Mindfulness and Acceptance Based Therapy for Adolescents Living With HIV

NCT05010317 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2023-08-14

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05010317 on ClinicalTrials.gov