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

NCT04791865 | Active Not Recruiting DMC

• 2 other identifiers: H-443001R01HD103512-01
• Study Type: interventional
• Target: 747
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV

Keywords

resources limited settings; HIV infected children

Outcome Measures

Primary Outcomes (1)

• HIV disclosure rate

  Structured and caregiver-centered and culturally-relevant disclosure intervention will be delivered by an adherence and disclosure specialist to the caregiver. After one year, the rate of disclosure of the HIV status of the children will be assessed.

  1 year after intervention

Secondary Outcomes (12)

• Change in Antiretroviral medication adherence

  5 year

• Antiretroviral medication adherence - Pharmacy refill measurement

  5 year

• Antiretroviral medication adherence - HIV-1 RNA

  5 year

• Immunologic health

  5 year

• Behavioral health - CBCL child version

  5 year

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

Disclosure intervention

EXPERIMENTAL

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: Disclosure intervention

Interventions

Disclosure intervention BEHAVIORAL

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).

Disclosure intervention

Usual Care BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• HIV infected children
• Children between the ages of 7-18 who do not know their HIV diagnosis (based on caregiver account and medical records confirmation) and their caregivers will be eligible to participate in the study

You may not qualify if:

• HIV-infected children less than 7 years
• HIV-infected children with congenital or developmental disorders
• HIV-infected children with comorbidities such as sickle cell disease or diabetes that require frequent clinic visits or hospitalizations
• Children with AIDS-defining illness or end stage AIDS.

Sponsors & Collaborators

• Boston University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Korle-Bu Teaching Hospital

Accra, Ghana

Location

Related Publications (2)

• Afrane AKA, Bobbala A, Martyn-Dickens C, Renner L, Antwi S, Kusah JT, Amissah K, Quaye D, Bosomtwe D, Gan G, Parziale S, Reynolds NR, Paintsil E, Shabanova V; Sankofa Study Team. Changes in caregiver psychosocial factors known to affect pediatric HIV disclosure: the Sankofa clinical trial experience in Ghana (2013-2023). AIDS Care. 2025 Dec 2:1-16. doi: 10.1080/09540121.2025.2594607. Online ahead of print.

  PMID: 41330401 DERIVED

• Reynolds NR, Shabanova V, Renner L, Antwi S, Ayisi Addo S, Enimil AK, Lartey M, Gan G, Parziale S, Aikins Amissah K, Kusah JT, Ofori-Atta AL, Slade E, Agyarko-Poku T, Paintsil E. Scale-up of a paediatric HIV disclosure intervention in Ghana using a stepped wedge cluster randomised trial design: Sankofa 2 protocol and implementation. BMJ Open. 2025 Nov 13;15(11):e099681. doi: 10.1136/bmjopen-2025-099681.

  PMID: 41238360 DERIVED

Study Officials

• Elijah Paintsil, MD, FAAP

  Boston University Chobanian & Avedisian School of Medicine, Pediatrics

  PRINCIPAL INVESTIGATOR

• Veronika Shabanova, PhD

  Yale University, Pediatrics, Biostatistician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 10, 2021
• Study Start: June 15, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

GH (1)