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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04442399
• Other study ID #: IRB00006271
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2020
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Africa
• Caregivers
• HIV

Intervention

Behavioral:
• Family Connections
Ten intervention sessions were covered, ranging form understanding HIV and to handling stigma and discrimination.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	FHI 360

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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)
Secondary	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]