Assessment of a screening tool to aid home-based identification of adolescents (aged 10-14) living with HIV in Zambia and South Africa: HPTN 071 (PopART) study.

INTRODUCTION: The HPTN071 (PopART) for Youth (P-ART-Y) study evaluated the acceptability and uptake of a community-level combination HIV prevention package including universal testing and treatment (UTT) among young people in Zambia and South Africa. We determined whether a four-question primary care level screening tool, validated for use in clinical settings, could enhance community (door-to-door) identification of undiagnosed HIV-positive younger adolescents (aged 10-14) who are frequently left out of HIV interventions. METHOD: Community HIV-care Providers (CHiPs) contacted and consented adolescents in their homes and offered them participation in the PopART intervention. CHiPs used a four question-screening tool, which included: history of hospital admission; recurring skin problems; poor health in last 3 months; and death of at least one parent. A "yes" response to one or more questions was classified as being "at risk" of being HIV-positive. Rapid HIV tests were offered to all children. Data were captured through an electronic data capture device from August 2016 to December 2017. The sensitivity, specificity, positive predictive value and negative predictive value were estimated for the screening tool, using the rapid HIV test result as the gold standard. RESULTS: In our 14 study sites, 33,710 adolescents aged 10-14 in Zambia and 8,610 in South Africa participated in the study. About 1.3% (427/33,710) and 1.2% (106/8,610) self-reported to be HIV positive. Excluding the self-reported HIV-positive, we classified 11.3% (3,746/33,283) of adolescents in Zambia and 17.5% (1,491/8,504) in South Africa as "at risk". In Zambia the estimated sensitivity was 35.3% (95% CI 27.3%-44.2%) and estimated specificity was 88.9% (88.5%-89.2%). In South Africa the sensitivity was 72.3% (26.8%-94.9%) and specificity was 82.5% (81.6-83.4%). CONCLUSION: The sensitivity of the screening tool in a community setting in Zambia was low, so this tool should not be considered a substitute for universal testing where that is possible. In South Africa the sensitivity was higher, but with a wide confidence interval. Where universal testing is not possible the tool may help direct resources to adolescents more likely to be living with undiagnosed HIV. TRIAL REGISTRATION: Clinical Trial Number: NCT01900977.

The association between HIV stigma and HIV incidence in the context of universal testing and treatment: analysis of data from the HPTN 071 (PopART) trial in Zambia and South Africa.

INTRODUCTION: To investigate the association between individual and community-level measures of HIV stigma and HIV incidence within the 21 communities participating in the HPTN (071) PopART trial in Zambia and South Africa. METHODS: Secondary analysis of data from a population-based cohort followed-up over 36 months between 2013 and 2018. The outcome was rate of incident HIV infection among individuals who were HIV negative at cohort entry. Individual-level exposures, measured in a random sample of all participants, were: (1) perception of stigma in the community, (2) perception of stigma in health settings and (3) fear and judgement towards people living with HIV. Individual-level analyses were conducted with adjusted, individual-level Poisson regression. Community-level HIV stigma exposures drew on data reported by people living with HIV, health workers and community members. We used linear regression to explore the association between HIV stigma and community-level HIV incidence. RESULTS: Among 8172 individuals who were HIV negative and answered individual-level stigma questions at enrolment to the cohort, there was no evidence of a statistically significant association between any domain of HIV stigma and risk of incident HIV infection. Among the full cohort of 26,110 individuals among whom HIV incidence was measured, there was no evidence that community-level HIV incidence was associated with any domain of HIV stigma. CONCLUSIONS: HIV stigma is often cited as a barrier to the effectiveness of HIV prevention programming. However, in the setting for the HPTN 071 "PopART trial," measured stigma alone was not associated with the risk of HIV infection.

Community-based health workers implementing universal access to HIV testing and treatment: lessons from South Africa and Zambia-HPTN 071 (PopART).

The global expansion of HIV testing, prevention and treatment services is necessary to achieve HIV epidemic control and promote individual and population health benefits for people living with HIV (PLHIV) in sub-Saharan Africa. Community-based health workers (CHWs) could play a key role in supporting implementation at scale. In the HPTN 071 (PopART) trial in Zambia and South Africa, a cadre of 737 study-specific CHWs, working closely with government-employed CHW, were deployed to deliver a 'universal' door-to-door HIV prevention package, including an annual offer of HIV testing and referral services for all households in 14 study communities. We conducted a process evaluation using qualitative and quantitative data collected during the trial (2013-2018) to document the implementation of the CHW intervention in practice. We focused on the recruitment, retention, training and support of CHWs, as they delivered study-specific services. We then used these descriptions to: (i) analyse the fidelity to design of the delivery of the intervention package, and (ii) suggest key insights for the transferability of the intervention to other settings. The data included baseline quantitative data collected with the study-specific CHWs (2014-2018); and qualitative data from key informant interviews with study management (n = 91), observations of CHW training events (n = 12) and annual observations of and group discussions (GD) with intervention staff (n = 68). We show that it was feasible for newly recruited CHWs to implement the PopART intervention with good fidelity, supporting the interpretation of the trial outcome findings. This was despite some challenges in managing service quality and CHW retention in the early years of the programme. We suggest that by prioritizing the adoption of key elements of the in-home HIV services delivery intervention model-including training, emotional support to workers, monitoring and appropriate remuneration for CHWs-these services could be successfully transferred to new settings.

Implementing 'universal' access to antiretroviral treatment in South Africa: a scoping review on research priorities.

'Universal' access to antiretroviral treatment (ART) has become the global standard for treating people living with HIV and achieving epidemic control; yet, findings from numerous 'test and treat' trials and implementation studies in sub-Saharan Africa suggest that bringing 'universal' access to ART to scale is more complex than anticipated. Using South Africa as a case example, we describe the research priorities and foci in the literature on expanded ART access. To do so, we adapted Arksey and O'Malley's six-stage scoping review framework to describe the peer-reviewed literature and opinion pieces on expanding access to ART in South Africa between 2000 and 2017. Data collection included systematic searches of two databases and hand-searching of a sub-sample of reference lists. We used an adapted socio-ecological thematic framework to categorize data according to where it located the challenges and opportunities of expanded ART eligibility: individual/client, health worker-client relationship, clinic/community context, health systems infrastructure and/or policy context. We included 194 research articles and 23 opinion pieces, of 1512 identified, addressing expanded ART access in South Africa. The peer-reviewed literature focused on the individual and health systems infrastructure; opinion pieces focused on changing roles of individuals, communities and health services implementers. We contextualized our findings through a consultative process with a group of researchers, HIV clinicians and programme managers to consider critical knowledge gaps. Unlike the published literature, the consultative process offered particular insights into the importance of researching and intervening in the relational aspects of HIV service delivery as South Africa's HIV programme expands. An overwhelming focus on individual and health systems infrastructure factors in the published literature on expanded ART access in South Africa may skew understanding of HIV programme shortfalls away from the relational aspects of HIV services delivery and delay progress with finding ways to leverage non-medical modalities for achieving HIV epidemic control.

Motivating people living with HIV to initiate antiretroviral treatment outside national guidelines in three clinics in the HPTN 071 (PopART) trial, South Africa.

Background: The HPTN 071 (PopART) trial implemented universal test and treat (UTT) in three clinics in the Western Cape, South Africa at a time when antiretroviral treatment (ART) was only offered by CD4 threshold and World Health Organization clinical staging. This required a concomitant shift in the way health workers communicated ART initiation messages. We provide insight into front-line ART initiation communication pre-national policy shift.Method: The design of this study was exploratory with a case descriptive analysis of ART initiation in three clinics. To characterise their demographic profiles, we reviewed 134 randomly selected patient clinical folders of people who initiated ART at CD4 counts greater than the recommended standard. Further, we conducted 12 key informant interviews with health workers at these facilities and thematically analysed health workers' responses.Results: The median age of patients initiating ART regardless of CD4 count (above the threshold level) was 33 years and most were women (73.9%), married (76.1%), and unemployed (48.5%). The median CD4 count of patients initiating outside guidelines was 566.5 cells/µl. Contrary to expectations, key informants indicated no radical shift in messaging to explain ART initiation regardless of CD4 count. Rather, they encouraged people living with HIV (PLHIV) to initiate ART while they still "feel well". The reduced risk of onward HIV transmission did not factor significantly in how health workers motivated clients.Conclusion: Motivating PLHIV to initiate ART regardless of CD4 count in high burden settings is possible. However, there are still opportunities to improve messaging about immediate ART initiation or at high CD4 counts for the prevention of onward transmission.

Impact of a community-wide combination HIV prevention intervention on knowledge of HIV status among adolescents.

OBJECTIVE: To determine the impact of a community-wide combination HIV-prevention package (PopART Intervention) that includes universal testing and treatment (UTT) on knowledge of HIV status, among adolescents aged 15--19 years. DESIGN: The HPTN 071 (PopART) for Youth (P-ART-Y) study was nested within HPTN 071 (PopART), a three-arm, cluster-randomized trial conducted from 2013 through 2018 in 21 communities in Zambia and South Africa. Communities were randomly assigned to arm A (combination prevention intervention with universal ART), arm B (prevention intervention with ART provided according to local guidelines), or arm C (standard-of-care). METHODS: Knowledge of HIV status was measured using data collected during the third round of the PopART intervention in arms A and B (October 2016 to December 2017) and by conducting a cross-sectional survey (August to November 2017) in arm C communities to provide comparative data. The survey was conducted among ∼200 randomly selected adolescents in each community. We used linear regression of the 21 community-level values to make comparisons among trial arms. RESULTS: Knowledge of HIV status was 78.2% (23 544/30 089) in arm A and 76.0% (24 417/32 148) in arm B communities, compared with 32.9% (698/2120) in arm C communities. Knowledge of HIV status varied by country, triplet, sex, and age. The adjusted mean difference was 42.3% between arm A with arm C, 95% CI 28.1-56.6, P less than 0.001 and 40.4% between arm B with arm C, 95% CI 24.6-56.2, P < 0.001). CONCLUSION: Implementation of a community-wide combination HIV-prevention package that includes UTT substantially enhanced knowledge of HIV status among adolescents.

Universal HIV testing and treatment and HIV stigma reduction: a comparative thematic analysis of qualitative data from the HPTN 071 (PopART) trial in South Africa and Zambia.

Despite continued development of effective HIV treatment, expanded access to care and advances in prevention modalities, HIV-related stigma persists. We examine how, in the context of a universal HIV-testing and treatment trial in South Africa and Zambia, increased availability of HIV services influenced conceptualisations of HIV. Using qualitative data, we explore people's stigma-related experiences of living in 'intervention' and 'control' study communities. We conducted exploratory data analysis from a qualitative cohort of 150 households in 13 study communities, collected between 2016 and 2018. We found that increased availability of HIV-testing services influenced conceptualisations of HIV as normative (non-exceptional) and the visibility of people living with HIV (PLHIV) in household and community spaces impacted opportunities for stigma. There was a shift in community narratives towards individual responsibility to take up (assumingly) widely available service - for PLHIV to take care of their own health and to prevent onward transmission. Based on empirical data, we show that, despite a growing acceptance of HIV-related testing services, anticipated stigma persists through the mechanism of shifting responsibilisation. To mitigate the responsibilisation of PLHIV, heath implementers need to adapt anti-stigma messaging and especially focus on anticipated stigma.

HIV Stigma and Viral Suppression Among People Living With HIV in the Context of Universal Test and Treat: Analysis of Data From the HPTN 071 (PopART) Trial in Zambia and South Africa.

BACKGROUND: The impact of HIV stigma on viral suppression among people living with HIV (PLHIV) is not well characterized. SETTING: Twenty-one communities in Zambia and South Africa, nested within the HPTN 071 (PopART) trial. METHODS: We analyzed data on viral suppression (<400 copies HIV RNA/mL) among 5662 laboratory-confirmed PLHIV aged 18-44 years who were randomly sampled within the PopART trial population cohort 24 months after enrolment (PC24). We collected data on experiences and internalization of stigma from those PLHIV who self-reported their HIV status (n = 3963/5662) and data on perceptions of stigma from a 20% random sample of all PLHIV (n = 1154/5662). We also measured stigma at the community-level among PLHIV, community members, and health workers. We analyzed the association between individual- and community-level measures of HIV stigma and viral suppression among PLHIV, adjusting for confounding. RESULTS: Of all 5662 PLHIV, 69.1% were virally suppressed at PC24. Viral suppression was highest among those 3963 cohort participants who self-reported living with HIV and were on ART (88.3%), and lower among those not on treatment (37.5%). Self-identifying PLHIV who reported internalized stigma were less likely to be virally suppressed (75.0%) than those who did not (80.7%; adjusted risk ratio, 0.94 95% CI: 0.89 to 0.98). Experiences, perceptions, and community-level measures of stigma were not associated with viral suppression. CONCLUSION: Internalized stigma among PLHIV was associated with a lower level of viral suppression; other dimensions of stigma were not. Stigma reduction approaches that address internalized stigma should be an integral component of efforts to control the HIV epidemic.

The effect of universal testing and treatment on HIV stigma in 21 communities in Zambia and South Africa.

OBJECTIVES: To assess the impact of a combination HIV prevention intervention including universal testing and treatment (UTT) on HIV stigma among people living with HIV, and among community members and health workers not living with HIV. DESIGN: This HIV stigma study was nested in the HPTN 071 (PopART) trial, a three-arm cluster randomised trial conducted between 2013 and 2018 in 21 urban/peri-urban communities (12 in Zambia and nine in South Africa). METHODS: Using an adjusted two-stage cluster-level analysis, controlling for baseline imbalances, we compared multiple domains of stigma between the trial arms at 36 months. Different domains of stigma were measured among three cohorts recruited across all study communities: 4178 randomly sampled adults aged 18-44 who were living with HIV, and 3487 randomly sampled adults and 1224 health workers who did not self-report living with HIV. RESULTS: Prevalence of any stigma reported by people living with HIV at 36 months was 20.2% in arm A, 26.1% in arm B, and 19.1% in arm C (adjusted prevalence ratio, A vs. C 1.01 95% CI 0.49-2.08, B vs. C 1.34 95% CI 0.65-2.75). There were no significant differences between arms in any other measures of stigma across all three cohorts. All measures of stigma reduced over time (0.2--4.1% reduction between rounds) with most reductions statistically significant. CONCLUSION: We found little evidence that UTT either increased or decreased HIV stigma measured among people living with HIV, or among community members or health workers not living with HIV. Stigma reduced over time, but slowly. CLINICALTRIALS. GOV NUMBER: NCT01900977.

"Being seen" at the clinic: Zambian and South African health worker reflections on the relationship between health facility spatial organisation and items and HIV stigma in 21 health facilities, the HPTN 071 (PopART) study.

Health workers in 21 government health facilities in Zambia and South Africa linked spatial organisation of HIV services and material items signifying HIV-status (for example, coloured client cards) to the risk of People Living with HIV (PLHIV) 'being seen' or identified by others. Demarcated HIV services, distinctive client flow and associated-items were considered especially distinguishing. Strategies to circumvent any resulting stigma mostly involved PLHIV avoiding and/or reducing contact with services and health workers reducing visibility of PLHIV through alterations to structures, items and systems. HIV spatial organisation and item adjustments, enacting PLHIV-friendly policies and wider stigma reduction initiatives could combined reduce risks of identification and enhance the privacy of health facility space and diminish stigma.

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.