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

Not Applicable

Not yet recruiting

• Conditions: Hiv

• Registration Number: NCT06721078
• Lead Sponsor: Africa Health Research Institute

Brief Summary

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.

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 months in three 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 three years (about 7 visits). The stepped-wedge trial will be implemented in the first 18 months, after which participants will be followed for an additional 18 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 Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Study Start: 2025-02
• Primary Completion: 2028-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Peer navigation - viral suppression (effectiveness)	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.
Peer navigation - retention in care (effectiveness)	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.

Secondary Outcome Measures

Name	Time	Method
Peer navigation - viral suppression (sustainability)	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 24 months and 36 months.
Peer navigation - retention (sustainability)	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.
long-acting injectable ART - acceptability	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.
Economic evaluation analysis of providing LAI	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)
Economic evaluation analysis of providing peer navigation	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).
Cost-effectiveness analyses of providing LAI	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.
Cost-effectiveness analyses of providing peer navigation	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.