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Pediatric HIV Disclosure Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01773642
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : April 28, 2017
Information provided by (Responsible Party):
Lisa Butler, University of Connecticut

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.

Condition or disease Intervention/treatment Phase
Paediatric HIV Diagnosis Disclosure Behavioral: Cognitive behavioral intervention to support pediatric HIV disclosure Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparative Effectiveness of Pediatric HIV Disclosure Interventions in Uganda
Actual Study Start Date : August 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Disclosure to child of child's HIV-positive status [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. HIV related morbidity [ Time Frame: 24 months ]
    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.

  2. Child antiretroviral medication adherence [ Time Frame: 24 months ]
  3. Cost and Cost-effectiveness [ Time Frame: 24 months ]
  4. Caregiver depression/anxiety [ Time Frame: 24 months ]
  5. Child behavior checklist [ Time Frame: 24 months ]
    captures depression, anxiety and behavior using the child behavior checklist

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01773642

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Kampala City Council Authority (KCCA) Kiswa Health Centre
Kampala, Uganda
KCCA Kawaala Health Centre
Kampala, Uganda
KCCA Kisenyi Health Centre
Kampala, Uganda
KCCA Kitebi Health Centre
Kampala, Uganda
Makerere University-Johns Hopkins University Research Collaboration (MUJHU) clinic
Kampala, Uganda
Nsambya Health Clinic
Kampala, Uganda
Sponsors and Collaborators
University of Connecticut
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Principal Investigator: Lisa M Butler U Connecticut

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Responsible Party: Lisa Butler, Associate Research Professor, University of Connecticut Identifier: NCT01773642    
Other Study ID Numbers: Pediatric HIV Disclosure
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Keywords provided by Lisa Butler, University of Connecticut:
pediatric HIV diagnosis disclosure
cognitive behavioral intervention