SANKOFA Pediatric HIV Disclosure Intervention

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Disclosure intervention; Behavioral: usual care

• Registration Number: NCT01701635
• Lead Sponsor: Yale University

Brief Summary

A culturally-relevant, theoretically and empirically sound, patient-centered, standardized disclosure intervention that can be integrated into routine clinical pediatric HIV care has potential to prevent transmission and improve the welfare of children and their caregivers in Ghana and other resource-limited settings. Results from this project will also further an understanding of factors and processes driving pediatric HIV disclosure.The study hypothesis is that several key barriers to disclosure of HIV status can be modified and the process of disclosure promoted with an intervention approach that is grounded in a traditional Ghanaian concept.

Detailed Description

The project aims to provide information on a structured disclosure intervention that can be integrated into usual care in Ghana and other resource-limited settings to improve the welfare of HIV-infected children and their caregivers. This area of investigation is profoundly understudied and of high importance to millions of children and their families in sub-Saharan Africa. While widely recognized as vital to better health outcomes, especially in the era of better access to HIV treatment, many children are not informed of their HIV diagnosis. A variety of sociocultural contextual barriers and deficient skills drive the persistent reluctance of caregivers and health care providers to inform children of the diagnosis. Our preliminary work shows that several key factors can be modified and the process of disclosure promoted with an intervention approach that is grounded in a traditional Ghanaian concept, "SANKOFA", and behavioral and bioecological systems theory. The patient-centered intervention approach uses an Adherence and Disclosure specialist model where a designated specialist familiar with the socio-cultural norms of the community is well trained to target modifiable information, motivation and behavioral skills of caregivers to facilitate their engagement in the process of disclosure (i.e., pre-disclosure, disclosure, and post-disclosure phases) in a manner suitable to the needs of the child.

The primary aims are: (1) To evaluate the effect of a structured, culturally-relevant disclosure intervention to caregivers delivered by a specialist as an integral component of routine HIV healthcare on the rate of caregiver disclosure of pediatric HIV at 1 year follow-up compared to treatment as usual, control condition, in a randomized trial and (2) To identify baseline characteristics (e.g., caregiver knowledge \& motivation, child's age) predictive of caregiver disclosure of pediatric HIV independent of and in the presence of the structured disclosure intervention at 1 year follow-up.

Secondary aims are: (3) To assess whether the effect of HIV pediatric disclosure on medication adherence and health outcomes of children (virologic, immunologic, psychosocial, and behavioral) and the caregiver (psychosocial) varies by exposure vs non-exposure to the structured disclosure intervention and (4) To assess the fidelity and acceptability of the disclosure intervention over time among the clinic personnel designated disclosure specialist, caregiver, and children to whom HIV status has been disclosed. Provider, caregiver and child participants will be enrolled from tertiary HIV clinics in Ghana with longitudinal outcomes evaluated every 3 months post-randomization to 24 months post disclosure.

Study Timeline

• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-05
• Study Start: 2013-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 446

Inclusion Criteria

• HIV-infected children receiving care at the study sites
• started on antiretroviral therapy (ART) for the first time within 12 months of screening
• Or Child is going on ART at the time of screening
• Or child had achieved and maintained at least 25% of CD4+ T-lymphocytes according to age on treatment irrespective of duration of ART within 6 months prior to enrollment
• do not know their HIV diagnosis (based on caregiver account and medical records confirmation)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Disclosure intervention	Disclosure intervention	In the disclosure intervention plus usual care arm the adherence and disclosure specialist will meet with caregiver at each clinic visit and provide information, education, disclosure skills, and support till disclosure occurs.
Usual care	usual care	In the "enhanced usual care (control)" arm the disclosure specialist will meet with caregiver at each clinic visit and provide them will general health education and no mention or effort will be made to improve disclosure skills of caregiver.

Primary Outcome Measures

Name	Time	Method
HIV disclosure rate	one 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 Outcome Measures

Name	Time	Method
Medication adherence of children	two years	The effect of HIV pediatric disclosure on medication adherence will be evaluated and compared between the two study arms - exposure vs non-exposure to the structured disclosure intervention.
Health outcomes of children	2 years	The effect of HIV pediatric disclosure on health outcomes of children (virologic - viral load, immunologic - CD4 count, psychosocial, and behavioral) will be evaluated and compared between the two study arms - exposure vs non-exposure to the structured disclosure intervention.
Health outcomes of caregiver	2 years	The effect of HIV pediatric disclosure on the psychosocial well being of the caregiver will be evaluated and compared between the two study arms - exposure vs non-exposure to the structured disclosure intervention.
Baseline characteristics of caregiver predictive of disclosure to the child his/her HIV status	one year	Baseline characteristics (e.g., caregiver knowledge \& motivation, child's age) predictive of caregiver disclosure of pediatric HIV independent of and in the presence of the structured disclosure intervention at 1 year follow-up.

Trial Locations

Locations (2)

Komfo Anoky Teaching Hospital; 🇬🇭 Kumasi, Ashanti Region, Ghana

Korle-Bu Teaching Hospital; 🇬🇭 Accra, Greater Accra Region, Ghana