Isisekelo Sempilo study protocol for the efectiveness 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
Date
2022
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Abstract
Background: Antiretroviral therapy (ART) through universal test and treat (UTT) and HIV pre-exposure prophylaxis
(PrEP) substantially reduces HIV-related mortality, morbidity and incidence. Efective 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 efectiveness of HIV prevention services with or without peer support to reduce prevalence of trans‑
missible 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 posi‑
tive 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 efectiveness 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 efective and risk informed biomedical HIV prevention and preliminary data on their efectiveness on
reducing the prevalence of transmissible HIV amongst all adolescents and youth.
Trial registration: Trial Registry: clincialtrials.gov. ClinicalTrials.gov Identifer NCT04532307. Registered: March 2020.
Keywords: Peer navigator, HIV prevention, Community-based care, Contraception, Pre-Exposure prophylaxis