CombinADO: Evaluation of an Intervention Aimed at Improving HIV Outcomes Among Adolescents and Young Adults Living With HIV in Mozambique

Not Applicable

Recruiting

• Conditions: HIV
• Interventions: Behavioral: Radio Ads; Behavioral: Community Sensitization Campaign; Behavioral: Informational Posters; Behavioral: Motivation Walls; Other: Pill Container; Other: CombinADO-specific training for healthcare workers; Other: One Stop Shop Model of Care; Other: Treatment Toolkit; Other: Self-reflection Kit; Behavioral: Peer Support; Behavioral: Informational and motivational Video; Behavioral: Support groups- caregivers of adolescents and young adults living with HIV; Behavioral: Support groups- adolescents and young adults living with HIV; Behavioral: Mental health screening and linkage to adolescent-focused mental health support

• Registration Number: NCT04930367
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2021-06-05
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-18
• Study Start: 2021-09-13
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Standard of Care	Pill Container	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)
CombinADO Strategy	Motivation Walls	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
CombinADO Strategy	Pill Container	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
Enhanced Standard of Care	Radio Ads	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)
CombinADO Strategy	Treatment Toolkit	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
CombinADO Strategy	Self-reflection Kit	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
Enhanced Standard of Care	Community Sensitization Campaign	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)
Enhanced Standard of Care	Informational Posters	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)
Enhanced Standard of Care	CombinADO-specific training for healthcare workers	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)
CombinADO Strategy	Radio Ads	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
CombinADO Strategy	One Stop Shop Model of Care	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
CombinADO Strategy	Peer Support	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
CombinADO Strategy	Informational and motivational Video	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
Enhanced Standard of Care	One Stop Shop Model 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)
Enhanced Standard of Care	Treatment Toolkit	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)
Enhanced Standard of Care	Motivation Walls	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)
Enhanced Standard of Care	Self-reflection Kit	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)
CombinADO Strategy	Community Sensitization Campaign	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
CombinADO Strategy	Support groups- caregivers of adolescents and young adults living with HIV	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
CombinADO Strategy	Support groups- adolescents and young adults living with HIV	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
CombinADO Strategy	Informational Posters	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
CombinADO Strategy	CombinADO-specific training for healthcare workers	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
CombinADO Strategy	Mental health screening and linkage to adolescent-focused mental health support	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

Primary Outcome Measures

Name	Time	Method
Proportion of adolescents and young people living with HIV (AYAHIV) with viral suppression (Viral load <50 copies/ml)	12 months post intervention implementation	Viral suppression among AYAHIV at intervention versus control sites

Secondary Outcome Measures

Name	Time	Method
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.	12 months post intervention implementation	Retention in HIV care \& treatment among AYAHIV at intervention versus control sites
Proportion of participants with detectable antiretroviral (ARV) on dried blood spot (DBS) specimen	12 months post intervention implementation	ART adherence among among adolescents and young people living with HIV (AYAHIV) at intervention versus control sites, ARV levels
Self-reported adherence measured using 3-item adherence scale (mean score)	12 months post intervention implementation	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.

Trial Locations

Locations (12)

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