Clinical trial NCT06721078: Evaluation of Long-Acting Injectable (LAI) and Teen Clubs in Adolescents (ATTUNE).
Official title: Evaluation of Long-Acting Injectable (LAI) and Teen Clubs in Adolescents (ATTUNE).
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hiv
Keywords: peer navigation
long acting injectables
antiretroviral therapy
Lead sponsor: Africa Health Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-12-06
Enrollment: 1400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In Stage 1, we will evaluate the peer navigation intervention in a stepped-wedge, cluster-randomised trial.
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Peer navigation - viral suppression (effectiveness)
timeFrame: 18 months
measure: Peer navigation - retention in care (effectiveness)
timeFrame: 18 months
Secondary outcomes:
measure: Peer navigation - viral suppression (sustainability)
timeFrame: 36 months
measure: Peer navigation - retention (sustainability)
timeFrame: 36 months
measure: long-acting injectable ART - acceptability
timeFrame: 36 months
measure: Economic evaluation analysis of providing LAI
timeFrame: 36 months
measure: Economic evaluation analysis of providing peer navigation
timeFrame: 36 months
measure: Cost-effectiveness analyses of providing LAI
timeFrame: 36 months
measure: Cost-effectiveness analyses of providing peer navigation
timeFrame: 36 months
Other outcomes:
measure: Providing long-acting injectable ART and peer navigators
timeFrame: 36 months
Locations:
Study officials:
affiliation: Africa Health Research Institute
name: Moherndran Archary, PhD
role: PRINCIPAL_INVESTIGATOR
References: