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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
1,715
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.
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
...and 2 more locations
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
Time frame: 12 months post intervention implementation
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.
Retention in HIV care \& treatment among AYAHIV at intervention versus control sites
Time frame: 12 months post intervention implementation
Self-reported adherence measured using 3-item adherence scale (mean score)
Self-reported ART adherence among adolescents and young people living with HIV at intervention versus control sites will be measured using a three-item adherence scale. The three items include (1) an assessment of the number of days with missed ART doses in the preceding 30 days \[0-30 days\]; (2) a scale rating of how good a job you did taking your medicines in the preceding 30 days (never/rarely/sometimes/usually/almost always/always) and (3) a scale rating of how often you took your medicines the way you were supposed to in the preceding 30 days (very poor/poor/fair/good/very good/ excellent). For analyses using raw scores, item responses for the three adherence items will be linearly transformed to a 0-100 scale with zero being the worst adherence, and 100 representing perfect adherence. The mean of the three scores are then taken to get an equally weight aggregate scale score. An overall mean from the scores from all participants will be reported.
Time frame: 12 months post intervention implementation
Proportion of participants with detectable antiretroviral (ARV) on dried blood spot (DBS) specimen
ART adherence among among adolescents and young people living with HIV (AYAHIV) at intervention versus control sites, ARV levels
Time frame: 12 months post intervention implementation
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