Pediatric HIV Disclosure Intervention

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Harvard University
Makerere University-Johns Hopkins University Research Collaboration
Information provided by (Responsible Party):
Lisa M. Butler, Harvard University Identifier:
First received: January 17, 2013
Last updated: November 17, 2014
Last verified: November 2014

January 17, 2013
November 17, 2014
August 2013
May 2016   (final data collection date for primary outcome measure)
Disclosure to child of child's HIV-positive status [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01773642 on Archive Site
  • 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
Same as current
Not Provided
Not Provided
Pediatric HIV Disclosure Intervention
Comparative Effectiveness of Pediatric HIV Disclosure Interventions in Uganda

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.

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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Paediatric HIV Diagnosis Disclosure
Behavioral: Cognitive behavioral intervention to support pediatric HIV disclosure
  • Experimental: Cognitive-behavioral intervention
    A cognitive-behavioural intervention aimed at supporting caregivers through paediatric HIV diagnosis disclosure to the child in their care.
    Intervention: Behavioral: Cognitive behavioral intervention to support pediatric HIV disclosure
  • No Intervention: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2017
May 2016   (final data collection date for primary outcome measure)

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.
7 Years and older
Pediatric HIV Disclosure
Not Provided
Not Provided
Lisa M. Butler, Harvard University
Harvard University
Makerere University-Johns Hopkins University Research Collaboration
Principal Investigator: Lisa M Butler Children's Hospital Boston
Harvard University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP