SANKOFA Pediatric HIV Disclosure Intervention

Study Overview
=================
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.

Official Title
-----------------
A Bioecological Pediatric HIV Disclosure Intervention in Ghana - SANKOFA

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Behavioral: Disclosure intervention
* Behavioral: usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
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) 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.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disclosure intervention<br>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. | Behavioral: Disclosure intervention<br>* An adherence and disclosure specialist will meet with caregiver-child dyad at each clinic visit and provide caregiver information and skills for HIV disclosure till the caregiver discloses the HIV status to the child.<br>|
| Active Comparator: Usual care<br>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. | Behavioral: usual care<br>* An adherence and disclosure specialist will meet with caregiver-child dyad at each clinic visit and provide caregiver with general health information without referencing HIV disclosure in their conversations till the caregiver discloses the HIV status to the child.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one year after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline characteristics of caregiver predictive of disclosure to the child his/her HIV status | 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. | one year | 
| Medication adherence of children | 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. | two years | 
| Health outcomes of children | 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. | 2 years | 
| Health outcomes of caregiver | 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. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Disclosure, HIV-infected children, Resource-limited settings