The adjusted risk ratio for ART uptake was similar for Arm A vs. ART uptake was associated with older age, female sex, enrollment year, seroconverter status, and self-reported ART (all p < 0.001). Drug resistance was observed in 237/612 (39%) viremic participants (95/102 with ARV drugs 142/510 without drugs). A two-stage cluster-based approach assessed the impact of the study intervention on ART uptake.ĪRV drugs were detected in 4,419/6,207 (71%) of samples (Arm A: 73%, B: 70%, C: 60%) 4,140 (94%) of samples with ARV drugs had viral loads <400 copies/mL. Resistance was evaluated in 612 randomly-selected viremic participants. ART uptake was defined as detection of ≥1 ARV drug. Samples were collected from people with HIV (PWH) during a survey visit conducted two years after study implementation these samples were tested for 22 antiretroviral (ARV) drugs. Study communities were randomized to three arms (A: combination-prevention intervention with universal ART B: combination-prevention intervention with ART according to local guidelines C: standard-of-care).
FHI 360 FEWS TRIAL
The primary aim of this study was to evaluate ART uptake in a trial in Zambia and South Africa which implemented a community-wide universal testing and treatment (UTT) package to reduce HIV incidence. National Institute of Allergy and Infectious Diseases, the National Institutes of Health, the International Initiative for Impact Evaluation (3ie), the Bill & Melinda Gates Foundation, the US President's Emergency Plan for AIDS Relief, and the Medical Research Council UK.Īntiretroviral therapy (ART) reduces HIV transmission risk. The findings do not help to explain the differences between the two intervention groups of the HPTN 071 (PopART) trial. We found little evidence of any change in sexual behaviour owing to the PopART interventions, and reassuringly for public health, we saw no evidence of sexual risk compensation. 3-year HSV-2 incidence was reduced in arm B versus arm C (adjusted risk ratio 0♷6 p=0♰10) no significant change was shown between arm A versus arm C (0♸9 p=0♱99). Adjusted for baseline community prevalence, reported condomless sex was significantly lower in arm A versus arm C (adjusted prevalence ratio 0♸0 p=0♰4) but not in arm B versus arm C (0♹4 p=0♵5). The PopART intervention did not substantially change probability of self-reported multiple sex partners, sexual debut, or pregnancy in women at 36 months. This trial is registered with ClinicalTrials. Secondary endpoints included differences in sexual risk behaviour measures at 36 months and were assessed using a two-stage method for matched cluster-randomised trials. A prespecified secondary objective was to evaluate the impact of the PopART intervention compared with standard of care on herpes simplex virus type 2 (HSV-2) and sexual behaviour (N=20 422 completed final visit). The trial included a population cohort of approximately 2000 randomly selected adults (aged 18–44 years) in each community (N=38 474 at baseline) who were followed up for 36 months. HPTN 071 (PopART) was a cluster-randomised trial conducted during 2013–18, in which we randomly assigned 21 communities with high HIV prevalence in Zambia and South Africa (total population, approximately 1 million) to combination prevention intervention with universal antiretroviral therapy (ART arm A), prevention intervention with ART provided according to local guidelines (universal since 2016 arm B), or standard of care (arm C). We investigated the prespecified secondary outcomes of the HPTN 071 (PopART) trial to determine whether a combination HIV prevention strategy, including universal HIV testing and treatment, changed sexual behaviour specifically, we investigated whether there was evidence of sexual risk compensation. Comprehensive HIV prevention strategies have raised concerns that knowledge of interventions to reduce risk of HIV infection might mitigate an individual's perception of risk, resulting in riskier sexual behaviour.
0 kommentar(er)
