Peer-led community health program for HIV prevention in South African youth

Thetha Nami Ngithethe Nawe ("Let's Talk"): A Step-wedge cRCT of Social Mobilisation by Peer-navigators Into Community-based Sexual Health and HIV Care (Incl. PrEP) to Reduce Sexually Transmissible HIV Amongst Youth in Rural KwaZulu-Natal

Not applicable Interventional Africa Health Research Institute · NCT05405582

This study is testing if a community program led by peers can help young people in South Africa access better HIV prevention services and reduce the spread of the virus.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment6000 (estimated)
Ages15 Years to 30 Years
SexAll
SponsorAfrica Health Research Institute Academic / other
Locations1 site (Somkele, KwaZulu-Natal)
Trial IDNCT05405582 on ClinicalTrials.gov

What this trial studies

This implementation trial aims to assess the impact of social mobilisation on engaging young people aged 15-30 in decentralized sexual reproductive health (SRH) services that provide tailored HIV prevention. The study employs a step-wedge cluster randomised control trial design, comparing the effectiveness of peer-led interventions with standard care in reducing the prevalence of transmissible HIV. It will also evaluate the acceptability, practicability, and cost-effectiveness of these interventions in the uMkhanyakude district of rural KwaZulu Natal. The trial will involve approximately 26,000 participants across 40 administrative areas over a period of 15 months.

Who should consider this trial

Good fit: Ideal candidates for this study are young individuals aged 15-30 residing in the uMkhanyakude district.

Not a fit: Patients outside the age range of 15-30 or those unable to provide consent will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the prevalence of HIV among young people in South Africa.

How similar studies have performed: Other studies have shown promise in using community-led approaches for HIV prevention, indicating potential success for this novel intervention.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Resident in the cluster
* Any gender
* Aged 15-30
* If aged 18-30 and able and willing to consent to participate
* If aged 15-17, able and willing to assent and whose guardian or parent are able and willing to consent to their participation.

Exclusion Criteria:

* Unable or unwilling to provide consent
* Aged 14 or less
* aged 31 or more

Where this trial is running

Somkele, KwaZulu-Natal

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions HIV-1-infectionSexually Transmitted Diseases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.