Skip to main content
Clinical Trials/NCT01773642
NCT01773642
Completed
Not Applicable

Comparative Effectiveness of Pediatric HIV Disclosure Interventions in Uganda

University of Connecticut6 sites in 1 country600 target enrollmentAugust 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Paediatric HIV Diagnosis Disclosure
Sponsor
University of Connecticut
Enrollment
600
Locations
6
Primary Endpoint
Disclosure to child of child's HIV-positive status
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

With increased availability of antiretroviral therapy (ART) and improved care, increasing numbers of perinatally infected children are surviving into adolescence. While HIV care and treatment programs are expanding, growing challenge faced by health providers and caregivers is diagnosis disclosure to HIV infected children.

The investigators propose a 4 year project to test the effectiveness of a cognitive-behavioural intervention that the investigators have designed to support developmentally appropriate disclosure to HIV infected children by their caregiver.

The investigators hypothesize that the intervention will lead to increased disclosure rates and will over time improve health and mental health outcomes among caregivers and children in the intervention group compared to those receiving standard care. The findings of the study will inform Ugandan and other countries' national policies on pediatric HIV care and treatment.

Detailed Description

At the end of 2009, there were an estimated 2.1 million children \< 15 years living with HIV, with almost 90% residing in sub-Saharan Africa (SSA). In Uganda alone there are an estimated 150,000 HIV-infected children. Although disclosing to a child that he or she is infected with HIV is an important and integral part of providing comprehensive HIV medical care, studies conducted in SSA have indicated that only 2% to 37.8% of HIV-infected children \< 15 years know their HIV status. Studies by the investigators' team and others have revealed a high demand by both caregivers and children for health provider-facilitated communication about HIV and disclosure to HIV-infected children. In Uganda despite the rapid expansion of HIV services for children, very few health providers receive formal training in how to support disclosure of an HIV diagnosis to an infected child. Despite the existence of international and national recommendations for disclosure there are no tested models for supporting caregivers and HIV-infected children in SSA through the process of disclosure. This study proposes to test the effectiveness of an innovative cognitive-behavioural intervention designed to support developmentally appropriate disclosure to HIV-infected children by their caregiver. The proposed intervention builds on the investigators' team's prior research is informed by a cognitive behavioral perspective, as well as the Disclosure Processes Model. The investigators will also adapt components of a multi-faceted program for caregivers of HIV-infected children, developed by members of the investigators' team with funding support from the US President's Emergency Plan for AIDS Relief (PEPFAR). Specific aims: 1. To determine the effectiveness of a cognitive-behavior intervention for increasing disclosure of children's HIV diagnosis by caregivers to their HIV-infected children age 7-12 years old in Uganda. 2. To determine the effect of disclosure on immediate and longer-term caregiver and child mental health, and child behavioral and clinical outcomes, and whether the intervention modifies these effects 3. To assess the incremental cost, health impact, and cost-effectiveness of the intervention

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
November 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lisa Butler

Associate Research Professor

University of Connecticut

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Disclosure to child of child's HIV-positive status

Time Frame: 24 months

Secondary Outcomes

  • HIV related morbidity(24 months)
  • Child antiretroviral medication adherence(24 months)
  • Cost and Cost-effectiveness(24 months)
  • Caregiver depression/anxiety(24 months)
  • Child behavior checklist(24 months)

Study Sites (6)

Loading locations...

Similar Trials