Barriers to linkage and retention in HIV care still persist among adolescent girls and young women in western Kenya.

Adolescent girls and young women (AGYW) in sub-Saharan Africa experience delayed linkage to and poor retention in HIV care. Identifying and addressing specific barriers in HIV care programming is important to achieving the upgraded UNAIDS 95-95-95 targets and epidemic control. We examined these challenges among 103 HIV-positive AGYW in and out of HIV care in communities around Lake Victoria in western Kenya as part of a larger qualitative study to identify drivers of HIV testing and HIV care utilisation in key populations. We used the social-ecological model to guide development of interview guides. Individual-level barriers included denial and forgetfulness and gendered household responsibilities, medication side effects, especially if taken without food, pills being too big and difficult to swallow and the burden of a daily medication-taking regimen. Interpersonal barriers included troubled family relationships and pervasive fears of stigma and discrimination by friends and family. Communitylevel barriers were stigmatising attitudes toward people living with HIV. Health-system barriers included negative provider attitudes and confidentiality breaches. At the structural level, participants noted high costs due to long travel times to facilities, long clinic waiting times, household food insecurity and school and work commitments. AGYW's limited decision-making autonomy due to age and gender norms, including their reliance on the authority of older adults, makes these barriers especially troubling. Innovative treatment approaches that take into account the unique vulnerabilities of AGYW are urgently needed.

Adherence Measured Using Electronic Dose Monitoring is Associated with Emergent Antiretroviral Resistance and Poor Outcomes in People with Human Immunodeficiency Virus/AIDS and Multidrug-Resistant Tuberculosis.

BACKGROUND: Medication adherence is known to challenge treatment of human immunodeficiency virus (HIV)/AIDS and multidrug-resistant tuberculosis (MDR-TB). We hypothesized that adherence using electronic dose monitoring (EDM) would identify an antiretroviral therapy (ART) adherence threshold for emergent ART resistance and predict treatment outcomes in patients with MDR-TB and HIV on ART and bedaquiline-containing TB regimens. METHODS: A prospective cohort of adults with MDR-TB and HIV on ART and initiating MDR-TB treatment with bedaquiline were enrolled at a public hospital in KwaZulu-Natal, South Africa (PRAXIS Study). Participants received separate EDM devices that measure adherence to bedaquiline and ART (nevirapine or lopinavir/ritonavir). Adherence was calculated cumulatively over 6 months. Participants were followed through completion of MDR-TB treatment. HIV genome sequencing was performed at baseline and 2 and 6 months on samples with HIV RNA ≥1000 copies/mL. RESULTS: From November 2016 through February 2018, 198 persons with MDR-TB and HIV were enrolled and followed (median, 17.2 months; interquartile range, 12.2-19.6). Eleven percent had baseline ART resistance mutations, and 7.5% developed emergent ART resistance at 6 months. ART adherence was independently associated with ART resistance and mortality. Modeling identified a significant (P < .001), linear association between ART adherence and emergent resistance, suggesting a strong association without a specific threshold. CONCLUSIONS: Our findings highlight the need for ART resistance testing, especially in patients with MDR-TB and HIV, which is currently not the standard of care in resource-limited settings. Despite short follow-up duration, reduced ART adherence was significantly associated with emergent resistance and increased mortality. CLINICAL TRIALS REGISTRATION: NCT03162107.

Factors Associated with HIV Disclosure Status Among iENGAGE Cohort of New to HIV Care Patients.

HIV disclosure is an important behavior with implications for HIV treatment and prevention but understudied among new to HIV care patients who face unique challenges adjusting to a new diagnosis. This study evaluated the factors associated with HIV disclosure status and patterns of HIV disclosure among new to HIV care patients. A cross-sectional study was conducted evaluating the iENGAGE (integrating ENGagement and Adherence Goals upon Entry) cohort. Participants were enrolled in this randomized behavioral trial between December 2013 and June 2016. The primary and secondary outcomes included HIV disclosure status (Yes/No) and patterns of disclosure (Broad, Selective and Nondisclosure), respectively. Logistic and Multinomial Logistic Regression were used to evaluate the association of participant factors with HIV disclosure and patterns of HIV disclosure, respectively. Of 371 participants, the average age was 37 ± 12 years, 79.3% were males, and 62.3% were African Americans. A majority of participants (78.4%) disclosed their HIV status at baseline, 63.1% were broad disclosers and 15.2% were selective disclosers. In multivariable regression, black race, emotional support, and unmet needs predicted any HIV and broad disclosure, whereas males, emotional support, active coping, and acceptance were associated with selective disclosure. Interventions to promote early disclosure should focus on coping strategies and unmet needs, particularly among black and male people living with HIV initiating care.

HIV-related stigma, depression, and social support are associated with health-related quality of life among patients newly entering HIV care.

Entering HIV care is a vulnerable time for newly diagnosed individuals often exacerbating psychosocial difficulties, which may contribute to poor health-related quality of life (HRQOL) ultimately influencing health behaviors including ART adherence, the driver of viral load suppression. Understanding HRQOL in people newly entering HIV care is critical and has the potential to guide practice and research. This exploratory cross-sectional study examined demographic, clinical, and psychosocial factors associated with limitations in four specific domains of HRQOL among persons initially entering outpatient HIV care at four sites in the United States (n = 335). In the unadjusted analysis, female gender was significantly associated with sub-optimal HRQOL with women having increased odds of reporting HRQOL challenges with pain, mood, mobility, and usual activity when compared to men. The adjusted models demonstrated attenuation of parameter estimates and loss of statistical significance for the associations with impaired HRQOL observed among women in unadjusted analyses, suggesting psychosocial factors related to HRQOL are complex and interrelated. Findings are consistent with a robust literature documenting gender-related health disparities. Programs aimed at improving HRQOL for persons initially entering HIV care are warranted generally, and specifically for women, and must address modifiable psychosocial factors via mechanisms including coping and social support.

Correction to: Experienced HIV-Related Stigma and Psychological Distress in Peruvian Sexual and Gender Minorities: A Longitudinal Study to Explore Mediating Roles of Internalized HIV-Related Stigma and Coping Styles.

Correction to: AIDS and Behavior (2018) 1-14 https://doi.org/10.1007/s10461-018-2348-2 . In the original publication of the article, the given name of the second author was not correct. The name has been corrected with this erratum.

Experienced HIV-Related Stigma and Psychological Distress in Peruvian Sexual and Gender Minorities: A Longitudinal Study to Explore Mediating Roles of Internalized HIV-Related Stigma and Coping Styles.

Experiencing HIV-related stigma has important impacts on the mental health of people living with HIV, which has implications for treatment adherence, disease progression, and health outcomes. The impacts of stigma are particularly important to consider among sexual and gender minorities, who often face a disproportionate burden of HIV. To address the implications of stigma in these key populations, we leveraged a longitudinal study conducted among Peruvian sexual and gender minorities to compare the relative effects of multiple mediators affecting the relationship between experienced HIV-related stigma and psychological distress: internalized HIV-related stigma, adaptive coping, and maladaptive coping. HIV-related stigma, coping, and distress were measured, respectively, at 24 weeks, 36 weeks, and 48 weeks post-diagnosis for 145 participants from the Sabes Study. HIV-related maladaptive coping largely mediated the relationship between experienced HIV-related stigma and distress. Our findings suggest interventions targeting maladaptive coping may alleviate the mental health consequences of experiencing HIV-related stigma.

A Web-Based Data Collection Platform for Multisite Randomized Behavioral Intervention Trials: Development, Key Software Features, and Results of a User Survey.

BACKGROUND: Meticulous tracking of study data must begin early in the study recruitment phase and must account for regulatory compliance, minimize missing data, and provide high information integrity and/or reduction of errors. In behavioral intervention trials, participants typically complete several study procedures at different time points. Among HIV-infected patients, behavioral interventions can favorably affect health outcomes. In order to empower newly diagnosed HIV positive individuals to learn skills to enhance retention in HIV care, we developed the behavioral health intervention Integrating ENGagement and Adherence Goals upon Entry (iENGAGE) funded by the National Institute of Allergy and Infectious Diseases (NIAID), where we deployed an in-clinic behavioral health intervention in 4 urban HIV outpatient clinics in the United States. To scale our intervention strategy homogenously across sites, we developed software that would function as a behavioral sciences research platform. OBJECTIVE: This manuscript aimed to: (1) describe the design and implementation of a Web-based software application to facilitate deployment of a multisite behavioral science intervention; and (2) report on results of a survey to capture end-user perspectives of the impact of this platform on the conduct of a behavioral intervention trial. METHODS: In order to support the implementation of the NIAID-funded trial iENGAGE, we developed software to deploy a 4-site behavioral intervention for new clinic patients with HIV/AIDS. We integrated the study coordinator into the informatics team to participate in the software development process. Here, we report the key software features and the results of the 25-item survey to evaluate user perspectives on research and intervention activities specific to the iENGAGE trial (N=13). RESULTS: The key features addressed are study enrollment, participant randomization, real-time data collection, facilitation of longitudinal workflow, reporting, and reusability. We found 100% user agreement (13/13) that participation in the database design and/or testing phase made it easier to understand user roles and responsibilities and recommended participation of research teams in developing databases for future studies. Users acknowledged ease of use, color flags, longitudinal work flow, and data storage in one location as the most useful features of the software platform and issues related to saving participant forms, security restrictions, and worklist layout as least useful features. CONCLUSIONS: The successful development of the iENGAGE behavioral science research platform validated an approach of early and continuous involvement of the study team in design development. In addition, we recommend post-hoc collection of data from users as this led to important insights on how to enhance future software and inform standard clinical practices. TRIAL REGISTRATION: Clinicaltrials.gov NCT01900236; (https://clinicaltrials.gov/ct2/show/NCT01900236 (Archived by WebCite at http://www.webcitation.org/6qAa8ld7v).

Risk, safety and sex among male PrEP users: time for a new understanding.

Recent advances in biomedical HIV prevention have led to optimistic projections of a dramatic worldwide reduction of new infections by 2030. This optimism is counterbalanced by concerns that the protective benefits of one such technology, HIV pre-exposure prophylaxis (PrEP), may be negated by increases in other behaviours that offset these benefits (risk compensation). To contribute to a deeper understanding of concepts of safety and risk in the context of HIV PrEP, we draw on the narrative accounts of 61 male PrEP users who participated in the inaugural PrEP demonstration project: the iPrEx open-label extension study. We conducted in-depth interviews with a purposeful sample of iPrEx participants. Overall, participants did not report significant changes to their sexual practices once they had begun taking PrEP. Rather, participants reported experiencing a sense of relief or reprieve from HIV-related stress. This unburdening of fear did not necessarily lead to condomless sex. Instead, men expressed feeling a sense of security and less free-floating fear of HIV. We contend that no longer living under the threat of HIV is a significant benefit that has not been adequately explored in HIV prevention research.

Characterization of HIV Seroconverters in a TDF/FTC PrEP Study: HPTN 067/ADAPT.

BACKGROUND: HIV Prevention Trials Network (HPTN) 067/ADAPT evaluated tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) pre-exposure prophylaxis (PrEP) in women (South Africa) and men who have sex with men (Thailand, US). Participants received once-weekly directly observed therapy (DOT) of TDF/FTC, and were then randomized to daily, time-driven, or event-driven PrEP. This report describes characterization of 12 HIV seroconversion events in this trial. METHODS: HIV rapid testing was performed at study sites. Retrospective testing included fourth generation assays, HIV RNA testing, Western blot, an HIV-1/2 discriminatory assay, resistance testing, and antiretroviral drug testing. RESULTS: Six of the 12 seroconverters received TDF/FTC in the DOT phase, but were not randomized (3 were acutely infected at enrollment; 2 were infected during the DOT phase; 1 was not randomized because of pregnancy). One of the 6 randomized participants had acute infection at randomization but was not diagnosed for 3-4 months because HIV rapid tests were nonreactive; continued daily PrEP use was associated with false-negative antibody tests and low HIV RNA levels. The 5 participants infected after randomization included 4 with low adherence to the PrEP regimen, and one who reported a 7-day period without dosing before infection. Three participants had TDF/FTC resistance (M184I, K65R), including 2 who received only 4 once-weekly TDF/FTC doses; most TDF/FTC mutations were detected by next generation sequencing only. CONCLUSIONS: In HPTN 067/ADAPT, participants who acquired HIV infection had infrequent PrEP dosing or low/suboptimal adherence. Sensitive assays improved detection of HIV infection and drug resistance. Drug resistance was observed with limited PrEP exposure.

Efficacy of peer-led interventions to reduce unprotected anal intercourse among men who have sex with men: a meta-analysis.

OBJECTIVE: To conduct a systematic review and meta-analysis to evaluate the efficacy of peer-led interventions in reducing unprotected anal intercourse (UAI) among men who have sex with men (MSM). METHODS: Randomized clinical trials (RCTs), quasi-experimental studies, pre- and post-intervention studies without control groups, and serial cross-sectional assessments involving peers delivering interventions among MSM and published as of February 2012 were identified by systematically searching 13 electronic databases and cross-referencing. Effect sizes (ES) were calculated as the changes of standardized mean difference (SMD) in UAI between groups or pre-post intervention. RESULTS: A total of 22 studies met the eligibility criteria, including five RCTs, six quasi-experimental studies, six pre-and-post intervention studies, and five serial cross-sectional intervention studies. We used 15 individual studies including 17 interventions for overall ES calculation; peer-led interventions reduced UAI with any sexual partners in meta-analysis (mean ES: -0.27; 95% confidence interval [CI]: -0.41, -0.13; P<0.01). Subgroup analyses demonstrated a statistically significant reduction on UAI in quasi-experimental studies (mean ES: -0.30; 95% CI: -0.50, -0.09; P = 0.01) and serial cross-sectional intervention studies (mean ES: -0.33; 95% CI: -0.57, -0.09; P = 0.01), but non-significant reduction in RCTs (mean ES: -0.15; 95% CI: -0.36, 0.07; P = 0.18) or pre- and post-intervention studies (mean ES: -0.29; 95% CI: -0.69, 0.11; P = 0.15). Heterogeneity was large across these 15 studies (I2 = 77.5%; P<0.01), largely due to pre-and-post intervention studies and serial cross-sectional intervention studies. CONCLUSIONS: Peer-led HIV prevention interventions reduced the overall UAI among MSM, but the efficacy varied by study design. More RCTs are needed to evaluate the effect of peer-led interventions while minimizing potential bias.

Clinician-delivered intervention during routine clinical care reduces unprotected sexual behavior among HIV-infected patients.

OBJECTIVE: To evaluate the effectiveness of a clinician-delivered intervention, implemented during routine clinical care, in reducing unprotected sexual behavior of HIV-infected patients. DESIGN: A prospective clinical trial comparing the impact of a clinician-delivered intervention arm vs. a standard-of-care control arm on unprotected sexual behavior of HIV-infected patients. SETTING: The 2 largest HIV clinics in Connecticut. PARTICIPANTS: A total of 497 HIV-infected patients, aged > or =18 years, receiving HIV clinical care. INTERVENTION: HIV clinical care providers conducted brief client-centered interventions at each clinical encounter that were designed to help HIV-infected patients reduce unprotected sexual behavior. MAIN OUTCOME MEASURES: Unprotected insertive and receptive vaginal and anal intercourse and unprotected insertive oral sex; unprotected insertive and receptive vaginal and anal intercourse only. RESULTS: HIV-infected patients who received the clinician-delivered intervention showed significantly reduced unprotected insertive and receptive vaginal and anal intercourse and insertive oral sex over a follow-up interval of 18 months (P < 0.05). These behaviors increased across the study interval for patients in the standard-of-care control arm (P < 0.01). For the measure of unprotected insertive and receptive vaginal and anal sex only, there was a trend toward a reduction in unprotected sex among intervention arm participants over time (P < 0.09), and a significant increase in unprotected sex in the standard-of-care control arm (P < 0.01). CONCLUSIONS: A clinician-delivered HIV prevention intervention targeting HIV-infected patients resulted in reductions in unprotected sex. Interventions of this kind should be integrated into routine HIV clinical care.