NCT04791865

Pediatric HIV Disclosure Benefits Study (PhD-BS) - Sankofa 2

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 747 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to conduct a pragmatic, stepped wedge cluster randomized trial in 12 HIV pediatric clinics in Ghana to determine effectiveness, health benefits, cost and implementation to inform scale-up and sustainability of pediatric disclosure.

Detailed description

In this 5-year study, the investigators would like to build upon the successful Sankofa trial by testing the intervention in a larger scale study delivered in "real-world" clinic conditions over time in Ghana. The purpose of this study is to conduct a pragmatic, stepped wedge cluster randomized trial in 12 HIV pediatric clinics in Ghana to determine effectiveness, health benefits, cost and implementation to inform scale-up and sustainability of pediatric disclosure. The study will recruit dyads of 720 children (ages 7-18) and their caregivers from twelve (12) clinics, which will be randomly assigned to each of the four roll-out schedules ("wedge steps"), with three clinics per step. The two groups in the study are usual care and disclosure intervention. During the control period, patients and caregivers recruited at the clinics will receive the current practice in the clinic, where the health care provider is expected to assess the caregiver and child readiness for disclosure during clinic appointments and give some information as they think indicated. No formal pediatric disclosure guidelines or educational materials exist in Ghana. During the intervention period, the manualized, with standard operation procedures, Sankofa intervention will be delivered. The intervention is guided by the disclosure model and contains key elements to target well-documented, modifiable barriers to promote disclosure. The primary outcome is disclosure after one year (48 weeks) of the intervention. Secondary outcomes are antiretroviral medication adherence, health (virologic, immunologic, psychosocial, behavioral), cost, and implementation. The trial will be conducted with a strong team of interdisciplinary investigators at two universities in Ghana, Yale and Johns Hopkins University in partnership with the Ghana Ministry of Health (MoH), Ghana Health Service (GHS) and a community advisory board.

Conditions

• HIV

Interventions

Type	Name	Description
BEHAVIORAL	Disclosure intervention	Participants who are assigned to the Sankofa intervention will take part in the process of disclosure (pre-disclosure, disclosure, and post-disclosure phases) with the adherence and disclosure specialist (ADDS).
BEHAVIORAL	Usual Care	During the control period, patients and caregivers recruited at the clinics will receive the current practice in the clinic, where the health care provider is expected to assess the caregiver and child readiness for disclosure during clinic appointments and give some information as they think indicated.

Timeline

• Start date: 2021-06-15
• Primary completion: 2025-12-31
• Completion: 2026-06-01
• First posted: 2021-03-10
• Last updated: 2026-02-24

Locations

1 site across 1 country: Ghana