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

ConditionHiv
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-19
SponsorAfrica Health Research Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged between 12 - <19, at enrolment

Living with HIV

Aware of their HIV status

Receiving ART for at least six months

Disqualifiers

Inability to read and/or speak English, isiZulu, Sepedi, Afrikaans, Xhosa, or Sesotho

Severe mental or physical illness preventing participation in informed consent activities.

Trial design

Design model

Single group

Treatments tested in this trial

  • Peer navigation effectiveness

    Behavioral

    To determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa.

Treatment groups

720 Participants
are divided into 1 treatment group
Group A: Peer navigation effectivenessOther 1 intervention

Trial outcomes

Primary outcomes

1

Peer navigation - viral suppression (effectiveness)

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.

Time frame
18 months
2

Peer navigation - retention in care (effectiveness)

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.

Time frame
18 months

Secondary outcomes

1

Peer navigation - viral suppression (sustainability)

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.

Time frame
36 months
2

Peer navigation - retention (sustainability)

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.

Time frame
36 months
3

long-acting injectable ART - acceptability

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.

Time frame
36 months
4

Economic evaluation analysis of providing LAI

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)

Time frame
36 months

Other outcomes

1

Providing long-acting injectable ART and peer navigators

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.

Time frame
36 months

Sponsors and contacts

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Africa Health Research Institute

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator