Clinical trial NCT01773642: Pediatric HIV Disclosure Intervention
Official title: Comparative Effectiveness of Pediatric HIV Disclosure Interventions in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paediatric HIV Diagnosis Disclosure
Keywords: pediatric HIV diagnosis disclosure
cognitive behavioral intervention
Uganda
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: MU-JHU CARE
First posted: 2013-01-23
Enrollment: 600
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

Primary outcomes:
measure: Disclosure to child of child's HIV-positive status
timeFrame: 24 months
Secondary outcomes:
measure: HIV related morbidity
timeFrame: 24 months
measure: Child antiretroviral medication adherence
timeFrame: 24 months
measure: Cost and Cost-effectiveness
timeFrame: 24 months
measure: Caregiver depression/anxiety
timeFrame: 24 months
measure: Child behavior checklist
timeFrame: 24 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Kampala City Council Authority (KCCA) Kiswa Health Centre
city: Kampala
country: Uganda
facility: KCCA Kawaala Health Centre
city: Kampala
country: Uganda
facility: KCCA Kisenyi Health Centre
city: Kampala
country: Uganda
facility: KCCA Kitebi Health Centre
city: Kampala
country: Uganda
facility: Makerere University-Johns Hopkins University Research Collaboration (MUJHU) clinic
city: Kampala
country: Uganda
facility: Nsambya Health Clinic
Study officials:
affiliation: U Connecticut
name: Lisa M Butler
role: PRINCIPAL_INVESTIGATOR
References: