCQPC whereas this undesirable behaviour is often observed in conventional gated devices. Finally, in the inset of RH measured outside of the interferometer (red trace) shows good quantization of the IQH plateaus and the 5/3 FQH plateau, as expected for a sample in this range of mobility. Due to the geometry of our design, it is not possible to directly measure RH under the interferometer; rather, we measure the diagonal resistance RD (blue trace), which includes a large longitudinal contribution. Also shown are Rxx outside of the interferometer and RxxT through the interferometer; again geometry plays a role, since the contacts outside are much closer together and the measured voltage is correspondingly smaller. The fact that RxxT does not reach zero in all of the states and that Rxx does may be due to the flip-chip blocking light from the LED used during the cooling process or to the non-ohmicity of particular contacts. Further investigation is required to clarify this. Finally, we note that in the quantum Hall regime the conductivity is related to the resistivity by the tensor relations RHall and Rxx in all regions of the sample in a well-controlled geometry, which is not the case here.As further confirmation of the quality and efficiency of the flip-chip devices, they were characterized in the quantum Hall regime at very low temperatures in a magnetic field up to 9 T. ν = 8. Plateaus occur for each integer multiple of e2/h, with the exception of the first plateau. The quantization for the lowest conductance plateaus  is excellent, but degrades for higher plateaus as the contribution of the longitudinal resistance in series with the QPC becomes significant. Along with the data in In In conclusion, we have demonstrated successful fabrication of split-gate devices on GaAs/AlGaAs 2DEG heterostructures using a flip-chip technique which avoids performing any potentially damaging fabrication steps directly on the ultra-high mobility wafer. This process has a yield on par with traditional fabrication techniques, and results in robust devices that can be measured at dilution refrigerator temperatures and in high magnetic fields. Benchmark measurements show that the samples perform as expected; we demonstrate pinch-off and quantized conductance both at zero field and in the quantum Hall regime. These devices have great potential for future studies of sensitive quantum Hall states such as interferometric measurements with the 5/2 and 12/5 FQHE that occur only in pristine ultra-high mobility devices.How to cite this article: Bennaceur, K. et al. Mechanical Flip-Chip for Ultra-High Electron Mobility Devices. Sci. Rep.5, 13494; doi: 10.1038/srep13494 (2015).


In the patient-centered medical home model of health care, both health care providers (HCPs) and patients must understand their respective roles and responsibilities, view the other as a partner, and use communication skills that promote shared decision making. This is particularly necessary in chronic conditions where outcomes depend on behavior change and in underserved populations where the burden of chronic disease is high.1c(HbA1c) level.The objectives of this study are to determine if a Patient Empowerment Program (PEP) (1) is acceptable to patients and feasible across multiple clinical sites; (2) will increase patient preference for control in medical decision making, improve patient perceptions of patient-HCP communication, and increase patient activation; (3) is associated with an increase in diabetes self-management behaviors; and (4) has an effect on hemoglobin A1c. These measures will be assessed at the time of enrollment, after the waiting period (deferred intervention only), and then postintervention at 1 week, 3 months, and 6 months.This study recruited English-speaking adult patients with type 2 diabetes mellitus from three urban clinical sites in New York City and randomized them to an immediate intervention group that completed the PEP intervention or a deferred intervention group that served as a wait-list control and completed the PEP intervention after 3-4 months. The PEP intervention consists of two facilitated small group sessions. Session 1 focuses on defining HCP and patient roles in the medical encounter by introducing ideal communication behaviors in each role and by providing both positive and negative examples of patient-HCP encounters. Session 2 focuses on practicing communication skills by role-playing with actors who serve as standardized health care providers. After the role play, participants set goals for their own health care and for future interactions with their HCPs. Outcome measures include the Patient Activation Measure; Ask, Understand, Remember Assessment; Krantz Health Opinion Survey; SF-12v2 Health Survey; Diabetes Self-Management Questionnaire; and HbAStudy recruitment occurred from November 2014 to June 2015, with a total of 80 patients enrolled. To date, 45 participants have attended at least one session of the PEP intervention. Further intervention sessions and post-intervention follow-up are ongoing, with data collection set to be completed in April 2016 and results of data analysis available by June 2016.From preliminary participant self-report data, our PEP intervention is acceptable to low-income, low–health literate patients and feasible to hold across multiple clinical sites. Participants have reported learning specific ways to change their behaviors at their next HCP visit . With the forthcoming quantitative data on participant attitudinal and behavior change, the PEP intervention may ultimately empower participants within the medical encounter and improve health outcomes. More than 25.8 million Americans have type 2 diabetes mellitus (T2DM). In 2012, T2DM cost the United States $245 billion in both direct and indirect medical costs -5.Preparing patients for the PCMH model is challenging because of the inherent power differential between HCPs and patients. Efforts to prepare HCPs to practice in the PCMH model have included strategies for encouraging patient self-care activities and behavior change  ,7. InteStandardized patient (SP) training, a well-established, performance-based intervention, offers a compelling method of activating patients to become partners in their health care. Standardized patients are trained to reliably and validly assess HCP clinical competence -37 and,Our Patient Empowerment Program (PEP) seeks to adapt the successful SP methodology currently used in HCP education and translate it onto the patient side of the medical encounter . To do s1c(HbA1c) level.The objectives of this study are to (1) assess the acceptability and feasibility of implementing the PEP across three urban clinical sites; (2) determine if a PEP will change patient preference for control in medical decision making, improve patient self-efficacy in patient-HCP communication, and increase patient activation; (3) determine if participation in the PEP is associated with an increase in diabetes self-management behaviors; and (4) explore the effect of the PEP on hemoglobin AThe PEP is a randomized, wait-list control study see that aimPatients were recruited in cohorts of 20 and then randomly assigned to attend the PEP intervention immediately (immediate intervention) or after a waiting period (deferred intervention). All participants completed a baseline assessment at the time of enrollment (T0) and will complete follow-up assessments 1 week (T2), 3 months (T3), and 6 months (T4) after completion of the PEP intervention see. Additio1cmonitoring, and all medications as directed by their physicians.Aside from attending the PEP intervention, all participants continued to receive their usual care, including all scheduled primary care and specialty clinic appointments, HbABellevue Hospital Center, Gouverneur Health, and Woodhull Medical Center are all within the Health and Hospitals Corporation, a large public hospital system in New York City. The adult ambulatory care clinics at these sites serve patients from the local community as well as immigrants from around the world, with English, Spanish, Mandarin, Cantonese, and Bengali among the most common languages spoken. Approximately one-third of patients have Medicaid or are without health insurance and the most common diagnoses in the clinic include obesity, hypertension, heart disease, diabetes, and asthma.1clevel was between 6.5% and 11%. Patients were excluded if they (1) were unable to speak English or (2) had a major psychiatric illness that impaired their ability to care for themselves .We recruited patients with T2DM who presented to the adult ambulatory care clinic at each site. Patients eligible for inclusion in the study (1) were at least 18 years old, (2) had a diagnosis of T2DM for at least 1 year, and (3) their most recent HbAResearch assistants (RAs) screened all of the clinic appointments each day to identify patients who were eligible for the study. Research assistants then briefly explained the study to all eligible patients who came to their appointment and obtained informed consent from those who decided to enroll see. After oAfter 20 participants were enrolled in the study, a Web-based random number generator was used to generate a list of 20 integers between one and two. The list was refreshed until it contained 10 ones and 10 twos. Based on this list, participants were assigned in order of their study identification number to the immediate intervention (1) or deferred intervention (2) group. All participants in the immediate intervention group were contacted by phone to schedule the PEP intervention sessions and all participants in the deferred intervention group were contacted by phone and informed that they would be recontacted in 3-4 months to schedule their PEP intervention sessions.Participants were compensated for participating in the study. They received US $10 and a MetroCard with US $10 at each of the two PEP intervention sessions. They also received US $60 and a MetroCard with US $10 for completing the study if they attended a post-PEP focus group.In order to increase retention of deferred intervention participants, they received a letter from our program and an educational handout about T2DM in the mail approximately every 3 weeks. Handouts were sent in the same order and all handouts came from the Diabetes Care and Education website . In totaOutcome measures for the study primarily consist of self-report questionnaires assessing health attitudes and behaviors see. BecauseThe primary outcome of the study is patient activation, as measured by the short form of the PAM . The PAMSecondary outcomes of the study include the ability to obtain information from HCPs, preferences for information and control in medical decision making, health quality of life, and diabetes self-care behaviors.r= .31) and moderately correlated with disease knowledge (r= .11). It also has good internal consistency reliability, with Cronbach’s alpha = .75.The ability of participants to obtain health information from HCPs was assessed by the Ask, Understand, Remember Assessment (AURA) . The AURr= .31) with an established health locus of control scale, and test-retest reliability was .74 for the Information subscale, .71 for the Behavioral Involvement subscale, and .59 for the overall scale. The PCS [Participants’ preferences for information and control in medical decision making were assessed by the Krantz Health Opinion Survey (Krantz)  and the The PCS  is a 1-iParticipants’ health quality of life was measured by the SF-12v2 Health Survey , a 12-it1c. It also has good internal consistency reliability, with Cronbach’s alpha = .60-.84.Finally, participants’ diabetes-specific health behaviors were assessed using the Diabetes Self-Management Questionnaire (DSMQ) . The DSM1cwill serve as an exploratory outcome for the study. HbA1cis exploratory for this study because participants did not undergo HbA1ctesting at specific times during the study period. Rather, participants will continue to have HbA1clevels monitored as part of their routine care and the HbA1cclosest to enrollment (T0) and each follow-up time point  will be collected from the electronic medical record (EMR) and used for data analysis. Therefore, it is possible that a significant number of follow-up HbA1cvalues may be missing or not collected at the time of follow-up and those that are will not correlate precisely to the same time period as the questionnaires.HbAPrevious studies have shown that there are numerous confounding variables that affect patients’ ability to participate in SDM ,18,59.In the study population, health literacy is also expected to be a significant confounding variable. Health literacy was measured at enrollment (T0) using the Newest Vital Sign (NVS) -53. TheAcceptability and feasibility were judged based on (1) willingness of potential research subjects to enroll in the study, (2) responses to the activities during the PEP sessions, and (3) ability to engage in the role-playing scenarios in PEP session 2. After completion of the PEP intervention, all participants were invited to attend a focus group to discuss their experiences with and reactions to the PEP intervention, which were then audiotaped and transcribed. The transcribed text will be parsed into segments that represent a perspective or theme and each segment will then be independently coded by three readers. Through an iterative process among the coders, a single parsimonious coding scheme will be derived and then applied to all transcripts by the same three coders toward providing a thematic analysis of the data.Our PEP is a two-session course led by a clinical health psychologist (LA) and assisted by research staff . Each session is 2 hours in length and the two sessions are held approximately 1 week apart. The PEP intervention is designed to be a group experience, with 2-6 participants attending each session. Ideally, the same participants who attended session 1 will return for session 2, but because of the limited availability of both research staff as well as participants, it is expected that this may not always be the case.The PEP intervention curriculum see and mateFocus groups were also held with internal medicine attending physicians (n=11), primary care residents (n=16), and medical students with at least 1 year experience on clinical rotations (n=11). In these groups, HCPs discussed their experiences with patients and expectations for patient engagement/activation. Overwhelmingly, HCPs reported preferring patients who were more informed about their medical conditions, who raised questions or concerns during the office visits, and who performed self-management behaviors in between appointments to those who were less activated .After these focus groups were completed and intervention materials were created, 6 patients from the focus groups were invited to complete a beta test of the PEP intervention. During the beta test, they provided feedback about timing of the sessions, realism of the video clips, and feasibility of asking patients to complete a 10-minute role-play scenario with SHPs. Their feedback was used to revise all materials before recruitment for the PEP intervention began.In order to standardize the intervention, a curriculum and detailed manual were created. A group of 7 actors with previous SP experience were trained to play SHPs at the beginning of the study and reoriented to each case by an SP trainer before each intervention session. Throughout the intervention sessions, participants were asked to rate each activity to determine if the learning goals were being achieved, using a simple visual Likert scale with responses ranging from 0 = not at all to 3 = very much. All PEP intervention sessions were also audiotaped so that they could be transcribed to evaluate consistency across each run of the intervention.In the beginning of PEP session 1, participants discussed their experiences with HCPs and beliefs about the role of the patient and HCP in the medical encounter. Two posters were used to frame this discussion see, which dParticipants then watched three pairs of video clips of patient-HCP interactions. These video clips were created using actors who were experienced SPs and to represent a range of sex, race, and ethnicity for both the patient and HCP. Each pair of video clips represented a different aspect of a conversation between a patient and HCP, including (1) HCP taking the patient's medical history, (2) HCP providing information, and (3) decision making about the treatment plan. All visits were designed as follow-up visits, implying an ongoing relationship between patient and HCP within the interactions.The first video in each pair represented a negative example of communication. In these videos, the patients were passive and did not voice their perspective or engage actively with the HCP. The HCPs, while trying to be helpful and sympathetic, were rushed, followed their own agendas, and acted with some sense that they knew the best approach. After the video clip, participants rated both the patient’s and HCP’s communication based on behaviors listed on the Team Works Well poster and discussed what each party could have done to improve the communication and the quality of the visit.The second video in each pair was example of positive communication in the same situation. The patients in these videos were more activated and engaged with their HCPs, while the HCPs demonstrated a patient-centered approach. Similar to the first video, afterwards participants rated the patient and HCP and then had a brief discussion about what was different or improved.PEP session 2 gave participants the opportunity to practice the communication skills that were discussed in session 1. Participants were first split into pairs to complete a brief role-play scenario with SHPs. While one participant was role-playing, the other observed and rated both the participant and the SHP in real time. The observing participant then led a debriefing of the scenario in order to practice giving feedback. After the debriefing, the participants switched places and the second participant completed a different role-play scenario.In the second part of PEP session 2, participants applied what they learned to an individualized 10-minute role-play scenario with a SHP, created specifically for each participant based on self-reported difficulties with diabetes. Common topics for this scenario included struggles with adhering to a healthy diet, difficulties performing frequent finger sticks to monitor blood glucose, and overall frustration when trying to control blood sugar numbers. Research personnel observed these role-plays and led a debriefing afterward. PEP session 2 concluded with a group discussion about lessons learned from the role-plays and each participant worked with a member of the research staff to create an individualized action plan for both diabetes self-care and future medical encounters. All ideas for the action plan were participant generated, but research staff provided feedback on the feasibility of their goals and brought up potential barriers to those goals when participants were unable to identify any on their own.Approximately 1 week after the completion of PEP session 2 all participants were invited to attend a focus group. The goals of focus group were to (1) collect the first set of follow-up questionnaires, (2) gather qualitative data on intervention, and (3) get feedback on each element of the PEP curriculum.1cavailable at these times will be collected from the EMR.After completion of the PEP intervention, participants will be followed up for 6 months and will complete repeat assessments at 1 week (T2), 3 months (T3), and 6 months (T4) after the PEP intervention see. The T2 d=0.48. Given the repeated-measures design of the study, setting alpha = .05 and beta = .2, and using the effect size calculated from the literature, the required sample size will be n=36 patients. It is our goal to have 40 participants complete the PEP intervention.Prior studies have pilot-tested interventions to increase patient activation and found that PAM scores increased by a range of 4-8 points ,31. ThiIn anticipation of significant participant dropout over the course of the study, we aimed to enroll 40 patients from Bellevue Hospital Center, 20 from Gouverneur Health, and 20 from Woodhull Medical Center. From these patients, it was our goal that 20 from Bellevue Hospital Center and 10 each from Gouverneur Health and Woodhull Medical Center would complete the PEP intervention. Because of these concerns about dropout, all participants who were randomized to the immediate intervention group but unable to attend the PEP intervention at that time were contacted for the T1 assessment with the deferred intervention group and invited back to attend the PEP intervention as part of that group see.ttest or Wilcoxon rank sum test for continuous variables.First, descriptive statistics including mean, standard deviation, range, skewness, and kurtosis for all continuous variables as well as frequencies for all categorical variables will be calculated at each time point (T0-T4). Because of concerns about the relatively small sample size and low literacy/health literacy, the normality of all continuous variables will be assessed both graphically with histograms as well as statistically using the Shapiro-Wilk and Kolmogorov-Smirnov tests, and transformations will be made if necessary. Then we will assess for any baseline (T0) differences between two separate groups: (1) the randomly determined immediate intervention and deferred intervention groups and (2) all participants who attended the PEP intervention and those who did not. Both of these analyses will be conducted using chi-square test for categorical variables and either independent samplesttest or Wilcoxon signed rank test for continuous variables . Initial assessment (T0) will be compared with each of the post-PEP assessments (T2-T4) for each variable. For the deferred intervention group, initial assessment (T0) will be compared with the assessment at the end of the waiting period (T1), which will then be compared with each post-PEP assessment (T2-T4).Next, analyses will be conducted within each intervention group to evaluate for any effect of the PEP intervention on the primary, secondary, and exploratory outcomes using chi-square test for categorical variables  and either repeated-measuresAfter analyzing each group individually, the groups will be combined in order to have a larger sample size for pre- and post-PEP comparisons. Pre-PEP intervention data for these analyses will consist of data from enrollment (T0) for participants in the immediate intervention group and data collected at the end of the waiting period (T1) for participants in the deferred intervention group. Repeated-measures analyses will be conducted on the primary, secondary, and exploratory outcomes as described above and pre-PEP data (either T0 or T1) will be compared with each post-PEP assessment (T2-T3).1c). Independent variables will include participant characteristics such as age, sex, race/ethnicity, education level, annual income, number of years with T2DM, and health literacy as measured by the NVS. Other independent variables will include group (immediate vs deferred intervention) and time (T0-T4).Finally, multivariate analyses will be conducted using a series of generalized mixed-effects models to determine what effect patient characteristics, group membership, and time have on each continuous outcome measure. In each model, the dependent variable will be the outcome measure (eg, PAM, AURA, Krantz, SF-12v2 Health Survey, DSMQ, and HbARecruitment for this study began in November 2014. As of June 2015, we met our enrollment goal of 80 patients. However, because of differences in site policies, the distribution of enrolled participants does not match our initial goals. By site, we have enrolled 40 participants from Bellevue Hospital Center, 31 from Gouverneur Health, and 9 from Woodhull Medical Center. As Woodhull Medical Center is located in a different part of New York City and serves a slightly different patient population, we plan to return to that site within the next few months to recruit an additional 11 patients.Out of these 80 participants enrolled, the 71 from Bellevue Hospital Center and Gouverneur Health have been invited to attend the PEP intervention. Because of staff turnover and site-specific policies, we have as of yet been unable to hold any PEP intervention sessions at Woodhull Medical Center. Of the 71 participants invited to attend the PEP intervention, 45 have attended PEP session 1, 36 have attended the full PEP intervention, and 33 have returned for the post-PEP focus group. Of the 11 participants switched from the immediate intervention group to the deferred intervention group, 6 completed the T1 assessment and 3 attended at least one session of the PEP intervention. Coding and thematic analysis of the focus group discussions is not completed, but participants have reported that the PEP intervention was not only acceptable but a valuable experience that made them feel more empowered in their own health care. Several participants have even reported seeing their HCPs after completing the PEP intervention and changing their behaviors in the visit, which resulted in improvement in the quality of their visit.Follow-up data collection is still underway and all patients who attended at least PEP session 1 will be called for all follow-up data points. Follow-up data collection is scheduled to conclude in April 2016 and the results of our data analysis are expected to be available by June 2016.Although there have been significant shifts in the power hierarchy between HCPs and patients, there continues to be an asymmetry that makes it difficult for patients to engage in true SDM as envisioned by the PCMH model. Little is understood about how to best activate patients to make the most of their visits with HCPs. With input from both patients and HCPs, we have developed an innovative PEP that seeks to prepare patients with T2DM to be better partners in their care and collaborate effectively with HCPs. We focused on improving patients’ communication skills in the context of the medical encounter by discussing behavioral descriptors for activated patients and then using performance-based training, adapted from SP methodology, to develop these skills.Study enrollment and implementation of the PEP intervention have been shown to be feasible across multiple hospital sites and acceptable to patients. Participants were able to engage in the skills development tasks and to self-reflect on their experiences with HCPs. Initial qualitative responses from participants were positive and collection of quantitative post-PEP data will conclude over the next few months, which will allow us to assess the effect of this intervention on patient activation and self-reported measures of diabetes care.


Australia is the only high income country with persisting endemic trachoma. A national control program involving mass drug administration with oral azithromycin, in place since 2006, has some characteristics which differ from programs in low income settings, particularly in regard to the use of a wider range of treatment strategies, and more regular assessments of community prevalence. We aimed to examine the association between treatment strategies and trachoma prevalence.Through the national surveillance program, annual data from 2007–2013 were collected on trachoma prevalence and treatment with oral azithromycin in children aged 5–9 years from three Australian regions with endemic trachoma. Communities were classified for each year according to one of four trachoma treatment strategies implemented . We estimated the change in trachoma prevalence between sequential pairs of years and across multiple years according to treatment strategy using random-effects meta-analyses.Over the study period, 182 unique remote Aboriginal communities had 881 annual records of both trachoma prevalence and treatment. From the analysis of pairs of years, the greatest annual fall in trachoma prevalence was in communities implementing community-wide strategies, with yearly absolute reductions ranging from -8% (95%CI -17% to 1%) to -31% (-26% to -37%); these communities also had the highest baseline trachoma prevalence (15.4%-43.9%). Restricting analyses to communities with moderate trachoma prevalence (5–19%) at initial measurement, and comparing community trachoma prevalence from the first to the last year of available data for the community, both community-wide and more targeted treatment strategies were associated with similar absolute reductions (-11% [-8% to -13%] and -7% [-5% to -10%] respectively). Results were similar stratified by region.Consistent with previous research, community-wide administration of azithromycin reduces trachoma prevalence. Our observation that less intensive treatment with a ‘household’ strategy in moderate prevalence communities (5-<20%) is associated with similar reductions in prevalence over time, will require confirmation in other settings if it is to be used as a basis for changes in control strategies. Australia is the only high income country with persisting endemic trachoma and a national control program has been in place since 2006. The program involves annual screening of children for trachoma in communities designated to be at high risk of disease and treatment of those affected with the antibiotic azithromycin. Depending on the level of trachoma detected in children, antibiotic treatment is also given to households and other community members. We used data collected annually from 2007 to 2013 to examine what effect the extent of azithromycin treatment had on subsequent levels of trachoma in children aged 5–9 years. We found that in communities with high levels of trachoma, when all community members received azithromycin (community-wide treatment), the greatest reduction in trachoma level was achieved. However in communities with moderate levels of trachoma, using either community-wide treatment or more targeted (household) treatment resulted in equivalent reductions in trachoma. This observation needs to be confirmed in other studies before changes to current recommendations regarding trachoma control strategies are considered. Chlamydia trachomatis is a major cause of blindness globally.[Trachoma, caused by serotypes of globally. In 1997 globally. There isglobally.,4 EvidenAustralia is the only high-income country with endemic trachoma. The diseSince 2006 the Australian Government has funded control programs based on regular mapping of trachoma prevalence in endemic areas. Trachoma management has been based on guidelines first endorsed in 2006  and reviSince 2006 when the National Trachoma Management Program was initiated, screening for trachoma and management has been consistently undertaken in three trachoma-endemic Australian jurisdictions, the NT, SA and WA. At program initiation, each jurisdiction identified Aboriginal communities considered to be at high risk of endemic trachoma from historical prevalence data and local knowledge, and over time, additional communities have been added to those considered at risk. In each designated community, regular screening rounds were undertaken over short time periods , involving external teams working with local health staff. In most communities, 5–9 year olds were the focus of screening, as they were mostly in school, although children aged under 5 or 10–14 years were also screened if present at the time. Between 2010 and 2013 the estimated proportion of children resident in communities aged 5–9 that were screened for trachoma ranged from 57–71%.,11 Of thDe-identified community-based data were obtained for each year from 2007, when comprehensive data collection began, through to 2013. As the majority of trachoma screening in communities was undertaken through primary school programs targeting 5–9 year olds, we restricted analyses of prevalence to this age group. The unit for analysis was a single episode of screening in 5–9 year olds within a single community. Community trachoma prevalence was estimated by dividing the number of 5–9 year olds with active trachoma during a screening round by the number screened. The treatment strategy adopted for a community in a given year was classified into one of four categories according to what was reported in the national database: no treatment; “active”cases only treated; “household” treatment under which active cases and their households members were treated; and “community-wide” treatment which covered both whole-of-community treatment  and a strategy under which active cases, household members and all children aged <15 years in the community were treated. For all strategies, the treatment administered for those over 6 months of age was a single weight-based dose (20mg/kg) of oral azithromycin [Descriptive analyses by calendar year, examining all communities with eligible screening episodes were conducted. From 2011 onwards treatment coverage in communities for which household or community-wide treatment strategies were recorded was calculated by summing the population aged 0–14 years recorded as treated with azithromycin, and dividing by the total estimated population aged 0–14 years according to both census and locaTo compare treatment strategies, we undertook two analyses. First we identified all communities for which data on trachoma prevalence in 5–9 year olds were available for pairs of consecutive calendar years. For each such pair of years, we estimated the change between the years in community prevalence, by simple difference. We then grouped communities by the first year of the consecutive pair and by the treatment strategy recorded in that year, and calculated a combined estimate of change for each treatment strategy using a random effects meta-analysis. Second, Administrative approvals for the data collection and analyses reported here were provided by the health departments of the three jurisdictions involved. Ethical approval was by the University of New South Wales Human Research Ethics Committee (ref 9-14-042).We identified 914 screening episodes from 215 unique remote Aboriginal communities with children aged 5–9 years screened at least once between 2007 and 2013. Of the 215 communities, the majority were in the NT  and WA . There were 33 communities screened only once, 46 had 2–3 episodes, 59 had 4–5 episodes, and 77 had 6–7. The communities screened less frequently were more likely to have been screened for the first time more recently, with the median year of screening for communities with 3 or fewer years of screening data being 2012 compared to 2010 for those with four or more years of data.For 2011 and 2012 , using lAfter excluding the 33 communities with only a single year of screening data available, there remained 881 records from 182 unique communities; 77 (42.3%) were from the NT, 21 (11.5%) from SA and 84 (46.2%) from WA. Of 121 communities that applied a treatment strategy in more than one of the years observed, 89 were recorded as having changed strategies over the time period, 30 communities used only household treatments, two used only community-wide treatments, and none applied the “active” case only strategy more than once.The majority of communities (n = 176) had annual records of trachoma screening that included at least two years of the eligible period (2007 to 2013), including 68 with data for 7 consecutive years, 47 with 6 years, 25 with 5 years, 12 with 4 and 24 with less than 4. Based on the treatment strategies used between the first and final year of data recorded, communities were grouped into three categories : those nWhen we restricted analyses to communities with moderate trachoma prevalence (5-<20%) in their first year of screening  we foundAnalyses of data restricted to 2007–2010, the period during which there were substantial increases in trachoma prevalence in previously trachoma-free communities that were untreated see , are shoIn this investigation of the relationship between different community treatment strategies for trachoma control and long-term changes in trachoma prevalence, we found that in high prevalence communities, community-wide administration of azithromycin, or MDA, was associated with a substantially reduced trachoma prevalence after one year or more. In settings with moderate trachoma prevalence (5-<20%), more limited strategies were equally effective in the longer term. As discussed in more detail below, this finding may have particular relevance for countries moving towards elimination, but with localised areas of moderate prevalence remaining.Observational studies have shown that a single MDA of azithromycin in communities with endemic trachoma results in substantial reductions at one year in trachoma prevalence in both hyperendemic ,17 and mIn the paired-year analyses , among cAs the paired-year analysis indicated no overall increase in trachoma prevalence in trachoma-free communities from 2010 onwards, we undertook analyses involving multiple years with the goal of distinguishing effects of treatment from temporal changes in trachoma. In these sensitivity analyses, only communities receiving community-wide treatment were found to have a reduction in trachoma prevalence see . It is tThis was an observational study using routinely collected surveillance data. While diThe strengths of our study are the use of annual trachoma screening data from all communities in the three jurisdictions with known endemic trachoma leading to a more comprehensive picture of not only the effects of different treatment strategies on single communities, but also programmatic effects on all communities in a real-world setting. We also had observations for the majority of communities over a significant period of time (at least four years) and were able to observe the effects of a targeted treatment strategy in a moderate prevalence setting.In summary, our study supports current evidence that recommends mass azithromycin administration to reduce trachoma prevalence in high prevalence settings. We also found that less intensive treatment with a “household” strategy in moderate prevalence communities (5-<20%) may be associated with reductions in prevalence similar to mass drug administration. This finding may have implications for countries that are moving to lower levels of endemic trachoma and wish to reduce the amount of azithromycin being used. The strategy does however have the requirement that individual examination must take place, to determine which households have affected members. If a targeted approach is to be considered, trials and health economic analyses are required to determine which option may be more cost-effective in particular programmatic and community contexts. Finally S1 Checklist(DOCX)Click here for additional data file.


There are concerns about potential increasing use of over-the-counter (OTC) analgesics. The aims of this study were to examine 1) the prevalence of self-reported use of OTC analgesics; 2) the prevalence of combining prescription analgesics drugs with OTC analgesics and 3) whether lifestyle factors such as physical activity were associated with prevalence of daily OTC analgesic use.Questionnaire data from the Nord–Trøndelag health study , which includes data from 40,000 adult respondents. The questionnaire included questions on use of OTC analgesics, socioeconomic conditions, health related behaviour, symptoms and diseases. Data were linked to individual data from the Norwegian Prescription Database. A logistic regression was used to investigate the association between different factors and daily use of paracetamol and/or non-steroid anti-inflammatory drugs (NSAIDs) in patients with and without chronic pain.The prevalence of using OTC analgesics at least once per week in the last month was 47%. Prevalence of paracetamol use was almost 40%, compared to 19% and 8% for NSAIDs and acetylsalicylic acid (ASA), respectively. While the use of NSAIDs decreased and the use of ASA increased with age, paracetamol consumption was unaffected by age. Overall more women used OTC analgesics. About 3-5% of subjects using OTC analgesics appeared to combine these with the same analgesic on prescription. Among subjects reporting chronic pain the prevalence of OTC analgesic use was almost twice as high as among subjects without chronic pain. Subjects with little physical activity had 1.5-4 times greater risk of daily use of OTC compared to physically active subjects.Use of OTC analgesics is prevalent, related to chronic pain, female gender and physical inactivity. In many countries, some analgesics are available over-the-counter (OTC) without a prescription from a doctor. Although OTCs are considered safe when used appropriately, intermittently and in the recommended doses, they have the same hazards regardless of source of supply. Not only is liver failure related to chronic unintended overdose of paracetamol, but the safety of chronic use of the drug was recently challenged . Also noPrevalence estimates for the use of OTC analgesics in previous studies varied between countries -6. Many The following analgesics are available as OTC on the Norwegian market: paracetamol; NSAIDs: ibuprofen, naproxen and diclofenac; ASA and phenazone. Paracetamol is most widely used followed by ibuprofen. According to wholesale data use of OTC analgesics increased in Norway for 20 years until 2008, but has been stabilized last years [Several factors have been shown to be associated with analgesic use in the general population ,5,9,10. Overall, and in men and womenWith ageDaily in the last month for muscle/joint pain or headacheWith chronic painWith opioid useWhat is the prevalence of self-reported use of the OTC group’s’ paracetamol, NSAIDs or ASA at least once a week in the last month?How many subjects combine prescription paracetamol with OTC paracetamol or prescription NSAID with OTC NSAID?What is the prevalence of prescribed analgesics 4, 6 and 8 weeks before entering the study among those taking OTC analgesics at least once a week in the last month?Are lifestyle factors such as physical activity associated with lower prevalence of daily OTC analgesic use?Analgesic OTC may constitute a health hazard to public health. Food and Drug Administration (FDA) has launched a campaign to advice on safe use of these drugs . ResearcA cross sectional descriptive study.All inhabitants aged 20 years or more in the county of Nord-Trøndelag in Norway were invited to participate in three population-based health surveys: the Nord-Trøndelag Health Study (HUNT) 1, 2 and 3. The HUNT Study constitutes a large population database for medical and health-related research. HUNT3 was carried out in 2006–2008, and a total of 93,860 individuals were invited to participate  and for alcohol use last 12 month  classification system. Prescribed analgesics with the following ATC code were included in the study: paracetamol (acetaminophen) (N02BE01); acetylsalicylic acid (N02BA01), NSAIDs: ibuprofen (M01AE01) and naproxen (M01AE02). In addition, strong and weak opioids, which are classified as ATC code N02A. Opioids are only available in Norway on prescription. N02A includes all opioid analgesics marketed in Norway, but not opioids primarily used in anesthesia, substitution therapy of opioid addiction and antitussives. In Norway only physicians are allowed to prescribe analgesics.Chronic pain was defined, as in previous studies, based on the HUNT 3 study: report of pain lasting six months or more and pain of at least moderate intensity during the last week prior to participation in HUNT3 ,16.Persistent opioid use was defined based on data from NorPD according to previously published criteria . The broSelf-reported information for all 50,805 participants from HUNT3 was linked to their prescription data from NorPD. 41,204 individuals returned Q2 by mail. Characteristics of the population who answered Q2 are available at HUNT3 webside . The queThe answers from the participants regarding use of overall OTC and different OTC analgesics at least once a week in recent months Figure  and 2 weFor participants who had reported use of non-prescription analgesics, analyses were performed to determine whether prescriptions of the same drug had been captured by NorPD during 4, 6 and 8 weeks prior to self-reported use.A logistic regression was used to investigate the association between leisure time physical activity  and other lifestyle factors, socio-demographic factors and health status and daily use of paracetamol and/or NSAIDs in patients with and without chronic pain. Unadjusted and adjusted odds ratios (OR) with 95% confidence intervals were calculated.All participants in HUNT3 were informed and gave consents to participation in the main and follow-up studies. All participants have consented to research being performed on their data and to linking to other data sources. The study was approved by the Regional Committee for Medical and Health Research Ethics in Central Norway. Linkage of databases was approved by the Norwegian Data Protection Authority.The overall prevalence of consumption of OTC analgesics at last once per week in the last month was 47% Table . The preThe prevalence of self-reported use of the different OTC analgesics at last once per week in the last month was 38.3% for paracetamol, 18.7% for NSAIDs and 8.1% for ASA Table . The preSubjects reporting chronic pain reported almost twice as high prevalence of use of paracetamol, NSAIDS and ASA Table . RegardlWhen the study population was stratified with regard to the level of opioid use and whether they reported chronic pain or not, prevalence of OTC analgesic use was highest in persons with non-persistent (intermittent) opioid use and chronic pain Table . A lowerFigures for concomitant use of OTC analgesics and prescriptions of the same group of analgesics were similar for paracetamol and NSAIDs: about 3, 4 and 5% had received prescriptions for the same group of analgesics during the last 4, 6 and 8 weeks, respectively, before HUNT 3 data collection  users of opioids, compared to those with chronic pain who were persistent users of opioids. A likely explanation is that the former group used OTC analgesics more regularly and substituted or supplemented with opioids in periods of exacerbations, while the latter did the opposite.Those subjects who reported little or no physical activity had a higher risk of using daily non-prescription analgesics than those who were active. Poor physical condition was a risk factor for analgesic use in the Swedish study , as wellIn the present study it was shown that possible concomitant use of OTC analgesics and prescribed paracetamol or NSAIDS varied between 2.8% and 5.2% depending on the duration  of the study period. Overlapping use of both prescribed and OTC analgesics may increase the risk of interactions and overdosing . TherefoStrength of the present study was the use of a complete national prescription database where data are not influenced by recall bias. Another strength is the size of the population included. Subjects responded to detailed questions regarding the use of OTC drugs and a number of other potential confounders including validated questions on chronic pain and physical activity. However, the response rate was only about 50%. Even though the study population in HUNT3 is considered fairly representative of the Norwegian population, a non-responder study reported higher prevalence of musculoskeletal pain in participants compared to non-participants . On the The finding that 47% of those participating in the large and representative population survey used OTC analgesics at least once a week during the last month, demonstrates that such drug use is more prevalent than the self-reporting of chronic non-malignant pain of moderate or higher intensity, which in Norway is estimated to be around 30%. This indicates that mild but recurrent pain might not be detected by definitions of chronic pain in spite of leading to analgesic use. The finding that approximately 11% of those using OTC analgesics used these drugs on a daily basis raises some concerns that health care personnel need to be aware of. Long term analgesic treatment should only be commenced after a physician has considered the anticipated effect, side effects and risks of interactions. If long-term treatment is indicated the physician should prescribe these drugs instead of approving long-term OTC use. Switching to prescriptions will give the physician better control, which is in the best interest of the patient. The present findings imply that doctors should ask for OTC analgesic use, and in cases of daily use the doctor should if treatment is indicated switch to prescription use, and if not, advise to terminate or substantially reduce the OTC analgesic use.