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Sponsor: Washington University School of Medicine
Conditions: HIV/AIDS
Interventions: Group Cognitive Behavioral Therapy (G-CBT), Multiple Family Group (MFG)
Countries: United States, Uganda
The study seeks to reduce HIV/AIDS-associated stigma and its negative impact on adolescent health and psychosocial well-being. This study will examine two evidence-informed interventions: 1) group cognitive behavior therapy (G-CBT) that aims at cognitive restructuring and strengthening coping skills at the individual level, and 2) multiple family group (MFG) that strengthens family relationships intended to address HIV/AIDS-associated stigma at the individual level and within families. Adolescents between 10-14 years, will be randomly assigned -at the clinic level, to one of three study arms: 1) Usual care to receive the currently implemented usual care addressing HIV/AIDS-associated stigma (educational materials from the Ugandan Ministry of Health); 2) G-CBT intervention + Usual care; and 3) MFG intervention + Usual care. The interventions will be delivered over a 3-month period. Assessments will be collected at baseline, 3 months and 6 months post intervention initiation. The study will also explore participants, caregivers and facilitators' intervention experiences, as well as multi-level facilitators and barriers to intervention implementation and participation.
Sex: ALL
Age: 10 Years to 14 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria for Children: 1. HIV+ status - defined as a child who has been tested for HIV with confirmation by medical report and has been disclosed to, i.e. know their status 2. Prescribed antiretroviral therapy 3. Living within a family (defined broadly - not necessarily with biological parents) 4. Ages 10 to 14 years. Exclusion Criteria for Children: 5. Unable to understand the study procedures and/or participant rights during the informed consent process 6. Unwilling or unable to commit to completing the study. 7. Presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation Inclusion Criteria for Caregivers: 1. Ages 18 and above 2. Agree to participate in the study. Exclusion Criteria for Caregivers 3. Unable to understand the study procedures and/or participant rights during the informed consent process 4. Unwilling or unable to commit to completing the study. 5. Presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation
- St Louis, Missouri, United States
- Masaka, Uganda
- Masaka, Uganda