Despite tremendous progress in controlling the HIV epidemic in sub-Saharan Africa (SSA), HIV-related mortality continues to increase among adolescents and young people living with HIV (AYPLHIV). Globally, SSA accounts for 85% of the AYPLHIV. This age group demonstrates the poorest outcomes along the care cascade due to various challenges in accessing and adhering to ART. To address the multiple barriers in adolescent HIV care and their unique needs, multicomponent packages of differentiated service delivery (DSD) models, specifically for AYPLHIV, are needed. This study aims to evaluate the feasibility and effectiveness of a multicomponent DSD model (PEBRA model) for AYPLHIV coordinated by a peer-educator.
PEBRA (Peer-Educator Based Refill of ART) is a cluster randomized, open-label, superiority trial conducted at 20 health facilities in three districts of Lesotho, Southern Africa. The clusters (health facilities) are randomly assigned to either the PEBRA model or standard of care in a 1:1 ratio, stratified by district. In the PEBRA model, a peer-educator coordinates the antiretroviral therapy (ART) services - such as medication pick-up, SMS notifications and support options - according to the preferences of the AYPLHIV. The peer-educator delivers this personalized model using a tablet-based application called PEBRApp. The control clusters continue to offer standard of care: ART services coordinated by the nurse. The primary endpoint is viral suppression at 12 months. Secondary endpoints include adherence to ART, quality of life, satisfaction with care and engagement in care. The target sample size is 300 AYPLHIV. Statistical analyses are conducted and reported in line with CONSORT guidelines for cluster randomized trials.
The PEBRA trial will provide evidence on the feasibility and effectiveness of an inclusive, holistic and preference-based DSD model for AYPLHIV that is coordinated by a peer-educator. Many countries in SSA have an existing peer-educator program. If proven to be effective, the PEBRA model and PEBRApp have the potential to be scaled up.
Clinicaltrials.gov, NCT03969030. Registered on 31 May 2019 -> https://clinicaltrials.gov/ct2/show/NCT03969030
The PEBRA trial is a cluster randomized, open-label, superiority trial in rural Lesotho. The clusters (health facilities) are randomized into two groups (intervention and control) in a 1:1 allocation stratified by district.
This trial has been developed jointly by a Swiss-Basotho research consortium. The main stakeholders are the Swiss Tropical and Public Health Institute (https://www.swisstph.ch/en/), SolidarMed (www.solidarmed.ch/en), Sentebale (www.sentebale.org) and the Lesotho Ministry of Health District Health Management Teams (https://www.gov.ls/ministry-of-health/).
More information about the research consortium can be found here: https://www.swisstph.ch/fr/projects/hiv-care-research-in-lesotho/
The PEBRA trial has been approved by both the Ethics committees from Switzerland and Lesotho and is registered under clinicaltrials.gov
Study protocol draft
2 youth workshops with Peer-Educators, Sentebale youth advocates, Adolescents and young people living with HIV, PEBRApp developers
Consultative meetings with more stakeholders, e.g. DHMTs, Adolescent focal person, etc.
Finalization of PEBRA model and PEBRApp (in collaboration with local developers: Technify Lesotho)
Registration on clinicaltrials.gov
Ethical approval from ethics committee Lesotho & Switzerland
Public Randomization events in the 3 districts with one representative per health center
Training of all involved 20 Peer-Educators
04.11.2019: Launch of the study recruitment (approximately 4 months per health center); Follow-up: 12 months.