Family Connections Cluster RCT in Zambia

HIV Clinical Trial

Official title:

Family Connections Cluster RCT in Zambia: Impact of a Youth and Caregiver Intervention on Virologic Status Among HIV-positive Youth (Ages 15-21)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05358795
• Other study ID #: IRB00020325
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: July 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Julie A. Denison, PhD
• Phone: 443-287-2704
• Email: jdenison[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 AYA viral status. 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.

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 (Lorig and Holman 2003). While there is an international call to support HIV self-management among adolescents (Gilliam, Ellen et al. 2011, Chakraborty, Van Dyke et al. 2013, WHO 2013), the reality is that AYAs living with HIV in SSA often do not have access to youth-specific services (WHO 2013) 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 (Sanders 2013). Furthermore, data show that some youth living with HIV experience delayed cognitive development, particularly youth that are perinatally infected with HIV (Eckard, Rosebush et al. 2017, Sherr, Hensels et al. 2018). 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 (Thurman, Jarabi et al. 2012, Kidman and Thurman 2014).

Peer group interventions, however, show promise in reducing HIV-related stigma in SSA among adults (Mburu, Ram et al. 2013) and in supporting adolescent ART adherence (WHO 2013). 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 (Greifinger and Dick 2009). 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 (Hodgson, Ross et al. 2012, Siu, Bakeera-Kitaka et al. 2012, Busza, Besana et al. 2013, Mburu, Hodgson et al. 2013, Lowenthal, Bakeera-Kitaka et al. 2014, Mburu, Hodgson et al. 2014) and to promote family involvement as AYA transition into adulthood and adult HIV services (Pediatrics, Physicians et al. 2002, Dowshen and D'Angelo 2011, Cervia 2013, Chakraborty, Van Dyke et al. 2013). 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 (PEPFAR) 2013) 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 an undetectable viral load. 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 undetectable viral load (VL) (<20 copies/mL) among AYA. A CRCT will be conducted comparing 200 pairs of AYA and caregivers at 10 intervention clinics versus 200 pairs at 10 control clinics (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 their 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' viral status 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 the Lusaka and Copperbelt Provinces. 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 and Lusaka Provinces 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 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 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 (see more detail below), 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. The study team will then move the research to the Lusaka Province where the same approach will be repeated. 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 province, 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: August 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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, Bemba, or Nyanja.

Eligibility criteria for the caregiver is:

• being 22 years of age or older,

• 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, Bemba, or Nyanja.

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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Related Conditions & MeSH terms

• Adolescent Behavior
• Adolescent Development
• Africa
• Caregivers
• HIV

Intervention

Behavioral:
• Family Connections
Family Connections is based on the WHO endorsed Positive Connections manual.

Locations

Country	Name	City	State
Zambia	New Masala	Ndola	Copperbelt

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Arthur Davison Children's Hospital, FHI 360

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with undetectable viral load	Defined as having <20 RNA copies/mL among adolescent and youth participants	~ 6 months from baseline to midline
Secondary	Number of caregivers experiencing caregiver burden measured using the Zarit Burden Interview	Zarit Burden Interview adapted 12-item 3 point Likert-scale (0=never, 1=sometimes, 2=Always) with higher scores indicating more challenges/burdens experienced in caregiving (among caregivers)	~ 6 months from baseline to midline
Secondary	Number of caregivers with higher social support measured with Medical Outcomes Study Social Support Survey (MOS-SS)	Medical Outcomes Study Social Support Survey (MOS-SS), 20-items, 5-point Likert Scales (1=none of the time; 2= a little of the time; 3= some of the time; 4=most of the time, 5=all of the time), with higher scores indicating receipt of greater social support (among caregivers)	~ 6 months from baseline to midline
Secondary	Number of adolescent and youth participants with cognitive challenges assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric cognitive function scale	Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric cognitive function adapted through cognitive interviewing (abbreviated 7-item, 5 point Likert-scales with 5=never; 4= a little of the time; 3= sometimes; 4=most of the time, 5=always), with a higher score assessing more difficulties in cognitive abilities/everyday tasks, in the past 4 weeks.	~ 6 months from baseline to midline
Secondary	Number of adolescent and youth participants with emotional regulation challenges measures using the Difficulties in Emotion Regulation Scale (DERS-SF)	Difficulties in Emotion Regulation Scale (DERS-SF), abbreviated 18-items, 5-point Likert scales (5=never; 4= a little of the time; 3= sometimes; 4=most of the time, 5=always), with a higher score assessing greater difficulties identifying/managing emotions.	~ 6 months from baseline to midline