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Little information is known about the cisgender women who seek and initiate pre-exposure prophylaxis (PrEP) for HIV prevention in the United States. Adherence Enhancement Guided by Individualized Texting and Drug Levels was a 48-week single-arm open-label demonstration study of daily oral tenofovir disoproxil fumaratel emtricitabine (TDF/FTC) in cisgender women ≥ 18 years old at risk for HIV. Participants were surveyed at screening and enrollment about sociodemographics, HIV risk perception and behaviors, and PrEP perspectives and aggregated into three risk groups according to HIV sexual risk behavior: being in a serodiscordant partnership (SD), engaging in sex work (SW), and having partners with unknown HIV status at risk for HIV (UP). One hundred sixty-seven women presented for screening with n = 31 screen failures. Of the 162 women completing enrollment, mean age was 40 (standard deviation 11), with 41% non-Hispanic Black, 22% non-Hispanic White, and 19% Latina. Compared with those who screened ineligible, enrolled participants were more likely to have heard of PrEP, had higher HIV risk perception, and reported higher perceived PrEP efficacy. Sixty-four women (47%) were categorized as SD, 21 (15%) as SW, and 51 (38%) as UP. The SW were more likely to report higher levels of drinking and drug use (p = 0.002) and history of intimate partner violence in the past year (p

A sizable portion of youth (ages 13–24) living with HIV in the United States have unsuppressed viral load. The AIDS Interventions (ATN) 152 study [evaluating the Triggered Escalating Real-Time Adherence (TERA) intervention] baseline data were examined to identify correlates of high viremia (>5000 copies/mL) and self-reported adherence, which can help in planning of differentiated services for viremic youth. Depression, HIV-stigma, and cannabis use were common in this sample of 87 youth. Almost half (48%) had high viremia, which associated with enacted stigma, moderate- to high-risk alcohol use, mental health diagnosis, and age ≥21. Self-reported adherence was related to viral load and associated with mental and physical health functioning, depression, social support, self-confident decision-making, total and internalized stigma, adherence motivation, and report of a missed a care visit in the past 6 months. Mental health emerged as a common correlate of viral load and adherence. Clinical Trial Registration number: NCT03292432.

Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention modality when taken as recommended. Women in sub-Saharan Africa may have adherence challenges that remain undisclosed to providers. Real-time measures that identify non-adherence can allow for immediate exploration of adherence challenges, counseling and interventions. We conducted a formative qualitative study in Kenya to explore oral PrEP experiences and reactions to a point-of-care urine test (UT) identifying recent (past 4 days) non-adherence to tenofovir-based PrEP among female PrEP users (25 in-depth interviews; 4 focus groups) and health care provider (10 key informant interviews). Findings indicate that use of the UT would be highly feasible in the context of regular PrEP care, largely acceptable to clients and providers, and could improve adherence. Clients emphasized the need for transparent client-centered strategies in delivering results. This formative study informs the development of tools to implement this point-of-care UT in future interventional studies and clinical settings.

Introduction To guide future preexposure prophylaxis (PrEP) implementation for women who inject drugs (WWID), a population increasingly represented in new HIV cases in the United States, we present results from a demonstration project integrated within a syringe services program (SSP) in Philadelphia, PA. Methods WWID ≥18 years were educated about and offered 24 weeks of daily PrEP. Participants completed surveys and clinical assessments at baseline and at weeks 1, 3, 12, and 24. We used descriptive statistics to estimate feasibility/acceptability, engagement in the care cascade, HIV/sexually transmitted diseases (STI) and pregnancy, issues of safety/tolerability, and preferences/satisfaction with PrEP services. Multivariable logistic regression with generalized estimating equations was used to identify factors associated with PrEP uptake and retention. Results We recruited 136 WWID. Of those, 95 were included in the final sample, and 63 accepted a PrEP prescription at week 1. Uptake was associated with greater baseline frequency of SSP access [adjusted odds ratio (aOR) = 1.85; 95% confidence interval (CI): 1.24 to 2.77], inconsistent condom use (aOR = 3.38; 95% CI: 1.07 to 10.7), and experiencing sexual assault (aOR = 5.89; 95% CI: 1.02, 33.9). Of these 95, 42 (44.2%) were retained at week 24. Retention was higher among women who reported more frequent baseline SSP access (aOR = 1.46; 95% CI: 1.04 to 2.24). Self-reported adherence was high but discordant with urine-based quantification of tenofovir. Baseline STI prevalence was 17.9%; there were 2 HIV seroconversions and 1 pregnancy. Safety/tolerability issues were uncommon, and acceptability/satisfaction was high. Conclusions Integrating PrEP with SSP services is feasible and acceptable for WWID. This suggests that daily PrEP is a viable prevention tool for this vulnerable population.

Background Intracellular tenofovir diphosphate (TFV-DP) concentration in dried blood spots (DBSs) is used to monitor cumulative pre-exposure prophylaxis (PrEP) adherence. We evaluated TFV-DP in DBSs following daily oral PrEP (emtricitabine 200 mg/tenofovir diphosphate 300 mg) among pregnant and postpartum adolescent girls and young women (AGYW). Methods Directly observed PrEP was administered for 12 weeks in a pregnancy (14–24 weeks’ gestation, n = 20) and postpartum (6–12 weeks postpartum, n = 20) group of AGYW aged 16–24 years in sub-Saharan Africa. Weekly DBS TFV-DP was measured by validated liquid chromatography–tandem mass spectrometry assay. Week 12 TFV-DP distributions were compared between groups with Wilcoxon test. Population pharmacokinetic models were fit to estimate steady-state concentrations and create benchmarks for adherence categories. Baseline correlates of TFV-DP were evaluated. Results Median age was 20 (IQR, 19–22) years. Of 3360 doses, 3352 (>99%) were directly observed. TFV-DP median (IQR) half-life was 10 (7–12) days in pregnancy and 17 (14–21) days postpartum, with steady state achieved by 5 and 8 weeks, respectively. Observed median (IQR) steady-state TFV-DP was 965 fmol/punch (691–1166) in pregnancy versus 1406 fmol/punch (1053–1859) postpartum (P = .006). Modeled median steady-state TFV-DP was 881 fmol/punch (667–1105) in pregnancy versus 1438 fmol/punch (1178–1919) postpartum. In pooled analysis, baseline creatinine clearance was associated with observed TFV-DP concentrations. Conclusions TFV-DP in African AGYW was approximately one-third lower in pregnancy than postpartum. These Population-specific benchmarks can be used to guide PrEP adherence support in pregnant/postpartum African women. Clinical Trials Registration NCT03386578, Concentrations of tenofovir diphosphate in dried blood spots were approximately one-third lower during pregnancy than postpartum after 12 weeks of directly observed dosing among African adolescent girls and young women on daily pre-exposure prophylaxis. We recommend population-specific benchmarks for adherence support.

BackgroundHIV- and MSM-related stigma are well documented as common for Chinese men who have sex with men (MSM) living with HIV, yet there is sparse literature on intimate partner violence (IPV) and its relationship with stigma in this vulnerable population. To evaluate the association between HIV-stigma and stigma related to homosexuality and IPV among newly HIV-diagnosed MSM in China.MethodsData were collected in the baseline survey among newly HIV-diagnosed Chinese MSM in a randomized clinical trial via face-to-face interviews. Univariate logistic and multivariate logistic regression analyses were performed to assess the associations between IPV and HIV- and MSM-related stigma.ResultsOf 367 newly HIV-diagnosed Chinese MSM, 23.7% experienced any IPV, including 16.6% physical, 7.4% psychological and 5.2% sexual IPV. Positive associations were found between HIV- and MSM-related stigma and IPV. Men with high HIV-related stigma (score ≥ 27) were 1.67 times as likely to experience any IPV as those with low stigma (adjusted odds ratio [AOR]: 1.67, 95% confidence interval [CI]: 1.02–2.76). Men with high MSM-related stigma (score ≥ 6) were 1.99 times as likely to experience any IPV as those with low stigma (AOR: 1.99, 95% CI: 1.18–3.36).ConclusionsHIV- and MSM-related stigmas was positively associated with IPV experiences among newly diagnosed MSM in China. The manner in which stigma may exacerbate IPV, and/or the influence of IPV on worsening stigma should be further evaluated. The high prevalence of IPV and stigma in this population suggests that interventions should be taken to reduce stigma and prevent this risky behavior among MSM.

Background Daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is effective for reducing human immunodeficiency virus (HIV) acquisition among cisgender women. We report results from the first US observational open-label demonstration project of pre-exposure prophylaxis (PrEP) among at-risk cisgender women. Methods Adherence Enhancement Guided by Individualized Texting and Drug Levels was a 48-week, single-arm, open-label demonstration study of daily oral TDF/FTC in cisgender women ≥18 years old at risk for HIV. Adherence was supported using 2-way text messaging and titrated adherence counseling based on rapid-turnaround tenofovir diphosphate concentrations from dried blood spots. Study visits occurred at baseline, weeks 4 and 12, and quarterly through week 48. Outcomes included TDF/FTC adherence, retention, and persistence. Results From June 2016 to October 2018, 136 cisgender women enrolled (mean age, 40 years (standard deviation, 11); 38% non-Hispanic Black and 19% Latina). At 48 weeks, 84 (62%) participants were retained and 62 (46%) remained on PrEP. More than one-third (12/31) of those on study but off PrEP throughout the study discontinued TDF/FTC because of side effects, and 1 adverse event led to study discontinuation. Of 120 participants with drug concentrations measured, 67 (56%) had at least 1 concentration consistent with 6 doses/week; 22 (18%) had consistent ≥6 doses/week across all study visits attended. There were no incident HIV infections and 4 incident bacterial sexually transmitted infections. Conclusion Adequate PrEP adherence for protective drug concentrations was not achieved for most study participants. More work needs to be done to fully explicate the reasons for nonadherence and low retention in cisgender women.

IntroductionTo realise the expected gains from prevention of mother-to-child HIV transmission initiatives, adherence to preventative and therapeutic antiretroviral regimens is critical and interventions deployable in busy programmatic settings with a high HIV burden are needed. Based on formative research, we developed an approach that integrates patient-centred counselling and engagement of an adherence supporter for pregnant and breastfeeding women initiating HIV treatment (ie, antiretroviral therapy (ART)) or biomedical HIV prevention (ie, pre-exposure prophylaxis (PrEP)).MethodsTonse Pamodzi 2 is a pilot study designed to provide acceptability, fidelity and clinical outcomes data on a set of behavioural interventions for adherence support. The study comprises two parallel randomised trials, enrolling HIV-positive pregnant women initiating ART (Trial 1, n=100) and HIV-negative pregnant women with risk of HIV acquisition and willing to initiate PrEP (Trial 2, n=200). Within each trial, participants are randomised 1:1 to either the intervention or control group. The Tonse Pamodzi adherence intervention comprises patient-centred counselling (adapted Integrated Next Step Counseling(iNSC)) and external adherence support tailored to the clinical context (ie, for ART or PrEP). Participants randomly assigned to the control group receive standard counselling based on local HIV guidelines. Participants are followed for 6 months. To assess intervention acceptability, we will employ a mixed method approach to describe participant engagement, satisfaction, and discussion content. We will audit and score recorded counselling sessions to evaluate the implementation fidelity of iNSC sessions. We will also assess clinical outcomes at 3 and 6 months for both Trial 1 (retention in care and viral suppression of HIV) and Trial 2 (retention in care, and plasma and intracellular tenofovir drug concentrations).Ethics and disseminationThe study protocol was approved by the Malawi National Health Science Research Committee (19/05/2334) and the University of North Carolina at Chapel Hill Institutional Review Board (19-1060).Trial registration numberNCT04330989.

BACKGROUND: We identified correlates of sex-related pre-exposure prophylaxis (PrEP) adherence in HPTN067/ADAPT, a phase 2, open-label feasibility study of daily and non-daily regimens of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)-based PrEP, among Thai men who have sex with men (MSM), and transgender women (TGW), Bangkok. METHODS: Participants were randomly assigned to one of three self-administered dosing regimens for 24 weeks: daily, time-driven, or event-driven. Demographic and behavioral information was obtained at screening. Pill-container opening was recorded with electronic dose monitoring, and self-reported information on PrEP use, sex events, and substance use were obtained during weekly interviews to confirm dose data. Sex-related PrEP adherence was calculated the proportion of sex events covered by PrEP use (at least one tablet taken within four days before sex and at least one tablet taken within 24 hours after sex) to total sex events. We used multivariate modeling with sex event as the unit of analysis to evaluate correlates associated with sex-related PrEP adherence. RESULTS: Among 178 MSM and TGW, sex-related PrEP adherence was similar in the daily and time-driven arms (p=0.79), both significantly greater than the event-driven arm (p=0.02 compared to daily). Sex-related PrEP adherence by those reporting stimulant use (74.2%) was similar to those reporting other non-alcohol drug use (76.3%, p=0.80), but lower than those reporting no substance use (84.6%, p=0.04). In a multivariable model, randomization to the event-driven arm, a higher pre-study number of reported sex events, and use of stimulant drugs were associated with significantly lower sex-related PrEP adherence. CONCLUSION: Adherence was influenced by treatment schedule and adversely impacted by non-alcoholic substance use. Regardless of these factors, Thai MSM and TGW maintained high adherence levels to oral PrEP dosing regimens and coverage of sexual exposures.

Uptake of pre-exposure prophylaxis (PrEP) has dramatically increased but remains well below the estimated number of individuals who could benefit from PrEP in the United States, and uptake remains limited among young men who have sex with men (YMSM) and MSM of color. Reasons for not adopting PrEP as a prevention strategy among those at elevated risk for HIV is an important area of inquiry that could advise efforts to better position PrEP as an active part of prevention programs. As part of a mixed methods study investigating experiences with repeat HIV testing, we identified main themes emerging from in-depth interview data pertaining to reasons why YMSM report not using PrEP, among YMSM with frequent access to HIV testing services. Themes from 14 in-depth interviews with predominantly Latino MSM for not using PrEP included perceived burden of daily dosing, feeling that risk was not high enough to warrant PrEP, and beliefs that PrEP would have severe adverse events affecting the kidneys and bones. Less prominent but noteworthy themes included stigma as a PrEP user, social or provider influence on decisions not to use PrEP, and preference for current prevention strategy. No differences in PrEP discourse were noted across those at different levels of HIV risk. Results suggest that efforts are needed to engage communities and individuals around PrEP-related education, facilitate risk evaluation, and reduce PrEP stigma. New formulations and nondaily regimens may also be of particular interest to YMSM who may perceive daily PrEP regimens as highly burdensome.

We evaluated the relationship between 2 types of social relationships, ie, (1) external support for use of HIV pre-exposure prophylaxis (PrEP) and related study supplies and (2) participants' disclosure of PrEP use and condom use and HIV PrEP adherence among daily-dosing regimen participants in HIV Prevention Trials Network (HPTN) 067, an open-label trial of oral tenofovir (TFV) disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg.Using HPTN 067 survey data, we developed scales examining (1) Low Perceived External Support for PrEP: low perceived support by others for PrEP use or perceived negative reactions to the pill case (scoring ranges from 0 to 2) and (2) Participant-Staff Disclosure Challenges Scale, which identifies challenges to sharing nonuse of PrEP or condoms to study staff (scoring ranges from 0 to 4); these scales are the primary independent variables. Adherence, the dependent variable, was determined using log-transformed plasma TFV concentrations. generalized estimating equation (GEE) linear regression was used to assess the association between both scales and adherence.Participants (n = 161) included HIV-uninfected women in South Africa, and men who have sex with men and transgender women, in Thailand and the United States. In multivariable analyses, higher scores in the Participant-Staff Disclosure Challenges Scale were significantly associated with lower PrEP adherence [exp(β) = 0.62, 95% CI: (0.46 to 0.84); P = 0.002] as were increased days since the last PrEP dose [exp(β) = 0.73, 95% CI: (0.65 to 0.83); P ≤ 0.001].Given the association with adherence, study staff-participant interactions and participants' disclosure of PrEP challenges may be worthwhile intervention targets for improving PrEP adherence in confirmatory studies.

The HPTN 067/ADAPT Study evaluated the feasibility, acceptability and patterns of adherence and coverage for three randomly assigned oral FTC/TDF pre-exposure prophylaxis (PrEP) dosing regimens to prevent HIV infection: daily, time-driven (twice a week with a post-sex dose), and event-driven (pre/post-sex dosing). Using qualitative methods, we explored facilitators and barriers for each regimen among a subset of men who have sex with men (MSM) participants in Bangkok, Thailand. Between August 2013 and March 2014, 32 (of 179) HPTN 067/ADAPT participants joined in six focus group discussions, and six attended key-informant interviews – two per each study regimen. Facilitators of PrEP adherence included use of strategies to have PrEP available when needed and constructing convenient dosing regimens, simplicity in regimen requirements with recognition that more complex regimens may take some time to master, ability to plan for sex (non-daily regimens), receipt of social and technology support, ability to use a PrEP regimen that best matches to one’s own patterns of sex, and experiences with PrEP as a part of health and well-being. Challenges to PrEP adherence included perceptions of no or low HIV risk, difficulties following regimens when drinking (intoxicated), concerns about short or long-term side-effects of PrEP, experience of HIV stigma (fears of being misidentified as HIV positive), inability to forecast sex events for non-daily regimens, and affordability of PrEP outside of study context influencing uptake and use in the community. Preferences for regimens varied, suggesting that multiple PrEP effective regimen options (daily and non-daily) should be available to fit those with different needs.

Author(s): Velloza, Jennifer; Bacchetti, Peter; Hendrix, Craig W; Murnane, Pamela; Hughes, James P; Li, Maoji; Curlin, Marcel E; Holtz, Timothy H; Mannheimer, Sharon; Marzinke, Mark A; Amico, K Rivet; Liu, Albert; Piwowar-Manning, Estelle; Eshleman, Susan H; Dye, Bonnie J; Gandhi, Monica; Grant, Robert M; HPTN 067/ADAPT Study Team | Abstract: BackgroundThe effectiveness of oral emtricitabine (FTC)/tenofovir (TFV) disoproxil fumarate-based HIV pre-exposure prophylaxis (PrEP) depends on adherence. Pharmacologic measures help interpret patterns and predictors of PrEP adherence.SettingWe analyzed data from the subsample of men who have sex with men enrolled in HPTN 067/ADAPT in Bangkok, Thailand, and Harlem, NY, U.S.MethodsAfter a 5-week directly observed therapy period, participants were randomized to daily, time-driven, or event-driven PrEP. Follow-up occurred at weeks 4, 12, and 24 after randomization. Plasma and hair FTC/TFV levels indicated short- and long-term PrEP use, respectively. Electronic pill bottle data (Wisepill) were collected weekly. Pearson correlation coefficients between PrEP use measures were calculated; linear mixed models assessed predictors of plasma and hair drug concentrations.ResultsAmong 350 participants (median age: 31 years, interquartile range: 25-38), 49.7% were from Harlem, half had less than college education, and 21% reported heavy alcohol use. In multivariable models, being enrolled in Harlem, being in non-daily arms, and having less than college education were associated with lower hair FTC/TFV concentrations; heavy alcohol use was associated with higher concentrations. Similar results were found for plasma concentrations by site and arm, but older age and greater number of sex partners were associated with higher concentrations. Hair and plasma FTC/TFV concentrations were moderately correlated with Wisepill data (r ≥ 0.29) across visits.ConclusionsIn HPTN067, plasma, hair, and Wisepill data correlated with one another and served as complementary adherence measures. Site, arm, education, age, alcohol, and sexual behavior influenced patterns of adherence.

Background Prior to implementing a pre-exposure prophylaxis (PrEP) demonstration study, we sought to explore cisgender women’s experiences with HIV prevention, PrEP knowledge and attitudes, and anticipated barriers and facilitators for PrEP uptake and adherence in Southern California. Methods Three focus groups were held with cisgender women of mixed HIV serostatus in San Diego and Los Angeles between November 2015 and January 2016. Women were recruited through local testing sites, community-based organizations, and social media. Focus groups were audio-recorded and transcripts were analyzed using thematic analysis. Results Twenty-two women participated in focus groups, with median age 44 (IQR 30–53) and 6 identifying as non-Hispanic Black, 7 non-Hispanic White, 8 Latina and 1 mixed race. Despite limited prior PrEP knowledge and no PrEP experience, participants expressed interest in taking PrEP. Anticipated benefits were freedom from worry about HIV and control over sexual health; however, these were tempered by concerns including the possibility of increased HIV risk behaviors and potential side effects. Cisgender women reported potential barriers to PrEP uptake and adherence barriers, like competing priorities and poor PrEP access. Conversely, PrEP facilitators included utilizing practical tools such as phone apps and pill boxes as well as receiving encouragement from loved ones and support from other cisgender women on PrEP, women living with HIV and their medical providers. Conclusions Although PrEP awareness was low, participants recognized the importance of PrEP and ways to facilitate adherence. Exploring perspectives of cisgender women is integral to developing effective interventions to support PrEP uptake and adherence for women at elevated risk for HIV.

Author(s): Sekabira, Rogers; McGowan, Ian; Yuhas, Krista; Brand, Rhonda M; Marzinke, Mark A; Manabe, Yukari C; Frank, Ian; Eron, Joseph; Landovitz, Raphael J; Anton, Peter; Cranston, Ross D; Anderson, Peter; Mayer, Kenneth H; Amico, K Rivet; Wilkin, Timothy J; Chege, Wairimu; Kekitiinwa, Adeodata R; McCauley, Marybeth; Gulick, Roy M; Hendrix, Craig W | Abstract: ObjectiveThe objective of this study was to compare HIV-negative cisgender women (CGW) with MSM for mucosal tissue differences in pharmacokinetics, HIV infectivity and cell phenotype.DesignA substudy of HPTN 069/ACTG A5305, 48-week study of three oral candidate preexposure prophylaxis regimens: maraviroc, maraviroc/emtricitabine and maraviroc/tenofovir disoproxil fumarate (TDF) compared with a TDF/emtricitabine control group.MethodsPlasma, peripheral blood mononuclear cells and cervical and colorectal tissue biopsies were collected at Baseline (no drug), Week 24 and 48 (on drug), and Week 49 (1-week postdrug). Drug concentrations were assessed in all matrices. HIV infectivity was assessed using tissue biopsy 'explants' challenged with HIV ex vivo followed by HIV p24 measurement. Flow cytometry evaluated colorectal cell phenotype.ResultsThirty-seven CGW and 54 MSM participated. CGW's colorectal explant p24 was higher than MSM before (0.31 log10, P = 0.046), during (1.01-1.19 log10, P = 0.016) and one week after (0.61 log10, P = 0.011) study drug dosing. Pooling regimens, cervical explant p24 did not differ among visits. CGW had higher plasma maraviroc and colorectal tissue tenofovir diphosphate and lower colorectal tissue emtricitabine (all P l 0.005) compared with MSM. Each study drug's cervical tissue concentrations were more than 10-fold below paired colorectal concentrations (P l 0.001). Cell phenotype sex differences included 4% higher CD38+/CD8+ cells at baseline and 3-7% higher CD69+/CD8+ cells throughout Weeks 24-49 in CGW compared with MSM (P l 0.05).ConclusionColorectal explants in CGW demonstrated greater HIV infectivity than MSM with and without study drugs. Small differences in adherence, drug concentration and colorectal tissue flow cytometry cannot fully explain this difference.

To eliminate mother-to-child transmission of HIV (EMTCT), scalable strategies to enhance antiretroviral adherence for both antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are needed as part of integrated HIV and maternal-child health services. We developed Tonse Pamodzi (“all of us together”), an adaptable intervention integrating biomedical and behavioral components to support HIV treatment and prevention. We describe our intervention development process, which comprised formative qualitative research, a review of the literature, and technical input from stakeholders representing the community, health systems, and policymakers. The resulting intervention, described herein, integrates patient-centered counseling and engagement of a patient-selected adherence supporter for pregnant and breastfeeding women initiating ART or PrEP. Patients receiving the intervention engage in Integrated Next Step Counseling (iNSC) sessions delivered by trained counselors to build and maintain adherence skills. Each patient also has the option of selecting an adherence supporter (partner, family member, or friend) who may participate in iNSC sessions and provide adherence support outside of these sessions. This flexible intervention is adaptable not only to ART or PrEP use, but also to the needs and preferences of each woman and the clinical context. If shown to be acceptable and feasible, the Tonse Pamodzi intervention may be an important tool in continuing efforts for EMTCT.

BackgroundAntiretroviral therapy (ART) during pregnancy is important for both maternal health and prevention of perinatal HIV-1 transmission; however adequate data on the safety and efficacy of different ART regimens that are likely to be used by pregnant women are scarce. In this trial we compared the safety and efficacy of three antiretroviral regimens started in pregnancy: dolutegravir, emtricitabine, and tenofovir alafenamide fumarate; dolutegravir, emtricitabine, and tenofovir disoproxil fumarate; and efavirenz, emtricitabine, and tenofovir disoproxil fumarate.MethodsThis multicentre, open-label, randomised controlled, phase 3 trial was done at 22 clinical research sites in nine countries (Botswana, Brazil, India, South Africa, Tanzania, Thailand, Uganda, the USA, and Zimbabwe). Pregnant women (aged ≥18 years) with confirmed HIV-1 infection and at 14-28 weeks' gestation were eligible. Women who had previously taken antiretrovirals in the past were excluded (up to 14 days of ART during the current pregnancy was permitted), as were women known to be pregnant with multiple fetuses, or those with known fetal anomaly or a history of psychiatric illness. Participants were randomly assigned (1:1:1) using a central computerised randomisation system. Randomisation was done using permuted blocks (size six) stratified by gestational age (14-18, 19-23, and 24-28 weeks' gestation) and country. Participants were randomly assigned to receive either once-daily oral dolutegravir 50 mg, and once-daily oral fixed-dose combination emtricitabine 200 mg and tenofovir alafenamide fumarate 25 mg; once-daily oral dolutegravir 50 mg, and once-daily oral fixed-dose combination emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; or once-daily oral fixed-dose combination of efavirenz 600 mg, emtricitabine 200 mg, and tenofovir disoproxil fumarate 300 mg. The primary efficacy outcome was the proportion of participants with viral suppression, defined as an HIV-1 RNA concentration of less than 200 copies per mL, at or within 14 days of delivery, assessed in all participants with an HIV-1 RNA result available from the delivery visit, with a prespecified non-inferiority margin of -10% in the combined dolutegravir-containing groups versus the efavirenz-containing group (superiority was tested in a pre-planned secondary analysis). Primary safety outcomes, compared pairwise among treatment groups, were the occurrence of a composite adverse pregnancy outcome (ie, either preterm delivery, the infant being born small for gestational age, stillbirth, or spontaneous abortion) in all participants with a pregnancy outcome, and the occurrence of grade 3 or higher maternal and infant adverse events in all randomised participants. This trial was registered with ClinicalTrials.gov, NCT03048422.FindingsBetween Jan 19, 2018, and Feb 8, 2019, we enrolled and randomly assigned 643 pregnant women: 217 to the dolutegravir, emtricitabine, and tenofovir alafenamide fumarate group, 215 to the dolutegravir, emtricitabine, and tenofovir disoproxil fumarate group, and 211 to the efavirenz, emtricitabine, and tenofovir disoproxil fumarate group. At enrolment, median gestational age was 21·9 weeks (IQR 18·3-25·3), the median HIV-1 RNA concentration among participants was 902·5 copies per mL (152·0-5182·5; 181 [28%] of 643 participants had HIV-1 RNA concentrations of

INTRODUCTION: Understanding the reasons why clients stop taking pre-exposure prophylaxis (PrEP) is critical to improving PrEP delivery and ultimately reducing HIV incidence. METHODS: We analyzed data from a programmatic evaluation conducted at the Los Angeles LGBT Center (the Center) from February-May 2018. In the evaluation, an online structured questionnaire was emailed to inactive PrEP clients. RESULTS: Of 180 survey respondents, 91 had stopped taking PrEP and 11 had never started. Most who stopped using PrEP did so for reasons spanning multiple categories. Among former PrEP users, the most common reasons for stopping were entering a monogamous relationship (43%) and side effects (40%). Ten of 11 who never started PrEP reported access barriers (e.g., cost was too high, problems with insurance). An unexpected finding was that the survey led 25% of inactive clients to re-engage with PrEP services at the Center and 15% to restart PrEP by October 2018. CONCLUSION: The findings show that improving PrEP retention may require multifaceted interventions – e.g., tailored discussions about stopping and restarting PrEP safely as HIV risk changes, ensuring consistent access to affordable PrEP, and alternative dosing strategies. An emailed survey appears to be a simple yet effective strategy to reengage some clients in PrEP care.

Summary Background There is little evidence of patient acceptability for drug-resistant tuberculosis (DRTB) care in the context of new treatment regimens and HIV co-infection. We aim to describe experiences of DRTB-HIV care among patients in KwaZulu-Natal province, South Africa. Methods In this qualitative study using Bury's framework for chronic illness, we conducted 13 focus groups at a tertiary hospital with 55 patients co-infected with DRTB and HIV (28 women, 27 men) who were receiving new bedaquiline-based treatment for DRTB, concurrent with antiretroviral therapy. Eligible patients were consenting adults (aged >18 years) with confirmed DRTB and HIV who were enrolled into the PRAXIS study within 2 weeks of initiating bedaquiline-based treatment for DRTB. Participants were recruited from the PRAXIS cohort to participate in a focus group based on their time in DRTB treatment: early (2–6 weeks after treatment initiation), middle (2–6 months after discharge or treatment initiation if never hospitalised), and late (>6 months after treatment initiation). Focus groups were carried out in isiZulu language, audio recorded, and translated to English within 4 weeks. Participants were asked about their experiences of DRTB and HIV care and treatment, and qualitative data were coded and thematically analysed. Findings From March, 2017, to June, 2018, distinctive patient challenges were identified at four critical stages of DRTB care: diagnosis, marked by centralised hospitalisation, renunciation from routine life, systemic stigmatisation and, for patients with longstanding HIV, renewed destabilisation; treatment initiation, marked by side-effects, isolation, and social disconnectedness; discharge, marked by brief respite and resurgent therapeutic and social disruption; and continuity, marked by deepening socioeconomic challenges despite clinical recovery. The periods of diagnosis and discharge into the community were particularly difficult. Treatment information and agency in decision making was a persistent gap. Sources of stigmatisation shifted with movement between the hospital and community. Resilience was built by connecting to peers, self-isolating, financial and material security, and a focus on recovery. Interpretation People with DRTB and HIV undergo disruptive, life-altering experiences. The lack of information, agency, and social protections in DRTB care and treatment causes wider-reaching challenges for patients compared with HIV. Decentralised, community, peer-support, and differentiated care models for DRTB might be ameliorative and help to maximise the promise of new regimens. Funding US National Institutes of Health. Translation For the isiZulu translation of the abstract see Supplementary Materials section.

In the United States, HIV infection rate inequities persist, with new infections highest among young, Black men who have sex with men (YBMSM) in the South. We conducted 23 in-depth interviews with YBMSM newly diagnosed with HIV to explore awareness of and barriers to uptake of HIV pre-exposure prophylaxis (PrEP). Participants were recruited from two university-based HIV Clinics in Alabama and were: (1) 16-29 years of age, (2) diagnosed with HIV within the prior 365 days, (3) Black race, (4) self-identified as a cis-gender male reporting sex with men AND (5) did not report prior PrEP use. Interview guides were grounded in Anderson's Behavioral Healthcare Utilization Model (ABM), with embedded constructs from the situated Information, Motivation and Behavioral Skills theoretical framework. Coding was conducted by three independent coders using thematic analysis methods. Participants (N = 23) median age was 24, more than two-thirds reported annual incomes less than $15,000 and the majority (84%) identified as gay. Major themes that emerged as barriers to accessing PrEP included low prioritization and interests in using PrEP; low perceived HIV risk due to feelings of invincibility and trust in sex partners; lack of information about accessing PrEP; negative beliefs around PrEP; and the suggestion to change PrEP messaging from only targeting YBMSM. These findings indicate that there are important missed opportunities for HIV prevention with PrEP among YBMSM in the South. In these high-risk young men, tailored interventions are needed to better inform and frame perceptions around risk, knowledge, access and prioritization of PrEP.En Estados Unidos, desigualdades en la tasa de infección por VIH persisten, y en el sur del pais, la tasa de nuevas infecciones hombres jóvenes Afro-americanos que tienen sexo con hombres son más altas. Realizamos veintitrés entrevistas en profundidad con YBMSM recién diagnosticado con VIH para explorar la conciencia y las barreras para la adopción de la profilaxis previa a la exposición al VIH (PrEP). Los participantes fueron reclutados de dos clínicas de VIH en centros medicos academicos en el estado de Alabama con los siguientes criterios: 1) 16-29 años de edad, 2) diagnostico VIH dentro de los 365 días, 3) raza afro-americana, 4) autoidentificados como un género cis-hombres que tienen sexo con hombres, y 5) no informaron el uso previo de PrEP. Las guías de la entrevista se basaron en el Modelo conductual de utilización de la salud (ABM) de Anderson, con construcciones integradas del marco teórico de Información, motivación y habilidades conductuales. Tres codificadores independientes codificaron utilizando métodos de análisis temáticos. La edad mediana de los participantes (N = 23) era de 24 años, más de dos tercios informaron ingresos anuales de menos de $15,000 (USD) y la mayoría (84%) se identificó como gay. Los temas principales que surgieron como barreras para acceder a PrEP incluyeron una baja priorización e interes en su; bajo riesgo percibido de VIH debido a sentimientos de invencibilidad y confianza en las parejas sexuales; falta de información sobre el acceso a PrEP; creencias negativas sobre PrEP; y la sugerencia de enfocar los mensajes sobre PreP no solo ha jovenes afro-americanos que tienen sexo con hombres. Estos hallazgos indican que hay importantes oportunidades perdidas para la prevención del VIH con PrEP entre esto jovenes en el Sur de EEUU. En estos hombres jóvenes de alto riesgo, se necesitan intervenciones personalizadas para mejor informar y enmarcar las percepciones sobre el riesgo, el conocimiento, el acceso y la priorización de PrEP.

Background Understanding factors influencing retention in care (RIC) and viral load improvement (VLI) in people with HIV (PWH) who are out of care and hospitalized will assist in intervention development for this vulnerable population. Methods The study was a post hoc analysis of prospectively collected data. Hospitalized participants were enrolled if they were newly diagnosed with HIV during the hospitalization or out of HIV care. Participants completed surveys at baseline and 6 months postenrollment and laboratory studies of viral load (VL). Outcomes were RIC (2 completed visits, 1 within 30 days of discharge) and VLI (VL Results The study cohort included 417 participants enrolled between 2010 and 2013. The population was 73% male, 67% non-Hispanic black, 19% Hispanic, and 70% uninsured. Sixty-five percent had a baseline CD4 400 copies/mL or missing, and the population was generally poor with low educational attainment. After discharge from the hospital, 60% did not meet the definition for RIC, and 49% did not have VLI. Modifiable factors associated with the outcomes include drug use (including marijuana alone and other drugs), life instability (eg, housing, employment, and life chaos), and using avoidance coping strategies in coping with HIV. Conclusions Hospitalized out-of-care PWH in the United States are at high risk of poor re-engagement in care after discharge. Interventions for this population should focus on improving socioeconomic stability and coping with HIV and reducing drug use.

BACKGROUND: Oral pre-exposure prophylaxis (PrEP) is highly efficacious but low adherence undermines effectiveness. Depression, common in African women, may be a barrier to consistent PrEP use. We aimed to assess the relationship between depression, psychosocial mediators, and PrEP adherence among South African women. METHODS: We analyzed data from 174 South African women in HPTN 067, an open-label oral PrEP trial conducted from 2011–2013. Participants were followed for 24 weeks. PrEP adherence was measured via Wisepill™ and weekly self-report interview data. We considered participants “adherent” at week 24 if Wisepill™ and interviews indicated that ≥80% of expected doses were taken in the prior month. Elevated depressive symptoms were assessed using the 20-item Center for Epidemiological Studies-Depression (CES-D) scale. We used marginal structural models to estimate the effect of elevated symptoms at baseline on PrEP adherence at week 24 and to assess whether the direct effect changed meaningfully after accounting for mediating effects of stigma, social support, and PrEP optimism. RESULTS: High PrEP adherence occurred less often among women with elevated depressive symptoms (N=35; 44.3%) compared with those without (N=52; 54.7%; adjusted relative risk [aRR]: 0.79; 95% confidence interval [CI]: 0.63–0.99). The effect of elevated depressive symptoms on PrEP adherence persisted in models accounting for the mediating influence of stigma (aRR: 0.74; 95% CI: 0.51–0.97) and PrEP optimism (aRR: 0.75; 95% CI: 0.55–0.99). We also found a direct effect of similar magnitude and direction when accounting for social support as the mediating variable, although this adjusted relative risk estimate was not statistically significant (aRR: 0.77; 95% CI: 0.57–1.03). CONCLUSIONS: Depressive symptoms were common and associated with lower PrEP adherence among South African women. Future work is needed to determine whether depression services integrated with PrEP delivery could improve PrEP effectiveness among African women.

Supplemental Digital Content is Available in the Text., Background: HIV-infected, postpartum women on antiretroviral therapy (ART) have high rates of viremia. We examined predictors of postpartum viremia in the PROMISE study. Methods: Women with pre-ART CD4+ T-cell counts ≥400 cells/mm3 who started ART during pregnancy were randomized postpartum to continue ART (CTART) or discontinue ART (DCART). Viral load and self-reported adherence were collected every 12 weeks, up to 144 weeks. Women in DCART reinitiated therapy when clinically indicated. Viremia was defined as 2 consecutive viral loads >1000 copies/mL after 24 weeks on ART. Adherence was dichotomized as missing versus not missing ART doses in the past 4 weeks. Predictors of viremia were examined using Cox proportional hazards regression with adherence as a time-varying covariate. Results: Among 802 women in the CTART arm, median age at entry was 27 years and median CD4+ T-cell count 696 cells/mm3. Of 175 women in CTART with viremia (22%), 141 had resistance data, and 12% had resistance to their current regimen. There was an estimated 0.12 probability of viremia by week 48 and 0.25 by week 144. Predictors of viremia included missed ART doses within the past 4 weeks, younger age, shorter duration of pre-entry ART, and being from the South American/Caribbean region. Of 137 women in DCART who reinitiated therapy, probability of viremia was similar to CTART (0.24 by week 96; 0.27 by week 144). Conclusions: Rates of postpartum viremia are high and viremia is more likely in younger postpartum women who start ART later in pregnancy. Interventions should target these higher-risk women.

To evaluate the association between general self-efficacy and depression/anxiety among newly HIV-diagnosed Chinese men who have sex with men (MSM) in Beijing, our study evaluated the baseline survey data of MSM taking part in a clinical trial among Chinese MSM in Beijing. The baseline survey of the trial was conducted between March 2013 and March 2014. General self-efficacy and depression/anxiety were measured using standard scales. Logistic regression and cumulative logistic regression were used to evaluate the associations between general self-efficacy and depression/anxiety. A total of 367 newly HIV-diagnosed Chinese MSM in Beijing were recruited. There were negative associations between general self-efficacy and depression/anxiety among the study population. As general self-efficacy increased by one unit, the odds of "likely" or "borderline" depression versus normal, or "likely" depression versus "borderline" depression or normal decreased by 12% [adjusted odds ratio (AOR): 0.88, 95% confidence interval (CI): 0.85-0.92] after adjusting for potential confounders. Similarly, general self-efficacy was negatively associated with anxiety (AOR: 0.89, 95% CI: 0.86-0.93). A higher level of general self-efficacy was associated with lower levels of depression and anxiety among newly HIV-diagnosed Chinese MSM. Interventions promoting overall health and wellness should address self-efficacy, depression and anxiety.

Pre-exposure prophylaxis (PrEP) with optimal adherence has demonstrated efficacy in reducing HIV incidence in women. Black women are disproportionately burdened by the HIV epidemic, accounting for more than half of all new HIV cases in women, thereby making PrEP an ideal prevention strategy for this group. However, to date, PrEP uptake by women in the United States has been slow. Further domestic research is needed to understand the multilevel factors related to PrEP awareness, uptake, and implementation in Black women. Our purpose was to review the current status of HIV prevention in Black women. We summarize clinical trials germane to federal approval of PrEP, discuss important PrEP studies focused on women including non-oral options, and review multilevel barriers to PrEP uptake. Lastly, we discuss the use of an integrated theoretical framework to organize multilevel factors related to PrEP uptake by Black women in order to guide intervention development.

INTRODUCTION: Despite the issuance of evidence-based and evidence–informed guidelines to improve engagement in HIV care and adherence-related outcomes, few studies have assessed contemporary adherence or engagement support practices of HIV care providers in US clinics. As a result, the standard of HIV care in the US and globally remains poorly understood. OBJECTIVE: This programmatic assessment approach aimed to identify the strengths and gaps in the current standard of HIV care from the perspective of HIV care providers. METHODS: A self-administered Standard of Care measure was developed and delivered through Qualtrics to HIV care providers at four different HIV care sites as a part of a multisite intervention study to improve engagement in HIV care and ART adherence. Providers were asked to provide demographic and clinic specific information, identify practices/strategies applied during typical initial visits with HIV-positive patients and visits prior to and at ART initiation, as well as their perceptions of patient behaviors and adequacy of HIV care services at their clinics. RESULTS: Of the 75 surveys which were completed, the majority of respondents were physicians, and on average, providers have worked in HIV care for 13.5 years. Across the sites, 91% of the providers’ patient panels consist of HIV-positive patients, the majority of whom are virally suppressed and 1/5 are considered “out of care.” Few resources were routinely available to providers by other staff related to monitoring patient adherence and engagement in care. During typical initial visits with HIV positive patients, the majority of providers report discussing topics focused on behavioral/life contexts such as sexual partnerships, sexual orientation, disclosure, and other sources of social support. Nearly all providers emphasize the importance of adherence to treatment recommendations and nearly 90% discuss outcomes of good adherence and managing common side effects during ART start visits. Overall, providers do not report often implementing practices to improve retention in care. CONCLUSIONS: Survey results point to opportunities to enhance engagement in HIV care and improve ART adherence through systematic data monitoring and increased collaboration across providers and other clinic staff, specifically when identifying patients defined as “in need” or “out of care.”

Pre-exposure prophylaxis (PrEP) for the prevention of HIV infection among young men who have sex with men is a critical part of the HIV prevention landscape in the US. Given the unique challenges and resources of young MSM negotiating safer sex practices, including PrEP, counseling and supportive discussions to optimize both PrEP use and sexual health protection more generally may facilitate reaching HIV prevention goals. Within the context of a large, open-label PrEP study (ATN110/113), support for sexual health promotion and PrEP use was provided through use of integrated Next Step Counseling (iNSC) as part of study visits. We detail iNSC and, using session documentation collected throughout this study, we characterize iNSC implementation and the content generated from these discussions. We detail features of iNSC, training of counselors and the implementation of iNSC in a multi-site PrEP study with young MSM in the US. Case report forms completed by iNSC counselors at study visits at weeks 4, 8, 12, 24, 36, and 48 were evaluated. Implementation of each intervention step for each discussion is summarized at and across timepoints, as well as features of specific steps (e.g., kinds of facilitators and barriers). Implementation differences by group (e.g., race/ethnicity, age) were examined. iNSC case report forms from 1000 sessions involving 178 unique participants ages 15–22 from sessions conducted between 2013 and 2015 were reviewed. High fidelity to iNSC steps in terms of inclusion in sessions was reported; 98–100% of sessions included critical steps for sexual health protection discussions and 96–98% for PrEP use discussions. The vast majority of sessions appeared to flow in line with iNSC’s emphasis on exploration and open discussion prior to considering specific needs and related strategies. Nearly three-quarters of sessions noted ‘commitment to staying negative’ as a motivator towards sexual health protection (more commonly reported by those identifying as White), while ‘assuming partner is negative’ was the most common challenge (less common for the older cohort), and ‘having access’ to a sexual health protection tool or strategy (besides PrEP) was the most common “need” (more common for those identifying as White or Latino). Carrying dose(s) to have them on-hand when needed was the most common PrEP adherence facilitator, drug and alcohol use was the most common challenge noted, and access to a dose when needed was the most common “need” (more common for participants self-identified as White). iNSC was implemented consistently throughout ATN110/113, and patient-centered discussions about sexual health protection and PrEP-use appeared feasible to incorporate into clinical care visits.

Background Young men who have sex with men are among the most vulnerable to human immunodeficiency virus (HIV) infection. Although preexposure prophylaxis (PrEP) has demonstrated effectiveness, adherence and retention have been low among youth. Methods We conducted a randomized controlled trial to evaluate the impact of a youth-tailored, bidirectional text-messaging intervention (PrEPmate) on study retention and PrEP adherence. Young individuals at risk for HIV initiating PrEP within Chicago’s safety-net system were randomized 2:1 to receive PrEPmate or standard of care (SoC) for 36 weeks. The primary retention outcome was study-visit completion, and the primary adherence outcome was tenofovir diphosphate (TFV-DP) concentrations ≥700 fmol/punch (consistent with ≥4 doses/week) assessed at 4, 12, 24, and 36 weeks. The impact of PrEPmate on retention and adherence was evaluated using generalized estimating equation logistic models with robust standard errors. Results From April 2015 to March 2016, 121 participants enrolled (mean age 24; 27% black, 36% Latino). Participants who received PrEPmate were more likely to attend study visits (86% PrEPmate vs. 71% SoC, odds ratio [OR] = 2.62, 95% confidence interval [CI] 1.24–5.54) and have TFV-DP levels consistent with ≥4 doses/week (72% PrEPmate vs. 57% SoC, OR = 2.05, 95% CI 1.06–3.94). PrEPmate efficacy did not differ significantly by age, race/ethnicity, education, or insurance. Overall, 88% reported PrEPmate to be very/somewhat helpful, and 92% would recommend PrEPmate to others. Conclusions An interactive text-messaging intervention had high acceptability and significantly increased study-visit retention and PrEP adherence among young individuals at risk for HIV acquisition. Clinical Trials Registration NCT02371525., This study evaluated the impact of a text-messaging preexposure prophylaxis-support intervention among young men who have sex with men at risk for human immunodeficiency virus. Participants who received the intervention had higher study retention and PrEP adherence as measured by blood drug levels.

Gay, bisexual, and other men who have sex with men (GBMSM) are highly stigmatized and male–male sex is often criminalized in sub-Saharan Africa, impeding access to quality care for sexual health, HIV prevention, and treatment. To better understand HIV care engagement and antiretroviral therapy (ART) adherence among GBMSM in this context, a conceptual model incorporating sociocultural factors is needed. We conducted a qualitative study of barriers to and facilitators of HIV care engagement and ART adherence among Kenyan GBMSM, informed by a conceptual model based on an access, information, motivation, and behavioral skills (access-IMB) model, with trust in providers and stigma and discrimination as a priori factors of interest. We conducted 30 semi-structured interviews with HIV-positive Kenyan GBMSM, of whom 20 were taking ART and 10 had not yet initiated treatment. A deductive approach was used to confirm the relevance of basic concepts of the access-IMB model, while an inductive approach was used to identify content that emerged from men’s lived experiences. Access-related information, motivation, and behavioral skills appeared relevant to HIV care engagement and ART adherence, with stigma and discrimination appearing consistently across discourse exploring facilitators and barriers. Trusted providers and supportive family and friends helped many men, and resilience-related concepts such as selective disclosure of GBMSM status, connection to lesbian, gay, bisexual, and transgender (LGBT) organizations, self-acceptance, goal-setting, social identity and altruism emerged as important facilitators. Findings suggest a need to increase support from providers and peers for Kenyan GBMSM living with HIV infection. In addition, they point toward the potential value of interventions that provide opportunities to build or enhance one’s sense of community belonging in order to improve HIV care engagement and promote ART adherence for this vulnerable population.

Supplemental Digital Content is available in the text, Objectives: To review the main factors influencing the costs of nondaily oral preexposure prophylaxis (PrEP) with tenofovir (±emtricitabine). To estimate the cost reductions possible with nondaily PrEP compared with daily PrEP for different populations (MSM and heterosexual populations). Design: Systematic review and data triangulation. Methods: We estimated the required number of tablets/person/week for dosing regimens used in the HPTN 067/ADAPT (daily/time-driven/event-driven) and IPERGAY (on-demand) trials for different patterns of sexual intercourse. Using trial data, and behavioural and cost data obtained through systematic literature reviews, we estimated cost savings resulting from tablet reductions for nondaily versus daily oral PrEP, assuming 100% adherence. Results: Among different populations being prioritized for PrEP, the median reported number of days of sexual activity varied between 0 and 2 days/week (0–1.5 days/week for MSM, 1–2 days/week for heterosexual populations). With 100% adherence and two or fewer sex-days/week, HPTN 067/ADAPT nondaily regimens reduced the number of tablets/week by more than 40% compared with daily PrEP. PrEP program costs were reduced the most in settings with high drug costs, for example, by 66–69% with event-driven PrEP for French/US populations reporting on average one sex-day/week. Conclusion: Nondaily oral PrEP could lower costs substantially (>50%) compared with daily PrEP, particularly in high-income countries. Adherence and efficacy data are needed to determine cost-effectiveness.

Achieving and sustaining high levels of adherence to medication regimens is essential to improving health outcomes, but continues to be a challenge for a sizable proportion of patients. Decades of research suggests that medication adherence is determined by a complex constellation of factors. Social-behavioral science research has focused on creating frameworks that identify which contextual, personal, social, or drug-related factors appear to most influence adherence. Comprehensive models of adherence propose specific structural relationships between these factors that can be used to plan for, implement, and monitor programs that seek to optimize adherence. The use of social-behavioral models offers multiple advantages in both practice and research environments; however, the breadth and depth of these models can deter many from engaging in this important exercise. To promote the use of social-behavioral frameworks and models of adherence, we provide a brief overview of the advantages in using a social-behavioral lens in adherence work, a sampling of models used in HIV medication adherence research that have high generalizability to other conditions, and practical guidance for grounding adherence promotion strategies in evidence informed by social-behavioral science research.

The HPTN 067/Alternative Dosing to Augment Pre-Exposure Prophylaxis Pill Taking (ADAPT) study evaluated daily and non-daily dosing schedules for oral pre-exposure prophylaxis (PrEP) to prevent HIV. A qualitative sub-study including focus groups and in-depth interviews was conducted among men who have sex with men participating in New York City to understand their experience with PrEP and study dosing schedules. The 37 sub-study participants were 68% black, 11% white, and 8% Asian; 27% were of Hispanic/Latino ethnicity. Mean age was 34 years. Themes resulting from qualitative analysis include: PrEP is a significant advance for HIV prevention; non-daily dosing of PrEP is congruent with HIV risk; and pervasive stigma connected to HIV and risk behavior is a barrier to PrEP adherence, especially for non-daily dosing schedules. The findings underscore how PrEP intersects with other HIV prevention practices and highlight the need to understand and address multidimensional stigma related to PrEP use.

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.

To assess the efficacy of an education- and strengths-based counselling programme to promote antiretroviral therapy (ART) adherence in a cohort of HIV-infected individuals with high prevalence of injection drug use in Estonia. Parallel-group randomized (1:1) controlled trial (RCT). Adults receiving ART in two clinics were followed for 12 months. The trial compared: (i) an intervention (three sessions) incorporated into routine clinic visits, providing education about HIV, ART, the role of adherence, and tailoring regimen to daily routines using problem-solving skills to address adherence barriers versus (ii) usual care (control). Primary and secondary outcomes were self-reported ART adherence (3-day recall) and viral load (respectively). 519 patients were randomized and 82% completed the study. Recent optimal ART adherence (3-day recall ≥95%) was reported by 75.6% in the intervention group and 72.9% of controls at baseline and 76.7% and 67.5%, respectively, at 12 months (RR 1.14, 95% CI 1.00-1.28; adjusted RR 1.13, 95% CI 1.00-1.27). There was no difference in the proportion of patients with undetectable viral load. At 12 months the intervention group reported significantly higher perceptions of ART necessity versus ART concerns [mean ART necessity-concerns differential: intervention group 1.32 (SD 1.22) vs control group 1.08 (SD 1.12); p = 0.048]. All-cause mortality among study participants was 27.7 per 1000 person years (95% CI 15.6-44.8). A brief, clinic-based adherence intervention alone may assist with adherence but lacks impact on viral load at 12 months.

Linkage to care (LTC) is a key element of the HIV care continuum, and a crucial bridge from testing and diagnosis to receipt of antiretroviral therapies and viral suppression. In 2012, the Los Angeles LGBT Center hired a full-time LTC specialist (LTC-S), who developed a unique client-centered approach to LTC. This single-arm demonstration project was designed to systematically evaluate the LTC-S intervention. Individuals who were newly diagnosed with HIV between March 2014 and September 2015 were eligible for enrollment. The LTC-S draws heavily from principles of motivational interviewing and strengths-based case management, helping to normalize fears while guiding clients at a pace that reflects individual needs and resources. These tailored, targeted methods facilitate the rapid development of rapport, enabling the LTC-S to help clients address particular reactions and barriers to care more effectively. Of the 118 newly HIV-diagnosed individuals who enrolled, 111 (94.1%) saw an HIV primary care provider within 3 months of diagnosis; the LTC-S spent an average of 2.1 h working with each participant. Enrolled clients were a racially diverse, urban group composed primarily of young men who have sex with men. The LTC-S intervention was effective in promoting LTC among this sample. Our results demonstrate that client-centered, resiliency-based LTC services can be seamlessly integrated into an existing HIV testing program, thereby increasing the chances that newly diagnosed individuals will link to care.

Depression and anxiety are common among persons recently diagnosed with HIV infection. We examined whether depression or anxiety was associated with delayed initiation of antiretroviral therapy (ART) among a prospective cohort of Chinese men who have sex with men (MSM) who were newly diagnosed with HIV. The Hospital Anxiety and Depression Scale (HADS) was used for measuring depression and anxiety, with scores of 0-7, 8-10, and 11-21 representing normal, borderline, and likely, respectively. ART initiation information was extracted from the National ART Database. Cox regression was performed to assess associations between HADS scores and the time to ART initiation. Of 364 eligible participants enrolling in the cohort within a median of 11 days after HIV diagnosis, 62% initiated ART during the 12-month follow-up period. The baseline prevalence for likely/borderline depression was 36%, and likely/borderline anxiety was 42%. In adjusted analyses, compared with a depression score of 0, the likelihood of starting ART was 1.82 [95% confidence interval (CI): 1.38-2.41], 3.11 (95% CI: 1.82-5.30), and 2.53 (95% CI: 1.48-4.32) times higher for depression scores of 3, 9, and 13, respectively. A similar pattern was observed for the anxiety score. In contrast to our hypothesis, both depression and anxiety were associated with earlier ART initiation among Chinese MSM with newly diagnosed HIV. We speculate that individuals who are more concerned about their new HIV diagnosis may be more likely to seek HIV care and follow a doctor's advice. The effects of depression or anxiety on ART initiation likely differ in varying subgroups and by symptom severity.

Rapid, if not same-day, start of antiretroviral therapy (ART) is quickly becoming a best practice around the world. In the US, multiple programs exist to facilitate rapid start of ART, but little is known about the experiences of newly diagnosed individuals receiving these recommendations and services. Twenty participants (19 men who have sex with men and 1 transgender woman) from an early ART start program (ART-NET) at the University of California San Diego were interviewed to better understand experiences with access to same-day ART. Interviews were analyzed for main themes emerging in three general areas: reasons to start, reasons to delay, and factors influencing early ART adherence. Participants reported starting anywhere from right away (same visit as diagnosis) to within a few weeks (median 10.5 days). Reasons to start right away included fear of what could happen if not treated, personal health, influence of people/resources at the clinic, and study participation. Most had small delays in ART start because of structural (insurance, costs) and intentional delays (getting additional medical consultations or additional information/resources). Adherence facilitators included desires to improve CD4/viral load and strong positive beliefs in benefits of suppression. Participants were largely supportive of rapid ART start and appeared to rely on CD4 and viral load data as “proof” of need for ART and its impact. Providing evidence for the impact of HIV on one’s body may be particularly helpful for asymptomatic, newly diagnosed individuals considering immediate ART start.

PrEP’s potential benefit for men who have sex with men (MSM) who use stimulants may be limited by adherence or prescriber willingness to recommend PrEP due to concerns of non-compliance. Using data from PATH-PrEP, a 48-week study evaluating PrEP for MSM in Los Angeles, we modeled an interaction between stimulant use and condomless sex with multiple partners (CAS-MP) on prevention-effective dried blood spot tenofovir-diphosphate concentrations. At week 4, participants reporting stimulant use and CAS-MP had a decreased odds of prevention-effective adherence compared to non-stimulant use and non-CAS-MP (AOR 0.15, 95% CI 0.04-0.57). From week 4 to 48, participants reporting stimulant use and CAS-MP had increased odds of prevention-effective adherence (AOR 1.06 per week, 95%CI 1.01-1.12). Participants reporting CAS-MP without stimulant use had no significant change in prevention-effective adherence (AOR 0.99 per week, 95%CI 0.96-1.02). Stimulant use moderated the association of CAS-MP on prevention-effective PrEP adherence over time.

Ancillary service needs likely influence time to diagnosis and presentation for HIV care. The effect of both met and unmet needs on late presentation to HIV care is not well understood. We used baseline data from 348 people with HIV (PWH) with no prior HIV care who enrolled in iENGAGE (a randomized controlled trial (RCT) of an intervention to support retention in care) at one of four HIV clinics in the US. A standardized baseline questionnaire collected information on ancillary service needs, and whether each need was presently unmet. We examined covariates known to be associated with disease stage at presentation to care and their association with needs. We subsequently assessed the relationship of needs with CD4 accounting for those other covariates by estimating prevalence ratios (PR) using inverse probability weights. Most patients enrolling in the RCT were male (79%) and the majority were Black (62%); median age was 34 years. Prevalence of any reported individual need was 69%. One-third of the sample had a baseline CD4 cell count

Pre-exposure prophylaxis (PrEP) has the ability to curb HIV transmission among women if they are highly adherent (e.g. 6/7 weekly doses). In a recent PrEP demonstration project with 95 women who inject drugs (WWID) in Philadelphia, PA, USA, PrEP uptake was high but adherence was low. This qualitative study draws upon the Behavioral Model for Vulnerable Populations (BMVP) to describe how the context of 23 WWID's lives challenged PrEP adherence using narrative data from in-depth interviews. Content analysis suggests that women's need to organize their day around predisposing survival needs made it difficult to prioritize PrEP. Adherence was further challenged by dis-enabling structural forces such as entry into institutions that do not provide PrEP (e.g., drug treatment and correctional facilities) and medication diversion to illicit marketplaces. Overtime, women's perceived need for PrEP was dynamic: in periods they characterized as risky, women considered PrEP highly beneficial and described enhanced motivation to adhere. In periods of low perceived risk, women were less committed to continuing daily PrEP in the context of their competing survival needs. In sum, WWID faced challenges to PrEP adherence that correspond to all of the BMVP domains. To optimize PrEP for WWID, multi-level programs are needed that address the determinants that both increase HIV susceptibility and undermine adherence.

Background Effective implementation strategies are needed to increase engagement in HIV services in hyperendemic settings. We conducted a pragmatic cluster-randomized trial in a high-risk, highly mobile fishing community (HIV prevalence: approximately 38%) in Rakai, Uganda, to assess the impact of a community health worker-delivered, theory-based (situated Information, Motivation, and Behavior Skills), motivational interviewing-informed, and mobile phone application-supported counseling strategy called “Health Scouts” to promote engagement in HIV treatment and prevention services. Methods and findings The study community was divided into 40 contiguous, randomly allocated clusters (20 intervention clusters, n = 1,054 participants at baseline; 20 control clusters, n = 1,094 participants at baseline). From September 2015 to December 2018, the Health Scouts were deployed in intervention clusters. Community-wide, cross-sectional surveys of consenting 15 to 49-year-old residents were conducted at approximately 15 months (mid-study) and at approximately 39 months (end-study) assessing the primary programmatic outcomes of self-reported linkage to HIV care, antiretroviral therapy (ART) use, and male circumcision, and the primary biologic outcome of HIV viral suppression (, Larry Chang and co-workers study an intervention by which community health workers aim to promote engagement in HIV treatment and prevention services in Uganda., Author summary Why was this study done? HIV remains a major global cause of morbidity and mortality. Some communities have very high levels of HIV infection. These hyperendemic communities may benefit from new strategies to better implement proven HIV treatment and prevention services. A client-centered and mobile phone application-supported counseling approach used by community health workers may be a new strategy to improve the uptake of HIV treatment and prevention services in these settings. What did the researchers do and find? We conducted a cluster randomized controlled trial to evaluate the effectiveness of a new community health worker strategy to improve HIV services uptake in a hyperendemic community in Uganda. These community health workers were deployed in this community for about 3 years. We compared outcomes in clusters randomized to community health workers with clusters randomized to not having community health workers. We found that residents in areas, which had the community health workers, were more likely to be in HIV care and to be on antiretroviral therapy. We found no significant changes in HIV viral suppression or male circumcision coverage. What do these findings mean? These findings suggest that this novel community health worker approach may be a useful strategy to help people living with HIV engage in care and get effective treatment. This type of intervention may contribute to controlling HIV in settings with high HIV burden.

Few studies have employed standardized alcohol misuse measures to assess relationships with sexual risk and HIV/syphilis infections among Chinese men who have sex with men (MSM).We conducted a cross-sectional study among MSM in Beijing during 2013-2014. An interviewer-administered survey was conducted to collect data on sociodemographics, high-risk behaviors, and alcohol use/misuse patterns (hazardous/binge drinking and risk of alcohol dependence) in the past 3 months using Alcohol Use Disorder Identification Test-Consumption (AUDIT-C). We defined AUDIT-C score ≥4 as recent hazardous drinkers, and drinking ≥6 standard drinks on one occasion as recent binge drinkers.Of 3588 participants, 14.4% reported hazardous drinking, 16.8% reported binge drinking. Hazardous and binge drinking are both associated with these factors (p0.05): older age, being migrants, living longer in Beijing, township/village origin, being employed, higher income, self-perceived low/no HIV risk, and sex-finding via non-Internet venues. Hazardous (vs non-hazardous) or binge (vs. non-binge) drinkers were more likely to use illicit drugs, use alcohol before sex, have multiple partnerships, pay for sex, and have condomless insertive anal intercourse. MSM who reported binge (AOR, 1.34, 95% CI, 1.02-1.77) or hazardous (AOR, 1.36, 95% CI, 1.02-1.82) drinking were more likely to be HIV-infected. MSM at high risk of current alcohol dependence (AUDIT-C ≥8) were more likely to be HIV- (AOR, 2.37, 95% CI, 1.39-4.04) or syphilis-infected (AOR, 1.96, 95% CI, 1.01-3.86).Recent alcohol misuse was associated with increased sexual and HIV/syphilis risks among Chinese MSM, emphasizing the needs of implementing alcohol risk reduction programs in this population.

Chinese men who have sex with men (MSM) are disproportionally affected by HIV and sexually transmitted infections (STIs), but little is known about the role of current marital status and living arrangements in shaping their HIV/syphilis risk. A cross-sectional study was conducted among MSM in Beijing, China to assess their sociodemographic/behavioral characteristics between married and single MSM, and test the hypothesis that currently married MSM have a lower odds of being HIV- and/or syphilis-infected. Participants were recruited via short message services, peer referral, internet, and community outreach. Data collection was based on a questionnaire survey and self-report. Infection status was lab-confirmed. Multivariable logistic regression modeling was used to assess the association of marital status and living arrangement with HIV/syphilis risk. Of the 3588 MSM, infection prevalence was high (HIV = 12.7%; syphilis = 7.5%). Compared to single MSM living with their boyfriends or male sex partners, single/alone MSM and married MSM living with wives were less likely to practice condomless insertive (CIAI) or receptive (CRAI) anal intercourse with men; while married MSM living with boyfriends or male sex partner were more likely to practice CIAI and CRAI, and married MSM were more likely to practice condomless vaginal sex. Compared to men living with boyfriends/sexual partners, significantly reduced odds of being HIV-positive were seen among married MSM who were living alone (aOR: 0.52; 95%CI: 0.28, 0.94) or living with their wives (aOR: 0.53; 95%CI: 0.31, 0.89). Similarly, single MSM living alone (aOR: 0.67; 95%CI: 0.48, 0.95) and married MSM living with their wives were comparatively less likely to be syphilis-infected (aOR: 0.43; 95%CI: 0.23, 0.79). Future efforts should consider characteristics of marital status and living arrangements for designing subgroup-specific risk reduction strategies among Chinese MSM.

We assessed the role of depressive symptoms on adherence to daily oral FTC/TDF for HIV PrEP in cisgender men who have sex with men (MSM) and transgender women who have sex with men (TGW) using data from the iPrEx OLE study. A marginal structural logistic regression model was used to estimate the effect of time-varying CES-D scores on having protective levels of drug concentration, adjusting for confounding by sexual practices over time, prior adherence, and baseline demographic characteristics. We found a non-monotonic relationship between CES-D score and odds of protective FTC/TDF levels in MSM. We found evidence that the effect of depression on adherence varied between MSM and TGW, and that depressive symptoms did not contribute greatly to decreased adherence on a population scale. We recommend that depressive symptoms not preclude the prescription of PrEP, and that MSM and TGW be studied separately.

Monitoring adherence to pre-exposure prophylaxis (PrEP) is part of the recommended package for PrEP prescribing, yet ongoing concerns about how to do so confidently are exacerbated by gross discrepancies in reported and actual use in clinical trials. We evaluated concordance between reports of recent PrEP dosing collected via neutral interviewing and drug quantitation in the iPrEx open-label extension, where participants (n = 1172) had the choice to receive or not receive PrEP. Self-report of recent dosing (at least one PrEP dose in the past 3-day) was the most common report (84 % of participants), and among these 83 % did have quantifiable levels of drug. The vast majority of those reporting no doses in the past 3-day (16 % of the sample) did not have quantifiable levels of drug (82 %). Predictors of over-report of dosing included younger age and lower educational attainment. Monitoring recent PrEP use through neutral interviewing may be a productive approach for clinicians to consider in implementation of real-world PrEP. Strategies to capture longer term or prevention-effective PrEP use, particularly for younger cohorts, are needed.

Linking and engaging HIV-positive patients in care is the key bridging step to glean the documented health and prevention advantages of antiretroviral therapy (ART). In China, HIV transmission among men who have sex with men (MSM) is surging, yet many HIV-positive MSM do not use HIV care services. We conducted a qualitative study in order to help positive interventions to promote linkage-to-care in this key population. Four focus group discussions (FGD) were held among HIV-positive MSM in Beijing, China, to ascertain knowledge, beliefs, attitudes, and practices related to HIV care. FGD participates highlighted six major barriers of linkage to/engagement in HIV care: (1) perceived discrimination from health care workers; (2) lack of guidance and follow-up; (3) clinic time or location inconvenience; (4) privacy disclosure concerns; (5) psychological burden of committing to HIV care; and (6) concerns about treatment. Five major sub-themes emerged from discussions on the facilitators of linkage to/engagement in care: (1) peer referral and accompaniment; (2) free HIV care; (3) advocacy from HIV-positive MSM counselors; (4) extended involvement for linking MSM to care; and (5) standardization of HIV care (i.e., reliable high quality care regardless of venue). An understanding of the barriers and facilitators that may impact the access to HIV care is essential for improving the continuum of care for MSM in China. Findings from our study provide research and policy guidance for how current HIV prevention and care interventions can be enhanced to link and engage HIV-positive MSM in HIV care.

Background Unmet needs among hospitalized patients with HIV may prevent engagement in HIV care leading to worse clinical outcomes. Our aim was to examine the role of unmet subsistence needs (eg, housing, transportation, and food) and medical needs (eg, mental health and substance abuse treatment) as barriers for retention in HIV care and viral load (VL) suppression. Methods We used data from the Mentor Approach for Promoting Patients' Self-Care intervention study, the enrolled hospitalized HIV patients at a large publicly funded hospital between 2010 and 2013, who were out-of-care. We examined the effect of unmet needs on retention in HIV care (attended HIV appointments within 0-30 days and 30-180 days) and VL suppression, 6 months after discharge. Results Four hundred seventeen participants were enrolled, 78% reported having ≥1 unmet need at baseline, most commonly dental care (55%), financial (43%), or housing needs (34%). Participants with unmet needs at baseline, compared to those with no needs, were more likely to be African American, have an existing HIV diagnosis and be insured. An unmet need for transportation was associated with lower odds of retention in care [odds ratio (OR): 0.5; 95% confidence interval (CI): 0.34 to 0.94, P = 0.03], even after adjusting for other factors. Compared to participants with no need, those who reported ≥3 unmet subsistence needs were less likely to demonstrate VL improvement (OR: 0.51; 95% CI: 0.28 to 0.92; P = 0.03) and to be retained in care (OR: 0.52; 95% CI: 0.28 to 0.95; P = 0.03). Conclusion Broader access to programs that can assist in meeting subsistence needs among hospitalized patients could have significant individual and public health benefits.

Bedaquiline, a potent new therapy for drug-resistant tuberculosis, results in improved survival including in HIV patients with multidrug and extensively drug-resistant tuberculosis. In line with WHO recommendations, in South Africa and other low-income and middle-income settings, antiretroviral therapy is switched from generic fixed-dose combination efavirenz-containing regimens to twice-daily nevirapine with separate companion pills because of interactions between efavirenz and bedaquiline. Early data suggest a signal for low antiretroviral therapy adherence after this antiretroviral therapy switch. Mortality and other tuberculosis-specific benefits noted with bedaquiline treatment in multidrug and extensively drug-resistant tuberculosis HIV might be compromised by HIV viral failure, and emergent antiretroviral resistance. Programmatic responses, such as adherence support and dual pharmacovigilance, should be instituted; antiretroviral therapy initiation with fixed-dose combinations without bedaquiline drug interactions should be strongly considered.

Background: Youth living with HIV (YLWH) are confronted with many self-care challenges that can be experienced as overwhelming in the context of normal developmental processes that characterize adolescence and young adulthood. A sizable minority of YLWH have unsuppressed viral loads in the United States attributable to antiretroviral therapy (ART) nonadherence. Interventions to promote sustained viral suppression in YLWH are needed. Objective: The aim of this study is to evaluate the efficacy of the Triggered Escalating Real-Time Adherence (TERA) intervention in comparison with standard of care (SOC) in YLWH (aged 13-24 years) failing ART on (1) primary outcome measures—HIV viral suppression (VLS), defined as both

Background In resource-limited rural settings, scale-up of services to eliminate mother-to-child transmission of HIV has not been as effective as in better resourced urban settings. In sub-Saharan Africa, women often require male partner approval to access and remain engaged in HIV care. Our study will evaluate a promising male engagement intervention (“Homens para Saude Mais” (HoPS+) [Men for Health Plus]) targeting the elimination of mother-to-child transmission in rural Mozambique. Design We will use a cluster randomized clinical trial design to engage 24 health facilities (12 intervention and 12 standard of care), with 45 HIV-infected seroconcordant couples per clinic. The planned intervention will engage male partners to address social-structural and cultural factors influencing eMTCT based on new couple-centered integrated HIV services. Conclusions The HoPS+ study will evaluate the effectiveness of engaging male partners in antenatal care to improve outcomes among HIV-infected pregnant women, their HIV-infected male partners, and their newborn children. Our objectives are to: (1) Implement and evaluate the impact of male-engaged, couple-centered services on partners' retention in care, adherence to antiretroviral therapy, early infant diagnosis uptake, and mother-to-child transmission throughout pregnancy and breastfeeding; (2) Investigate the impact of HoPS+ intervention on hypothesized mechanisms of change; and (3) Use validated simulation models to evaluate the cost-effectiveness of the HoPS+ intervention with the use of routine clinical data from our trial. We expect the intervention to lead to strategies that can improve outcomes related to partners' retention in care, uptake of services for HIV-exposed infants, and reduced MTCT.