Mindfulness and Acceptance Based Therapy for Adolescents Living With HIV

August 10, 2023 updated by: Infectious Diseases Research Collaboration, Uganda

Acceptability, Feasibility and Effectiveness of a Mindfulness Based Intervention to Promote Adherence to Antiretroviral Therapy Among Adolescents in Kampala.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background The success of antiretroviral therapy (ART) is highly dependent on adherence and persistent care engagement. However, despite efforts to improve sustained ART use among adolescents, non-adherence persists. Studies using medication possession ratios and clinical counts have found adherence to ART among adults to be at 72% compared to 68% among young people, furthermore, statistics on VL measures in 2017 show that 74.2% of adults above 50 years had achieved viral load suppression compared to 39.6% of adolescents. Additionally, almost 50% of HIV cases in Uganda are among young people. Poor adherence among ALWHA undermines the HIV care cascade and efforts to end the AIDS epidemic by 2030. As a consequence, young people are the only group in Uganda among whom HIV mortality is increasing. The unique developmental changes at the onset of adolescence have been cited as main factors influencing psychosocial pathways into health, resulting in psychopathological barriers to medication adherence among ALWHA. Developmentally appropriate psychosocial interventions need to be added into adolescents' HIV care. However, to date, psychosocial support interventions targeted for the unique developmental changes in adolescence remain limited. Most interventions in use with young people are developed for adult populations, despite adult-focused interventions being shown to have limited effectiveness among young people. Besides, some interventions like short message services are expensive and difficult to sustain, while others lack a clear mechanism of change for replication.

Mindfulness and acceptance based interventions, specifically ACT-DNA-v, are developmentally appropriate for adolescents because they are designed to promote emotion regulation and values consistent living, counteracting the imbalance created by developmental changes amidst undeveloped executive functions such as judgment. Besides, ACT-DNA-v relies on use of art and metaphors which serve as aids to symbolic reasoning (a change instigated by adolescence). The intervention is also centered around values and adolescence is a stage of establishing identity. Finally, ACT-DNA-V has a proper mechanism of change called psychological flexibility, thus, it can easily be replicated. However, while mindfulness and acceptance based interventions have been found to be effective in improving mental health of adolescents in the developed world, they have not been tested in resource limited settings, with adolescents living with HIV and for outcomes beyond mental health. Thus, this study set out to adapt ACT-DNA-v for use in a resource limited setting, explore its acceptability among users (ALWHAs) and providers (HCPs), measure its feasibility when used with adolescents and evaluate its impact on reducing psychosocial barriers to adherence, improve self-reported adherence and reducing viral load.

Study Objectives The study aims to achieve the following objectives;

.To adapt and explore acceptability of ACT-DNA-v among users (ALWHA) and providers (HCPs).

.To measure feasibility of the adapted ACT-DNA-v for use with ALWHA.

.To examine the impact of ACT-DNA-v on reducing proximal psychosocial barriers to medication adherence (depression, anxiety and stigma) among ALWHA.

.To measure effectiveness of a mindfulness based intervention (ACT-DNA-v) on self-reported adherence among ALWHA in Kampala, and ascertain its impact on viral load reduction via analysis of data from medical records

Hypothesis .Participants receiving the ACT-DNA-v intervention will report a significant reduction in depression, anxiety & stigma at four months' follow-up as compared to participants in the control group.

.Participants receiving the ACT-DNA-v intervention will have significantly higher levels of reported ART adherence and lowered viral load at four months' follow-up compared to participants not receiving this intervention.

Methods Overall design To achieve the study goals, a mixed methods design will be used, specifically exploratory sequential. The mixing is intended for purposes of expansion (where qualitative data will explore acceptability of the mindfulness based intervention and quantitative data measures if the accepted intervention is effective). This will improve the usefulness of the findings, (qualitative data evaluating the process while quantitative data evaluate the outcomes). The study will involve two sub-studies; formative/qualitative study and intervention/quantitative study.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Uganda
    • Central Region
      • Kampala, Central Region, Uganda, +256
        • Kisenyi Health Center IV
    • Non-US/Non-Canadian
      • Kampala, Non-US/Non-Canadian, Uganda, +256
        • Kitebi health center iii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant should be 15-19 years of age.
  • Diagnosed HIV positive.
  • Attending care at the two study sites (Kisenyi and Kitebi) for the last 6 months.
  • On first or second line of treatment.
  • Can speak/understand Luganda or English.
  • Willing to provide informed consent/assent.
  • All records will be confirmed via clinic medical charts.

Exclusion Criteria:

  • A participant plan to move out of the catchment area within six months.
  • Participant is participating in another study related to HIV and care improvement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
This group will continue receiving the usual clinic based care (counselling) only.
Behavioral: Standard of care
Usual clinic based counselling offered as routine care to adolescents
Experimental: Group receiving the mindfulness and acceptance intervention
This group will under go four sessions of the mindfulness and acceptance based therapy. These sessions will be delivered in four weeks, utilizing 2 hours every week. This will be in addition to the standard of care (clinic based counselling).
Behavioral: Standard of care
Usual clinic based counselling offered as routine care to adolescents
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.
Other Names:
  • Acceptance and commitment therapy
  • Discoverer, Noticer, Advisor-Values

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in levels of Depression; measured by Beck's Depression Inventory-ii
Time Frame: pre-intervention and at four weeks post intervention assessment
The outcome measure will be; number of participants in a given study group reporting change from baseline depression levels at post intervention and after three months follow-up. The change will be assessed by Beck's depression inventory-ii. According to the BDI-ii, scores in the range of 0-13 represent minimal depression, 14-19 mild depression, 20-28 moderate, while 29-63 severe depression.
pre-intervention and at four weeks post intervention assessment
Change in Health related anxiety; measured by the short health anxiety inventory
Time Frame: At pre-intervention and at four weeks post intervention assessment
The outcome measure will be number of participants in a given study arm reporting change from baseline health anxiety at post intervention and at three months follow-up. According to the SHAI, 40.5 is the cut-off score separating clinical and non-clinical health related anxiety.
At pre-intervention and at four weeks post intervention assessment
Change in AIDS related Internalized stigma; measured by Internalized AIDS related stigma scale (IARSS-6)
Time Frame: At pre-intervention and at four weeks post intervention assessment
After dichotomizing the IARSS-6 at median value (0-2 & 3-6), two categories will be created. Category 1 is in the 0-2 range (representing low-moderate stigma) while category 2 is the 3-6 range (representing higher experience of stigma). The measure will then be; the number of participants in a given study arm reporting change from baseline AIDS related stigma at post intervention and at three months follow-up as assessed by the internalized AIDS related stigma scale.
At pre-intervention and at four weeks post intervention assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported medication adherence; measured by the Morisky Medication Adherence scale-MMAS-8.
Time Frame: At three months
The 3 categorical Likert Scale is low adherence = <6, medium adherence = 6-<8 and high adherence is = 8.
At three months
Viral load
Time Frame: At three months
This measure will be based on clinic records. Viral load measures (copies/milliliter of blood) for each participant in both groups will be recorded at baseline and at follow-up. A comparison will be made to detect if there is a difference at time points and across groups.
At three months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological flexibility; measured by the Avoidance and Fusion Questionnaire for youths (AFQ-Y8).
Time Frame: At three months
This is a process measure and mechanism of change. AFQ-Y8 measures cognitive fusion and experiential avoidance as impediments to attaining Psychological Flexibility. Scores of the AFQ-Y8 range from 0-24, with higher scores indicating higher levels of psychological inflexibility. The outcome measure for Psychological flexibility will be the number of participants in a given study arm reporting change from baseline psychological inflexibility at post intervention and at three months follow-up as assessed by the AFQ-Y8.
At three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infectious Diseases Research Collaboration, Uganda

Collaborators

National Institutes of Health (NIH)
Fogarty International Center of the National Institute of Health
Makerere University

Investigators

  • Study Chair: Moses R Kamya, IDRC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D43TW011304 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be accessed through a public repository or upon reasonable request from the corresponding author

IPD Sharing Time Frame

Data will become available effective 1st June 2023. It will remain available for one year

IPD Sharing Access Criteria

through clinicaltrials.gov

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Medication Adherence

Clinical Trials on Standard of care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe