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

NCT04442399 | Completed

• 1 other identifier: IRB00006271
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Adolescent Behavior; Caregivers; Africa

Keywords

HIV; Adolescents; Youth; Caregivers; Africa; Intervention

Outcome Measures

Primary Outcomes (2)

• Number of adolescent/caregiver pairs who attend Family Connections (feasibility)

  Feasibility was assessed based on attendance at the intervention sessions.We considered the intervention feasible if at least two-thirds of the pairs attended 80% or more of the intervention sessions.

  Attendance over the course of the 6 month intervention collected using attendance log.

• Proportion of participants who would recommend the Family Connections program (acceptability)

  The proportion of participants who reported during the endline survey that they would recommend the intervention to others.

  At the six-month endline data collection

Secondary Outcomes (3)

• Youth Participants' mean ART adherence over six months using daily medication electronic monitoring system (MEMS) caps data

  Collected monthly over the course of the six month intervention

• Proportion of participants with viral failure (1,000 copies or more per mL)

  ~ 6 months (from baseline to endline)

• Youth Participants' adolescent internalized stigma measures (yes/no)

  ~ 6 months (from baseline to endline]

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Family Connections

Comparison

NO INTERVENTION

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

Interventions

Family Connections BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• FHI 360: collaborator

Study Sites (1)

Unknown Facility

Ndola, Zambia

Location

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Julie A Denison, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: March 22, 2023

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)