Pediatric HIV Disclosure Intervention

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by University of California, San Francisco
Sponsor:
Collaborators:
Makerere University-Johns Hopkins University Research Collaboration
Zoe Life, Durban, South Africa
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01773642
First received: January 17, 2013
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Paediatric HIV Diagnosis Disclosure
Behavioral: Cognitive behavioral intervention to support pediatric HIV disclosure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparative Effectiveness of Pediatric HIV Disclosure Interventions in Uganda

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Disclosure to child of child's HIV-positive status [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HIV related morbidity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    For all children and HIV-infected caregivers, information on WHO stage of HIV infection, treatment status, opportunistic infections, CD4 counts will be abstracted from medical records.

  • Child antiretroviral medication adherence [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Cost and Cost-effectiveness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Caregiver depression/anxiety [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Child behavior checklist [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    captures depression, anxiety and behavior using the child behavior checklist


Estimated Enrollment: 800
Study Start Date: April 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive-behavioral intervention
A cognitive-behavioural intervention aimed at supporting caregivers through paediatric HIV diagnosis disclosure to the child in their care.
Behavioral: Cognitive behavioral intervention to support pediatric HIV disclosure
No Intervention: Standard of Care

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
  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • children of age 7 to 12 years;
  • confirmed HIV-infected;
  • unaware of their HIV status, according to caregiver report;
  • principal caregiver, age 18 years or older, of the eligible study child is able and willing to participate in their regular treatment program (monthly visits) and data collection visits at the study clinic at 6-month intervals for 24 months;
  • agreement to participate in 3 group sessions with other caregivers over a 6 week period, and 3 counseling session with the eligible child(ren), scheduled at the same time as usual clinic visits;
  • resides within a 30km radius around the study clinic, and not planning on moving during the study period; caregiver and child must both consent / assent for participation.

Exclusion criteria:

  • caregivers and children who are unable to consent or assent to participation in the study due to cognitive impairment or illness;
  • for children, medical history of serious birth complications, severe malnutrition, bacterial meningitis, encephalitis, cerebral malaria, or other known brain injury or disorder requiring hospitalization or continued evidence of seizure or other neurological disability;
  • for caregivers, severe mental illness or developmental disability.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773642

Contacts
Contact: Lisa M Butler, PhD, MPH LButler@psg.ucsf.edu

Locations
Uganda
Kampala City Council Authority (KCCA) Kiswa Health Centre Not yet recruiting
Kampala, Uganda
Principal Investigator: Philippa Musoke, MBChB         
KCCA Kawaala Health Centre Not yet recruiting
Kampala, Uganda
Principal Investigator: Philippa Musoke, MBChB         
KCCA Kawempe Health Centre Not yet recruiting
Kampala, Uganda
Principal Investigator: Philippa Musoke, MBChB         
Makerere University-Johns Hopkins University Research Collaboration (MUJHU) clinic Not yet recruiting
Kampala, Uganda
Principal Investigator: Philippa Musoke, MBChB         
Sponsors and Collaborators
University of California, San Francisco
Makerere University-Johns Hopkins University Research Collaboration
Zoe Life, Durban, South Africa
Investigators
Principal Investigator: Lisa Butler University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01773642     History of Changes
Other Study ID Numbers: Pediatric HIV Disclosure
Study First Received: January 17, 2013
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board
Uganda: National Council for Science and Technology

Keywords provided by University of California, San Francisco:
pediatric HIV diagnosis disclosure
cognitive behavioral intervention
Uganda

ClinicalTrials.gov processed this record on October 20, 2014