CombinADO: Evaluation of an Intervention Aimed At Improving HIV Outcomes Among Adolescents and Young Adults Living with HIV in Mozambique
NCT ID: NCT04930367
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1715 participants
INTERVENTIONAL
2021-09-13
2023-08-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Enhanced Standard of Care
To 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)
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.
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.
Informational Posters
Large-scale, infographic posters located in clinic waiting areas to normalize HIV and build confidence in treatment.
Motivation Walls
Interactive, patient-generated posters located in the consultation room where patients can post words and phrases about themselves and their futures.
Pill Container
A discreet pill container to support ART adherence.
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
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.
Treatment Toolkit
A guide to clinic visits and discussions on ART and viral load monitoring to help healthcare workers better communicate with patients.
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.
CombinADO Strategy
To 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
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.
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.
Informational Posters
Large-scale, infographic posters located in clinic waiting areas to normalize HIV and build confidence in treatment.
Motivation Walls
Interactive, patient-generated posters located in the consultation room where patients can post words and phrases about themselves and their futures.
Pill Container
A discreet pill container to support ART adherence.
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
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.
Treatment Toolkit
A guide to clinic visits and discussions on ART and viral load monitoring to help healthcare workers better communicate with patients.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
Informational Posters
Large-scale, infographic posters located in clinic waiting areas to normalize HIV and build confidence in treatment.
Motivation Walls
Interactive, patient-generated posters located in the consultation room where patients can post words and phrases about themselves and their futures.
Pill Container
A discreet pill container to support ART adherence.
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
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.
Treatment Toolkit
A guide to clinic visits and discussions on ART and viral load monitoring to help healthcare workers better communicate with patients.
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Age 10 to 24 years
3. Registered as a patient at study site
4. Aware of HIV+ status
5. Provision of signed and dated informed consent form
6. For adolescents under 18 years of age, informed assent and parental informed consent to participate in the study
7. Stated willingness to comply with all study procedures
1. Age 18 years and older
2. Attending a caregiver-specific support group
3. Willingness to be audio-recorded
Healthcare Workers (HCW) and Key Informants (KI):
1. Age 18 years and older
2. Involved in the provision, management, or oversight of adolescent-focused HIV services at the 12 specified study sites
3. Willingness to be audio-recorded
For all study participants (AYAHIV, caregivers, HCW and KI):
Exclusion Criteria
Caregivers of AYAHIV:
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.
10 Years
24 Years
ALL
No
Sponsors
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University of Cape Town
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Columbia University
OTHER
Responsible Party
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Elaine J. Abrams, MD
Senior Research Director, ICAP
Principal Investigators
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Elaine J Abrams, MD
Role: PRINCIPAL_INVESTIGATOR
ICAP at Columbia University
Locations
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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
Countries
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References
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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.
Mogoba 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.
Mogoba 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.
Other Identifiers
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AAAT5971
Identifier Type: -
Identifier Source: org_study_id
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