Lessons learned from implementation of four HIV self-testing (HIVST) distribution models in Zambia: applying the Consolidated Framework for Implementation Research to understand impact of contextual factors on implementation.

BACKGROUND: Although Zambia has integrated HIV-self-testing (HIVST) into its Human Immunodeficiency Virus (HIV) regulatory frameworks, few best practices to optimize the use of HIV self-testing to increase testing coverage have been documented. We conducted a prospective case study to understand contextual factors guiding implementation of four HIVST distribution models to inform scale-up in Zambia. METHODS: We used the qualitative case study method to explore user and provider experiences with four HIVST distribution models (two secondary distribution models in Antenatal Care (ANC) and Antiretroviral Therapy (ART) clinics, community-led, and workplace) to understand factors influencing HIVST distribution. Participants were purposefully selected based on their participation in HIVST and on their ability to provide rich contextual experience of the distribution models. Data were collected using observations (n = 31), group discussions (n = 10), and in-depth interviews (n = 77). Data were analyzed using the thematic approach and aligned to the four Consolidated Framework for Implementation Research (CFIR) domains. RESULTS: Implementation of the four distribution models was influenced by an interplay of outer and inner setting factors. Inadequate compensation and incentives for distributors may have contributed to distributor attrition in the community-led and workplace HIVST models. Stockouts, experienced at the start of implementation in the secondary-distribution and community-led distribution models often disrupted distribution. The existence of policy and practices aided integration of HIVST in the workplace. External factors complimented internal factors for successful implementation. For instance, despite distributor attrition leading to excessive workload, distributors often multi-tasked to keep up with demand for kits, even though distribution points were geographically widespread in the workplace, and to a less extent in the community-led models. Use of existing communication platforms such as lunchtime and safety meetings to promote and distribute kits, peers to support distributors, reduction in trips by distributors to replenish stocks, increase in monetary incentives and reorganisation of stakeholder roles proved to be good adaptations. CONCLUSION: HIVST distribution was influenced by a combination of contextual factors in variable ways. Understanding how the factors interacted in real world settings informed adaptations to implementation devised to minimize disruptions to distribution.

Being both a grandmother and a health worker: experiences of community-based health workers in addressing adolescents' sexual and reproductive health needs in rural Zambia.

INTRODUCTION: Community-based health workers (CBHWs) possess great potential to be the missing link between the community and the formal health system for improving adolescents' access to sexual and reproductive health and rights (SRHR) information and services. Yet, their role in addressing adolescents' SRHR within the context of the community-based health system has received very little attention. This paper analyses how CBHWs experience and perceive their role in addressing adolescents' SRHR needs in rural Zambia, including the possible barriers, dilemmas, and opportunities that emerge as CBHWs work with adolescents. METHODS: Between July and September 2019, we conducted 14 in-depth interviews with 14 community-based health workers recruited across 14 different communities in the central province of Zambia. The interviews were focused on eliciting their experiences and perceptions of providing sexual and reproductive health services to adolescents. Charmaz's grounded theory approach was used for the analysis. RESULTS: We present the core category "being both a grandmother and a CBHW", which builds upon four categories: being educators about sexual and reproductive health; being service providers and a link to SRHR services; being advocates for adolescents' SRHR; and reporting sexual violence. These categories show that CBHWs adopt a dual role of being part of the community (as a grandmother) and part of the health system (as a professional CBHW), in order to create/maximise opportunities and navigate challenges. CONCLUSION: Community-based health workers could be key actors providing context-specific comprehensive SRHR information and services that could span all the boundaries in the community-based health system. When addressing adolescents SRHR, playing dual roles of being both a grandmother and a professional CBHW were sometimes complimentary and at other times conflicting. Additional research is required to understand how to improve the role of CBHWs in addressing adolescents and young people's sexual and reproductive health.

Halting and re-issuing of the Zambia community health strategy (2017-2021): a retrospective analysis of the policy process and implications for community health systems.

BACKGROUND: Over the years, low-and middle-income countries have adopted several policy initiatives to strengthen community health systems as means to attain Universal Health Coverage (UHC). In this regard, Zambia passed a Community Health Strategy in 2017 that was later halted in 2019. This paper explores the processes that led to the halting and re-issuing of this strategy with the view of drawing lessons to inform the development of such strategies in Zambia and other similar settings. METHODS: We employed a qualitative case study comprising 20 semi-structured interviews with key stakeholders who had participated in either the development, halting, or re-issuing of the two strategies, respectively. These stakeholders represented the Ministry of Health, cooperating partners and other non-government organizations. Inductive thematic analysis approach was used for analysis. RESULTS: The major reasons for halting and re-issuing the community health strategy included the need to realign it with the national development framework such as the 7th National Development Plan, lack of policy ownership, political influence, and the need to streamline the coordination of community health interventions. The policy process inadequately addressed the key tenets of community health systems such as complexity, adaptation, resilience and engagement of community actors resulting in shortcomings in the policy content. Furthermore, the short implementation period, lack of dedicated staff, and inadequate engagement of stakeholders from other sectors threatened the sustainability of the re-issued strategy. CONCLUSION: This study underscores the complexity of community health systems and highlights the challenges these complexities pose to health policymaking efforts. Countries that embark on health policymaking for community health systems must reflect on issues such as persistent fragmentation, which threaten the policy development process. It is crucial to ensure that these complexities are considered within similar policy engagement processes.

Experiences of teachers and community-based health workers in addressing adolescents' sexual reproductive health and rights problems in rural health systems: a case of the RISE project in Zambia.

BACKGROUND: Adolescents in low-and-middle-income countries like Zambia face a high burden of sexual, reproductive, health and rights problems including coerced sex, teenage pregnancies, and early marriages. The Zambia government through Ministry of Education has integrated comprehensive sexuality education (CSE) in the education and school system to contribute towards addressing Adolescents sexual, reproductive, health and rights (ASRHR) problems. This paper sought to explore teachers and community based health workers (CBHWs)' experiences in addressing ASRHR problems in in rural health systems in Zambia. METHODOLOGY: The study was conducted under Research Initiative to Support the Empowerment of Girls (RISE) community randomized trial that aims to measure the effectiveness of economic and community interventions in reducing early marriages, teenage pregnancies, and school dropout in Zambia. We conducted qualitative 21 in-depth interviews with teachers and CBHWs involved in the implementation of CSE in communities. Thematic analysis was used to analyse teachers and CBHWs´ roles, challenges, and opportunities in promoting ASRHR services. RESULTS: The study identified teachers and CBHWs roles, and challenges experienced in promoting ASRHR and suggested strategies to enhance delivery of the intervention. The role of teachers and CBHWs in addressing ASRHR problems included mobilizing and sensitizing the community for meetings, providing SRHR counseling services to both adolescents and guardians, and strengthening referral to SRHR services if needed. The challenges experienced included stigmatization associated with difficult experiences such as sexual abuse and pregnancy, shyness among girls to participate when discussing SRHR in the presence of the boys and myths about contraception. The suggested strategies for addressing the challenges included creating safe spaces for adolescents to discuss SRHR issues and engaging adolescents in coming up with the solution. CONCLUSION: This study provides significant insight on the important roles that teachers CBHWs can play in addressing adolescents SRHR related problems. Overall, the study emphasizes the need to fully engage adolescents in addressing adolescents SRHR problems.

Comprehensive sexuality education programmes are often not implemented properly because facilitators are not adequately prepared, and the community usually resist such programs. Similarly, in Zambia, the teachers and CBHWs implementing sexual and reproductive health activities often felt uncomfortable discussing sensitive sexuality topics with adolescents. This study was conducted within a bigger research project exploring whether teachers and community-based health workers together can effectively deliver sexual and reproductive health information at school and community levels. Discussions on the delivery of ASRHR services were held with teachers and CBHWs to identify their roles, and challenges that they experienced, and find solutions to problems. The interviews showed that the teachers and CBHWs provided sexual reproductive health and rights (SRHR) counselling to adolescents and parents. They were also involved in mobilising communities to attend SRHR meetings, sensitise, and refer them to SRHR services. However, teachers and CBHWs encountered several challenges. These include late reporting and hiding of sexual abuse cases, myths about contraceptives, and stigmatisation of girls with history of sexual abuse, and pregnancy. Further, girls felt shy to participate in SRHR discussions due to customary norms and values regarding marriage. More community engagement opportunities are needed to break the barriers of communication, and shift cultural norms to help enhance adolescent uptake of SRHR services in order to prevent pregnancy and other related challenges.

Combining photo-elicitation and discourse analysis to examine adolescents' sexuality in rural Zambia.

INTRODUCTION: This article aimed to analyse constructions of adolescents' sexualities and sexual health and the consequences of these discourses for adolescents' exercise of their sexual reproductive health and rights (SRHR) in rural Zambia. METHODS: Interpretative repertoires, which is rooted in discursive psychology was used to analyse data from photo-elicitations interviews and focus group discussions. Our participants included 25 adolescents who participated in a SRHR intervention that aimed to reduce adolescents' pregnancies and early marriages. RESULTS: We identified three interpretative repertories: 1) sex is for mature people in which adolescents positioned themselves as 'immature, and young to engage in sex; 2) gendered respectful behaviours in which what was considered disrespectful (and respectful) behaviour in relation to sexuality were strongly influenced by gender, and more clearly defined for girls than it was for boys. Sexuality was not only about individual choices but about being respectful to parents; and 3) acquiring and using knowledge about sexuality in which adolescents conflicted between having and applying SRHR knowledge. CONCLUSION: These repertories offer an important context that shape how adolescents negotiate, adopt and resist SRHR interventions. Future interventions that target adolescents' SRHR must aim to address the sexual scripts that serve to erect barriers against positive sexual behaviours, including access to SRHR services that promote safer sex.

Conducting research with young people at the margins - lessons learnt and shared through case studies in Cambodia, India, Sweden and Zambia.

Building on the value of engaging with and enabling the participation of marginalised young people in research, the aim of this article was to profile practical and procedural issues faced when conducting studies with young people who experience some form of marginalisation. Drawing on observations and research experiences from four diverse case studies involving young people who were either imprisoned in Cambodia, living in informal urban communities in North India, residing in rural northern Sweden or attending school in rural Zambia, learnings were identified under three thematic areas. Firstly, a need exists to develop trusting relationships with stakeholders, and especially the participating young people, through multiple interactions. Secondly, the value of research methods that are creative and context sensitive are required to make the process equitable and meaningful for young people. Thirdly, it is important to flatten power relations between adults and young people, researchers and the researched, to maximise participation. These findings can inform future youth research in the field of global public health by detailing opportunities and challenges of engaging in research with young people on the margins to promote their participation.

Social response to the delivery of HIV self-testing in households: experiences from four Zambian HPTN 071 (PopART) urban communities.

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-to-door 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.

Can sexual health interventions make community-based health systems more responsive to adolescents? A realist informed study in rural Zambia.

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. CONCLUSION: The two alternative programme theories describe how, why and under what circumstances SRHR interventions that target adolescents can transform 'ordinary' community-based health systems into systems that are responsive to adolescents.

Community based interventions for strengthening adolescent sexual reproductive health and rights: how can they be integrated and sustained? A realist evaluation protocol from Zambia.

BACKGROUND: Research 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. METHODS: This 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. DISCUSSION: The 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.

Social and clinical attributes of patients who restart antiretroviral therapy in central and Copperbelt provinces, Zambia: a retrospective longitudinal study.

BACKGROUND: About 30% of the patients initiated on antiretroviral therapy in Zambia default treatment. Some of these patients later restart treatment; however, the characteristics of these patients have not been well described and documented. The aim of this study was to describe and document the socio-demographic and clinical characteristics of patients who default and restart antiretroviral therapy, and to determine the socio-demographic characteristics associated with CD4 count response at 6 and 24 months of restarting antiretroviral therapy. METHODS: A longitudinal retrospective analysis was performed on data from 535 adult patients restarting antiretroviral therapy in 2009 and 2010 at five antiretroviral therapy centres in Copperbelt and Central provinces of Zambia. To determine the association between the socio-demographic characteristics and CD4 cell count, quantile regression models were used. RESULTS: Older age above 45 years was associated with a significantly lower CD4 cell response by 38.1 cells/mm(3) (95% Confidence interval [CI]: -109.4 to -0.2) compared to the younger age (15-29 years). Patients in formal employment (Adjusted Coefficient [AC] 29.5, 95% CI: 22.8 to 81.1) and self-employment (AC 48.1, 95% CI: 18.6 to 77.4) gained significantly higher CD4 cells than those unemployed. In addition, baseline CD4 count, type of treatment, WHO staging, total duration on treatment and duration lost to follow-up were found to be strong predictors of CD4 cell count at 6 and 24 months after restarting antiretroviral therapy treatment. CONCLUSION: Age and occupation were the only socio-demographic characteristics predicting CD4 count in the patients at 6 months after restarting antiretroviral therapy after adjusting for other confounding clinical variables.

Programme science in action: lessons from an observational study of HIV prevention programming for key populations in Lusaka, Zambia.

INTRODUCTION: Optimizing uptake of pre-exposure prophylaxis (PrEP) for individuals at risk of HIV acquisition has been challenging despite clear scientific evidence and normative guidelines, particularly for key populations (KPs) such as men who have sex with men (MSM), female sex workers (FSWs), transgender (TG) people and persons who inject drugs (PWID). Applying an iterative Programme Science cycle, building on the effective programme coverage framework, we describe the approach used by the Centre for Infectious Disease Research in Zambia (CIDRZ) to scale up PrEP delivery and address inequities in PrEP access for KP in Lusaka, Zambia. METHODS: In 2019, CIDRZ partnered with 10 local KP civil society organizations (CSOs) and the Ministry of Health (MOH) to offer HIV services within KP-designated community safe spaces. KP CSO partners led KP mobilization, managed safe spaces and delivered peer support; MOH organized clinicians and clinical commodities; and CIDRZ provided technical oversight. In December 2021, we introduced a community-based intervention focused on PrEP delivery in venues where KP socialize. We collected routine programme data from September 2019 to June 2023 using programme-specific tools and the national electronic health record. We estimated the before-after effects of our intervention on PrEP uptake, continuation and equity for KP using descriptive statistics and interrupted time series regression, and used mixed-effects regression to estimate marginal probabilities of PrEP continuity. RESULTS: Most (25,658) of the 38,307 (67.0%) Key Population Investment Fund beneficiaries were reached with HIV prevention services at community-based venues. In total, 23,527 (61.4%) received HIV testing services, with 15,508 (65.9%) testing HIV negative and found PrEP eligible, and 15,241 (98.3%) initiating PrEP. Across all programme quarters and KP types, PrEP uptake was >90%. After introducing venue-based PrEP delivery, PrEP uptake (98.7% after vs. 96.5% before, p < 0.001) and the number of initiations (p = 0.014) increased significantly. The proportion of KP with ≥1 PrEP continuation visit within 6 months of initiation was unchanged post-intervention (46.7%, 95% confidence interval [CI]: 45.7%, 47.6%) versus pre-intervention (47.2%, 95% CI: 45.4%, 49.1%). CONCLUSIONS: Applying Programme Science principles, we demonstrate how decentralizing HIV prevention services to KP venues and safe spaces in partnership with KP CSOs enabled successful community-based PrEP delivery beyond the reach of traditional facility-based services.

Mixed-methods protocol for the WiSSPr study: Women in Sex work, Stigma and psychosocial barriers to Pre-exposure prophylaxis in Zambia.

INTRODUCTION: Women engaging in sex work (WESW) have 21 times the risk of HIV acquisition compared with the general population. However, accessing HIV pre-exposure prophylaxis (PrEP) remains challenging, and PrEP initiation and persistence are low due to stigma and related psychosocial factors. The WiSSPr (Women in Sex work, Stigma and PrEP) study aims to (1) estimate the effect of multiple stigmas on PrEP initiation and persistence and (2) qualitatively explore the enablers and barriers to PrEP use for WESW in Lusaka, Zambia. METHODS AND ANALYSIS: WiSSPr is a prospective observational cohort study grounded in community-based participatory research principles with a community advisory board (CAB) of key population (KP) civil society organi sations (KP-CSOs) and the Ministry of Health (MoH). We will administer a one-time psychosocial survey vetted by the CAB and follow 300 WESW in the electronic medical record for three months to measure PrEP initiation (#/% ever taking PrEP) and persistence (immediate discontinuation and a medication possession ratio). We will conduct in-depth interviews with a purposive sample of 18 women, including 12 WESW and 6 peer navigators who support routine HIV screening and PrEP delivery, in two community hubs serving KPs since October 2021. We seek to value KP communities as equal contributors to the knowledge production process by actively engaging KP-CSOs throughout the research process. Expected outcomes include quantitative measures of PrEP initiation and persistence among WESW, and qualitative insights into the enablers and barriers to PrEP use informed by participants' lived experiences. ETHICS AND DISSEMINATION: WiSSPr was approved by the Institutional Review Boards of the University of Zambia (#3650-2023) and University of North Carolina (#22-3147). Participants must give written informed consent. Findings will be disseminated to the CAB, who will determine how to relay them to the community and stakeholders.

Psychosocial challenges and coping strategies among people with minority gender and sexual identities in Zambia: health promotion and human rights implications.

Background: Sexual and gender minorities face high levels of stigma, discrimination, and violence. In many countries, they are often criminalized and are at risk of mental health challenges. In Zambia, little is known about the psychosocial challenges and coping strategies of sexual and gender minorities. This study sought to explore psychosocial challenges and coping strategies among sexual and gender minority populations in Lusaka, Zambia to inform mental health and human rights promotion for this population. Methods: The study used a qualitative phenomenological study design. Data were collected through in-depth interviews with 16 sexual and gender minority participants (lesbian, gay, bisexual, and transgender) and four key informants. The sexual minorities included four lesbian, five gay, and three bisexual participants while the gender minorities included two transgender men and two transgender women. Interviews with gender and sexual minorities were mostly focused on the lived experiences of participants, while those of key informants focused on their work with sexual and gender minorities. Snowball strategy was used to recruit participants, while purposive sampling was used to select key informants. All interviews were recorded and transcribed verbatim. Thematic analysis was carried out with the aid of Nvivo 12 software. Results: Psychosocial challenges included victimization in the form of threats and physical assault. Stigma and discrimination were experienced in different settings such as healthcare, the workplace, and school. Participants reported having experienced feelings of depression. Rejection from family members was experienced by those who revealed their sexual or gender minority status. Reported coping strategies included social support, self-concealment, listening to music, and substance use. Conclusion: This study suggests that sexual and gender minorities in Zambia experience various psychosocial challenges related to their sexuality and gender identity. To assist them cope better with the obstacles they experience, improved psychosocial counseling and mental health services are needed.

Exploring Politics and Contestation in the Policy Process: The Case of Zambia's Contested Community Health Strategy.

There have been increased calls for low- and middle-income countries to develop community health systems (CHS) policies or strategies. However, emerging global guidance brackets the inherent complexity and contestation of policy development at the country level. This is explored through the case of Zambia's 5-year Community Health Strategy (CH Strategy), formulated in 2017 and then summarily withdrawn and reissued two years later, with largely similar content. This paper examines the events, actors, and contexts behind this abrupt change in the Strategy, through an analysis of documentary sources and interviews with 21 stakeholders involved in the policy process. We describe an environment of contestation, characterised by numerous international partners weighing in on the CH Strategy, interfacing with shifting loci of responsibility for the CHS in the Ministry of Health (MoH). Despite the rhetoric of participation, providers and communities played no part in the policy process. These dynamics created the conditions for the abrupt change in strategy, illustrating the inherently fraught and political nature of policy development on the CHS in many countries. Going forward, we conclude that paying attention to processes of CHS policy development, and in particular the interaction between events, actors, and contexts, is as important as ensuring meaningful policy content.

Closing the gap: did delivery approaches complementary to home-based testing reach men with HIV testing services during and after the HPTN 071 (PopART) trial in Zambia?

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.

Framing Contraceptive Use Motivations Among Adolescents and Young Adults Living in Informal Settlements in Kira Municipality, Wakiso District, Uganda.

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.

Does community-based distribution of HIV self-tests increase uptake of HIV testing? Results of pair-matched cluster randomised trial in Zambia.

OBJECTIVES: Ending HIV by 2030 is a global priority. Achieving this requires alternative HIV testing strategies, such as HIV self-testing (HIVST) to reach all individuals with HIV testing services (HTS). We present the results of a trial evaluating the impact of community-based distribution of HIVST in community and facility settings on the uptake of HTS in rural and urban Zambia. DESIGN: Pair-matched cluster randomised trial. METHODS: In catchment areas of government health facilities, OraQuick HIVST kits were distributed by community-based distributors (CBDs) over 12 months in 2016-2017. Within matched pairs, clusters were randomised to receive the HIVST intervention or standard of care (SOC). Individuals aged ≥16 years were eligible for HIVST. Within communities, CBDs offered HIVST in high traffic areas, door to door and at healthcare facilities. The primary outcome was self-reported recent testing within the previous 12 months measured using a population-based survey. RESULTS: In six intervention clusters (population 148 541), 60 CBDs distributed 65 585 HIVST kits. A recent test was reported by 66% (1622/2465) in the intervention arm compared with 60% (1456/2429) in SOC arm (adjusted risk ratio 1.08, 95% CI 0.94 to 1.24; p=0.15). Uptake of the HIVST intervention was low: 24% of respondents in the intervention arm (585/2493) used an HIVST kit in the previous 12 months. No social harms were identified during implementation. CONCLUSION: Despite distributing a large number of HIVST kits, we found no evidence that this community-based HIVST distribution intervention increased HTS uptake. Other models of HIVST distribution, including secondary distribution and community-designed distribution models, provide alternative strategies to reach target populations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT02793804).

Who Accepts and Who Uses Community-Based Secondary Distribution HIV Self-Testing (HIVST) Kits? Findings From the Intervention Arm of a Cluster-Randomized Trial of HIVST Distribution Nested in Four HPTN 071 (PopART) Communities in Zambia.

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.

Community based distribution of oral HIV self-testing kits in Zambia: a cluster-randomised trial nested in four HPTN 071 (PopART) intervention communities.

BACKGROUND: The 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. METHODS: We 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. FINDINGS: Between 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. INTERPRETATION: Providing a choice of HIV self-testing during delivery of door-to-door HIV testing services increased knowledge of HIV status, driven by an effect among men. Lay counsellors have a vital role to play in adapting HIV self-testing interventions to local context. FUNDING: The International Initiative for Impact Evaluation (3ie), the Bill & Melinda Gates Foundation, National Institute of Allergy and Infectious Diseases, National Institute on Drug Abuse, National Institute of Mental Health, and the President's Emergency Plan for AIDS Relief.

Predictors of timely linkage-to-ART within universal test and treat in the HPTN 071 (PopART) trial in Zambia and South Africa: findings from a nested case-control study.

INTRODUCTION: HPTN 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. METHODS: Of 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. RESULTS: Data 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 (ptrend  = 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 (ptrend  = 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). DISCUSSION: The 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.