ArticleTrials2021
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.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04930367 (CombinADO), which is not on this map. Cited by 10 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
10 citing papers in PubMed.
- 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 services research · 2023Trial
- Human-Centered Design for Public Health Innovation: Codesigning a Multicomponent Intervention to Support Youth Across the HIV Care Continuum in Mozambique.Global health, science and practice · 2022Trial
- Correlates of Viral Suppression in Adolescents With HIV Taking Antiretroviral Therapy in Mozambique: Results of a Multicenter Cross-Sectional Survey.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2026Article
- 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 services research · 2025Article
- Article
- Contraception and PrEP knowledge, attitudes, and practices among adolescent girls and young women in Nampula, Mozambique.PLOS global public health · 2025Article
- MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial.JMIR research protocols · 2023Article
- Integrating Adolescent Mental Health into HIV Prevention and Treatment Programs: Can Implementation Science Pave the Path Forward?AIDS and behavior · 2023Article
- Article
- Retaining Versus Engaging Youth in HIV Care: Perspectives From a Qualitative Study among Youth Living With HIV and Their Care Providers in Kenya and Uganda.Journal of the International Association of Providers of AIDS CareArticle
Corrections and comments
- Erratum issued
Authors and funding
10 authors.
Funding
Abstract
backgroundAdolescents and youth living with HIV (AYAHIV) have worse HIV outcomes than other age groups, particularly in sub-Saharan Africa (SSA). AYAHIV in SSA face formidable health system, interpersonal- and individual-level barriers to retention in HIV care, uptake of ART, and achievement of viral suppression (VS), underscoring an urgent need for multi-component interventions to address these challenges. This cluster-randomized control trial (cRCT) aims to evaluate the effectiveness and monitor implementation of a community-informed multi-component intervention ("CombinADO strategy") addressing individual-, facility-, and community-level factors to improve health outcomes for AYAHIV.
methodsThis trial will be conducted in 12 clinics in Nampula Province, Northern Mozambique. All clinics will implement an optimized standard of care (control) including (1) billboards/posters and radio shows, (2) healthcare worker (HCW) training, (3) one-stop adolescent and youth-friendly services, (4) information/motivation walls, (5) pill containers, and (6) tools to be used by HCW during clinical visits. The CombinADO strategy (intervention) will be superadded to control conditions at 6 randomly selected clinics. It will include five additional components: (1) peer support, (2) informational/motivational video, (3) support groups for AYAHIV caregivers, (4) AYAHIV support groups, and (5) mental health screening and linkage to adolescent-focused mental health support. The study conditions will be in place for 12 months; all AYAHIV (ages 10-24 years, on ART) seeking care in the participating sites will be exposed to either the control or intervention condition based on the clinic they attend. The primary outcome is VS (viral load < 50 copies/mL) at 12 months among AYAHIV attending participating clinics. Secondary outcomes include ART adherence (self-reported and TDF levels) and retention in care (engagement in the preceding 90 days). Uptake, feasibility, acceptability, and fidelity of the CombinADO strategy during implementation will be measured. Trial outcomes will be assessed in AYAHIV, caregivers, healthcare workers, and key informants. Statistical analyses will be conducted and reported in line with CONSORT guidelines for cRCTs. DISCUSSION: The CombinADO study will provide evidence on effectiveness and inform implementation of a novel community-informed multi-component intervention to improve retention, adherence, and VS among AYAHIV. If found effective, results will strengthen the rationale for scale up in SSA.
trial registrationClinicalTrials.gov NCT04930367 . Registered on 18 June 2021.
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