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. 2022 Mar 7;22(1):454.
doi: 10.1186/s12889-022-12796-8.

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

Glory Chidumwa  1 , Natsayi Chimbindi  1   2   3 , Carina Herbst  1 , Nonhlanhla Okeselo  1 , Jaco Dreyer  1 , Thembelihle Zuma  1   2   3 , Theresa Smith  1 , Jean-Michel Molina  4 , Thandeka Khoza  1 , Nuala McGrath  1   5 , Janet Seeley  1   6 , Deenan Pillay  2 , Frank Tanser  1   7 , Guy Harling  1   2   3   8   9 , Lorraine Sherr  2 , Andrew Copas  2 , Kathy Baisley  1   6 , Maryam Shahmanesh  10   11   12
Affiliations

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

Glory Chidumwa et al. BMC Public Health. .

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. 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.

Trial registration: Trial Registry: clincialtrials.gov.

Clinicaltrials: gov Identifier NCT04532307 . Registered: March 2020.

Keywords: Community-based care; Contraception; HIV prevention; Peer navigator; Pre-Exposure prophylaxis.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Isisekelo Sempilo 2x2 factorial RCT Diagram
Fig. 2
Fig. 2
South Africa National Guidelines PrEP screening tool
Fig. 3
Fig. 3
Isisekelo Sempilo RCT Theory of Change
See this image and copyright information in PMC

References

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