Evaluation of Long-Acting Injectable (LAI) and Teen Clubs in Adolescents (ATTUNE). (ATTUNE)

March 30, 2026 updated by: Africa Health Research Institute
This is a 2-stage study assessing the effect of peer navigation (support from peers) and long-acting injectable antiretroviral therapy (ART) on viral suppression and retention in care among adolescents living with HIV and receiving care in South Africa.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to deploy peer-navigated support (psychosocial support, HIV education, appointment reminders, adherence support, sexual and reproductive health, and healthcare navigation) to facilitate viral suppression and retention in care as adolescents living with HIV transition into adult care. The study population includes adolescents from South Africa aged 12 to less than 19 years, living with HIV, aware of their HIV status and receiving ART for at least six months.

In Stage 1, the peer navigation intervention in a stepped-wedge, cluster-randomised trial implemented over 18-24 months in two 6-month steps across 12 clinics will be evaluated. In addition, during Stage 1, user and key stakeholder preferences will be evaluated for the uptake and use of long-acting injectable ART, perform a costing and economic analysis and a program evaluation of the public health impact of the intervention. In Stage 2, an individually-randomised trial will be nested in a subset of clinics to evaluate long-acting injectable ART in adolescents with HIV.

The study procedures include a peer navigation intervention in Stage 1, alongside a user and key stakeholder preferences evaluation for the uptake and use of long-acting injectable ART and a cost and economic evaluation.

The study duration is two years (about 5-7 visits). The stepped-wedge trial will be implemented in the first 18 months, after which participants will be followed for an additional 12 months to assess the sustainability of the intervention. The nested individually-randomised trial of long-acting ART will be conducted during the second 18-month period.

Study Type

Interventional

Enrollment (Estimated)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dr Moherndran Archary, MBChB, PhD
  • Phone Number: +27834461973
  • Email: mo.archary@ahri.org

Study Locations

  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2001
        • Recruiting
        • Charlotte Maxeke Hospital
        • Contact:
        • Principal Investigator:
          • Prof Lee Fairlie
      • Johannesburg, Gauteng, South Africa, 2001
        • Recruiting
        • Rahima Moosa Mother and Child Hospital
        • Principal Investigator:
          • Prof Lee Fairlie
        • Contact:
      • Pretoria, Gauteng, South Africa, 0001
        • Not yet recruiting
        • Kgabo CHC
        • Principal Investigator:
          • Prof Lee Fairlie
        • Contact:
      • Pretoria, Gauteng, South Africa, 0001
        • Not yet recruiting
        • KT Motubatse CHC
        • Principal Investigator:
          • Prof Lee Fairlie
        • Contact:
      • Pretoria, Gauteng, South Africa, 0001
        • Not yet recruiting
        • Soshanguve Block JJ
        • Principal Investigator:
          • Prof Lee Fairlie
        • Contact:
      • Pretoria, Gauteng, South Africa, 0001
        • Not yet recruiting
        • Soshanguve Block TT
        • Principal Investigator:
          • Prof Lee Fairlie
        • Contact:
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Recruiting
        • Cato Manor CHC
        • Contact:
        • Principal Investigator:
          • Prof Moherndran Archary
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Recruiting
        • KwaMashu CHC
        • Principal Investigator:
          • Prof Moherndran Archary
        • Contact:
      • Mtubatuba, KwaZulu-Natal, South Africa, 3935
        • Recruiting
        • Mtubatuba CHC
        • Principal Investigator:
          • Prof Moherndran Archary
        • Contact:
      • Mtubatuba, KwaZulu-Natal, South Africa, 3935
        • Recruiting
        • Somkhele CHC
        • Principal Investigator:
          • Prof Moherndran Archary
        • Contact:
          • Operational Manager, Ms Mpumelelo Mazibuko
          • Phone Number: +27 35 550 9999
          • Email: madzimpume@gmail.com
    • Western Cape
      • Cape Town, Western Cape, South Africa, 8001
        • Not yet recruiting
        • Eerste River Hospital
        • Contact:
        • Principal Investigator:
          • Prof Brian Van Wyk
      • Cape Town, Western Cape, South Africa, 8001
        • Not yet recruiting
        • Michael Mapongwana CHC
        • Principal Investigator:
          • Prof Brian Van Wyk
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Peer navigation effectiveness
To determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa.
Behavioral: Peer navigation effectiveness
To determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peer navigation - viral suppression (effectiveness)
Time Frame: 18 months
To determine the effectiveness of peer navigation on viral suppression among adolescents living with HIV in South Africa using the endpoint of viral load suppression (VL <50 copies/ml) over 18 months.
18 months
Peer navigation - retention in care (effectiveness)
Time Frame: 18 months
To determine the effectiveness of peer navigation on retention among adolescents living with HIV in South Africa using the endpoint of retention (at least 1 health care visit in the last 90 days) over 18 months.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peer navigation - retention (sustainability)
Time Frame: 36 months
To assess the sustainability of the impact of peer navigation on retention in care among adolescents living with HIV in South Africa using the endpoint of retention (at least 1 health care visit in the last 90 days) at 24 months and 36 months.
36 months
long-acting injectable ART - acceptability
Time Frame: 36 months
To identify the preferred user characteristics influencing the acceptability of long-acting injectable ART for adolescents with HIV with a qualitative evaluation of preferred user characteristics. Nine focus group discussions (FGDs) will be conducted with key stakeholders (caregivers of ALHIV, ALHIV ages 12 to less than 19, and adolescent HCWs/policy makers) to identify preferred user characteristics.
36 months
Economic evaluation analysis of providing LAI
Time Frame: 36 months
The cost analysis and economic impact of long-acting injectable antiretroviral therapy on viral suppression and care retention in adolescents living with HIV and receiving care in South Africa. Average per patient treated per year; average cost per patient retained; average cost per patient virally suppressed; incremental cost per additional person virally suppressed; incremental cost per additional person retained; incremental cost per life year saved (ART)
36 months
Economic evaluation analysis of providing peer navigation
Time Frame: 36 months
The cost analysis and economic impact of peer navigation on viral suppression and care retention in adolescents living with HIV and receiving care in South Africa. Average per patient treated per year; average cost per patient retained; average cost per patient virally suppressed; incremental cost per additional person virally suppressed; incremental cost per additional person retained; incremental cost per life year saved (ART).
36 months
Cost-effectiveness analyses of providing LAI
Time Frame: 36 months
A time and motion evaluation will be conducted. The estimated average staff time-spend with patients triangulated with the cost of clinical staff salaries from public sector salaries, the type and number of laboratory tests per patient (patient medical records), and cost per test (National Health Laboratory Service, NHLS). Medication costs will also be monitored (patient medical records, published national drug unit costs), and consumable resources will be used during study procedures (staff interviews, government tenders from the National Department of Health, National Treasury). The total floor space required for the study will be calculated, and a market-related average rental cost per square meter will be applied to estimate the cost of the building. Utility costs will be obtained for the facility and applied by square meter.
36 months
Cost-effectiveness analyses of providing peer navigation
Time Frame: 36 months
A time and motion evaluation will be conducted. The estimated average staff time-spend with patients triangulated with the cost of clinical staff salaries from public sector salaries, the type and number of laboratory tests per patient (patient medical records), and cost per test (National Health Laboratory Service, NHLS). Medication costs will also be monitored (patient medical records, published national drug unit costs), and consumable resources will be used during study procedures (staff interviews, government tenders from the National Department of Health, National Treasury). The total floor space required for the study will be calculated, and a market-related average rental cost per square meter will be applied to estimate the cost of the building. Utility costs will be obtained for the facility and applied by square meter.
36 months
Peer navigation - viral suppression (sustainability)
Time Frame: 36 months
To assess the sustainability of the impact of peer navigation on viral suppression among adolescents living with HIV in South Africa using the endpoint of viral load suppression (VL <50 copies/ml) at 18 and/or 24 months.
36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Providing long-acting injectable ART and peer navigators
Time Frame: 36 months
Using the RE-AIM framework, determine the implementation factors involved in providing peer navigation and long-acting injectable ART during adolescent-friendly clinics across multiple settings in South Africa. Based on the implementation science framework RE-AIM, the Reach (enrolment in each region), Effectiveness (viral suppression and retention in care), Adoption (uptake at each regional clinic, acceptability, and feasibility), Implementation (fidelity to protocol) and Maintenance (sustainability and costing) of the interventions will be measured using the implementation strategies of peer navigation and audit and feedback.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Africa Health Research Institute

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Prof Moherndran Archary, MBChB, PhD, Africa Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Actual)

December 6, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0005-6490/2023
  • 1UG1MD019435-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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