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

Pilot of Family-based Self-management for HIV-infected Adolescents in Two Clinics in Ndola

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.

Study Overview

• Status: Completed
• Conditions: HIV; Adolescent Behavior; Caregivers; Africa
• Intervention / Treatment: Behavioral: Family Connections

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Ndola, Zambia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Family Connections; Ten intervention sessions were covered, ranging form understanding HIV and to handling stigma and discrimination.
No Intervention: Comparison; The comparison arm consisted of standard of care for adolescents as offered at the HIV clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Youth Participants' mean ART adherence over six months using daily medication electronic monitoring system (MEMS) caps data	Medication electronic monitoring system (MEMS) caps data recorded the date and time the pill bottle was opened.	Collected monthly over the course of the six month intervention
Proportion of participants with viral failure (1,000 copies or more per mL)	Defined as having 1,000 or more RNA copies per mL	~ 6 months (from baseline to endline)
Youth Participants' adolescent internalized stigma measures (yes/no)	Three agree/disagree statements from the Internalized AIDS Stigma Scale (IA-RSS) as adapted previously in Zambia - low chronbach's alpha resulted in the three measures being analyzed as separate indicators.	~ 6 months (from baseline to endline]

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: FHI 360
• Investigators: Principal Investigator: Julie A Denison, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Adolescents; HIV; Africa; Intervention; Caregivers; Youth
• Other Study ID Numbers: IRB00006271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We did not get assent/consent from participants to make their data available to a third party, therefore we are not able to make the data publicly available, rather our consent forms specified the following "the study research team will have access to your data. This team includes the study investigators, research assistants and data analysts".

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No