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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,715
- 试验地点
- 12
- 主要终点
- Proportion of adolescents and young people living with HIV (AYAHIV) with viral suppression (Viral load <50 copies/ml)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents and young adults living with HIV (AYAHIV):
- •Inclusion Criteria:
- •HIV-positive, per medical records and confirmed by health facility staff
- •Age 10 to 24 years
- •Registered as a patient at study site
- •Aware of HIV+ status
- •Provision of signed and dated informed consent form
- •For adolescents under 18 years of age, informed assent and parental informed consent to participate in the study
- •Stated willingness to comply with all study procedures
排除标准
- •Has an acute medical condition requiring immediate medical care
- •Caregivers of AYAHIV:
- •Inclusion Criteria:
- •Age 18 years and older
- •Attending a caregiver-specific support group
- •Willingness to be audio-recorded
- •Healthcare Workers (HCW) and Key Informants (KI):
- •Inclusion Criteria:
- •Age 18 years and older
- •Involved in the provision, management, or oversight of adolescent-focused HIV services at the 12 specified study sites
- •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.
研究组 & 干预措施
Enhanced Standard 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)
干预措施: Radio Ads (Behavioral)
Enhanced Standard 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)
干预措施: Community Sensitization Campaign (Behavioral)
Enhanced Standard 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)
干预措施: Informational Posters (Behavioral)
Enhanced Standard 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)
干预措施: Motivation Walls (Behavioral)
Enhanced Standard 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)
干预措施: Pill Container (Other)
Enhanced Standard 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)
干预措施: CombinADO-specific training for healthcare workers (Other)
Enhanced Standard 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)
干预措施: One Stop Shop Model of Care (Other)
Enhanced Standard 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)
干预措施: Treatment Toolkit (Other)
Enhanced Standard 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)
干预措施: Self-reflection Kit (Other)
CombinADO Strategy
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
干预措施: Radio Ads (Behavioral)
CombinADO Strategy
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
干预措施: Community Sensitization Campaign (Behavioral)
CombinADO Strategy
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
干预措施: Informational Posters (Behavioral)
CombinADO Strategy
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
干预措施: Motivation Walls (Behavioral)
CombinADO Strategy
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
干预措施: Pill Container (Other)
CombinADO Strategy
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
干预措施: CombinADO-specific training for healthcare workers (Other)
CombinADO Strategy
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
干预措施: One Stop Shop Model of Care (Other)
CombinADO Strategy
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
干预措施: Treatment Toolkit (Other)
CombinADO Strategy
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
干预措施: Self-reflection Kit (Other)
CombinADO Strategy
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
干预措施: Peer Support (Behavioral)
CombinADO Strategy
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
干预措施: Informational and motivational Video (Behavioral)
CombinADO Strategy
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
干预措施: Support groups- caregivers of adolescents and young adults living with HIV (Behavioral)
CombinADO Strategy
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
干预措施: Support groups- adolescents and young adults living with HIV (Behavioral)
CombinADO Strategy
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
干预措施: Mental health screening and linkage to adolescent-focused mental health support (Behavioral)
结局指标
主要结局
Proportion of adolescents and young people living with HIV (AYAHIV) with viral suppression (Viral load <50 copies/ml)
时间窗: 12 months post intervention implementation
Viral suppression among AYAHIV at intervention versus control sites
次要结局
- 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)
- Proportion of participants with detectable antiretroviral (ARV) on dried blood spot (DBS) specimen(12 months post intervention implementation)
- Self-reported adherence measured using 3-item adherence scale (mean score)(12 months post intervention implementation)
研究者
Elaine J. Abrams, MD
Senior Research Director, ICAP
Columbia University