NCT04930367

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,715 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 10 Years – 24 Years
• Healthy volunteers: Not accepted

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.

Detailed description

HIV burden among adolescents and young people worldwide is substantial, with an estimated 1.7 million adolescents aged 10-19 years living with HIV in 2019, and 460,000 adolescents aged 15-24 newly infected reported in the same year. Adolescent girls continue to be disproportionately affected, accounting for 56% of new infections worldwide. With increased availability of antiretroviral therapy (ART), pediatric mortality has decreased and healthcare workers (HCW) are now challenged to meet the complex needs of the large number of surviving youth who must cope with HIV as a chronic, highly stigmatized, and transmittable illness. There are 1.8 billion people between ages 10 and 24 and it is projected that the number of people \<20 years will double by 2030. In sub-Saharan Africa (SSA), youth aged 10-24 years comprise 30-35% of the countries' population. Failure to prevent new HIV infections among adolescents will result in increased numbers of adolescents and young adults living with HIV (AYAHIV) who will strain health and social service systems as they transition to adulthood.

Conditions

• HIV

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-13
• Primary completion: 2023-08-04
• Completion: 2023-08-04
• First posted: 2021-06-18
• Last updated: 2024-09-19

Locations

12 sites across 1 country: Mozambique