Patient-Centered Disclosure Intervention for HIV-Infected Children
Condition: HIV
Study type: Interventional

Summary: 
      In the resource-limited settings where most HIV-infected children live, neither the most
      effective strategies to inform children of their HIV status, nor the impact of disclosure is
      well understood. This team's long-term goal is to provide evidence to improve the chronic
      disease management of HIV-infected children in resource-limited settings. The purpose of this
      study is to assess the effect of a patient-centered intervention guiding disclosure to
      HIV-infected Kenyan children using a randomized trial comparing the intervention to routine
      care. The primary endpoint will be probability of disclosure among children, with secondary
      endpoints of adherence, clinical outcomes, psychological distress and social outcomes. This
      work will be done within the Academic Model Providing Access to Healthcare (AMPATH) which
      currently cares for almost 120,000 adult and pediatric HIV-infected patients in 25 clinics in
      Kenya. We will utilize the excellent infrastructure of this academic partnership to provide
      the first comprehensive assessment of the physical, psychological, and social impact of
      disclosure for HIV-infected children in East Africa. We will evaluate the impact of an
      intensive disclosure intervention by pursuing these specific aims: Aim 1: Expand and modify
      an existing pediatric HIV disclosure intervention used in Kenya to include patient-centered
      components; Aim 2: Perform a randomized trial to compare the impact of clinic implementation
      of the culturally adapted, pediatric disclosure intervention on the prevalence of disclosure
      and on the medical, psychological, and social outcomes for HIV-infected Kenyan children ages
      10-15 years compared to children exposed to standard clinical care. The usual care control
      arm will have disclosure training for all clinicians, disclosure chart materials, and an
      existing protocol to implement disclosure for patients over 10 years. The disclosure
      intervention will consist of patient-centered materials to guide disclosure, including
      videotaped narratives; disclosure counselors; post-disclosure child support groups; and the
      usual care resources. The central hypothesis is that an intensive disclosure intervention
      based on culture-specific qualitative work and a patient-centered approach will allow for
      disclosure in which more children know their HIV status at younger ages, and they also have
      improved medication adherence, improved medical outcomes, unimpaired psychological outcomes,
      and no increase in experienced stigma over time.
    

Detailed description: 
      Access to highly active antiretroviral therapy (ART) transforms HIV/AIDS management from
      responding to an acute infection and its co-morbidities into coordinating the care of a
      complex chronic disease. Ninety percent of the world's 2.3 million HIV-infected children live
      in sub-Saharan Africa. As HIV-infected children receiving ART grow and thrive, clinicians in
      these resource-limited settings face new challenges. As children age, they need to be
      transitioned into taking responsibility for their own care. Central to this transition is the
      process of telling children that they are infected with HIV. The most effective strategies
      for disclosing HIV status to children in resource-limited settings are not known. Moreover,
      parents and healthcare providers often fear disclosure, worrying about the personal and
      social impact on the child and the family. To date, only a modicum of research describes the
      prevalence of pediatric disclosure, effective disclosure processes, or the impact of
      disclosure in resource-limited settings.

      The long-term goal of our research team is to provide evidence to improve the chronic care
      and disease management of HIV-infected children in resource-limited settings. We have
      evaluated the experience of medication-taking and ART adherence for children in Kenya and
      East Africa, and we are currently carrying out a validation study developing pediatric ART
      adherence measurement strategies that include disclosure assessment.(1K23MH087225-01) We have
      conducted a systematic review of disclosure to children in resource-limited settings,
      implemented a clinical training program in pediatric disclosure in Kenya, and have done pilot
      work to evaluate the prevalence and impact of disclosure within the AMPATH HIV care system in
      western Kenya. Our results consistently demonstrate the importance of disclosure for
      pediatric adherence and the sustained daily care of children with HIV, and yet disclosure
      rates remain low with standard care, particularly because parents and guardians fear
      disclosure. We now propose a cluster randomized trial to assess the effectiveness of a
      patient-centered disclosure intervention for HIV-infected Kenyan children and their families.
      In the HADITHI (Helping AMPATH Disclose Information and Talk about HIV Infection) trial, the
      objective is to evaluate the efficacy of an intensive, culturally adapted, narrative-based
      disclosure intervention for HIV-infected Kenyan children compared to the less intensive
      disclosure process currently used as the standard of care. Our primary endpoint will be
      disclosure status over two-years follow-up, with secondary endpoints related to clinical,
      psychological, and social outcomes. The central hypothesis is that an intensive disclosure
      intervention based on culture-specific qualitative work and a patient-centered approach will
      allow for higher rates of disclosure and allow children not only to know their HIV status,
      but also to have improved medication adherence, improved medical outcomes, unimpaired
      psychological and/or behavioral outcomes, and no increase in experienced stigma or social
      isolation over time. The rationale for evaluating this disclosure intervention is to provide
      a robust test of efficacy for a disclosure process in a resource-limited setting.
    

Intervention name(s): HADITHI Intervention
Intervention type(s): Behavioral
Intervention description(s): The HADITHI Intervention consists of a culturally adapted, multi-component clinic-based intervention designed to support families in pediatric HIV disclosure in Kenya.
In addition to the Usual Care components, the HADITHI Intervention clinics will have the following intervention components:
Culturally modified curricula materials, including videotaped narratives, to guide counseling and group sessions.
Dedicated disclosure counselors to initiate and conduct disclosure, with one-on-one counseling for caregivers and children, as well as family-based sessions.
Post-disclosure peer support groups, facilitated by the disclosure counselors, for children who have gone through disclosure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: HIV; Disclosure; Pediatrics