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Completed

NCT Number: NCT04791865

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

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.

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Key information

Conditions

HIV

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korle-Bu Teaching Hospital

Accra, Ghana

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. HIV disclosure rate

    Time frame: 1 year after intervention

    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.

Secondary outcomes

  1. Change in Antiretroviral medication adherence

    Time frame: 5 year

    Medication adherence will be assessed with the AIDS Clinical Trials Group (ACTG) Adherence Questionnaire self-report questionnaire. This will be assessed every 3 months up until end of study. This measures provides a ratio of adherence to antiviral medication requirements. A score of 1 equals perfect adherence and 0 represents no adherence.

  2. Antiretroviral medication adherence - Pharmacy refill measurement

    Time frame: 5 year

    The pharmacy-based time-to-refill measure adherence is calculated as the number of months for which antiretroviral therapy claims were submitted to the pharmacy, divided by the number of complete months during the period under consideration, and the results multiplied by 100

  3. Antiretroviral medication adherence - HIV-1 RNA

    Time frame: 5 year

    HIV-1 RNA is calculated by

  4. Immunologic health

    Time frame: 5 year

    The immunologic staging of their disease according to both the U.S. CDC and WHO classification criteria will be used to determine immunologic health using patient's medical chart.

  5. Behavioral health - CBCL child version

    Time frame: 5 year

    Children health will be measured by using the Child Behavior checklist-child version (CBCL). For each item on the CBCL, the respondent is asked to choose from a three-point response scale indicating whether a problem behavioral description is "not true" (= 0), "somewhat or sometimes true" (= 1), or "very true or often true" (= 2) of the child

  6. Behavioral health - CBCL parent version

    Time frame: 5 year

    Children health will be measured by using the Child Behavior checklist-child version (CBCL). For each item on the CBCL, the respondent is asked to choose from a three-point response scale indicating whether a problem behavioral description is "not true" (= 0), "somewhat or sometimes true" (= 1), or "very true or often true" (= 2) of the child

  7. Child Depression Inventory (CDI)

    Time frame: 5 year

    The CDI is an 27 item questionnaire on a three-point scale to assess depression symptoms. The cumulative score will be calculated

  8. Beck Depression Inventory

    Time frame: 5 year

    The Caregiver's psychosocial health will be measured with the 21-item Beck Depression Inventory (BDI). The Beck Depression Inventory (BDI) is a 21-item, multiple-choice inventory. Respondents are asked to rate each item based on four response choices according to the severity of the symptoms, ranging from the absence of a symptom to an intense level, during the past week. BDI scores from 0 through 9 indicate no or minimal depression; scores from 10 through 18 indicate mild to moderate depression; scores from 19 through 29 indicate moderate to severe depression; and scores from 30 through 63 indicate severe depression.

  9. Implementation - Retention

    Time frame: 5 year

    Proportion of subjects retained throughout the implementation phase. This will be reported >90%, 60-90%, and <60%)

  10. Implementation - Caregiver 6-month log

    Time frame: 6 month

    The caregivers' 6-month surveys (e.g., caregivers' experience summarized into 3 categories: 1=Not Satisfactory, 2=Satisfactory, 3=Very Satisfactory). will be used to characterize a composite outcome for implementation success: 1= successful, 2= intermediate, 3= problematic

  11. Incremental cost-effectiveness ratio

    Time frame: 5 year

    The incremental cost effectiveness ratio (ICER) will be used to compare pediatric intervention relative to the standard of care to assess cost-effectiveness. The 1 year ratio will provide directly observed near term economic impact of disclosure.

  12. Change in HIV -1 RNA Viral Load

    Time frame: 5 years

    The HIV-1 RNA viral load will be measured every 6 months to determine the change over 5 years.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2021
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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