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.

BackgroundResearch that explores how community-based interventions for strengthening adolescent sexual reproductive health and rights (SRHR) can be integrated and sustained in community health systems, is, to the best of our knowledge, very scarce, if not absent. It is important to document mechanisms that shape integration process in order to improve health systems’ responsiveness towards adolescents’ SRHR. This realist evaluation protocol will contribute to this knowledge in Zambia where there is increased attention towards promoting maternal, neonatal and child health as a means of addressing the current high early pregnancy and marriage rates. The protocol will ascertain: why, how, and under what conditions the integration of SRHR interventions into Zambian community health systems will optimise (or not) acceptability and adoption of SRHR services. This study is embedded within a randomized controlled trial - “Research Initiative to Support the Empowerment of Girls (RISE)”- which aims to reduce adolescent girl pregnancies and marriages through a package of interventions including economic support to families, payment of school fees to keep girls in school, pocket money for girls, as well as youth club and community meetings on reproductive health.MethodsThis is a multiple-case study design. Data will be collected from schools, health facilities and communities through individual and group interviews, photovoice, documentary review, and observations. The study process will involve 1) developing an initial causal theory that proposes an explanation of how the integration of a community-based intervention that aimed to integrate adolescent SRHR into the community health system may lead to adolescent-friendly services; 2) refining the causal theory through case studies; 3) identifying contextual conditions and mechanisms that shape the integration process; and 4) finally proposing a refined causal theory and set of recommendations to guide policy makers, steer further research, and inform teaching programmes.DiscussionThe study will document relevant values as well as less formal and horizontal mechanisms which shape the integration process of SRHR interventions at community level. Knowledge on mechanisms is essential for guiding development of strategies for effectively facilitating the integration process, scaling up processes and sustainability of interventions aimed at reducing SRH problems and health inequalities among adolescents.

Background: HPTN 071 (PopART) was a community-randomized trial of a universal testing-and-treatment intervention on HIV incidence at population level in Zambia and South Africa. In Zambia, a trial of community-based distribution of HIV self-testing (HIVST) kits, including secondary distribution, as an option for HIV-testing was nested within 4 PopART intervention communities. We used data from the intervention arm of the nested trial to measure levels of and factors associated with acceptance and use of secondary distribution HIVST kits. Methods: Community HIV care providers offered the PopART combination HIV-prevention intervention door-to-door, systematically visiting all households and enumerating all household members. From 1 February to 30 April 2017, individuals aged 16 years and older consenting to PopART were offered the option to HIV self-test, if eligible for HIV-testing services. Individuals aged 18 years and older who reported a partner absent during household visits were offered an HIVST kit for secondary distribution to this partner. We used two data sources to measure acceptance and use of secondary distribution HIVST kits. Results: Among 9105 individuals aged 18 years and older consenting to PopART, 9.1% (n = 825) accepted an HIVST kit for secondary distribution. Approximately 55.8% reported that the kit had been used. Women were more likely to accept, and men more likely to use, secondary distribution HIVST kits. Kits were more likely to be used by individuals aged 30+ and who had not participated in a previous round of PopART. Approximately 6.8% had a reactive result. Conclusions: Community-based secondary distribution of HIVST kits reached men absent during community HIV care provider household visits and is a complement to facility- and community-based HIV-testing services, which often miss men.

Background: Door-to-door distribution of HIV self-testing kits (HIVST) has the potential to increase uptake of HIV testing services (HTS). However, very few studies have explored the social response to and implications of door-todoor including secondary distribution of HIVST on household relations and the ability of individuals to self-test with or without supervision within households. Methods: A CRT of HIVST distribution was nested within the HPTN 071 (PopART) trial, in four Zambian communities randomised to receive the PopART intervention. The nested HIVST trial aimed to increase knowledge of HIV status at population level. Between February 1 and April 30, 2017, 66 zones (clusters) within these four communities were randomly allocated to either the PopART standard of care door-to-door HTS (33 clusters) or PopART standard of care door-to-door HTS plus oral HIVST (33 clusters). In clusters randomised to HIVST, trained Community HIV care provider (CHiPs) visited households and offered individuals aged ≥ 16 and eligible for an offer of HTS the choice of HIV testing using HIVST or routine door-to-door HTS (finger-prick RDT). To document participants' experiences with HIVST, Interviews (n = 40), observations (n = 22) and group discussions (n = 91) with household members and CHiPs were conducted. Data were coded using Atlas.ti 7 and analysed thematically. Results: The usage and storage of HIVST kits was facilitated by familiarity with and trust in CHiPs, the novelty of HIVST, and demonstrations and supervision provided by CHiPs. Door-to-door distribution of HIVST kits was appreciated for being novel, convenient, private, empowering, autonomous and easy-to-use. Literacy and age influenced accurate usage of HIVST kits. The novelty of using oral fluids to test for HIV raised questions, some anxiety and doubts about the accuracy of HIVST. Although HIVST protected participants from experiencing clinic-based stigma, it did not address self-stigma. Within households, HIVST usually strengthened relationships but, amongst couples, there were a few reports of social harms. Conclusion: Door-to-door distribution of HIVST as a choice for how to HIV test is appreciated at community level and provides an important testing option in the sub-Saharan context. However, it should be accompanied by counselling to manage social harms and by supporting those testing HIV-positive to link to care.

Introduction The HPTN 071 (PopART) trial demonstrated that universal HIV testing‐and‐treatment reduced community‐level HIV incidence. Door‐to‐door delivery of HIV testing services (HTS) was one of the main components of the intervention. From an early stage, men were less likely to know their HIV status than women, primarily because they were not home during service delivery. To reach more men, different strategies were implemented during the trial. We present the relative contribution of these strategies to coverage of HTS and the impact of community hubs implemented after completion of the trial among men. Methods Between 2013 and 2017, three intervention rounds (IRs) of door‐to‐door HTS delivery were conducted in eight PopART communities in Zambia. Additional strategies implemented in parallel, included: community‐wide “Man‐up” campaigns (IR1), smaller HTS campaigns at work/social places (IR2) and revisits to households with the option of HIV self‐testing (HIVST) (IR3). In 2018, community “hubs” offering HTS were implemented for 7 months in all eight communities. Population enumeration data for each round of HTS provided the denominator, allowing for calculation of the proportion of men tested as a result of each strategy during different time periods. Results By the end of the three IRs, 65–75% of men were reached with HTS, primarily through door‐to‐door service delivery. In IR1 and IR2, “Man‐up” and work/social place campaigns accounted for ∼1 percentage point each and in IR3, revisits with the option of self‐testing for ∼15 percentage points of this total coverage per IR. The yield of newly diagnosed HIV‐positive men ranged from 2.2% for HIVST revisits to 9.9% in work/social places. At community hubs, the majority of visitors accepting services were men (62.8%). In total, we estimated that ∼36% (2.2% tested HIV positive) of men resident but not found at their household during IR3 of PopART accessed HTS provided at the hubs after trial completion. Conclusions Achieving high coverage of HTS among men requires universal, home‐based service delivery combined with an option of HIVST and delivery of HTS through community‐based hubs. When men are reached, they are willing to test for HIV. Reaching men thus requires implementers to adapt their HTS delivery strategies to meet men's needs. Clinical Trial Number NCT01900977

Introduction: The use of contraceptives among adolescents and young adults is one of the most cost-effective strategies to address many sexual and reproductive health (SRH) challenges, including unintended pregnancies, early marriages, and sexually transmitted infections. Despite a high burden of SRH challenges, uptake and unmet needs of modern contraceptives remain low in Uganda, especially among adolescents and young adults in informal settlement settings. This study aimed to explore the motivations of adolescents and young people to use modern contraceptives (or not).Methods: We analysed qualitative data from eight focus group discussions with 88 adolescents and young people aged 18–24 years residing in informal settlements of urban communities in Kira Municipality of Wakiso district, Uganda.Results: Motivations for use (or not) of modern contraceptives were framed by two interrelated constructs, sources of information on contraception and the unacceptable use of contraceptives among adolescents widespread in the community. These two, in turn, formed the scope of knowledge upon which adolescents and young people based their decision on whether or not to access and use modern contraceptives.Conclusion: To be more effective, sexual and reproductive health programs and interventions that aim to motivate the use of modern contraceptives among adolescents and young people in informal settings should be more comprehensive and focused on alleviating individual, health systems, social, religious factors that reinforce negative health-seeking behaviours towards contraceptive use. In addition, there is a need to support adolescents and young people with socio-economic empowering strategies that equip them with sufficient resources to choose contraceptives of their choice.