CombinADO: Evaluation of an Intervention Aimed At Improving HIV Outcomes Among Adolescents and Young Adults Living with HIV in Mozambique
CombinADO: a Cluster-randomized Controlled Trial to Compare the Efficacy, Uptake, Feasibility and Acceptability of the CombinADO Strategy Versus Optimized Standard of Care on Viral Suppression, ART Adherence and Retention in HIV Care Among Adolescents and Young Adults Living with HIV Ages 10-24yrs in Nampula Province, Mozambique
2 other identifiers
interventional
1,715
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Sep 2021
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2021
CompletedFirst Posted
Study publicly available on registry
June 18, 2021
CompletedStudy Start
First participant enrolled
September 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2023
CompletedSeptember 19, 2024
September 1, 2024
1.9 years
June 5, 2021
September 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of adolescents and young people living with HIV (AYAHIV) with viral suppression (Viral load <50 copies/ml)
Viral suppression among AYAHIV at intervention versus control sites
12 months post intervention implementation
Secondary Outcomes (3)
Proportion of eligible adolescents and young people living with HIV (AYAHIV) attending clinic in a 90 day window from end of intervention implementation, as assessed at 12 months post intervention.
12 months post intervention implementation
Self-reported adherence measured using 3-item adherence scale (mean score)
12 months post intervention implementation
Proportion of participants with detectable antiretroviral (ARV) on dried blood spot (DBS) specimen
12 months post intervention implementation
Study Arms (2)
Enhanced Standard of Care
ACTIVE COMPARATORTo be implemented at all 12 clinic sites, includes a set of interventions aimed at optimizing the national standard of care (billboards/posters and radio shows, healthcare worker training, one-stop adolescent and youth friendly services, information/motivation walls, pill containers and tools to be used by clinic staff during clinical visits)
CombinADO Strategy
EXPERIMENTALTo be implemented at 6 randomly selected clinic sites, includes all interventions in the "Enhanced Standard of Care" arm plus five additional intervention components, including 1) Mental health screening and linkage to adolescent-focused mental health support, 2) peer navigation support, 3) an informational video, 4) peer support groups for AYAHIV and 5) support groups for caregivers of AYAHIV
Interventions
Engaging radio mini shows that address community stigma and medical literacy through busting common myths with humor and building empathy with heartfelt storytelling.
Large-scale, infographic billboards and posters located in public areas and secondary schools to address stigma, medical literacy and promote community support for AYAHIV.
Large-scale, infographic posters located in clinic waiting areas to normalize HIV and build confidence in treatment.
Interactive, patient-generated posters located in the consultation room where patients can post words and phrases about themselves and their futures.
A discreet pill container to support ART adherence.
Comprehensive in-service training for healthcare workers focused on the needs of adolescents and young adults living with HIV
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.
A guide to clinic visits and discussions on ART and viral load monitoring to help healthcare workers better communicate with patients.
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.
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- HIV-positive, per medical records and confirmed by health facility staff
- Age 10 to 24 years
- Registered as a patient at study site
- Aware of HIV+ status
- Provision of signed and dated informed consent form
- For adolescents under 18 years of age, informed assent and parental informed consent to participate in the study
- Stated willingness to comply with all study procedures
You may not qualify if:
- \. Has an acute medical condition requiring immediate medical care
- Caregivers of AYAHIV:
- Age 18 years and older
- Attending a caregiver-specific support group
- Willingness to be audio-recorded
- Healthcare Workers (HCW) and Key Informants (KI):
- Age 18 years and older
- Involved in the provision, management, or oversight of adolescent-focused HIV services at the 12 specified study sites
- Willingness to be audio-recorded
- For all study participants (AYAHIV, caregivers, HCW and KI):
- Any other condition, including but not limited to alcohol or substance abuse and uncontrolled medical condition and/or allergies, that, in the opinion of the study team, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Cs 1 de Maio
Nampula, Mozambique
Cs 25 Setembro
Nampula, Mozambique
Cs Alua
Nampula, Mozambique
Cs Anexo Psi
Nampula, Mozambique
Cs Malema
Nampula, Mozambique
Cs Muhala Expansao
Nampula, Mozambique
Cs n1 Nacala Porto
Nampula, Mozambique
Cs Nametil
Nampula, Mozambique
Cs Namialo
Nampula, Mozambique
Cs Namicopo
Nampula, Mozambique
HG Marere
Nampula, Mozambique
HR Angoche
Nampula, Mozambique
Related Publications (3)
Mogoba P, Falcao J, Tolla T, Zerbe A, De Gusmao EP, Myer L, Abrams EJ. A qualitative evaluation of stakeholder perspectives on the implementation of HIV services within adolescent and youth-friendly services for the youth in Nampula, Mozambique. BMC Health Serv Res. 2025 Sep 30;25(1):1229. doi: 10.1186/s12913-025-13414-0.
PMID: 41029606DERIVEDMogoba P, Lesosky M, Mukonda EE, Zerbe A, Falcao J, Zandamela R, Myer L, Abrams EJ. 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. BMC Health Serv Res. 2023 Jun 6;23(1):582. doi: 10.1186/s12913-023-09630-1.
PMID: 37280638DERIVEDMogoba P, Lesosky M, Zerbe A, Falcao J, Mellins CA, Desmond C, Arnaldo C, Kapogiannis B, Myer L, Abrams EJ. 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. Trials. 2021 Dec 27;22(1):956. doi: 10.1186/s13063-021-05943-w.
PMID: 34961567DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elaine J Abrams, MD
ICAP at Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Research Director, ICAP
Study Record Dates
First Submitted
June 5, 2021
First Posted
June 18, 2021
Study Start
September 13, 2021
Primary Completion
August 4, 2023
Study Completion
August 4, 2023
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Within one year after end of the study
- Access Criteria
- When the study is completed, access to study data will be provided through NICHD's DASH repository. Researchers seeking to access data stored in DASH will need to follow pre-specified requirements around data access requests.
As required by study funder, de-identified, archived data will be transmitted to and stored at NICHD's Data and Specimen Hub (DASH) for use by other researchers including those outside of the study. Permission to transmit data to DASH will be included in the informed consent signed by all study participants. This data will only be shared after the end of the study.