NCT04930367

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

Completed NA Last updated 19 September 2024

What this trial tests

NA trial testing Radio Ads in HIV in 1,715 participants. Completed in 4 August 2023.

Timeline

13 September 2021

Primary endpoint
4 August 2023

4 August 2023

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	1,715
Start date	13 September 2021
Primary completion	4 August 2023
Estimated completion	4 August 2023
Sites	12 locations across Mozambique

Drugs / interventions tested

• Radio Ads
• Community Sensitization Campaign
• Informational Posters
• Motivation Walls
• Pill Container
• CombinADO-specific training for healthcare workers
• One Stop Shop Model of Care
• Treatment Toolkit
• Self-reflection Kit
• Peer Support
• Informational and motivational Video
• Support groups- caregivers of adolescents and young adults living with HIV
• Support groups- adolescents and young adults living with HIV
• Mental health screening and linkage to adolescent-focused mental health support

Conditions studied

• HIV — all drugs for HIV →

Sponsor

Columbia University

Who can join

Adults 10 to 24, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Human-Centered Design for Public Health Innovation: Codesigning a Multicomponent Intervention to Support Youth Across the HIV Care Continuum in Mozambique.
   Mukherjee TI, Zerbe A, Falcao J, Carey S, et al · · 2022 · cited 27× · PMID 35487546 · DOI 10.9745/ghsp-d-21-00664
2. The CombinADO study to assess the impact of a combination intervention strategy on viral suppression, antiretroviral therapy adherence, and retention in HIV care among adolescents and young people living with HIV: protocol for a cluster-randomized controlled trial.
   Mogoba P, Lesosky M, Zerbe A, Falcao J, et al · · 2021 · cited 10× · PMID 34961567 · DOI 10.1186/s13063-021-05943-w
3. Integrating Adolescent Mental Health into HIV Prevention and Treatment Programs: Can Implementation Science Pave the Path Forward?
   Boshe J, Brtek V, Beima-Sofie K, Braitstein P, et al · · 2023 · cited 6× · PMID 36322219 · DOI 10.1007/s10461-022-03876-2
4. A qualitative evaluation of stakeholder perspectives on the implementation of HIV services within adolescent and youth-friendly services for the youth in Nampula, Mozambique.
   Mogoba P, Falcao J, Tolla T, Zerbe A, et al · · 2025 · cited 1× · PMID 41029606 · DOI 10.1186/s12913-025-13414-0
5. Correlates of Viral Suppression in Adolescents With HIV Taking Antiretroviral Therapy in Mozambique: Results of a Multicenter Cross-Sectional Survey.
   Falcao J, Abrams EJ, Chammartin F, Couto A, et al · · 2026 · PMID 42080774 · DOI 10.1016/j.jadohealth.2026.02.023
6. Positive attitudes toward adoption of a multi-component intervention strategy aimed at improving HIV outcomes among adolescents and young people in Nampula, Mozambique: perspectives of HIV care providers.
   Mogoba P, Lesosky M, Mukonda EE, Zerbe A, et al · · 2023 · PMID 37280638 · DOI 10.1186/s12913-023-09630-1