SANKOFA Pediatric HIV Disclosure Intervention
Condition: HIV
Study type: Interventional

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.
    

Intervention name(s): Disclosure intervention; usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Disclosure; HIV-infected children; Resource-limited settings