Clinical trial NCT04442399: Family Connection: Pilot of Family-based Self-management for HIV-infected Adolescents
Official title: Pilot of Family-based Self-management for HIV-infected Adolescents in Two Clinics in Ndola
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Adolescent Behavior
Caregivers
Africa
Keywords: HIV
Adolescents
Youth
Caregivers
Africa
Intervention
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: FHI 360
First posted: 2020-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study design has two phases. The first phase is the refinement of intervention manual for an adolescent living with HIV (ALHIV)and their caregiver intervention, followed by a second phase feasibility pilot study. The study goals are to refine and pilot a feasible intervention that fosters resiliency and draws upon the strengths of adolescents and their families. Specific aims include to: (1) Refine activities and an intervention manual for a family-focused group intervention for adolescents and their caregivers to improve HIV self-management among adolescents living with HIV; (2) conduct a pilot study to assess the acceptability and feasibility of the group intervention among 50 adolescent/caregiver pairs that are randomly assigned to the intervention or the comparison arms, and (sub aim 2a) examine preliminary trends in outcome measures, including Anti-Retroviral Therapy (ART) adherence, safer sex behaviors and stigma, comparing the intervention and comparison study arms.

Detailed description: The need for effective interventions to support adolescent HIV self-management is particularly pressing in Sub-Saharan Africa (SSA) where the majority of the 2.1 million ALHIV reside. Highlighting the vulnerability of ALHIV is their increasing HIV-related mortality, up 50% in 2012 compared to 2005, while the global number of HIV-related deaths among all ages decreased by 30%. In response to the disparate burden of HIV mortality among ALHIV, combined with the compelling evidence from HIV prevention and chronic illness literature and research on the influential role of families, the study team propose to refine and pilot test an ALHIV/caregiver group intervention. This intervention will draw upon principles of Positive Youth Development (PYD) and Social Cognitive theory (SCT) to emphasize skills building, self-efficacy, youth participation, and strengthening adult relationships. The intervention will build upon an existing ALHIV support group guide and utilize trained facilitators to hold group sessions with ALHIV and their caregivers to: 1) improve understanding of HIV among ALHIV and caregivers; 2) help ALHIV develop strategies for healthy living including adherence to ART; 3) build the capacity of ALHIV to make informed decisions about their sexual and reproductive health; 4) build the capacity of caregivers to support ALHIV; and 5) help ALHIV develop life skills to communicate their HIV diagnosis effectively, and to plan for their future. The study design has two phases. The first phase is the refinement of the ALHIV/caregiver intervention manual followed by a second phase feasibility pilot study. The Study goals are to refine and pilot a feasible intervention that fosters resiliency and draws upon the strengths of adolescents and their families. Specific aims include to: (1) Refine activities and an intervention manual for a family-focused group intervention for adolescents and their caregivers to improve HIV self-management among adolescents living with HIV; (2) conduct a pilot study to assess the acceptability and feasibility of the group intervention among 50 adolescent/caregiver pairs that are randomly assigned to the intervention or the comparison arms, and (sub aim 2a) examine preliminary trends in outcome measures, including ART adherence, safer sex behaviors and stigma, comparing the intervention and comparison study arms.

Eligibility criteria: Inclusion Criteria:

* Adolescents: 15 and 19 years old, aware of their HIV status, and had been on ART for at least six months
* Caregivers:nominated by the adolescents and were at least 20 years old

Exclusion Criteria:

- Caregiver: Being a biological parent is not an eligibility criterion

Primary outcomes:
measure: Number of adolescent/caregiver pairs who attend Family Connections (feasibility)
timeFrame: Attendance over the course of the 6 month intervention collected using attendance log.
measure: Proportion of participants who would recommend the Family Connections program (acceptability)
timeFrame: At the six-month endline data collection
Secondary outcomes:
measure: Youth Participants' mean ART adherence over six months using daily medication electronic monitoring system (MEMS) caps data
timeFrame: Collected monthly over the course of the six month intervention
measure: Proportion of participants with viral failure (1,000 copies or more per mL)
timeFrame: ~ 6 months (from baseline to endline)
measure: Youth Participants' adolescent internalized stigma measures (yes/no)
timeFrame: ~ 6 months (from baseline to endline]
Other outcomes:
Locations:
city: Ndola
country: Zambia
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Julie A Denison, PhD
role: PRINCIPAL_INVESTIGATOR
References: