Pediatric HIV Disclosure Intervention
- Conditions
- Paediatric HIV Diagnosis Disclosure
- Interventions
- Behavioral: Cognitive behavioral intervention to support pediatric HIV disclosure
- Registration Number
- NCT01773642
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive-behavioral intervention Cognitive behavioral intervention to support pediatric HIV disclosure A cognitive-behavioural intervention aimed at supporting caregivers through paediatric HIV diagnosis disclosure to the child in their care.
- Primary Outcome Measures
Name Time Method Disclosure to child of child's HIV-positive status 24 months
- Secondary Outcome Measures
Name Time Method HIV related morbidity 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.
Child antiretroviral medication adherence 24 months Cost and Cost-effectiveness 24 months Caregiver depression/anxiety 24 months Child behavior checklist 24 months captures depression, anxiety and behavior using the child behavior checklist
Trial Locations
- Locations (6)
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
Kampala City Council Authority (KCCA) Kiswa Health Centre
🇺🇬Kampala, Uganda