NCT04532307

Isisekelo Sempilo Trial to Optimize Peer (Thetha Nami) Delivery of HIV Prevention to Young People in Rural KwaZulu-Natal

Completed NA Last updated 3 January 2024

What this trial tests

NA trial testing Standard of Care SOC in HIV Prevention in 1,743 participants. Completed in 30 September 2022.

Timeline

12 March 2020

Primary endpoint
30 June 2022

30 September 2022

Quick facts

Lead sponsor	Africa Health Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	prevention
Enrollment	1,743
Start date	12 March 2020
Primary completion	30 June 2022
Estimated completion	30 September 2022
Sites	1 location across South Africa

Drugs / interventions tested

• Standard of Care SOC
• SRH enhanced Isisekelo Sempilo
• Peer-support (Thetha-Nami)
• SOC + SRH + peer-support

Conditions studied

• HIV Prevention — all drugs for HIV Prevention →

Sponsor

Africa Health Research Institute

Who can join

Adults 16 to 29, any sex, with HIV Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Despite advances in efficacious, efficient and safe biomedical tools to reduce HIV transmission and acquisition the HIV epidemic in South Africa(SA) remains an intractable problem, with the lifetime risk of infection approaching 70% for a 15-year-old girl currently living in northern KwaZulu-Natal, the Africa Health Research Institute(AHRI) research setting. This is in part due to the difficulty in engaging adolescents and youth in HIV interventions. We build on formative work to develop and tailor the interventions to young people's needs. Our findings suggested that young people want to focus on sexual and reproductive health(SRH) and value health-promotion from people of their own age and background (peer-support). In a 2016 population-based study of 15-24-year-olds in the study area we found that one in five had a curable Sexually Transmitted Infection(STI) of which three quarters of did not report any symptoms and would not have been cured with current syndromic management. We also found that home-based self-sampling and treatment for STIs was acceptable and desirable to young people. Based on this we developed and conducted a 6-month pilot of the Isisekelo Sempilo adolescent and youth friendly clinics. These are mobile and fixed clinics that are linked to existing primary care services. The clinics deliver nurse-led HIV-testing, prevention and care integrated with SRH. To date n=337 of those referred from the community(\~10%) have attended the clinic. In our setting \>85% of school-leavers are unemployed; there are high levels of common mental disorders which increase with age (rising to 32% of those aged 20-22). Systematic reviews have found that community-based delivery of HIV care and peers are effective in supporting HIV care, adherence and virologic suppression. However, none of these interventions have been tested for HIV-prevention and in youth. Based on this we developed and piloted Thetha Nami, an area-based peer-navigator intervention promoting psychosocial well-being in addition to HIV-prevention to young people aged 15-29. Over a four-month period 24-pairs of peer navigators approached 5872, 15-29-year-old men and women, of which 5272 (90%) accepted the needs assessment. We aim to use advances in intervention design and evaluation to answer the question, "will these tailored HIV-prevention interventions developed in partnership with young people arrest the HIV epidemic and improve well-being?"

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Thetha Nami: participatory development of a peer-navigator intervention to deliver biosocial HIV prevention for adolescents and youth in rural South Africa.
   Shahmanesh M, Okesola N, Chimbindi N, Zuma T, et al · · 2021 · cited 43× · PMID 34256725 · DOI 10.1186/s12889-021-11399-z
2. Effectiveness of integrating HIV prevention within sexual reproductive health services with or without peer support among adolescents and young adults in rural KwaZulu-Natal, South Africa (Isisekelo Sempilo): 2 × 2 factorial, open-label, randomised controlled trial.
   Shahmanesh M, Chimbindi N, Busang J, Chidumwa G, et al · · 2024 · cited 11× · PMID 38925731 · DOI 10.1016/s2352-3018(24)00119-x
3. Prevalence of Curable Sexually Transmitted Infections in a Population-Representative Sample of Young Adults in a High HIV Incidence Area in South Africa.
   Jarolimova J, Chidumwa G, Chimbindi N, Okesola N, et al · · 2023 · cited 11× · PMID 37944161 · DOI 10.1097/olq.0000000000001871
4. 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 randomi
   Chidumwa G, Chimbindi N, Herbst C, Okeselo N, et al · · 2022 · cited 8× · PMID 35255859 · DOI 10.1186/s12889-022-12796-8
5. A mixed methods process evaluation: understanding the implementation and delivery of HIV prevention services integrated within sexual reproductive health (SRH) with or without peer support amongst adolescents and young adults in rural KwaZulu-Natal, South Africa.
   Zuma T, Busang J, Hlongwane S, Chidumwa G, et al · · 2024 · cited 4× · PMID 38961492 · DOI 10.1186/s13063-024-08279-3
6. Thetha Nami : Participatory development of a peer-navigator intervention to deliver biosocial HIV prevention for adolescents and youth in rural South Africa
   Shahmanesh M, Okesola N, Chimbindi N, Zuma T, et al · · 2021 · DOI 10.21203/rs.3.rs-42209/v2