SANKOFA Pediatric HIV Disclosure Intervention

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Yale University
Sponsor:
Collaborators:
Purdue University
University of Ghana
Kwame Nkrumah University of Science and Technology
Information provided by (Responsible Party):
Elijah Paintsil, Yale University
ClinicalTrials.gov Identifier:
NCT01701635
First received: October 2, 2012
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
HIV
Behavioral: Disclosure intervention
Behavioral: Enhanced usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Bioecological Pediatric HIV Disclosure Intervention in Ghana - "SANKOFA"

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • HIV disclosure rate [ Time Frame: one year after intervention ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Baseline characteristics of caregiver predictive of disclosure to the child his/her HIV status [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.

  • Medication adherence of children [ Time Frame: two years ] [ Designated as safety issue: No ]
    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.

  • Health outcomes of children [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Health outcomes of caregiver [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Fidelity of the disclosure intervention [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.

  • Acceptability of the disclosure intervention [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 756
Study Start Date: January 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Sham Comparator: Enhanced 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.
Behavioral: Enhanced 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.

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

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701635

Contacts
Contact: Elijah Paintsil, MD 203 785 6101 elijah.paintsil@yale.edu
Contact: Nancy Reynolds, PhD 203 737 5501 ext 256 nancy.reynolds@yale.edu

Locations
Ghana
Komfo Anoky Teaching Hospital Recruiting
Kumasi, Ashanti Region, Ghana
Contact: Sampson Antwi, MBChB    +233-322024654    Kantwisampson@gmail.com   
Principal Investigator: Sampson Antwi, MBChB         
Korle-Bu Teaching Hospital Recruiting
Accra, Greater Accra Region, Ghana
Contact: Lorna Renner, MBChB    +233-208243945    lornarenner@gmail.com   
Principal Investigator: Lorna Renner, MBChB         
Sponsors and Collaborators
Yale University
Purdue University
University of Ghana
Kwame Nkrumah University of Science and Technology
Investigators
Principal Investigator: Elijah Pantsil, MD Yale University
  More Information

No publications provided

Responsible Party: Elijah Paintsil, Assistant Professor of Pediatrics and Pharmacology, Yale University
ClinicalTrials.gov Identifier: NCT01701635     History of Changes
Other Study ID Numbers: R01 HD074253, NIH/NICHD
Study First Received: October 2, 2012
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Disclosure
HIV-infected children
Resource-limited settings

ClinicalTrials.gov processed this record on September 14, 2014