Clinical trial NCT04791865: Pediatric HIV Disclosure Benefits Study (PhD-BS) - Sankofa 2
Official title: Pediatric HIV Disclosure Benefits Study (PhD-BS) - Sankofa 2
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV
Keywords: resources limited settings
HIV infected children
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-03-10
Enrollment: 747
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: HIV disclosure rate
timeFrame: 1 year after intervention
Secondary outcomes:
measure: Change in Antiretroviral medication adherence
timeFrame: 5 year
measure: Antiretroviral medication adherence - Pharmacy refill measurement
timeFrame: 5 year
measure: Antiretroviral medication adherence - HIV-1 RNA
timeFrame: 5 year
measure: Immunologic health
timeFrame: 5 year
measure: Behavioral health - CBCL child version
timeFrame: 5 year
measure: Behavioral health - CBCL parent version
timeFrame: 5 year
measure: Child Depression Inventory (CDI)
timeFrame: 5 year
measure: Beck Depression Inventory
timeFrame: 5 year
measure: Implementation - Retention
timeFrame: 5 year
measure: Implementation - Caregiver 6-month log
timeFrame: 6 month
measure: Incremental cost-effectiveness ratio
timeFrame: 5 year
measure: Change in HIV -1 RNA Viral Load
timeFrame: 5 years
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: Korle-Bu Teaching Hospital
Study officials:
affiliation: Boston University Chobanian & Avedisian School of Medicine, Pediatrics
name: Elijah Paintsil, MD, FAAP
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University, Pediatrics, Biostatistician
name: Veronika Shabanova, PhD
role: PRINCIPAL_INVESTIGATOR
References: