Isisekelo Sempilo study protocol for the effectiveness of HIV prevention embedded in sexual health with or without peer navigator support (Thetha Nami) to reduce prevalence of transmissible HIV amongst adolescents and young adults in rural KwaZulu-Natal: a 2 × 2 factorial randomised controlled trial

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dc.contributor.authorChidumwa, Glory
dc.contributor.authorChimbindi, Natsayi
dc.contributor.authorHerbst, Carina
dc.contributor.authorOkeselo, Nonhlanhla
dc.contributor.authorDreyer, Jaco
dc.contributor.authorZuma, Thembelihle
dc.contributor.authorSmith, Theresa
dc.contributor.authorMolina, Jean-Michel
dc.contributor.authorKhoza, Thandeka
dc.contributor.authorMcGrath, Nuala
dc.contributor.authorSeeley, Janet
dc.contributor.authorPillay, Deenan
dc.contributor.authorTanser, Frank
dc.contributor.authorHarling, Guy
dc.contributor.authorSherr, Lorraine
dc.contributor.authorCopas, Andrew
dc.contributor.authorBaisley, Kathy
dc.contributor.authorShahmanesh, Maryam
dc.date.accessioned2022-12-11T06:08:06Z
dc.date.available2022-12-11T06:08:06Z
dc.date.issued2022-03-07
dc.description.abstractBackground: Antiretroviral therapy (ART) through universal test and treat (UTT) and HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV-related mortality, morbidity and incidence. Effective individual-level prevention modalities have not translated into population-level impact in southern Africa due to sub-optimal coverage among adolescents and youth who are hard to engage. We aim to investigate the feasibility, acceptability, and preliminary population level effectiveness of HIV prevention services with or without peer support to reduce prevalence of transmissible HIV amongst adolescents and young adults in KwaZulu-Natal. Methods: We are conducting a 2 × 2 factorial trial among young men and women aged 16–29 years, randomly selected from the Africa Health Research Institute demographic surveillance area. Participants are randomly allocated to one of four intervention combinations: 1) Standard of Care (SOC): nurse-led services for HIV testing plus ART if positive or PrEP for those eligible and negative; 2) Sexual and Reproductive Health (SRH): Baseline self-collected vaginal and urine samples with study-organized clinic appointments for results, treatment and delivery of HIV testing, ART and PrEP integrated with SRH services; 3) Peer-support: Study referral of participants to a peer navigator to assess their health, social and educational needs and provide risk-informed HIV prevention, including facilitating clinic attendance; or 4) SRH + peer-support. The primary outcomes for effectiveness are: (1) the proportion of individuals with infectious HIV at 12 months and (2) uptake of risk-informed comprehensive HIV prevention services within 60 days of enrolment. At 12 months, all participants will be contacted at home and the study team will collect a dried blood spot for HIV ELISA and HIV viral load testing. Discussion: This trial will enable us to understand the relative importance of SRH and peer support in creating demand for effective and risk informed biomedical HIV prevention and preliminary data on their effectiveness on reducing the prevalence of transmissible HIV amongst all adolescents and youth.en_US
dc.identifier.citationChidumwa, G., Chimbindi, N., Herbst, C., Okeselo, N., Dreyer, J., Zuma, T., Smith, T., Molina, J. M., Khoza, T., McGrath, N., Seeley, J., Pillay, D., Tanser, F., Harling, G., Sherr, L., Copas, A., Baisley, K., & Shahmanesh, M. (2022). Isisekelo Sempilo study protocol for the effectiveness of HIV prevention embedded in sexual health with or without peer navigator support (Thetha Nami) to reduce prevalence of transmissible HIV amongst adolescents and young adults in rural KwaZulu-Natal: a 2 × 2 factorial randomised controlled trial. BMC public health, 22(1), 454. https://doi.org/10.1186/s12889-022-12796-8en_US
dc.identifier.otherDOI: 10.1186/s12889-022-12796-8
dc.identifier.urihttps://hdl.handle.net/20.500.14041/4548
dc.language.isoen_USen_US
dc.publisherBMC Public Healthen_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.subjectPeer Navigatoren_US
dc.subjectHIV Preventionen_US
dc.subjectCommunity-Based Careen_US
dc.subjectContraceptionen_US
dc.subjectPre-Exposure Prophylaxisen_US
dc.titleIsisekelo Sempilo study protocol for the effectiveness of HIV prevention embedded in sexual health with or without peer navigator support (Thetha Nami) to reduce prevalence of transmissible HIV amongst adolescents and young adults in rural KwaZulu-Natal: a 2 × 2 factorial randomised controlled trialen_US
dc.typeArticleen_US
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