SANKOFA Pediatric HIV Disclosure Intervention

HIV Clinical Trial

Official title:

A Bioecological Pediatric HIV Disclosure Intervention in Ghana - "SANKOFA"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701635
• Other study ID #: 1205010310
• Secondary ID: NIH/NICHDR01HD07
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: June 30, 2017

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Disclosure intervention
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.
• usual care
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.

Locations

Country	Name	City	State
Ghana	Korle-Bu Teaching Hospital	Accra	Greater Accra Region
Ghana	Komfo Anoky Teaching Hospital	Kumasi	Ashanti Region

Sponsors (5)

Lead Sponsor	Collaborator
Yale University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kwame Nkrumah University of Science and Technology, Purdue University, University of Ghana

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fidelity of the disclosure intervention	The fidelity of the disclosure intervention over time among the clinic personnel designated disclosure specialist, caregiver, and children to whom HIV status has been disclosed will be assessed over the study period.	5 years
Other	Acceptability of the disclosure intervention	The acceptability of the disclosure intervention over time among the clinic personnel designated disclosure specialist, caregiver, and children to whom HIV status has been disclosed will be assessed over the study period.	5 years
Primary	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	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
Secondary	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
Secondary	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
Secondary	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