ABSTRACT
OBJECTIVES: To assess the safety, acceptability, and preliminary efficacy of a culturally-adapted disclosure intervention for perinatally HIV-infected combined antiretroviral therapy patients in Haiti and the Dominican Republic. DESIGN: A quasi-experimental trial was conducted comparing caregiver-youth pairs who completed the intervention [adapted Blasini disclosure model (aBDM)] to pairs who discontinued aBDM participation before disclosure. aBDM consists of five components: structured healthcare worker training; one-on one pre-disclosure intervention/education sessions for youth (describing pediatric chronic diseases including cancer, diabetes and HIV) and for caregivers (strengthening capacity for disclosure); a scheduled supportive disclosure session; and one-on-one postdisclosure support for caregivers and youth. METHODS: Caregivers of nondisclosed combined antiretroviral therapy patients aged 10.0-17.8 years were invited to participate. Data were collected by separate one-on-one face-to-face interviews of caregivers and youth by study staff and medical record review by pediatricians at enrollment and 3 months after disclosure or after intervention discontinuation. RESULTS: To date, 65 Dominican Republic and 27 Haiti caregiver-youth pairs have enrolled. At enrollment, only 46.4% of youth had viral suppression and 43.4% of caregivers had clinically significant depressive symptomatology. To date, two serious study-related adverse events have occurred. Seven of the 92 (7.6%, 6 in the Dominican Republic) enrolled pairs discontinued participation before disclosure and 39 had completed postdisclosure participation. Median plasma HIV-RNA concentration was lower in youth who completed aBDM than in youth who discontinued participation before aBDM disclosure (<40 versus 8673 copies/ml; Pâ=â0.027). Completers expressed considerable satisfaction with aBDM. CONCLUSION: Preliminary results suggest safety, acceptability, and possible effectiveness of the aBDM.