- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01701635
SANKOFA Pediatric HIV Disclosure Intervention
A Bioecological Pediatric HIV Disclosure Intervention in Ghana - "SANKOFA"
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ashanti Region
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Kumasi, Ashanti Region, Ghana
- Komfo Anoky Teaching Hospital
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Greater Accra Region
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Accra, Greater Accra Region, Ghana
- Korle-Bu Teaching Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
|
Active Comparator: 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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV disclosure rate
Time Frame: 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.
|
one year after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline characteristics of caregiver predictive of disclosure to the child his/her HIV status
Time Frame: 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.
|
one year
|
Medication adherence of children
Time Frame: 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.
|
two years
|
Health outcomes of children
Time Frame: 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.
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2 years
|
Health outcomes of caregiver
Time Frame: 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.
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2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fidelity of the disclosure intervention
Time Frame: 5 years
|
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
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Acceptability of the disclosure intervention
Time Frame: 5 years
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elijah Pantsil, MD, Yale University
Publications and helpful links
General Publications
- Radcliffe C, Sam A, Matos Q, Antwi S, Amissah K, Alhassan A, Ofori IP, Xu Y, Deng Y, Reynolds NR, Paintsil E; Sankofa Team. Sankofa pediatric HIV disclosure intervention did not worsen depression scores in children living with HIV and their caregivers in Ghana. BMC Public Health. 2020 Oct 20;20(1):1578. doi: 10.1186/s12889-020-09678-2.
- Farthing H, Reynolds NR, Antwi S, Alhassan A, Ofori IP, Renner L, Amissah KA, Kusah JT, Lartey M, Paintsil E; Sankofa Study Team. Illness Narratives of Children Living with HIV Who Do Not Know Their HIV Status in Ghana: I'm Sick, But I Don't Know the Sickness-A Qualitative Study. AIDS Behav. 2020 Nov;24(11):3225-3231. doi: 10.1007/s10461-020-02884-4.
- Paintsil E, Kyriakides TC, Antwi S, Renner L, Nichols JS, Amissah K, Kusah JT, Alhassan A, Ofori IP, Catlin AC, Gan G, Lartey M, Reynolds NR; Sankofa Study Team. Clinic-Based Pediatric Disclosure Intervention Trial Improves Pediatric HIV Status Disclosure in Ghana. J Acquir Immune Defic Syndr. 2020 May 1;84(1):122-131. doi: 10.1097/QAI.0000000000002316.
- Ofori-Atta A, Reynolds NR, Antwi S, Renner L, Nichols JS, Lartey M, Amissah K, Tettey JK, Alhassan A, Ofori IP, Catlin AC, Gan G, Kyriakides TC, Paintsil E; Sankofa Study Team. Prevalence and correlates of depression among caregivers of children living with HIV in Ghana: findings from the Sankofa pediatric disclosure study. AIDS Care. 2019 Mar;31(3):283-292. doi: 10.1080/09540121.2018.1537463. Epub 2018 Oct 25.
- Nichols JS, Kyriakides TC, Antwi S, Renner L, Lartey M, Seaneke OA, Obeng R, Catlin AC, Gan G, Reynolds NR, Paintsil E; Sankofa Study Team. High prevalence of non-adherence to antiretroviral therapy among undisclosed HIV-infected children in Ghana. AIDS Care. 2019 Jan;31(1):25-34. doi: 10.1080/09540121.2018.1524113. Epub 2018 Sep 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1205010310
- NIH/NICHD (Other Grant/Funding Number: NIH/NICHD 074253)
- R01HD074253 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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