Family Connection: Pilot of Family-based Self-management for HIV-infected Adolescents

NCT ID: NCT04442399

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-06-30

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.

Conditions

HIV; Adolescent Behavior; Caregivers; Africa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

The intervention was based on the WHO-endorsed manual entitled Positive Connections: Leading Information and Support Groups for Adolescents Living with HIV. For Family Connections, a caregiver companion guide was developed. In brief, adolescent/caregiver pairs attended 10 intervention sessions held every other Saturday at their HIV clinic over a six-month period.

Group Type: EXPERIMENTAL

Family Connections

Intervention Type: BEHAVIORAL

Ten intervention sessions were covered, ranging form understanding HIV and to handling stigma and discrimination.

Comparison

The comparison arm consisted of standard of care for adolescents as offered at the HIV clinics.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Family Connections

Ten intervention sessions were covered, ranging form understanding HIV and to handling stigma and discrimination.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

FHI 360

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie A Denison, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Ndola, , Zambia

Countries

Zambia

Other Identifiers

IRB00006271

Identifier Type: -

Identifier Source: org_study_id