Peer-Educator-coordinated vs Nurse-coordinated ART Refill for Adolescents and Young Adults Living With HIV in Lesotho

NCT03969030 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2021-06-02

No results posted yet for this study

Summary

Sub-Saharan Africa (SSA) is home to 85% of the adolescents and young people living with HIV (AYPLHIV) globally and they are heavily affected by the HIV/AIDS epidemic: AYPLHIV in SSA are the only population group for whom HIV-related mortality continues to increase, and they have overall poorer outcomes than all other age groups. Lesotho with worldwide the second-highest HIV prevalence shows a viral suppression rate among AYPLHIV of only 49%.

In order to address the multiple barriers in the adolescent HIV care cascade and their unique needs, multicomponent packages of differentiated service delivery (DSD) are a promising approach.

In close collaboration with different local stakeholders, the researchers designed a DSD model specifically for AYPLHIV, called the PEBRA model. In the PEBRA model the peer-educator (PE) plays a pivotal role, by coordinating the ART refill/care according to the patient's preferences using a tablet-based application, called PEBRApp (https://github.com/chrisly-bear/PEBRApp). The PEBRApp helps the PE to assess each participant's preference, to adapt the ART refill according to these preferences in a feasible manner, to keep track of the ART refill, and to ensure regular contact between the PE and the participant. The model includes key innovative options such as individualized automatic SMS notifications and decentralized ART delivery.

The PEBRApp was developed with ❤️ by Technify Maseru, Lesotho (www.technifyls.com) \& Christoph Schwizer Zurich, Switzerland (www.christophschwizer.ch).

Conditions

Interventions

OTHER

PEBRA model

The participants in the intervention clusters are offered the PEBRA model. In the PEBRA model the ART visit/refill is coordinated by the PE, as much as feasible according to the participants' preferences. Thus, the preferences of each participant are captured at enrolment and after a strict schedule thereafter. The PE conducts the preference assessment using a tablet-based application, called PEBRApp, accoring to a specific schedule. First, the participant will be asked his/her preference regarding different domains of DSD (see below) and this will be entered into the PEBRApp. Secondly, the chosen preferences are assessed regarding feasibility with specific questions, as not all preference options are available to everyone all the time. The preference assessment entails the following three domains of DSD: 1. ART Refill 2. SMS notifications 3. Support

Sponsors & Collaborators

  • International AIDS Society (CIPHER grant)

    collaborator UNKNOWN
  • Swiss Tropical & Public Health Institute

    collaborator OTHER
  • SolidarMed

    collaborator OTHER
  • Sentebale

    collaborator OTHER
  • University of Basel

    collaborator OTHER
  • University Hospital, Basel, Switzerland

    collaborator OTHER
  • Swiss National Science Foundation

    collaborator OTHER
  • Amstutz Alain

    lead OTHER

Principal Investigators

  • Niklaus Labhardt, MD MIH · Swiss TPH & University Hospital Basel & University of Basel

  • Alain Amstutz, MD · Swiss TPH & University Hospital Basel & University of Basel

  • Mathebe Kopo · SolidarMed

  • Jennifer Brown, MSc · Swiss TPH & University of Basel

  • Nadine Bachmann, MSc · Swiss TPH & University of Basel

  • Thabo Lejone, MIH · SolidarMed

  • Lebohang Sao, MD · DHMT BB

  • Tracy Glass, PhD · Swiss TPH & University of Basel

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Lesotho

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03969030 on ClinicalTrials.gov