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Background The long-term impact of universal home-based testing and treatment as part of universal testing and treatment (UTT) on HIV incidence is unknown. We made projections using a detailed individual-based model of the effect of the intervention delivered in the HPTN 071 (PopART) cluster-randomised trial. Methods In this modelling study, we fitted an individual-based model to the HIV epidemic and HIV care cascade in 21 high prevalence communities in Zambia and South Africa that were part of the PopART cluster-randomised trial (intervention period Nov 1, 2013, to Dec 31, 2017). The model represents coverage of home-based testing and counselling by age and sex, delivered as part of the trial, antiretroviral therapy (ART) uptake, and any changes in national guidelines on ART eligibility. In PopART, communities were randomly assigned to one of three arms: arm A received the full PopART intervention for all individuals who tested positive for HIV, arm B received the intervention with ART provided in accordance with national guidelines, and arm C received standard of care. We fitted the model to trial data twice using Approximate Bayesian Computation, once before data unblinding and then again after data unblinding. We compared projections of intervention impact with observed effects, and for four different scenarios of UTT up to Jan 1, 2030 in the study communities. Findings Compared with standard of care, a 51% (95% credible interval 40–60) reduction in HIV incidence is projected if the trial intervention (arms A and B combined) is continued from 2020 to 2030, over and above a declining trend in HIV incidence under standard of care. Interpretation A widespread and continued commitment to UTT via home-based testing and counselling can have a substantial effect on HIV incidence in high prevalence communities. Funding National Institute of Allergy and Infectious Diseases, US President's Emergency Plan for AIDS Relief, International Initiative for Impact Evaluation, Bill & Melinda Gates Foundation, National Institute on Drug Abuse, and National Institute of Mental Health.

The HPTN 071 (PopART) trial of universal HIV testing and treatment to reduce HIV incidence was conducted in nine communities in South Africa and 12 in Zambia. The trial's primary outcome results were complicated to explain. Dissemination of these complicated results in participating communities in Zambia was done using a community dialogue approach. The approach, which involved interactive activities and a gradual and systematic approach to discussion of results in each community, facilitated respect and inclusion of participants in the dissemination process. The use of local language, pictures, images, and familiar analogies enhanced comprehension of the findings and created a two-way communication process between researchers and participants. The dialogue approach enabled both groups to use community perspectives, lived experiences, and local socio-structural features to interpret the trial results. Further, community members reflected on what the results meant to them individually and collectively. Although this community dialogue was both productive and appreciated, making this community interpretation apparent across disciplines in key quantitative scientific outputs remained a challenge.

Summary Background Non-facility-based antiretroviral therapy (ART) delivery for people with stable HIV might increase sustainable ART coverage in low-income and middle-income countries. Within the HPTN 071 (PopART) trial, two interventions, home-based delivery (HBD) and adherence clubs (AC), which included groups of 15–30 participants who met at a communal venue, were compared with standard of care (SoC). In this trial we looked at the effectiveness and feasibility of these alternative models of care. Specifically, this trial aimed to assess whether these models of care had similar virological suppression to that of SoC 12 months after enrolment. Methods This was a three-arm, cluster-randomised, non-inferiority trial, done in two urban communities in Lusaka, Zambia included in the HPTN 071 trial. The two communities were split into zones, which were randomly assigned (1:1:1) to the three treatment strategies: 35 zones to the SoC group, 35 zones to the HBD group, and 34 zones to the AC group. ART and adherence support were delivered once every 3 months at home for the HBD group, in groups of 15–30 people in the AC group, or in the clinic for the SoC group. Adults with HIV who were receiving first-line ART for at least 6 months, virally suppressed using national HIV guidelines in the last 12 months, had no other health conditions requiring the clinicians attention, live in the study catchment area, and provided written informed consent, were eligible for inclusion. The primary endpoint was viral suppression at 12 months (with a 6 month final measurement window [ie, 9–15 months]), defined as less than 1000 HIV RNA copies per mL, with a non-inferiority margin of 5%. Findings Between May 5 and Dec 19, 2017, 9900 individuals were screened for inclusion, of whom 2489 (25·1%) participants were enrolled into the trial: 781 (31%) in the SoC group, 852 (34%) in the HBD group, and 856 (34%) in the AC group. A higher proportion of participants had viral load measurements in the primary outcome window in the HBD (581 [61%]of 852 participants) and AC (485 [57%] of 856 participants) groups than in the SoC (390 [50%] of 781 patients) group (p=0·0021). Of the 1096 missing observations, 152 (13·8%) were attributable to either deaths (25 [16%] participants), relocations (37 [24%] participants), or lost to follow-up (90 [59%]); 690 (63·0%) participants had viral load results outside the window period; and 254 (23·2%) did not have a viral load result. The prevalence of viral suppression was estimated to be 98·3% (95% CI 96·6 to 99·7) in the SoC group, 98·7% (97·5 to 99·6) in the HBD group, and 99·2% (98·4 to 99·8) in the AC group. This gave an estimated risk difference of 0·3% (95% CI −1·5 to 2·4) for the HBD group compared with the SoC group and 0·9% (−0·8 to 2·8) for the AC group compared with the SoC group. There was strong evidence (p

BackgroundAntiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection. MethodsWe conducted a phase 3, randomized, double-blind, placebo-controlled trial of a monthly vaginal ring containing dapivirine, a non-nucleoside HIV-1 reverse-transcriptase inhibitor, involving women between the ages of 18 and 45 years in Malawi, South Africa, Uganda, and Zimbabwe. ResultsAmong the 2629 women who were enrolled, 168 HIV-1 infections occurred: 71 in the dapivirine group and 97 in the placebo group (incidence, 3.3 and 4.5 per 100 person-years, respectively). The incidence of HIV-1 infection in the dapivirine group was lower by 27% (95% confidence interval [CI], 1 to 46; P=0....

Key to the success of a HIV combination prevention strategy, including galvanizing the current push to roll out universal test and treat (UTT), is the involvement and buy-in of the populations that the strategy aims to reach. Drawing on the experiences of engaging with 21 communities in Zambia and South Africa in the design and implementation of a community-randomized study of combination HIV prevention including UTT, this paper reflects on the commitment to, approaches for and benefits of involving communities. Key lessons learnt include that all communities require continuous community engagement (CE) and engagement needs to be adapted to diverse local contexts. Intrinsic goals of CE, such as building trusting relationships between study stakeholders, are necessary precursors to instrumental goals which strengthen the research quality. Engaging the community for combination prevention requires that CE successfully bridges science and real life, paying attention to influences in the wider social landscape.

(Abstracted from N Engl J Med 2016; DOI: 10.1056/NEJMoa1506110)The objective of this study was to examine the efficacy of dapivirine vaginal rings in providing protection against human immunodeficiency virus type 1 (HIV-1). HIV-1 infection incidence is one of the highest in sub-Saharan Africa.

Studies have indicated disproportionate health risks among African American adolescents. Given these estimates, research has focused on the prevention of health risk behaviors among this population. Using a strengths-based approach, the current study explored associations between community involvement and African American youths’ health risk behaviors. Additionally, this investigation examined youths’ empowerment beliefs as a mediator of this association. Participants in this study were 1,452 African American youth ( M = 14.41; SD = 1.14; 59% female) residing in a large Midwestern city. Results indicated that community involvement was not directly associated with adolescent health risk behaviors. However, empowerment beliefs mediated the association between community youth involvement and adolescent sexual risk behaviors. Findings suggest the importance of identifying mechanisms that better illuminate the link between community involvement and African American adolescents’ health risk behaviors.

Background Most trials of interventions are designed to address the traditional null hypothesis of no benefit. VOICE, a phase 2B HIV prevention trial funded by NIH and conducted in Africa, is designed to assess if the intervention will prevent a substantial fraction of infections. Planned interim analysis may provide conclusive evidence against the traditional null hypothesis without establishing substantial benefit. At this interim point, the Data and Safety Monitoring Board would then face the dilemma of knowing the product has some positive effect, but perhaps not as great an effect as the protocol has declared necessary. Purpose In March 2008, NIH program staff recommended that the VOICE protocol team discuss the stopping rules with stakeholders prior to initiating the protocol. The goals of the workshop were to inform community representatives about the potential ethical dilemma associated with stopping rules and engage in dialogue about these issues. We describe the resulting community consultation and summarize the outcomes. Methods A 2-day workshop was convened with the goal of having a clear and transparent consultation with the stakeholders around the question, ‘Given emerging evidence that a product could prevent some infections, would the community support a decision to continue accruing to the trial?’ Participants included research staff and community stakeholders. Lectures with visual aids, discussions, and exercises using interactive learning tasks were used, with a focus on statistics and interpreting data from trials, particularly interim data. Results Results of oral and written evaluations by participants were reviewed. The feedback was mostly positive, with some residual confusion regarding statistical concepts. However, discussions with attendees later revealed that not all felt prepared to engage fully in the workshop. Limitations This was the presenters’ first experience facilitating a formal discussion with an audience that had no advanced science, research, or mathematics training. Community representatives’ concern regarding speaking for their communities without consulting them also created a challenge for the workshop. Conclusions Open discussion around trial stopping rules requires that all discussants have an understanding of trial design concepts and feel a sense of empowerment to ask and answer questions. The VOICE CWG workshop was a first step toward the goal of open discussion regarding trial stopping rules and interim results for the study; however, ongoing education and dialogue must occur to ensure that all stakeholders fully participate in the process.