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To determine retention in care and virologic suppression among HIV-infected adolescents and young adults attending an adolescent-friendly clinic compared to those attending the standard pediatric clinic at the same site. Retrospective cohort analysis. Government supported, hospital-based antiretroviral clinic in KwaZulu-Natal, South Africa. Two hundred forty-one perinatally HIV-infected adolescents and young adults aged 13 to 24 years attending an adolescent-friendly clinic or the standard pediatric clinic from April 2007 to November 2015. Attendance in an adolescent-friendly clinic compared to a standard pediatric clinic. Retention in care defined as one clinic visit or pharmacy refill in the prior 6 months; HIV-1 viral suppression defined as < 400 copies/ml. Overall, among 241 adolescents and young adults, retention was 89% (214/241) and viral suppression was 81% (196/241). Retention was higher among those attending adolescent clinic (95%) versus standard pediatric clinic (85%; OR 3.7; 95% confidence interval (CI) 1.2-11.1; p = 0.018). Multivariable logistic regression adjusted for age at ART initiation, gender, pre-ART CD4 count, months on ART, and tuberculosis history indicated higher odds of retention in adolescents and young adults attending adolescent compared to standard clinic (AOR = 8.5; 95% CI 2.3-32.4; p = 0.002). Viral suppression was higher among adolescents and young adults attending adolescent (91%) versus standard pediatric clinic (80%; OR 2.5; 95% CI 1.1-5.8; p = 0.028). A similar multivariable logistic regression model indicated higher odds of viral suppression in adolescents and young adults attending adolescent versus standard pediatric clinic (AOR = 3.8; 95% CI 1.5-9.7; p = 0.005). Adolescents and young adults attending an adolescent-friendly clinic had higher retention in care and viral suppression compared to adolescents attending the standard pediatric clinic. Further studies are needed to prospectively assess the impact of adolescent-friendly services on these outcomes.

Successful scale-up of PrEP for HIV prevention in African adolescent girls and young women (AGYW) requires integration of PrEP into young women’s everyday lives. We conducted interviews and focus group discussions with 137 AGYW PrEP users aged 16–25 from South Africa and Kenya. Individual and relational enablers and disablers were explored at key moments during their PrEP-user journey from awareness, initiation and early use through persistence, including PrEP pauses, restarts, and discontinuation. PrEP uptake was facilitated when offered as part of an integrated sexual reproductive health service, but hampered by low awareness, stigma and misconceptions about PrEP in the community. Daily pill-taking was challenging for AGYW due to individual, relational and structural factors and PrEP interruptions (intended or unintended) were described as part of AGYW’s PrEP-user journey. Disclosure, social support, adolescent-friendly health counseling, and convenient access to PrEP were reported as key enablers for PrEP persistence.

To determine rates of retention and viral suppression among adolescents living with perinatally-acquired HIV who remained in pediatric care compared to those who transitioned to adult care. We evaluated a natural experiment involving adolescents living with perinatally-acquired HIV who were attending a government-supported antiretroviral clinic in KwaZulu-Natal, South Africa. Prior to 2011, all adolescents transitioned to adult care at 12 years of age. Due to a policy change, all adolescents were retained in pediatric care after 2011. We analyzed adolescents two years before and two years after this policy change. Outcomes were retention in care and HIV viral suppression one year after transition to adult care or the 13th birthday if remaining in pediatric care. In the natural experiment, 180 adolescents who turned 12 years old between 2011 and 2014 were evaluated; 35 (20%) transitioned to adult care under the old policy and 145 (80%) remained in pediatric care under the new policy. Adolescents who transitioned to the adult clinic had lower rates of retention in care (49%; 17/35) compared to adolescents remaining in the pediatric clinic (92%; 134/145; p<0.001). Retention in care was lower (ARR 0.59; 95%CI 0.43-0.82; p = 0.001) and viral suppression was similar (ARR = 1.06, 95%CI 0.89-1.26; p = 0.53) for adolescents who transitioned to adult care compared to adolescents remaining in pediatric care. Adolescents living with perinatally-acquired HIV appear to have higher retention in care when cared for in pediatric clinics compared to adult clinics. Longer-term follow-up is needed to fully assess viral suppression.

HIV self-testing allows HIV testing at any place and time and without health workers. HIV self-testing may thus be particularly useful for female sex workers (FSWs), who should test frequently but face stigma and financial and time barriers when accessing healthcare facilities. We conducted a cluster-randomized controlled health systems trial among FSWs in Kampala, Uganda, to measure the effect of 2 HIV self-testing delivery models on HIV testing and linkage to care outcomes. FSW peer educator groups (1 peer educator and 8 participants) were randomized to either (1) direct provision of HIV self-tests, (2) provision of coupons for free collection of HIV self-tests in a healthcare facility, or (3) standard of care HIV testing. We randomized 960 participants in 120 peer educator groups from October 18, 2016, to November 16, 2016. Participants' median age was 28 years (IQR 24-32). Our prespecified primary outcomes were self-report of any HIV testing at 1 month and at 4 months; our prespecified secondary outcomes were self-report of HIV self-test use, seeking HIV-related medical care and ART initiation. In addition, we analyzed 2 secondary outcomes that were not prespecified: self-report of repeat HIV testing-to understand the intervention effects on frequent testing-and self-reported facility-based testing-to quantify substitution effects. Participants in the direct provision arm were significantly more likely to have tested for HIV than those in the standard of care arm, both at 1 month (risk ratio [RR] 1.33, 95% CI 1.17-1.51, p < 0.001) and at 4 months (RR 1.14, 95% CI 1.07-1.22, p < 0.001). Participants in the direct provision arm were also significantly more likely to have tested for HIV than those in the facility collection arm, both at 1 month (RR 1.18, 95% CI 1.07-1.31, p = 0.001) and at 4 months (RR 1.03, 95% CI 1.01-1.05, p = 0.02). At 1 month, fewer participants in the intervention arms had sought medical care for HIV than in the standard of care arm, but these differences were not significant and were reduced in magnitude at 4 months. There were no statistically significant differences in ART initiation across study arms. At 4 months, participants in the direct provision arm were significantly more likely to have tested twice for HIV than those in the standard of care arm (RR 1.51, 95% CI 1.29-1.77, p < 0.001) and those in the facility collection arm (RR 1.22, 95% CI 1.08-1.37, p = 0.001). Participants in the HIV self-testing arms almost completely replaced facility-based testing with self-testing. Two adverse events related to HIV self-testing were reported: interpersonal violence and mental distress. Study limitations included self-reported outcomes and limited generalizability beyond FSWs in similar settings. In this study, HIV self-testing appeared to be safe and increased recent and repeat HIV testing among FSWs. We found that direct provision of HIV self-tests was significantly more effective in increasing HIV testing among FSWs than passively offering HIV self-tests for collection in healthcare facilities. HIV self-testing could play an important role in supporting HIV interventions that require frequent HIV testing, such as HIV treatment as prevention, behavior change for transmission reduction, and pre-exposure prophylaxis. ClinicalTrials.gov NCT02846402.

Antiretroviral-based interventions for HIV-1 prevention, including antiretroviral therapy (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) to reduce the susceptibility of HIV-1 uninfected persons, showed high efficacy for HIV-1 protection in randomized clinical trials. We conducted a prospective implementation study to understand the feasibility and effectiveness of these interventions in delivery settings. Between November 5, 2012, and January 5, 2015, we enrolled and followed 1,013 heterosexual HIV-1-serodiscordant couples in Kenya and Uganda in a prospective implementation study. ART and PrEP were offered through a pragmatic strategy, with ART promoted for all couples and PrEP offered until 6 mo after ART initiation by the HIV-1 infected partner, permitting time to achieve virologic suppression. One thousand thirteen couples were enrolled, 78% of partnerships initiated ART, and 97% used PrEP, during a median follow-up of 0.9 years. Objective measures of adherence to both prevention strategies demonstrated high use (≥85%). Given the low HIV-1 incidence observed in the study, an additional analysis was added to compare observed incidence to incidence estimated under a simulated counterfactual model constructed using data from a prior prospective study of HIV-1-serodiscordant couples. Counterfactual simulations predicted 39.7 HIV-1 infections would be expected in the population at an incidence of 5.2 per 100 person-years (95% CI 3.7-6.9). However, only two incident HIV-1 infections were observed, at an incidence of 0.2 per 100 person-years (95% CI 0.0-0.9, p < 0.0001 versus predicted). The use of a non-concurrent comparison of HIV-1 incidence is a potential limitation of this approach; however, it would not have been ethical to enroll a contemporaneous population not provided access to ART and PrEP. Integrated delivery of time-limited PrEP until sustained ART use in African HIV-1-serodiscordant couples was feasible, demonstrated high uptake and adherence, and resulted in near elimination of HIV-1 transmission, with an observed HIV incidence of <0.5% per year compared to an expected incidence of >5% per year.

Scale-up of oral pre-exposure prophylaxis (PrEP) for HIV prevention in Uganda began with serodiscordant couples (SDC) and has expanded to other most at-risk populations (MARPs). We explored knowledge, acceptability, barriers and facilitators of PrEP use among potential PrEP users in four MARPs (SDC; men who have sex with men [MSM]; female sex workers [FSW], and fisher folk). We administered quantitative surveys to potential PrEP users in multiple settings in Central Uganda at baseline and approximately 9 months after healthcare worker (HCW) training on PrEP. The survey was completed by 250 potential PrEP users at baseline and 125 after HCW training; 55 completed both surveys. For these 250 participants, mean age was 28.5 years (SD 6.9), 47% were male and 6% were transgender women, with approximately even distribution across MARPs and recruitment locations (urban, peri-urban, and rural). Most (65%) had not heard about PrEP. After HCW training, 24% of those sampled were aware of PrEP, and the proportion of those who accurately described PrEP as \"antiretrovirals to be used before HIV exposure\" increased from 54% in the baseline survey to 74% in the second survey (p<0.001). The proportion of participants who reported HCW as a source of PrEP information increased after training (59% vs 91%, p<0.001). In both surveys, nearly all participants indicated they were willing to take PrEP if offered. The most common anticipated barriers to PrEP were stigma, transportation, accessibility, busy schedules, and forgetfulness. Closeness to home was a common facilitator for all participant categories. Initial awareness of PrEP was low, but PrEP knowledge and interest increased among diverse MARPs after HCW training. Demand creation and HCW training will be critical for increasing PrEP awareness among key populations, with support to overcome barriers to PrEP use. These findings should encourage the acceleration of PrEP rollout in Uganda.

Randomized clinical trials of oral antiretroviral pre-exposure prophylaxis (PrEP) for HIV prevention have widely divergent efficacy estimates, ranging from 0% to 75%. These discrepancies are likely due to differences in adherence. To our knowledge, no studies to date have examined the impact of improving adherence through monitoring and/or intervention, which may increase PrEP efficacy, or reported on objective behavioral measures of adherence, which can inform PrEP effectiveness and implementation. Within the Partners PrEP Study (a randomized placebo-controlled trial of oral tenofovir and emtricitabine/tenofovir among HIV-uninfected members of serodiscordant couples in Kenya and Uganda), we collected objective measures of PrEP adherence using unannounced home-based pill counts and electronic pill bottle monitoring. Participants received individual and couples-based adherence counseling at PrEP initiation and throughout the study; counseling was intensified if unannounced pill count adherence fell to <80%. Participants were followed monthly to provide study medication, adherence counseling, and HIV testing. A total of 1,147 HIV-uninfected participants were enrolled: 53% were male, median age was 34 years, and median partnership duration was 8.5 years. Fourteen HIV infections occurred among adherence study participants--all of whom were assigned to placebo (PrEP efficacy = 100%, 95% confidence interval 83.7%-100%, p<0.001). Median adherence was 99.1% (interquartile range [IQR] 96.9%-100%) by unannounced pill counts and 97.2% (90.6%-100%) by electronic monitoring over 807 person-years. Report of no sex or sex with another person besides the study partner, younger age, and heavy alcohol use were associated with <80% adherence; the first 6 months of PrEP use and polygamous marriage were associated with >80% adherence. Study limitations include potential shortcomings of the adherence measures and use of a convenience sample within the substudy cohort. The high PrEP adherence achieved in the setting of active adherence monitoring and counseling support was associated with a high degree of protection from HIV acquisition by the HIV-uninfected partner in heterosexual serodiscordant couples. Low PrEP adherence was associated with sexual behavior, alcohol use, younger age, and length of PrEP use. Please see later in the article for the Editors' Summary.

Disclosure of the diagnosis of HIV to HIV-infected children is challenging for caregivers. Despite current recommendations, data suggest that levels of disclosure of HIV status to HIV-infected children receiving care in resource-limited settings are very low. Few studies describe the disclosure process for children in these settings, particularly the motivators, antecedent goals, and immediate outcomes of disclosure to HIV-infected children. This study examined caregivers' perception of the disclosure concept prior to disclosure, their motivation towards or away from disclosure, and their short- and long-term intentions for disclosure to their HIV-infected children. In-depth interviews were conducted with primary caregivers of 40 HIV-infected children (ages 5-15 years) who were receiving HIV care but did not know their HIV status. Caregivers of HIV-infected children mainly perceived disclosure as a single event rather than a process of gradual delivery of information about the child's illness. They viewed disclosure as potentially beneficial both to children and themselves, as well as an opportunity to explain the parents' role in the transmission of HIV to the children. Caregivers desired to personally conduct the disclosure; however, most reported being over-whelmed with fear of negative outcomes and revealed a lack of self-efficacy towards managing the disclosure process. Consequently, most cope by deception to avoid or delay disclosure until they perceive their own readiness to disclose. Interventions for HIV disclosure should consider that caregivers may desire to be directly responsible for disclosure to children under their care. They, however, need to be empowered with practical skills to recognize opportunities to initiate the disclosure process early, as well as supported to manage it in a phased, developmentally appropriate manner. The potential role for peer counselors in the disclosure process deserves further study.

Participation in longitudinal research studies in resource-limited settings often involves frequent interactions with study staff and other participants, as well as receipt of incentives and transportation reimbursements. Social support-receipt of material and emotional resources from one's social network-has been linked to antiretroviral adherence in sub-Saharan Africa. The extent to which social support arises from study participation, its range and depth, and its implications for observational study conduct, have not been extensively described. We conducted individual open-ended and semi-structured interviews with participants in a longitudinal, observational antiretroviral therapy adherence monitoring study in Mbarara, Uganda. Participants were asked about their experiences in the longitudinal study and their interactions with research staff. We also interviewed study research assistants (RAs). Deductive and inductive coding were used to identify content related to the experience of study participation. Codes were organized into themes, and relationships between themes were used to develop overarching categories. Sixty longitudinal study participants and 6 RAs were interviewed. Instrumental and emotional social support emerged as pervasive and valued aspects of longitudinal study participation. Instrumental support that participants received consisted of enhanced linkage to medical care, health education, and direct and indirect material benefits. Emotional support consisted of perceptions of feeling \"cared for\" and social interactions that permitted escape from HIV-related stigma. Both instrumental and emotional support often arose through the close relationships participants formed with research staff and with each other. Study-derived social support motivated some participants to adhere to antiretroviral therapy-an unanticipated effect potentially influencing the longitudinal study's primary observational outcome. Longitudinal study participation resulted in instrumental and emotional social support for participants. The depth of support participants experienced has implications for observational study design in resource-limited settings, including need to assess potential effects on study outcomes; consideration of social support during risk/benefit assessment in study ethics review and consent; and vigilance for consequences of social support loss when studies end.

Non-communicable diseases (NCDs) are a growing health burden in Sub-Saharan Africa and especially Uganda, where they account for over one third of all deaths. During the COVID-19 pandemic, public health control measures such as societal “lockdowns” had a significant impact on longitudinal NCD care though no studies have looked at the lived experience around NCD care during the pandemic. Our objective was to understand the experience of NCD care for both patients and providers in southwestern Uganda during the COVID-19 pandemic. We conducted in-depth, in-person qualitative interviews with 20 patients living with hypertension, diabetes, and/or cardiac disease purposefully selected from the outpatient clinics at Mbarara Regional Referral Hospital and 11 healthcare providers from public health facilities in Mbarara, southwestern Uganda. We analyzed transcripts according to conventional content analysis. We identified four major themes that emerged from the interviews; (1) difficulty accessing medication; (2) food insecurity; (3) barriers to the delivery of NCD clinical care and (4) alternative forms of care. Pre-existing challenges with NCD care were exacerbated during COVID-19 lockdown periods and care was severely disrupted, leading to worsened patient health and even death. The barriers to care were exacerbations of underlying systemic problems with NCD care delivery that require targeted interventions. Future work should leverage digital health interventions, de-centralizing NCD care, improving follow-up, providing social supports to NCD patients, and rectifying supply chain issues.