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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Peer navigation effectiveness
BehavioralTo determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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.
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.
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)
Other outcomes
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.
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