SummaryBackgroundThe HPTN 071 (PopART) cluster-randomised trial provided door-to-door HIV testing services to a large proportion of individuals residing in 21 intervention communities in Zambia and South Africa from 2014 to 2017 and reached the UNAIDS first 90 target among women in Zambia, yet gaps remained among men and young adults. This cluster-randomised study nested in the HPTN 071 (PopART) trial sought to increase knowledge of HIV status across all groups by offering the choice of oral HIV self-testing in addition to routine door-to-door HIV testing services.MethodsWe nested this cluster-randomised trial in four HTPN 071 (PopART) intervention communities in northern Zambia. 66 zones (clusters) in these communities were randomly allocated (1:1) to either oral HIV self-testing plus routine door-to-door HIV testing services (HIV self-testing group) or the PopART standard of care of door-to-door HIV testing services alone (non- HIV self-testing group) over a 3-month period. All individuals aged 16 years or older were eligible for HIV testing. Randomisation was achieved by randomly selecting one allocation from a list of 10 000 possible allocations during a public ceremony. In HIV self-testing zones, trained lay-counsellors (known as community HIV care providers) visited households and offered eligible individuals the choice of HIV testing using HIV self-testing or routine door-to-door HIV testing services. For individuals aged 18 years or older whose partner was absent during the household visit, an HIV self-test kit could be left for secondary distribution to the absent partner. The primary outcome was knowledge of HIV status (defined as self-reporting HIV positive to the community HIV care providers or accepting an offer of HIV testing services). Outcomes were measured among households that were first visited, and individuals first enumerated as a household member during the HIV self-testing intervention period. We analysed data at the individual level using population-average logistic regression models, accounting for clustering of outcomes by zone, to estimate the effect of the intervention. This trial is registered with ClinicalTrials.gov, number NCT02994329.FindingsBetween Feb 1, and April 30, 2017, the community HIV care providers enumerated 13 267 eligible individuals in the HIV self-testing group and 13 706 in the non-HIV self-testing group. After intervention implementation, 9027 (68%) of 13 267 in the HIV self-testing group had knowledge of HIV status compared with 8952 (65%) of 13 706 in the non-HIV self-testing group (adjusted odds ratio 1·30, 95% CI 1·03–1·65; p=0·03). The effect differed by sex (pinteraction=0·01). Among men, knowledge of HIV status was higher in the HIV self-testing group than in the non-HIV self-testing group (3843 [60%] of 6368 vs 3571 [55%] of 6486; adjusted odds ratio 1·31, 95% CI 1·07–1·60; p=0·01). There was no evidence of a between-group difference among female participants.InterpretationProviding a choice of HIV self-testing during delivery of door-to-door HIV testing ser...
Introduction: Community-based sexual reproductive interventions are key in attaining universal health coverage for all by 2030, yet adolescents in many countries still lack health services that are responsive to their sexual reproductive health and rights' needs. As the first step of realist evaluation, this study provides a programme theory that explains how, why and under what circumstances community-based sexual reproductive health interventions can transform (or not) 'ordinary' community-based health systems (CBHSs) into systems that are responsive to the sexual reproductive health of adolescents.Methods: This realist approach adopted a case study design. We nested the study in the full intervention arm of the Research Initiative to Support the Empowerment of Girls trial in Zambia. Sixteen in-depth interviews were conducted with stakeholders involved in the development and/or implementation of the trial. All the interviews were recorded and analysed using NVIVO version 12.0. Thematic analysis was used guided by realist evaluation concepts. The findings were later synthesized using the Intervention−Context−Actors−Mechanism−Outcomes conceptualization tool. Using the retroduction approach, we summarized the findings into two programme theories. Results: We identified two initial testable programme theories. The first theory presumes that adolescent sexual reproductive health and rights (SRHR) interventions that are supported by contextual factors, such as existing policies and guidelines related to SRHR, socio-cultural norms and CBHS structures are more likely to trigger mechanisms among the different actors that can encourage uptake of the interventions, and thus contribute to making the CBHS responsive to the SRHR needs of adolescents. The second and alternative theory suggests that SRHR interventions, if not supported by contextual factors, are less likely to transform the CBHSs in which they are implemented. At individual level the mechanisms, awareness and knowledge were expected to lead to value clarification', which was also expected would lead to individuals developing a 'supportive attitude towards adolescent SRHR. It was anticipated that these individual mechanisms would in turn trigger the collective mechanisms, communication, cohesion, social connection and linkages.
IntroductionHPTN 071 (PopART) is a three‐arm community randomized trial in Zambia and South Africa evaluating the impact of a combination HIV prevention package, including universal test and treat (UTT), on HIV incidence. This nested study examined factors associated with timely linkage‐to‐care and ART initiation (TLA) (i.e. within six‐months of referral) in the context of UTT within the intervention communities of the HPTN 071 (PopART) trial.MethodsOf the 7572 individuals identified as persons living with HIV (PLWH) (and not on antiretroviral treatment (ART)) during the first year of the PopART intervention provided by Community HIV‐care Providers (CHiPs) through door‐to‐door household visits, individuals who achieved TLA (controls) and those who did not (cases), stratified by gender and community, were randomly selected to be re‐contacted for interview. Standardized questionnaires were administered to explore factors potentially associated with TLA, including demographic and behavioural characteristics, and participants’ opinions on HIV and related services. Odds ratios comparing cases and controls were estimated using a multi‐variable logistic regression.ResultsData from 705 participants (333 cases/372 controls) were analysed. There were negligible differences between cases and controls by demographic characteristics including age, marital or socio‐economic position. Prior familiarity with the CHiPs encouraged TLA (aOR of being a case: 0.58, 95% CI: 0.39 to 0.86, p = 0.006).Participants who found clinics overcrowded (aOR: 1.51, 95% CI: 1.08 to 2.12, p = 0.006) or opening hours inconvenient (aOR: 1.63, 95% CI: 1.06 to 2.51, p = 0.02) were less likely to achieve TLA, as were those expressing stronger feelings of shame about having HIV (p trend = 0.007). Expressing “not feeling ready” (aOR: 2.75, 95% CI: 1.89 to 4.01, p < 0.001) and preferring to wait until they felt sick (aOR: 2.00, 95% CI: 1.27 to 3.14, p = 0.02) were similarly indicative of being a case. Worrying about being seen in the clinic or about how staff treated patients was not associated with TLA.While the association was not strong, we found that the greater the number of self‐reported lifetime sexual partners the more likely participants were to achieve TLA (p trend = 0.06). There was some evidence that participants with HIV‐positive partners on ART were less likely to be cases (aOR: 0.75, 95% CI: 0.53 to 1.06, p = 0.07).DiscussionThe lack of socio‐demographic differences between cases and controls is encouraging for a “universal” intervention that seeks to ensure high coverage across whole communities. Making clinics more “patient‐friendly” could enhance treatment uptake further. The finding that those with higher risk behaviour are more actively engaging with UTT holds promise for treatment‐as‐prevention.
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