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AbstractIntroductionAdolescents living with perinatally acquired HIV have low rates of retention in care and viral suppression after the transition from paediatric to adult care. In this study, we developed and validated a tool to identify adolescent transition readiness.MethodsWe developed the HIV Adolescent Readiness for Transition Scale (HARTS) from June 2016 to May 2019 by iteratively adapting existing transition readiness scales for other chronic illnesses by conducting focus groups with 11 healthcare providers and 20 adolescents in South Africa. We administered a preliminary questionnaire to 131 adolescents to determine psychometric properties and assess test–retest variability. We used confirmatory factor analysis to verify the proposed scale structure using the underlying variable approach. We correlated responses to self‐described transition readiness and age using linear regression. We subsequently validated the scale by prospectively administering it to 199 adolescents in a second South African setting before their transition. We then used multivariable logistic regression to assess the effects of the HARTS and relevant socio‐behavioural covariates on viral suppression one year after transition.ResultsWe identified four domains relevant to transition readiness: disclosure, health navigation, self‐advocacy and health literacy. Fifteen questions with a significant factor loading of 0.3 to 0.9 were identified. No significant test–retest variability was seen among 10% of participants. Positive correlations with self‐described transition readiness were significant with the overall HARTS and domains of health navigation, self‐advocacy and health literacy. In the prospective analysis, for adolescents not using drugs, each 10‐point increase in the HARTS was associated with 0.62 odds of viral failure (95% CI 0.45 to 0.86; p = 0.004). The individual domains of self‐advocacy (AOR 0.56; 95% CI 0.33 to 0.94; p = 0.029), disclosure (AOR 0.02; 95% CI 0.01 to 0.25; p = 0.002), health navigation (AOR 0.51; 95%CI 0.25 to 1.02; p = 0.056) and health literacy (AOR 0.37; 95% CI 0.10 to 1.30; p = 0.121) were associated with viral failure adjusting for age at antiretroviral therapy initiation, ART regimen, sex, disclosure status, and alcohol use in both analyses.ConclusionsThe HARTS is a validated scale that can be used to identify which adolescents may require additional interventions prior to transitioning to adult care to improve viral suppression after transition.

AbstractIntroductionMajor depressive disorder, highly prevalent among people with HIV (PWH) globally, including South Africa, is associated with suboptimal adherence to antiretroviral therapy. Globally, there are insufficient numbers of mental health providers and tested depression treatments. This study's aim was to test task‐shared cognitive‐behavioural therapy for adherence and depression (CBT‐AD) in HIV, delivered by clinic nurses in South Africa.MethodsThis was a two‐arm randomized controlled effectiveness trial (recruitment: 14 July 2016 to 4 June 2019, last follow 9 June 2020). One‐hundred‐sixty‐one participants with clinical depression and virally uncontrolled HIV were recruited from primary care clinics providing HIV care, in Khayelitsha, South Africa. Arm 1 was task‐shared, nurse‐delivered CBT‐AD; and arm 2 was enhanced treatment as usual (ETAU). Primary outcomes (baseline to 4 months) were blinded Hamilton Depression Rating Scale (HAM‐D) scores, and weekly adherence via real‐time monitoring (Wisepill). Secondary outcomes were adherence and depression over 4‐, 8‐ and 12‐month follow‐ups, proportion of participants with undetectable viremia and continuous CD4 cell counts at 12 months. Additional analyses involved viral load and CD4 over time.ResultsAt 4 months, the HAMD scores in the CBT‐AD condition improved by an estimated 4.88 points more (CI: –7.86, –1.87, p = 0.0016), and for weekly adherence, 1.61 percentage points more per week (CI: 0.64, 2.58, p = 0.001) than ETAU. Over follow‐ups, CBT‐AD had an estimated 5.63 lower HAMD scores (CI: –7.90, –3.36, p < 0.001) and 23.56 percentage points higher adherence (CI: 10.51, 34.21, p < 0.001) than ETAU. At 12 months, adjusted models indicated that the odds of having an undetectable viremia was 2.51 greater at 12 months (CI: 1.01, 6.66, p = 0.047), and 3.54 greater over all of the follow‐ups (aOR = 3.54, CI: 1.59, 20.50; p = 0.038) for those assigned CBT‐AD. CD4 was not significantly different between groups at 12 months or over time.ConclusionsTask‐shared, nurse‐delivered, CBT‐AD is effective in improving clinical depression, ART adherence and viral load for virally unsuppressed PWH. The strategy of reducing depression to allow patients with self‐care components of medical illness to benefit from adherence interventions is one to extend. Implementation science trials and analyses of cost‐effectiveness are needed to translate findings into clinical practice.Trial RegistrationClinicalTrials.gov Identifier: NCT02696824 https://clinicaltrials.gov/ct2/show/NCT02696824

AbstractIntroductionReal‐time electronic adherence monitoring (EAM) systems could inform on‐going risk assessment for HIV viraemia and be used to personalize viral load testing schedules. We evaluated the potential of real‐time EAM (transferred via cellular signal) and standard EAM (downloaded via USB cable) in rural Uganda to inform individually differentiated viral load testing strategies by applying machine learning approaches.MethodsWe evaluated an observational cohort of persons living with HIV and treated with antiretroviral therapy (ART) who were monitored longitudinally with standard EAM from 2005 to 2011 and real‐time EAM from 2011 to 2015. Super learner, an ensemble machine learning method, was used to develop a tool for targeting viral load testing to detect viraemia (>1000 copies/ml) based on clinical (CD4 count, ART regimen), viral load and demographic data, together with EAM‐based adherence. Using sample‐splitting (cross‐validation), we evaluated area under the receiver operating characteristic curve (cvAUC), potential for EAM data to selectively defer viral load tests while minimizing delays in viraemia detection, and performance compared to WHO‐recommended testing schedules.ResultsIn total, 443 persons (1801 person‐years) and 485 persons (930 person‐years) contributed to standard and real‐time EAM analyses respectively. In the 2011 to 2015 dataset, addition of real‐time EAM (cvAUC: 0.88; 95% CI: 0.83, 0.93) significantly improved prediction compared to clinical/demographic data alone (cvAUC: 0.78; 95% CI: 0.72, 0.86; p = 0.03). In the 2005 to 2011 dataset, addition of standard EAM (cvAUC: 0.77; 95% CI: 0.72, 0.81) did not significantly improve prediction compared to clinical/demographic data alone (cvAUC: 0.70; 95% CI: 0.64, 0.76; p = 0.08). A hypothetical testing strategy using real‐time EAM to guide deferral of viral load tests would have reduced the number of tests by 32% while detecting 87% of viraemia cases without delay. By comparison, the WHO‐recommended testing schedule would have reduced the number of tests by 69%, but resulted in delayed detection of viraemia a mean of 74 days for 84% of individuals with viraemia. Similar rules derived from standard EAM also resulted in potential testing frequency reductions.ConclusionsOur machine learning approach demonstrates potential for combining EAM data with other clinical measures to develop a selective testing rule that reduces number of viral load tests ordered, while still identifying those at highest risk for viraemia.

AbstractIntroductionYoung women in sub‐Saharan Africa are a priority population for HIV prevention, yet challenges with adherence and persistence to HIV pre‐exposure prophylaxis (PrEP) are common. This study involved the development and pilot testing of My Way—a novel delivery system for PrEP and co‐packaged sexual health services.MethodsMy Way was developed in Kisumu, Kenya through a user‐centred design process (2020). The intervention involves peer‐delivery and support for HIV testing and PrEP use, self‐collected vaginal swabs for sexually transmitted infection (STI) testing, pregnancy testing, oral contraceptive pills, self‐injectable medroxyprogesterone and/or condoms. My Way was assessed among 16‐ to 24‐year‐old sexually active women in a randomized controlled trial versus standard of care (SoC; 2021–2022). Use of PrEP and other sexual health services were tracked at 1, 3 and 6 months for feasibility. Acceptability was determined by questionnaire. The effect of the intervention on tenofovir diphosphate (TFV‐DP) levels was assessed by chi‐square test (primary outcome); other predictors were explored with regression analysis.ResultsAmong 150 women, the median age was 22 years and the median number of sexual partners was 2. Moderate/severe depression was common (60%). In the intervention arm, peers made 88% (198/225) of possible kit deliveries (177 with PrEP) and 49 STIs were diagnosed. In the SoC arm, 24% (55/225) of expected clinic visits occurred (53 with PrEP); no STI testing was performed. TVF‐DP was detected in 16 participants at 6 months: 16% (12/75) in the intervention arm versus 5% (4/75) in the SoC arm (p = 0.03). Persistence among those with ongoing HIV prevention needs (i.e. prevention‐effective persistence) was 18% (12/67) versus 7% (4/56; p = 0.08). No women acquired HIV. The intervention was significantly associated with detectable TFV‐DP (OR 3.5, 1.1‐11.4; p = 0.04); moderate/severe depression trended towards an association with TFV‐DP (OR 0.2, 0.03–1.6; p = 0.13).ConclusionsMy Way is a promising delivery system for PrEP and other sexual health services among young women in Western Kenya. We found high feasibility and acceptability. PrEP use was modest, but higher with My Way compared to SoC. Long‐acting PrEP formulations may overcome important barriers to PrEP use and should be explored in combination with the My Way delivery model.

AbstractIntroductionWe conducted a cohort study to understand patterns of anti‐retroviral therapy (ART) adherence during pregnancy, postpartum and non‐pregnancy follow‐up among women initiating ART in public clinics offering Option B+ in rural Uganda and urban South Africa.MethodsWe collected survey data, continuously monitored ART adherence (Wisepill), HIV‐RNA and pregnancy tests at zero, six and twelve months from women initiating ART in Uganda and South Africa, 2015 to 2017. The primary predictor of interest was follow‐up time categorized as pregnant (pregnancy diagnosis to pregnancy end), postpartum (pregnancy end to study exit) or non‐pregnancy‐related (neither pregnant nor postpartum). Fractional regression models included demographics and socio‐behavioural factors informed by the Behavioral Model for Vulnerable Populations. We evaluated HIV‐RNA at 12 months by ever‐ versus never‐pregnant status.ResultsIn Uganda, 247 women contributed 676, 900 and 1274 months of pregnancy, postpartum and non‐pregnancy‐related follow‐up. Median ART adherence was consistently ≥90%: pregnancy, 94% (interquartile range [IQR] 78,98); postpartum, 90% (IQR 70,97) and non‐pregnancy, 90% (IQR 80,98). Poorer adherence was associated with younger age (0.98% [95% CI 0.33%, 1.62%] average increase per year of age) and higher CD4 cell count (1.01% [0.08%, 1.94%] average decrease per 50 cells/mm3). HIV‐RNA was suppressed among 91% (N = 135) ever‐pregnant and 86% (N = 85) never‐pregnant women. In South Africa, 190 women contributed 259, 624 and 1247 months of pregnancy, postpartum and non‐pregnancy‐related follow‐up. Median adherence was low during pregnancy, 74% (IQR 31,96); postpartum, 40% (IQR 4,65) and non‐pregnancy, 77% (IQR 47,92). Poorer adherence was associated with postpartum status (22.3% [95%CI 8.6%, 35.4%] average decrease compared to non‐pregnancy‐related follow‐up) and less emotional support (1.4% [0.22%, 2.58%] average increase per unit increase). HIV‐RNA was suppressed among 57% (N = 47) ever‐pregnant and 86% (N = 93) never‐pregnant women.ConclusionsWomen in rural Uganda maintained high adherence with 91% of ever‐pregnant and 86% of never‐pregnant women suppressing HIV‐RNA at 12 months. Women in urban South Africa struggled with adherence, particularly during postpartum follow‐up with median adherence of 40% and 57% of women with HIV‐RNA suppression at one year, suggesting a crisis for postpartum women with HIV in South Africa. Findings suggest that effective interventions should promote emotional support.

AbstractIntroductionThe success of universal antiretroviral therapy (ART) access and aspirations for an AIDS‐free generation depend on high adherence in individuals initiating ART during early‐stage HIV infection; however, adherence may be difficult in the absence of illness and associated support.MethodsFrom March 2015 to October 2017, we prospectively observed three groups initiating ART in routine care in Uganda and South Africa: men and non‐pregnant women with early‐stage HIV infection (CD4 > 350 cells/μL), pregnant women with early‐stage HIV infection and men and non‐pregnant women with late‐stage HIV infection (CD4 < 200 cells/μL). Socio‐behavioural questionnaires were administered and viral loads were performed at 0, 6 and 12 months. Adherence was monitored electronically.ResultsAdherence data were available for 869 participants: 322 (37%) early/non‐pregnant, 199 (23%) early/pregnant and 348 (40%) late/non‐pregnant participants. In Uganda, median adherence was 89% (interquartile range 74 to 96) and viral suppression was 90% at 12 months; neither differed among groups (p > 0.72). In South Africa, median adherence was higher in early/non‐pregnant versus early/pregnant or late/non‐pregnant participants (76%, 37%, 52%; p < 0.001), with similar trends in viral suppression (86%, 51%, 79%; p < 0.001). Among early/non‐pregnant individuals in Uganda, adherence was higher with increasing age and lower with structural barriers; whereas in South Africa, adherence was higher with regular income, higher perceived stigma and use of other medications, but lower with maladaptive coping and cigarette smoking.DiscussionART adherence among non‐pregnant individuals with early‐stage infection is as high or higher than with late‐stage initiation, supporting universal access to ART. Challenges remain for some pregnant women and individuals with late‐stage infection in South Africa and highlight the need for differentiated care delivery.