Mindfulness and Acceptance Based Therapy for Adolescents Living With HIV
NCT05010317 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2023-08-14
Summary
Adolescents represent a growing share of people living with HIV in sub-Saharan Africa (SSA), yet show poor adherence to medication and viral suppression (VS) compared to adults. Investigators postulate that to achieve optimal adherence, support interventions that resonate with life-stages changes in adolescence need to be tested and promoted. Mindfulness and acceptance based interventions are slowly gaining traction as appropriate for adolescents.
The study proposes to explore acceptability of an adapted mindfulness and acceptance-based psychosocial intervention (acceptance and commitment therapy: Discoverer, Noticer, Advisor-values model-ACT-DNA-v), among providers (health care practitioners -HCPs) and users (adolescents living with HIV/AIDS-ALWHA). Further, it endeavors to measure feasibility and effectiveness of ACT-DNA-v in reducing psychological barriers to adherence among ALWHAs. The study is to be conducted at two public health centers in Kampala-Uganda. The study design is exploratory sequential mixed-methods; where qualitative data is to be used to explore acceptance of ACT-DNA-v, while quantitative data will be used to measure feasibility of the intervention and its effectiveness in reducing psychosocial barriers to adherence. Qualitative exploratory methods will guide exploration of acceptability of ACT-DNA-v among users and providers; collecting data with a semi-structured interview on domains of inquiry including; understanding, satisfaction, intention to use and perceived appropriateness of ACT-DNA-v. A randomized control trial with quantitative surveys at baseline, post-intervention and follow-up will used to measure the effects of the intervention on process and clinical outcomes among ALWHA. Thematic data analysis will be used to analyze qualitative data, while T-test, Wilcoxon rank sum test, Fisher's exact and Chi-square tests respectively will be used to ascertain average mean differences between the ACT group and the control group on the outcome parameters.
Conditions
- Medication Adherence
- Adjustment Reaction With Anxiety and Depression
- Mental Health Issue
Interventions
- BEHAVIORAL
-
Mindfulness and acceptance based therapy
This is a behavioral intervention that is aimed at building psychological flexibility among adolescents. It involves careful use of language, metaphors, experiential learning and mindfulness to develop skills that support values guided living. Participants learn to relate with their inner thoughts, feelings and urges in an open and elaborative way as conscious human beings and make choices that improve their lives even in the presence of such difficult experiences.
- BEHAVIORAL
-
Standard of care
Usual clinic based counselling offered as routine care to adolescents
Sponsors & Collaborators
-
Makerere University
collaborator OTHER -
National Institutes of Health (NIH)
collaborator NIH -
Fogarty International Center of the National Institute of Health
collaborator NIH -
Infectious Diseases Research Collaboration, Uganda
lead OTHER
Principal Investigators
-
Moses R Kamya · IDRC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-01
- Primary Completion
- 2023-06-15
- Completion
- 2023-06-15
Countries
- Uganda
Study Locations
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