SANKOFA Pediatric HIV Disclosure Intervention

NCT01701635 | Completed

• 3 other identifiers: 1205010310NIH/NICHDR01HD074253
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV

Keywords

Disclosure; HIV-infected children; Resource-limited settings

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Baseline characteristics of caregiver predictive of disclosure to the child his/her HIV status

  one year

• Medication adherence of children

  two years

• Health outcomes of children

  2 years

• Health outcomes of caregiver

  2 years

Other Outcomes (2)

• Fidelity of the disclosure intervention

  5 years

• Acceptability of the disclosure intervention

  5 years

Study Arms (2)

Disclosure intervention

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

Disclosure intervention BEHAVIORAL

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.

Disclosure intervention

usual care BEHAVIORAL

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.

Usual care

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Purdue University: collaborator
• University of Ghana: collaborator
• Kwame Nkrumah University of Science and Technology: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Komfo Anoky Teaching Hospital

Kumasi, Ashanti Region, Ghana

Location

Korle-Bu Teaching Hospital

Accra, Greater Accra Region, Ghana

Location

Related Publications (7)

• Afrane AKA, Bobbala A, Martyn-Dickens C, Renner L, Antwi S, Kusah JT, Amissah K, Quaye D, Bosomtwe D, Gan G, Parziale S, Reynolds NR, Paintsil E, Shabanova V; Sankofa Study Team. Changes in caregiver psychosocial factors known to affect pediatric HIV disclosure: the Sankofa clinical trial experience in Ghana (2013-2023). AIDS Care. 2025 Dec 2:1-16. doi: 10.1080/09540121.2025.2594607. Online ahead of print.

  PMID: 41330401 DERIVED

• Shabanova V, Emuren L, Gan G, Antwi S, Renner L, Amissah K, Kusah JT, Lartey M, Reynolds NR, Paintsil E; Sankofa Study Team. Pediatric HIV Disclosure Intervention Improves Immunologic Outcome at 48 Weeks: The Sankofa Trial Experience. J Acquir Immune Defic Syndr. 2023 Dec 1;94(4):371-380. doi: 10.1097/QAI.0000000000003292.

  PMID: 37643414 DERIVED

• 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.

  PMID: 33081739 DERIVED

• 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.

  PMID: 32333207 DERIVED

• 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.

  PMID: 32049772 DERIVED

• 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.

  PMID: 30360643 DERIVED

• 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.

  PMID: 30235940 DERIVED

Study Officials

• Elijah Pantsil, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: October 5, 2012
• Study Start: January 1, 2013
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: March 9, 2020

Record last verified: 2020-03

Locations

GH (2)