Clinical trial NCT01701635: SANKOFA Pediatric HIV Disclosure Intervention
Official title: A Bioecological Pediatric HIV Disclosure Intervention in Ghana - "SANKOFA"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Disclosure
HIV-infected children
Resource-limited settings
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Purdue University
name: University of Ghana
name: Kwame Nkrumah University of Science and Technology
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2012-10-05
Enrollment: 446
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: HIV disclosure rate
timeFrame: one year after intervention
Secondary outcomes:
measure: Baseline characteristics of caregiver predictive of disclosure to the child his/her HIV status
timeFrame: one year
measure: Medication adherence of children
timeFrame: two years
measure: Health outcomes of children
timeFrame: 2 years
measure: Health outcomes of caregiver
timeFrame: 2 years
Other outcomes:
measure: Fidelity of the disclosure intervention
timeFrame: 5 years
measure: Acceptability of the disclosure intervention
timeFrame: 5 years
Locations:
city: Kumasi
country: Ghana
facility: Komfo Anoky Teaching Hospital
state: Ashanti Region
city: Accra
country: Ghana
facility: Korle-Bu Teaching Hospital
state: Greater Accra Region
Study officials:
affiliation: Yale University
name: Elijah Pantsil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.