Family Connections Cluster RCT in Zambia

Not Applicable

Recruiting

• Conditions: HIV; Africa; Adolescent Development; Caregivers; Adolescent Behavior

• Registration Number: NCT05358795
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-4-28
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

Inclusion Criteria:<br><br>Eligibility criteria for AYA include:<br><br> - being between 15 and 21 years,<br><br> - HIV positive and aware of their HIV status,<br><br> - on ART for at least 6 months,<br><br> - on first-line ART,<br><br> - living within 30-minutes, by personal transportation, of the clinic by self-report,<br><br> - being available to attend 10 sessions over 6 months,<br><br> - being available for the next 14 months,<br><br> - and speaks one of the study languages, English or Bemba<br><br>Eligibility criteria for the caregiver is:<br><br> - being 22 years of age or older,<br><br> - does not work at the study clinic,<br><br> - living within 30-minutes, by personal transportation, of the clinic by self-report,<br><br> - caring for an AYA who meets the study eligibility criteria,<br><br> - being available to attend 10 sessions over 6 months,<br><br> - being available over the next 14 months,<br><br> - and speaks one of the study languages English or Bemba.<br><br>Being a biological parent or family member is not an eligibility criterion.<br><br>Exclusion Criteria:<br><br>The only exclusion criteria are not fulfilling the inclusion criteria.<br><br>

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with undetectable viral load and low self-stigma

Secondary Outcome Measures

Name	Time	Method
Number of caregivers experiencing caregiver burden measured using the Zarit Burden Interview;Number of caregivers with higher social support measured with Medical Outcomes Study Social Support Survey (MOS-SS);Number of adolescent and youth participants with cognitive challenges assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric cognitive function scale;Number of adolescent and youth participants with emotional regulation challenges measures using the Difficulties in Emotion Regulation Scale (DERS-SF)