Peer support and long-acting injectable HIV treatment for adolescents (ATTUNE)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Charlotte Maxeke Hospital
  Johannesburg, Gauteng, South Africa Recruiting
• Rahima Moosa Mother and Child Hospital
  Johannesburg, Gauteng, South Africa 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.