Clinical trial NCT05358795: Family Connections Cluster RCT in Zambia
Official title: Family Connections Cluster RCT in Zambia: Impact of a Youth and Caregiver Intervention on HIV Management Among HIV-positive Youth (Ages 15-21)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Adolescent Development
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
name: Arthur Davison Children's Hospital
name: Tropical Diseases Research Centre
name: National Institute of Mental Health (NIMH)
First posted: 2022-05-03
Enrollment: 1400
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Cluster Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will evaluate the impact of Family Connections, a family-based group intervention for adolescents and young adults (AYA) living with HIV and their family caregivers, on achieving HIV self-management defined as having an undetectable viral load (VL) and low self-stigma (a score of 1 or less), among older adolescents and young adults (AYA) ages 15-to-21 years. The intervention seeks to increase social and family support and decrease self-stigma among AYA, so they may improve their medication adherence and achieve an undetectable viral load. Findings will fill a critical gap in available evidence-based intervention options for improving the HIV-related outcomes and wellbeing of HIV-positive AYA in sub-Saharan Africa.

Detailed description: BACKGROUND/INTRODUCTION

A dearth of programs exist that actively promote HIV self-management among older adolescents and young adults (AYA) in sub-Saharan Africa (SSA). Literature on chronic illness has identified the following skills for promoting self-management: problem-solving, decision-making, resource utilization, formation of a patient-provider partnership, action planning, and self-tailoring skills to one's own situation. While there is an international call to support HIV self-management among adolescents, the reality is that AYAs living with HIV in SSA often do not have access to youth-specific services or opportunities to build life skills. Some clinics hold monthly AYA peer group meetings, however such meetings are typically vulnerable to changes in staff and funding; are often not systematically incorporated into service provision; and do not involve AYAs' family members.

There is also lack evidence on how HIV self-management differs by AYAs' developmental characteristics. Adolescence is a period characterized by intense physical, cognitive, and emotional growth and a desire for independence. Furthermore, data show that some youth living with HIV experience delayed cognitive development, particularly youth that are perinatally infected with HIV. Despite these data, studies rarely examine program impact accounting for variations in AYAs' development. Furthermore, evidence exists that managing chronic illnesses has negative impacts on caregivers and families, particularly in low-income and highly stigmatized environments.

Peer group interventions, however, show promise in reducing HIV-related stigma in SSA among adults and in supporting adolescent ART adherence. Given that HIV is a highly stigmatized chronic illness, peer groups provide a safe environment in which to share experiences and learn from others who understand the day-to-day reality of living with HIV. There is also a growing body of literature from SSA, including Zambia, calling for interventions to involve families in supporting AYA living with HIV to self-manage HIV and to promote family involvement as AYA transition into adulthood and adult HIV services. While experts agree on the need for family-centered approaches and peer support groups, few family-based interventions exist that specifically address the needs of older AYAs aged 15-21 years.

In response to the lack of interventions to promote HIV self-management among AYA that harness the support of caregivers, the study team developed Family Connections- a family group-based intervention. In the study team's earlier pilot study of Family Connections the team adapted an existing adolescent support group guide called Positive Connections (The United States President's Plan for AIDS Relief using mixed-methods formative research. The study team also updated the AYA support group materials and developed a corresponding support group component for caregivers. The feasibility and acceptability of Family Connections was tested in an randomized controlled trial (RCT) among older adolescents (15 to 19 years) and their caregivers in two clinics in Ndola, Zambia. Fifty adolescent/caregiver pairs (100 individuals) were enrolled. Study results found that Family Connections was highly feasible and acceptable. Of the 24 adolescent/caregiver pairs assigned to the intervention arm, 88% attended eight or more of the 10 Family Connections sessions together, and most adolescents (96%) and all caregivers would recommend the intervention to their peers. Although not powered to find differences in outcomes, the prior pilot study showed a signal for efficacy in reducing adolescents' HIV-related feelings of worthlessness (I: 54% to 22% vs. C:38% to 35%, p=0.06) and shame (I: 58% to 30% vs. C:54% to 58%, p=0.07), and reducing caregiver burden (mean scores: I: 0.16 to -0.25 vs. C: -0.15 to -0.25, p=0.08).

Building off this pilot study, this cluster randomized controlled trial (CRCT) will contribute to the field of HIV empirical research and care practices by testing the impact of a feasible and acceptable family-based intervention on increasing the proportion of 15- to 21-year-old AYA who achieve HIV self-management defined as having an undetectable viral load and low self-stigma. This study will also help improve the understanding of how cognitive and developmental processes may moderate intervention outcomes among AYA.

STUDY AIMS:

The specific aims of the research are to:

Aim 1: Assess the impact of Family Connections on achieving HIV self-management defined as having an undetectable viral load (VL \<20 copies/mL) and low self-stigma, among AYA. A cluster randomized controlled trial will be conducted comparing 200 pairs of AYA and caregivers at 10 intervention health facilities versus 200 pairs at 10 control health facilities (n=800 total: 400 AYA, 400 caregivers).

Aim 2: Assess the impact of Family Connections on caregiver burden (e.g., How often does the caregiver feel stressed between caring for adolescent and trying to meet other responsibilities for family or work?) and social support among the 200 AYA caregiver participants in the intervention arm versus the 200 AYA caregiver participants in the control arm (n=400).

Aim 3: Examine if the impact of Family Connections on AYAs' HIV self-management is moderated by developmental differences among youth assessed through measures of cognitive functioning, executive functioning, impulse control, and emotional regulation.

STUDY DESIGN

This study is a multi-site, pair-matched CRCT to evaluate the impact of the Family Connections intervention on achieving undetectable VL among AYA living with HIV. The study team will enroll pairs of AYA living with HIV (ages 15-21) and their caregivers in 20 matched pairs of HIV clinics in Copperbelt Province. The team will enroll and collect baseline data, including a VL test, from an estimated 500 to 700 AYA 15-to-21 years living with HIV in Copperbelt Province and 500 to 700 of their caregivers. The range of participants enrolled is provided as it depends on the proportion of youth initially enrolled who have a detectable VL or high self-stigma at baseline. Based on prior research, approximately 20% of AYA enrolled in the study will have an undetectable viral load. These participants will end study participation at that point. An estimated 35 AYA/caregiver pairs in each clinic will be enrolled until there are approximately 400 AYA participants with a detectable VL or high self-stigma and their caregivers who will continue in the study. After a run-in period, during which study procedures will be refined and facilitators will hold Family Connection sessions, the study will commence in 4 clinics (2-matched pairs) in the Copperbelt Province, and then roll out to the remaining clinics in the Copperbelt. Data collection will occur at baseline, midline (at the end of the Family Connections intervention, approximately six months after baseline), and endline (about six months after midline), and will consist of a survey among caregivers and AYA, a blood draw for AYA, and a point of care (POC) urine adherence test for AYA taking Tenofovir as part of their antiretroviral therapy (ART). The 20 clinics have been pair-matched by number of AYA on ART, and location type. One clinic within each of the matched pairs will be randomly assigned to receive the Family Connections intervention, consisting of 10 in-person group sessions that will take place over an estimated 6 months. The other clinic in the matched pair will be assigned to a standard of care control group. The main comparison will be based on the effect at midline after the 6 months of intervention in the intervention group. Additional contrasts will be tested to examine changes of effects over time (e.g., at endline).

Eligibility criteria: Inclusion Criteria:

Eligibility criteria for AYA include:

* being between 15 and 21 years,
* HIV positive and aware of their HIV status,
* on ART for at least 6 months,
* on first-line ART,
* living within 30-minutes, by personal transportation, of the clinic by self-report,
* being available to attend 10 sessions over 6 months,
* being available for the next 14 months,
* and speaks one of the study languages, English or Bemba

Eligibility criteria for the caregiver is:

* being 22 years of age or older,
* does not work at the study clinic,
* living within 30-minutes, by personal transportation, of the clinic by self-report,
* caring for an AYA who meets the study eligibility criteria,
* being available to attend 10 sessions over 6 months,
* being available over the next 14 months,
* and speaks one of the study languages English or Bemba.

Being a biological parent or family member is not an eligibility criterion.

Exclusion Criteria:

The only exclusion criteria are not fulfilling the inclusion criteria.

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Primary outcomes:
measure: Number of participants with undetectable viral load and low self-stigma
timeFrame: ~ 6 months from baseline to midline
Secondary outcomes:
measure: Number of caregivers experiencing caregiver burden measured using the Zarit Burden Interview
timeFrame: ~ 6 months from baseline to midline
measure: Number of caregivers with higher social support measured with Medical Outcomes Study Social Support Survey (MOS-SS)
timeFrame: ~ 6 months from baseline to midline
measure: Number of adolescent and youth participants with cognitive challenges assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric cognitive function scale
timeFrame: ~ 6 months from baseline to midline
measure: Number of adolescent and youth participants with emotional regulation challenges measures using the Difficulties in Emotion Regulation Scale (DERS-SF)
timeFrame: ~ 6 months from baseline to midline
Other outcomes:
Locations:
city: Ndola
country: Zambia
facility: Copperbelt Province Clinics
state: Copperbelt
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Julie A. Denison, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tropical Diseases Research Center
name: Gershom Chongwe, PhD
role: PRINCIPAL_INVESTIGATOR
References: