Isisekelo Sempilo 2x2 factorial randomised controlled trial of the effectiveness of integrating HIV prevention within sexual reproductive health (SRH) services with or without peer support amongst adolescents and young adults in rural KwaZulu-Natal

Abstract

Background: approximately 200,000 South Africans acquired HIV in 2021 despite universal HIV test and treat (UTT) and Pre-Exposure Prophylaxis (PrEP).

Methods: we conducted a 2x2 factorial open label randomised controlled trial. N=3000 potentially eligible 16-29-year-olds, randomly sampled from a population surveillance area in a mostly rural part of KwaZulu-Natal, were randomised to one of 4 arms: 1) enhanced Standard of Care (SoC): access to mobile youth-friendly services for differentiated HIV prevention (condoms, UTT, PrEP if eligible); 2) Sexual and Reproductive Health (SRH): baseline self-collected specimens for sexually transmitted infection testing and referral to differentiated HIV prevention services; 3) Peer-support: referral to a peer navigator for support, condom provision and facilitation of attendance for differentiated HIV prevention services; 4) SRH + peer-support. Co-primary effectiveness outcomes were: 1) linkage to differentiated HIV prevention services within 60 days of enrolment; 2) transmissible HIV (HIV viral load ≥400 copies/mL) measured from dried blood spots (DBS) at 12 months. 3) the proportion of sampled individuals who consented to participation and gave a DBS for HIV testing at 12 months. Logistic regression was used for analyses, adjusted for age, sex and rural/peri-urban area.

Findings: between March 2020 and August 2022, 1743/2301(76%) eligible individuals were enrolled, with a 12-month DBS collected from 1168 (67%). Baseline characteristics and 12-month outcome ascertainment were similar by arm. 755 (43.3%) linked to services by 60 days; SRH increased linkage (aOR 1.68;95%CI=1.39-2.04) but peer-support had no effect. At 12 months, 227 (19%) tested ELISA-positive for HIV, of whom 41 (18%) had a viral load ≥400 copies/ml. The overall prevalence of transmissible HIV was 3.5%. There was no evidence of an effect of either intervention on transmissible HIV (main effects: SRH aOR 1.12; 95%CI=0.60-2.11; peer-support aOR 1.03; 95%CI=0.55-1.94).

Interpretation: in this representative sample of adolescents and youth in a mostly rural area of South Africa, STI testing and SRH (but not peer support) increased uptake of differentiated HIV prevention. While the UNAIDS target of 90:90:90 was exceeded, neither SRH nor peer support showed evidence of reducing transmissible HIV.

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Identifiers

ORCID for Nuala Mcgrath: orcid.org/0000-0002-1039-0159

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