Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women.

BACKGROUND: Safe and effective long-acting injectable agents for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection are needed to increase the options for preventing HIV infection. METHODS: We conducted a randomized, double-blind, double-dummy, noninferiority trial to compare long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor [INSTI]) at a dose of 600 mg, given intramuscularly every 8 weeks, with daily oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) for the prevention of HIV infection in at-risk cisgender men who have sex with men (MSM) and in at-risk transgender women who have sex with men. Participants were randomly assigned (1:1) to receive one of the two regimens and were followed for 153 weeks. HIV testing and safety evaluations were performed. The primary end point was incident HIV infection. RESULTS: The intention-to-treat population included 4566 participants who underwent randomization; 570 (12.5%) identified as transgender women, and the median age was 26 years (interquartile range, 22 to 32). The trial was stopped early for efficacy on review of the results of the first preplanned interim end-point analysis. Among 1698 participants from the United States, 845 (49.8%) identified as Black. Incident HIV infection occurred in 52 participants: 13 in the cabotegravir group (incidence, 0.41 per 100 person-years) and 39 in the TDF-FTC group (incidence, 1.22 per 100 person-years) (hazard ratio, 0.34; 95% confidence interval, 0.18 to 0.62). The effect was consistent across prespecified subgroups. Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF-FTC group. In the participants in whom HIV infection was diagnosed after exposure to CAB-LA, INSTI resistance and delays in the detection of HIV infection were noted. No safety concerns were identified. CONCLUSIONS: CAB-LA was superior to daily oral TDF-FTC in preventing HIV infection among MSM and transgender women. Strategies are needed to prevent INSTI resistance in cases of CAB-LA PrEP failure. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 083 ClinicalTrials.gov number, NCT02720094.).

History of Rectal Product Use and Country of Residence Influence Preference for Rectal Microbicide Dosage Forms Among Young Sexual and Gender Minorities: A Multi-country Trial Comparing Placebo Douche, Suppository, and Insert Products.

The DESIRE Study (MTN-035) explored product preference among three placebo rectal microbicide (RM) formulations, a rectal douche (RD), a suppository, and an insert, among 210 sexually active transgender people and men who have sex with men in five counties: the United States, Peru, Thailand, South Africa, and Malawi. Participants used each product prior to receptive anal sex (RAS) for 1 month, following a randomly assigned sequence, then selected their preferred product via computer assisted self-interview. In-depth interviews examined reasons for preference. We compared product preference and prior product use by country to explore whether geographic location and experience with the similar products impacted preference. A majority in the United States (56%) and Peru (58%) and nearly half in South Africa (48%) preferred the douche. Most in Malawi (59%) preferred the suppository, while half in Thailand (50%) and nearly half in South Africa (47%) preferred the insert. Participants who preferred the douche described it as quick and easy, already routinized, and serving a dual purpose of cleansing and protecting. Those who preferred the insert found it small, portable, discreet, with quick dissolution. Those who preferred the suppository found the size and shape acceptable and liked the added lubrication it provided. Experience with product use varied by country. Participants with RD experience were significantly more likely to prefer the douche (p = 0.03). Diversifying availability of multiple RM dosage forms can increase uptake and improve HIV prevention efforts globally.

RESUMEN: El estudio DESIRE (MTN-035) exploró la preferencia de producto entre tres formulaciones de microbicida rectal (MR) de placebo, una ducha rectal, un supositorio y un inserto, entre 210 personas transgénero y hombres que tienen sexo con hombres en cinco países: los Estados Unidos, Perú., Tailandia, Sudáfrica y Malawi. Los participantes utilizaron cada producto antes del sexo anal receptive (SAR) durante un mes, siguiendo una secuencia asignada al azar, luego seleccionaron su producto preferido mediante una autoentrevista asistida por computadora. Las entrevistas en profundidad examinaron los motivos de preferencia. Comparamos la preferencia de producto y el uso previo del producto por país para explorar si la ubicación geográfica y la experiencia con la forma farmacéutica impactaron la preferencia. Una mayoría en los Estados Unidos (56%) y Perú (58%) y casi la mitad en Sudáfrica (48%) prefirieron la ducha rectal. La mayoría en Malawi (59%) prefirió el supositorio, mientras que la mitad en Tailandia (50%) y casi la mitad en Sudáfrica (47%) prefirió el inserto. Los participantes que prefirieron la ducha rectal la describieron como rápida y fácil, ya parte de su rutina y que tenía el doble propósito de limpiar y proteger. Los que prefirieron el inserto lo consideraron pequeño, portátil, discreto y de rápida disolución. Los que prefirieron el supositorio encontraron que tenía un tamaño y forma aceptables y proveía lubricación adicional. La experiencia con el uso del producto varió según el país. Los participantes con experiencia con duchas rectales tenían significativamente más probabilidades de preferir la ducha rectal (p = 0,03). Diversificar la disponibilidad de múltiples formas farmacéuticas de MR puede aumentar la aceptación y mejorar los esfuerzos de prevención del VIH a nivel mundial.

Extended Analysis of HIV Infection in Cisgender Men and Transgender Women Who Have Sex with Men Receiving Injectable Cabotegravir for HIV Prevention: HPTN 083.

HPTN 083 demonstrated that injectable cabotegravir (CAB) was superior to oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) for HIV prevention in cisgender men and transgender women who have sex with men. We previously analyzed 58 infections in the blinded phase of HPTN 083 (16 in the CAB arm and 42 in the TDF-FTC arm). This report describes 52 additional infections that occurred up to 1 year after study unblinding (18 in the CAB arm and 34 in the TDF-FTC arm). Retrospective testing included HIV testing, viral load testing, quantification of study drug concentrations, and drug resistance testing. The new CAB arm infections included 7 with CAB administration within 6 months of the first HIV-positive visit (2 with on-time injections, 3 with ≥1 delayed injection, and 2 who restarted CAB) and 11 with no recent CAB administration. Three cases had integrase strand transfer inhibitor (INSTI) resistance (2 with on-time injections and 1 who restarted CAB). Among 34 CAB infections analyzed to date, diagnosis delays and INSTI resistance were significantly more common in infections with CAB administration within 6 months of the first HIV-positive visit. This report further characterizes HIV infections in persons receiving CAB preexposure prophylaxis and helps define the impact of CAB on the detection of infection and the emergence of INSTI resistance.

A latent trajectory analysis of young sexual and gender minorities' adherence to three rectal microbicide placebo formulations (MTN-035; a randomized crossover trial).

BACKGROUND: Rectal microbicides (RM) are biomedical HIV prevention products that aim to prevent or reduce the transmission of HIV and other sexually transmitted infections (STIs). RM modalities may be beneficial for populations who have complex lifestyles, difficulties adhering to pre-exposure prophylaxis (PrEP) regimens, and/or have limited access to care. MTN-035 (DESIRE; Developing and Evaluating Short-Acting Innovations for Rectal Use), a randomized crossover trial, aimed to evaluate the safety and acceptability of, and adherence to, three placebo RM modalities (douche, insert, and suppository) prior to receptive anal intercourse. METHODS: We conducted latent trajectory analysis to identify clusters of individuals who shared similar trajectories in acceptability and adherence for each product (douche, insert, and suppository) over time. We analyzed weekly short messaging service (SMS) use reports for each modality as reported by enrolled sexual and gender minority (SGM) participants. RESULTS: Two trajectories for each product were identified: a "protocol compliant" trajectory (i.e., at least one product use occasion per week) and "high use" trajectory (i.e., more than three product use occasions per week). Participants with high use were more likely to lack access to PrEP and have higher intentions to utilize RM modalities compared to those who were protocol compliant. CONCLUSIONS: This study highlighted high adherence to RM modalities among SGM. As research into viable HIV prevention modalities continues to evolve, tailored intervention strategies are needed to support the uptake of and adherence to alternative prevention modalities that are behaviorally congruent with targeted users. TRIAL REGISTRATION: NCT03671239 (14/09/2018).

Sleep duration and risk of high blood pressure in Thai adolescents: the Thai National Health Examination Survey V, 2014 (NHES-V).

BACKGROUND: Sleep duration has been proposed to be associated with high blood pressure. However, nationwide studies regarding this association in adolescents remain limited. This study aimed to explore the national prevalence of high blood pressure among Thai adolescents and to determine the association between sleep duration and high blood pressure. METHODS: Data from adolescents aged 10-19 years from the Thai National Health and Examination Survey V were included. We collected demographic data (including age and gender), height, weight, waist circumference, blood pressure, fasting blood chemistries and sleep duration data. Sleep durations were categorized as short, normal or long for each age group based on the United States National Sleep Foundation's recommendations. High blood pressure was diagnosed using the 2017 guidelines of the American Academy of Pediatrics. Factors associated with high blood pressure were analyzed using multivariate logistic regression. RESULTS: A total of 3505 adolescents (1785 female) were included. The prevalence of high blood pressure was 9.4% (95% CI 8.5-10.4%). The high blood pressure group had higher BMI z-score, LDL-C, triglyceride and lower HDL-C than the normotensive group. In the multivariate analysis, BMI z-score, LDL-C and HDL-C were independently associated with high blood pressure. However, there was no association between sleep duration and high blood pressure. CONCLUSIONS: High blood pressure risk was increased in adolescents with high BMI z-score. Neither short nor long sleep duration was associated with an increased risk of high blood pressure.

Evaluation of Phylogenetic Methods for Inferring the Direction of Human Immunodeficiency Virus (HIV) Transmission: HIV Prevention Trials Network (HPTN) 052.

BACKGROUND: Phylogenetic analysis can be used to assess human immunodeficiency virus (HIV) transmission in populations. We inferred the direction of HIV transmission using whole-genome HIV sequences from couples with known linked infection and known transmission direction. METHODS: Complete next-generation sequencing (NGS) data were obtained for 105 unique index-partner sample pairs from 32 couples enrolled in the HIV Prevention Trials Network (HPTN) 052 study (up to 2 samples/person). Index samples were obtained up to 5.5 years before partner infection; partner samples were obtained near the time of seroconversion. The bioinformatics method, phyloscanner, was used to infer transmission direction. Analyses were performed using samples from individual sample pairs, samples from all couples (1 sample/person; group analysis), and all available samples (multisample group analysis). Analysis was also performed using NGS data from defined regions of the HIV genome (gag, pol, env). RESULTS: Using whole-genome NGS data, transmission direction was inferred correctly (index to partner) for 98 of 105 (93.3%) of the individual sample pairs, 99 of 105 (94.3%) sample pairs using group analysis, and 31 of the 32 couples (96.9%) using multisample group analysis. There were no cases where the incorrect transmission direction (partner to index) was inferred. The accuracy of the method was higher with greater time between index and partner sample collection. Pol region sequences performed better than env or gag sequences for inferring transmission direction. CONCLUSIONS: We demonstrate the potential of a phylogenetic method to infer the direction of HIV transmission between 2 individuals using whole-genome and pol NGS data.

Application technology to fight the COVID-19 pandemic: Lessons learned in Thailand.

Demands to address the COVID-19 pandemic rapidly surpassed global resources. Successful implementation of application technology resulting in people taking greater control of their own health and medical and public health personnel improving efficiency was requested by authorities in Thailand to reduce the demand on health resources to meet the health needs of the people. This paper examines the creation and implementation of three real-time application technologies using a bottom-up approach in an attempt to examine COVID-19 challenges and highlight control measures. These lessons learned represent participatory action research methods involving the people who were responsible for taking actions to improve their own and their communities' health. The objective was to build participation of users, academics and service organizations in a novel technology enhanced system leading to quality management of the COVID-19 pandemic. A new technology enhanced system for medical field personnel encouraged network participation resulting in co-creation of a health data center. Application technology assisted COVID-19 infected patients and high-risk people to identify their own symptoms and to provide a rapid tracking method that could be employed until public health surveillance was achieved. A patient and hospital management system employing new application technology was effective in monitoring COVID-19 patients utilizing an interconnected hospital network. Application technology was beneficial in promoting health, enhancing patient satisfaction, reducing readmission rates and extending health resources.

Application technology to fight the COVID-19 pandemic: Lessons learned in Thailand.

Demands to address the COVID-19 pandemic rapidly surpassed global resources. Successful implementation of application technology resulting in people taking greater control of their own health and medical and public health personnel improving efficiency was requested by authorities in Thailand to reduce the demand on health resources to meet the health needs of the people. This paper examines the creation and implementation of three real-time application technologies using a bottom-up approach in an attempt to examine COVID-19 challenges and highlight control measures. These lessons learned represent participatory action research methods involving the people who were responsible for taking actions to improve their own and their communities' health. The objective was to build participation of users, academics and service organizations in a novel technology enhanced system leading to quality management of the COVID-19 pandemic. A new technology enhanced system for medical field personnel encouraged network participation resulting in co-creation of a health data center. Application technology assisted COVID-19 infected patients and high-risk people to identify their own symptoms and to provide a rapid tracking method that could be employed until public health surveillance was achieved. A patient and hospital management system employing new application technology was effective in monitoring COVID-19 patients utilizing an interconnected hospital network. Application technology was beneficial in promoting health, enhancing patient satisfaction, reducing readmission rates and extending health resources.

Metabolic syndrome in Thai adolescents and associated factors: the Thai National Health Examination Survey V (NHES V).

BACKGROUND: Presence of metabolic syndrome (MetS) in early life may influence cardiovascular outcome later in adulthood. There is limited data regarding MetS among Thai adolescents. This study aimed to estimate the prevalence of MetS and related factors in Thai adolescents. METHODS: Data on MetS components of 1934 Thai adolescents aged 10-16 years were obtained from the 5th National Health Examination Survey. Age at first screen time exposure, duration of screen time, frequency of food intake and physical activities were collected from interviews. MetS was defined according to 3 definitions: International Diabetes Federation (IDF), Cook's, and de Ferranti's. RESULTS: The prevalence of MetS was 4.1% by IDF, 8.0% by Cook's, and 16.8% by de Ferranti's definition. The overall prevalence was higher in male (19.0%) than female adolescents (15.3%). The most common MetS components composition among Thai adolescents was high waist circumference with high serum triglyceride and low HDL-cholesterol (40.0% for IDF, 22.6% for Cook's and 43.5% for de Ferranti's definition). Exposure to screen media during the first 2 years of life had a 1.3- fold increased odds of MetS by 1 out of 3 definitions (OR 1.30, 95% CI. 1.01-1.68). Duration of physical activity associated with decreased odds of MetS by Cook's definition (OR 0.96, 95% CI. 0.92-0.99). CONCLUSIONS: The prevalence of MetS among Thai adolescents was higher than previously reported by other studies. Screen media exposure during the first 2 years of life should be discouraged and measures to promote physical activity among children and adolescents should be strengthen.

Handedness and Birth Order Among Heterosexual Men, Gay Men, and Sao Praphet Song in Northern Thailand.

Previous research has examined handedness and birth order to inform sexual orientation and gender identity/role expression development; however, sexual orientation and gender identity/role expression have rarely been disentangled to provide a more nuanced perspective. In Thailand, we investigated sexual orientation and gender identity simultaneously via comparison of 282 heterosexual men, 201 gay men, and 178 sao praphet song-i.e., androphilic, markedly feminine males recognized as a "third" gender. Handedness was examined as: extremely left-handed, moderately left-handed, ambidextrous, moderately right-handed, or extremely right-handed. Birth order was examined as numbers of older and younger brothers and sisters, by using Berglin's, fraternal, and sororal indices, and by examining the older brother odds ratio and sibling sex ratio. Compared with heterosexual men, gay men and sao praphet song were more likely to be extremely right-handed. Sao praphet song were also more likely to be extremely left-handed than heterosexual and gay men. Heterosexual men and sao praphet song had later sororal birth order compared with the expected Thai population value, suggesting stopping rules influenced when probands' mothers ceased having children. These findings provide new insights and replicate previous findings in a non-Western sample. Regarding handedness, in males, mechanisms related to extreme right-handedness likely influence the development of androphilia, whereas mechanisms related to both extreme right- and extreme left-handedness likely explain the combination of androphilia and feminine gender identity/role expression. Regarding birth order, similar to the conclusions of some prior research, stopping rules pose a challenge for testing the fraternal birth order effect.

Socio-economic inequalities in the association between alcohol use disorder and depressive disorder among Thai adults: a population-based study.

BACKGROUND: Previous evidence indicates significant associations between depressive disorders and alcohol use disorder (AUD) and their strong links with social conditions. This study aims to investigate the association between major depressive episode (MDE) and AUD across various socio-economic groups. METHODS: We analysed data from the 2014 Thai National Health Examination Survey containing a random sample of 13,177 adults aged > 20 years from the general population. The Alcohol Use Disorder Identification Test was used to classify respondents into non-problem drinking (score 0-7), hazardous drinking (score 8-15), and harmful-dependent drinking (score 16-40). MDE was identified using questions based on the DSM-IV. Adjusted odds ratios (AOR) and 95% confidence intervals (CI) were calculated using multinomial logistic regression to determine the strength of associations between MDE as a predictor and AUD as an outcome variable across different socio-economic levels. RESULTS: The prevalence of MDE, hazardous, and harmful-dependent drinking was 2.5, 10.3, and 1.9%, respectively. The association between MDE and AUD was modified by wealth index, education level and area of residence. AORs for the association between MDE and harmful-dependent drinking were high among those in the highest (AOR = 8.68, 95% CI: 5.34, 14.11) and lowest (AOR = 7.14, 95% CI: 3.71, 13.73) levels of wealth index but not significant among those in the middle level (AOR = 1.78, 95% CI: 0.74, 4.25). Education had the strongest effect on the relationship between MDE and harmful-dependent drinking (AOR = 16.0, 95% CI: 10.30, 24.90 among those completing secondary school or higher and AOR = 1.44, 95% CI: 0.63, 3.33 among those completing primary school only). The association between MDE and harmful-dependent drinking was higher among people who lived in urban areas (AOR = 8.50, 95% CI: 5.50, 13.13) compared to those living in rural areas (AOR = 4.73, 95% CI: 3.31, 6.77). CONCLUSION: Socio-economic factors modify the association between alcohol use disorder and major depressive disorder among Thai people.

Phylogenetic Methods Inconsistently Predict the Direction of HIV Transmission Among Heterosexual Pairs in the HPTN 052 Cohort.

BACKGROUND: We evaluated use of phylogenetic methods to predict the direction of human immunodeficiency virus (HIV) transmission. METHODS: For 33 pairs of HIV-infected patients (hereafter, "index patients") and their partners who acquired genetically linked HIV infection during the study, samples were collected from partners and index patients close to the time when the partner seroconverted (hereafter, "SC samples"); for 31 pairs, samples collected from the index patient at an earlier time point (hereafter, "early index samples") were also available. Phylogenies were inferred using env next-generation sequences (1 tree per pair/subtype). The direction of transmission (DoT) predicted from each tree was classified as correct or incorrect on the basis of which sequences (those from the index patient or the partner) were closest to the root. DoT was also assessed using maximum parsimony to infer ancestral node states for 100 bootstrap trees. RESULTS: DoT was predicted correctly for both single-pair and subtype-specific trees in 22 pairs (67%) by using SC samples and in 23 pairs (74%) by using early index samples. DoT was predicted incorrectly for 4 pairs (15%) by using SC or early index samples. In the bootstrap analysis, DoT was predicted correctly for 18 pairs (55%) by using SC samples and for 24 pairs (73%) by using early index samples. DoT was predicted incorrectly for 7 pairs (21%) by using SC samples and for 4 pairs (13%) by using early index samples. CONCLUSIONS: Phylogenetic methods based solely on the tree topology of HIV env sequences, particularly without consideration of phylogenetic uncertainty, may be insufficient for determining DoT.

Antiretroviral Therapy for the Prevention of HIV-1 Transmission.

BACKGROUND: An interim analysis of data from the HIV Prevention Trials Network (HPTN) 052 trial showed that antiretroviral therapy (ART) prevented more than 96% of genetically linked infections caused by human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. ART was then offered to all patients with HIV-1 infection (index participants). The study included more than 5 years of follow-up to assess the durability of such therapy for the prevention of HIV-1 transmission. METHODS: We randomly assigned 1763 index participants to receive either early or delayed ART. In the early-ART group, 886 participants started therapy at enrollment (CD4+ count, 350 to 550 cells per cubic millimeter). In the delayed-ART group, 877 participants started therapy after two consecutive CD4+ counts fell below 250 cells per cubic millimeter or if an illness indicative of the acquired immunodeficiency syndrome (i.e., an AIDS-defining illness) developed. The primary study end point was the diagnosis of genetically linked HIV-1 infection in the previously HIV-1-negative partner in an intention-to-treat analysis. RESULTS: Index participants were followed for 10,031 person-years; partners were followed for 8509 person-years. Among partners, 78 HIV-1 infections were observed during the trial (annual incidence, 0.9%; 95% confidence interval [CI], 0.7 to 1.1). Viral-linkage status was determined for 72 (92%) of the partner infections. Of these infections, 46 were linked (3 in the early-ART group and 43 in the delayed-ART group; incidence, 0.5%; 95% CI, 0.4 to 0.7) and 26 were unlinked (14 in the early-ART group and 12 in the delayed-ART group; incidence, 0.3%; 95% CI, 0.2 to 0.4). Early ART was associated with a 93% lower risk of linked partner infection than was delayed ART (hazard ratio, 0.07; 95% CI, 0.02 to 0.22). No linked infections were observed when HIV-1 infection was stably suppressed by ART in the index participant. CONCLUSIONS: The early initiation of ART led to a sustained decrease in genetically linked HIV-1 infections in sexual partners. (Funded by the National Institute of Allergy and Infectious Diseases; HPTN 052 ClinicalTrials.gov number, NCT00074581 .).

Metabolic Effects of Preexposure Prophylaxis With Coformulated Tenofovir Disoproxil Fumarate and Emtricitabine.

Background: Antiretroviral drugs have been associated with changes in lipids, fat mass and dat distribution. Tenofovir disoproxil fumarate (TDF) has been shown to have a more favorable metabolic profile than other drugs in its class. However, the metabolic effects of TDF in preexposure prophylaxis (PrEP) are unknown. Methods: We evaluated the effects of TDF/emtricitabine (FTC) on lipids and body composition in a blinded, placebo-controlled PrEP trial. Participants enrolled in a metabolic subcohort (N = 251, TDF/FTC; N = 247, placebo) consented to fasting lipid panels, dual-energy X-ray absorptiometry scans for body composition, and pharmacologic testing of drug metabolites at baseline and every 24 weeks thereafter. Results: Lean body mass was stable and unaffected by TDF/FTC. Body weight increased in both groups but was lower on TDF/FTC through week 72. This difference was explained by lower fat accumulation on TDF/FTC. The net median percent difference (standard error, P value) for TDF/FTC vs placebo at week 24 was -0.8% (0.4%, P = .02), +0.3% (0.4%, P = .46), and -3.8% (1.4%, P = .009) for total, lean, and fat mass, respectively. There was no apparent differential regional fat accumulation on TDF/FTC. Decreases in cholesterol, but not triglycerides, were seen in TDF/FTC participants, with detectable drug levels compared to placebo. Conclusions: TDF/FTC for PrEP showed cholesterol reductions and appeared to transiently suppress the accumulation of weight and body fat compared to placebo. There was no evidence of altered fat distribution or lipodystrophy during daily oral TDF/FTC PrEP. Clinical Trials Registration: NCT00458393.

HIV sero disclosure among men who have sex with men and transgender women on HIV pre-exposure prophylaxis.

HIV pre-exposure prophyalxis (PrEP) might lead individuals to view serodisclosure as unnecessary. We examined the prevalence of non-disclosure and lack of knowledge of partner status in a global cohort of men who have sex with men (MSM) and transgender women (TW) enrolled in the iPrEx Open Label Extension (OLE). We calculated prevalence ratios by fitting a logistic model and estimating predicted probabilities using marginal standardization. Prevalence of non-disclosure and lack of knowledge of partner status were highest in Thailand (73% and 74%, respectively) and lowest in the USA (23% and 37%, respectively). In adjusted analyses, PrEP use was not significantly associated with non-disclosure or lack of knowledge of partner status (p-values>0.05). We found that relationship characteristics were significantly associated with both outcomes. Non-disclosure was higher among casual (adjusted prevalence ratio [aPR] 1.54, [95% confidence interval 1.24-1.84]) and transactional sex partners (aPR 2.03, [1.44-2.62]), and among partners whom participants have known only minutes or hours before their first sexual encounter (aPR 1.62, [1.33-1.92]). Similarly, participants were less likely to know the HIV status of casual partners (aPR 1.50, [1.30-1.71]), transactional sex partners (aPR 1.62, [1.30-1.95]), and those they have known for only days or weeks (aPR 1.13, [0.99-1.27]) or minutes or hours (aPR 1.27, [1.11-1.42]). Our findings underscore the role of dyadic factors in influencing serodisclosure. Comprehensive risk reduction counseling provided in conjunction with PrEP that address relationship characteristics are needed to help patients navigate discussions around HIV status.

MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel.

Background: Human immunodeficiency virus (HIV) disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed. Methods: MTN-017 was a phase 2, 3-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/TDF). In each 8-week study period participants were randomized to RG-TFV rectal gel daily, or RG-TFV rectal gel before and after receptive anal intercourse (RAI; or at least twice weekly in the event of no RAI), or daily oral FTC/TDF. Results: MSM and TGW (n = 195) were enrolled from 8 sites in the United States, Thailand, Peru, and South Africa with mean age of 31.1 years (range 18-64). There were no differences in ≥grade 2 adverse event rates between daily gel (incidence rate ratio [IRR], 1.09; P = .59) or RAI gel (IRR, 0.90; P = .51) compared to FTC/TDF. High adherence (≥80% of prescribed doses assessed by unused product return and Short Message System reports) was less likely in the daily gel regimen (odds ratio [OR], 0.35; P < .001), and participants reported less likelihood of future daily gel use for HIV protection compared to FTC/TDF (OR, 0.38; P < .001). Conclusions: Rectal application of RG TFV gel was safe in MSM and TGW. Adherence and product use likelihood were similar for the intermittent gel and daily oral FTC/TDF regimens, but lower for the daily gel regimen. Clinical Trials Registration: NCT01687218.

International Sexual Partnerships May Be Shaped by Sexual Histories and Socioeconomic Status.

Exchange sex and higher education were associated with an increased likelihood of international sexual partnerships (ISPs). Exchange sex and older age were associated with an increased likelihood of condomless sex in ISPs. Educational and socioeconomic factors may create unbalanced power dynamics that influence exchange sex and condomless sex in ISPs.

Preference of Oral Tenofovir Disoproxil Fumarate/Emtricitabine Versus Rectal Tenofovir Reduced-Glycerin 1% Gel Regimens for HIV Prevention Among Cisgender Men and Transgender Women Who Engage in Receptive Anal Intercourse with Men.

Oral pre-exposure prophylaxis (PrEP) can prevent HIV transmission. Yet, some may prefer not to take systemic daily medication. MTN-017 was a 3-period, phase 2 safety and acceptability study of microbicide gel applied rectally either daily or before and after receptive anal intercourse (RAI), compared to daily oral tablet. At baseline, cisgender men and transgender women who reported RAI (N = 187) rated the daily oral regimen higher in overall liking, ease of use, and likelihood of future use than the gel regimens. After trying all three, 28% liked daily oral the least. Gel did not affect sexual enjoyment (88%) or improved it (7-8%). Most partners had no reaction to gel use. Ease of gel use improved significantly between the first and the last few times of daily use. A rectal gel used before and after RAI may constitute an attractive alternative to daily tablet. Experience with product use may increase acceptability.

Building the evidence base for stigma and discrimination-reduction programming in Thailand: development of tools to measure healthcare stigma and discrimination.

BACKGROUND: HIV-related stigma and discrimination (S&D) are recognized as key impediments to controlling the HIV epidemic. S&D are particularly detrimental within health care settings because people who are at risk of HIV and people living with HIV (PLHIV) must seek services from health care facilities. Standardized tools and monitoring systems are needed to inform S&D reduction efforts, measure progress, and monitor trends. This article describes the processes followed to adapt and refine a standardized global health facility staff S&D questionnaire for the context of Thailand and develop a similar questionnaire measuring health facility stigma experienced by PLHIV. Both questionnaires are currently being used for the routine monitoring of HIV-related S&D in the Thai healthcare system. METHODS: The questionnaires were adapted through a series of consultative meetings, pre-testing, and revision. The revised questionnaires then underwent field testing, and the data and field experiences were analyzed. RESULTS: Two brief questionnaires were finalized and are now being used by the Department of Disease Control to collect national routine data for monitoring health facility S&D: 1) a health facility staff questionnaire that collects data on key drivers of S&D in health facilities (i.e., fear of HIV infection, attitudes toward PLHIV and key populations, and health facility policy and environment) and observed enacted stigma and 2) a brief PLHIV questionnaire that captures data on experienced discriminatory practices at health care facilities. CONCLUSIONS: This effort provides an example of how a country can adapt global S&D measurement tools to a local context for use in national routine monitoring. Such data helps to strengthen the national response to HIV through the provision of evidence to shape S&D-reduction programming.

RISKY SEXUAL BEHAVIOR AMONG OUT-OF-SCHOOL THAI AND NON-THAI YOUTH IN URBAN CHIANG MAI, THAILAND.

Out-of-school youth in Thailand engage in risky sexual behavior that puts them at risk for contracting HIV infection and can have other negative sexual reproductive health outcomes. No study has examined risky sexual behaviors and compared them between Thai and non-Thai out-of-school youth. The current study compares sexual risk behavior and HIV testing behavior between out-of-school Thai and non-Thai youth. We conducted face-to-face interviews in this study population in urban Chiang Mai during 2014. Participants were recruited through convenience sampling from two main sources: non-formal education centers (NFECs) and social meeting places. We recruited 924 youth, aged 15-24 years, of whom 424 (45.9%) were Thai and 500 (54.1%) were non-Thai. The majority were attending NFECs (82.3%). Of the sexually experienced participants (57.7%), 75.4% did not use condoms consistently, and 50.3% had at least 2 lifetime sexual partners. Among the study participants, the Thai studied youth had significantly higher odds of ever having had sex (AOR=2.33; 95% CI: 1.56-3.49; p<0.001), having an earlier sexual debut (AOR=5.52; 95% CI: 2.71-11.25; p<0.001) and having a larger number of lifetime sexual partners (AOR=2.31; 95% CI: 1.37-3.88; p=0.002) than non-Thai participants. There was no significant difference between the Thai and non-Thai participants in terms of having HIV testing. The Thai studied youth were more likely to engage in risky sexual behavior than the non-Thai youth. However, both groups displayed risky sexual behaviors. Future research should explore indepth the drivers of risky sexual behaviors among both Thai and non-Thai youth.