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

Africa Health Research Institute

Status

Not yet enrolling

Conditions

Hiv

Treatments

Behavioral: Peer navigation effectiveness

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06721078

1UG1MD019435-01 (U.S. NIH Grant/Contract)

A0005-6490/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,400 estimated patients

Sex

All

Ages

12 to 19 years old

Volunteers

Accepts Healthy Volunteers

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.