Pediatric HIV Disclosure Intervention

NCT ID: NCT01773642

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-11-30

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

Conditions

Paediatric HIV Diagnosis Disclosure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Cognitive-behavioral intervention

A cognitive-behavioural intervention aimed at supporting caregivers through paediatric HIV diagnosis disclosure to the child in their care.

Group Type: EXPERIMENTAL

Cognitive behavioral intervention to support pediatric HIV disclosure

Intervention Type: BEHAVIORAL

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive behavioral intervention to support pediatric HIV disclosure

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MU-JHU CARE

OTHER

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Lisa Butler

Associate Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa M Butler

Role: PRINCIPAL_INVESTIGATOR

U Connecticut

Locations

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

Countries

Uganda

Other Identifiers

Pediatric HIV Disclosure

Identifier Type: -

Identifier Source: org_study_id