CombinADO: Evaluation of an Intervention Aimed At Improving HIV Outcomes Among Adolescents and Young Adults Living with HIV in Mozambique

Summary

This is a cluster-randomized trial designed to compare the effectiveness of the CombinADO strategy versus optimized standard of care (SOC) on viral suppression, antiretroviral therapy (ART) adherence and retention in HIV care among adolescents living with HIV (ALHIV) ages 10 to 24 years attending participating health facilities. Clinics are the units of intervention allocation and randomization. The control condition will be implemented at all facilities (n=12) participating in the trial. The enhanced intervention condition will be superadded to this at a randomly selected half (n=6) of facilities. The goal of this study is to learn whether an enhanced, tailored intervention helps AYAHIV do better with their HIV care (take their medications, stay in care) than the usual care that they receive.

Conditions

• HIV

Interventions

BEHAVIORAL

Radio Ads

Engaging radio mini shows that address community stigma and medical literacy through busting common myths with humor and building empathy with heartfelt storytelling.

BEHAVIORAL

Community Sensitization Campaign

Large-scale, infographic billboards and posters located in public areas and secondary schools to address stigma, medical literacy and promote community support for AYAHIV.

BEHAVIORAL

Informational Posters

Large-scale, infographic posters located in clinic waiting areas to normalize HIV and build confidence in treatment.

BEHAVIORAL

Motivation Walls

Interactive, patient-generated posters located in the consultation room where patients can post words and phrases about themselves and their futures.

OTHER

Pill Container

A discreet pill container to support ART adherence.

OTHER

CombinADO-specific training for healthcare workers

Comprehensive in-service training for healthcare workers focused on the needs of adolescents and young adults living with HIV

OTHER

One Stop Shop Model of Care

Model of care that allows adolescents and young adults living with HIV to access a complete set of services, including HIV care, in one central location.

OTHER

Treatment Toolkit

A guide to clinic visits and discussions on ART and viral load monitoring to help healthcare workers better communicate with patients.

OTHER

Self-reflection Kit

A simple handout for healthcare workers to help patients reflect on their ART progress and understand the concept of viral load as a measure of ART success.

BEHAVIORAL

Peer Support

Peer exposure to examples of adolescents and young adults openly living with HIV (AYAHIV) and; opportunities to share their experiences with HIV in one-on-one interactions with other AYAHIV during clinic visits.

BEHAVIORAL

Informational and motivational Video

An informational and motivational video that in simple language with engaging graphics that a) demystifies and simplifies HIV, ART, and viral load and; b) emphasizes that people can live long, healthy lives.

BEHAVIORAL

Support groups- caregivers of adolescents and young adults living with HIV

A learning, support, and empowerment group for caregivers of adolescents and young adults living with HIV (AYAHIV). Through monthly gatherings, the program aims to foster confidence, and equip caregivers with strategies to support AYAHIV adherence journey.

BEHAVIORAL

Support groups- adolescents and young adults living with HIV

A peer-to-peer learning, support, and empowerment group to address loss of hope and improve medical literacy. Through biweekly gatherings, the program aims to foster belonging and confidence, equipping young people and caregivers with strategies to navigate the adherence journey.

BEHAVIORAL

Mental health screening and linkage to adolescent-focused mental health support

HCWs will be trained in the use of a brief mental health screening tool focusing on depression, anxiety, and post-traumatic stress disorder. Mental health service providers at each facility will be trained and supported to provide diagnostic and mental health support to youth with positive screens who agree to further evaluation.

Sponsors & Collaborators

• University of Cape Town

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Elaine J Abrams, MD · ICAP at Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

24 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-13

Primary Completion

2023-08-04

Completion

2023-08-04

Countries

• Mozambique

Study Locations