Peer support and long-acting injectable HIV treatment for adolescents (ATTUNE)
Evaluation of Long-Acting Injectable (LAI) and Teen Clubs in Adolescents (ATTUNE).
NA · Africa Health Research Institute · NCT06721078
This project will try peer navigation plus long-acting injectable HIV medicines to see if they help adolescents aged 12 to under 19 in South Africa stay on treatment and achieve viral suppression.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 720 (estimated) |
| Ages | 12 Years to 19 Years |
| Sex | All |
| Sponsor | Africa Health Research Institute (other) |
| Locations | 12 sites (Johannesburg, Gauteng and 11 other locations) |
| Trial ID | NCT06721078 on ClinicalTrials.gov |
What this trial studies
The study has two stages: Stage 1 uses a stepped-wedge, cluster-randomized design across 12 clinics to roll out a peer navigation program over 18–24 months, and Stage 2 nests an individually randomized trial in a subset of clinics to test long-acting injectable ART in eligible adolescents. During Stage 1 the team will also gather user and stakeholder preferences for injectable ART, conduct costing and economic analyses, and perform a program evaluation of public health impact. Participants are adolescents 12 to <19 years living with HIV who know their status and have been on ART for at least six months, with follow-up visits (about 5–7 visits) over roughly two years. Primary outcomes include viral suppression and retention in care, measured through clinic visits and viral load testing.
Who should consider this trial
Good fit: Adolescents aged 12 to under 19 in South Africa who are living with HIV, aware of their status, and have been on ART for at least six months are the intended participants.
Not a fit: Individuals who cannot communicate in the study languages, have severe mental or physical illness preventing consent or participation, or who do not receive care at participating clinics are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the interventions could increase viral suppression rates and improve long-term engagement in care for adolescents living with HIV.
How similar studies have performed: Long-acting injectable ART and peer-support approaches have shown effectiveness in some adult studies, but randomized evidence in adolescents is limited and the combined approach is relatively novel for this age group.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged between 12 - \<19, at enrolment * Living with HIV * Aware of their HIV status * Receiving ART for at least six months * Able to read and/or speak English, isiZulu, Sepedi, Afrikaans, Xhosa, or Sesotho * Willing and able to consent to study activities * Willing and able to get parental consent for study activities * (Stage 1, objective 2 only) Age ≥ 18 years and Caregiver of an adolescent with HIV * (Stage 1, objective 2 only) Age ≥ 18 years and provides clinical services or is a policy maker involved in adolescents with HIV Exclusion Criteria: * Inability to read and/or speak English, isiZulu, Sepedi, Afrikaans, Xhosa, or Sesotho * Severe mental or physical illness preventing participation in informed consent activities.
Where this trial is running
Johannesburg, Gauteng and 11 other locations
- Charlotte Maxeke Hospital — Johannesburg, Gauteng, South Africa (RECRUITING)
- Rahima Moosa Mother and Child Hospital — Johannesburg, Gauteng, South Africa (RECRUITING)
- Kgabo CHC — Pretoria, Gauteng, South Africa (NOT_YET_RECRUITING)
- KT Motubatse CHC — Pretoria, Gauteng, South Africa (NOT_YET_RECRUITING)
- Soshanguve Block JJ — Pretoria, Gauteng, South Africa (NOT_YET_RECRUITING)
- Soshanguve Block TT — Pretoria, Gauteng, South Africa (NOT_YET_RECRUITING)
- Cato Manor CHC — Durban, KwaZulu-Natal, South Africa (RECRUITING)
- KwaMashu CHC — Durban, KwaZulu-Natal, South Africa (RECRUITING)
- Mtubatuba CHC — Mtubatuba, KwaZulu-Natal, South Africa (RECRUITING)
- Somkhele CHC — Mtubatuba, KwaZulu-Natal, South Africa (RECRUITING)
- Eerste River Hospital — Cape Town, Western Cape, South Africa (NOT_YET_RECRUITING)
- Michael Mapongwana CHC — Cape Town, Western Cape, South Africa (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Prof Moherndran Archary, MBChB, PhD — Africa Health Research Institute
- Study coordinator: Dr Moherndran Archary, MBChB, PhD
- Email: mo.archary@ahri.org
- Phone: +27834461973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hiv, peer navigation, long acting injectables, antiretroviral therapy