Patient-Centered Disclosure Intervention for HIV-Infected Children

NCT01947764 | Completed

• 1 other identifier: 1R01MH099747-01
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV; Disclosure; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Disclosure Status

  Percent of children (ages 10-15) documented as knowing their HIV status; Percent knowing why they take medicines; Percent knowing why they attend AMPATH clinic

  2 years

Study Arms (2)

Usual Care

NO INTERVENTION

The Usual Care components for the control clinics will include the following: * All clinicians (pediatricians, medical officers, clinical officers, and nurses) caring for children undergo the existing 3-day disclosure training * Chart materials to guide and document disclosure counseling and visits * The presence of the AMPATH SOP mandating disclosure to children ages 10 and older. In Usual Care clinics, no specific personnel will be dedicated to disclosure.

HADITHI Intervention

EXPERIMENTAL

In addition to the Usual Care components, the HADITHI Intervention clinics will include: * Modified materials to guide disclosure sessions * Videotaped narratives for parental counseling * Dedicated disclosure counselors to initiate and conduct the disclosure process * Post-disclosure support groups for children The disclosure counselors will avail themselves for conducting disclosure with any families referred to them by the AMPATH clinicians. They will post fliers that describe their services for parents and caregivers so that families can self-refer for disclosure counseling. Similarly, the post-disclosure support groups for children will be available for anyone enrolled in the clinic and families will be able to self-refer or to be referred by the clinicians.

Behavioral: HADITHI Intervention

Interventions

HADITHI Intervention BEHAVIORAL

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.

HADITHI Intervention

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• HIV-infected (documented by DNA-PCR \[Amplicor, Roche, Basel, Switzerland\] for children younger than 18 months and by 2 parallel HIV rapid ELISA tests using Determine and Bioline for children older than 18 months), AND
• Child age 10 to 15 years, AND
• Child is currently enrolled or newly enrolled in HIV care at one of the following AMPATH HIV clinics: Moi Teaching and Referral Hospital (Eldoret), Chulaimbo, Kitale, Mosoriot, Turbo, Webuye, Burnt Forest, or Khuyangu.

You may not qualify if:

• Mental or physical incapacity of legal caregiver leading to inability to provide informed consent.
• Mental or physical incapacity of the child leading to inability to answer the evaluation questions.

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Mental Health (NIMH): collaborator
• Moi University: collaborator

Study Sites (1)

Moi Teaching and Referral Hospital - AMPATH Center

Eldoret, 30100, Kenya

Location

Study Officials

• Rachel C Vreeman, MD, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

• Winstone Nyandiko, MBChB, MPH

  Moi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 20, 2013
• Study Start: August 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 8, 2017

Record last verified: 2017-03

Locations

KE (1)