Clinical trial NCT04930367: CombinADO: Evaluation of an Intervention Aimed At Improving HIV Outcomes Among Adolescents and Young Adults Living with HIV in Mozambique
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Adolescents
Mozambique
ART adherence
Viral suppression
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-06-18
Enrollment: 1715
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster-randomized trial to compare the effectiveness of the CombinADO strategy versus optimized standard of care (SOC) on viral suppression, ART adherence and retention in HIV care among AYAHIV ages 10-24yrs 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Adolescents and young adults living with HIV (AYAHIV):

Inclusion Criteria:

1. HIV-positive, per medical records and confirmed by health facility staff
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

Exclusion Criteria:

1. Has an acute medical condition requiring immediate medical care

Caregivers of AYAHIV:

Inclusion Criteria:

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):

Inclusion Criteria:

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:

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.

Primary outcomes:
measure: Proportion of adolescents and young people living with HIV (AYAHIV) with viral suppression (Viral load <50 copies/ml)
timeFrame: 12 months post intervention implementation
Secondary outcomes:
measure: 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.
timeFrame: 12 months post intervention implementation
measure: Self-reported adherence measured using 3-item adherence scale (mean score)
timeFrame: 12 months post intervention implementation
measure: Proportion of participants with detectable antiretroviral (ARV) on dried blood spot (DBS) specimen
timeFrame: 12 months post intervention implementation
Other outcomes:
Locations:
city: Nampula
country: Mozambique
facility: Cs 1 de Maio
city: Nampula
country: Mozambique
facility: Cs 25 Setembro
city: Nampula
country: Mozambique
facility: Cs Alua
city: Nampula
country: Mozambique
facility: Cs Anexo Psi
city: Nampula
country: Mozambique
facility: Cs Malema
city: Nampula
country: Mozambique
facility: Cs Muhala Expansao
city: Nampula
country: Mozambique
facility: Cs n1 Nacala Porto
city: Nampula
country: Mozambique
facility: Cs Nametil
city: Nampula
country: Mozambique
facility: Cs Namialo
city: Nampula
country: Mozambique
facility: Cs Namicopo
city: Nampula
country: Mozambique
facility: HG Marere
city: Nampula
country: Mozambique
facility: HR Angoche
Study officials:
affiliation: ICAP at Columbia University
name: Elaine J Abrams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.