Patient-Centered Disclosure Intervention for HIV-Infected Children

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.

Conditions

• HIV

Interventions

BEHAVIORAL

HADITHI Intervention

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Moi University

  collaborator OTHER

• Indiana University

  lead OTHER

Principal Investigators

• Rachel C Vreeman, MD, MS · Indiana University

• Winstone Nyandiko, MBChB, MPH · Moi University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2016-06-30

Completion

2016-06-30

Countries

• Kenya

Study Locations