Mindfulness and Acceptance Based Therapy for Adolescents Living With HIV
Condition: Medication Adherence; Adjustment Reaction With Anxiety and Depression; Mental Health Issue
MeSH terms: Depression
Study type: Interventional

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.
    

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.
    

Intervention name(s): Mindfulness and acceptance based therapy; Standard of care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Usual clinic based counselling offered as routine care to adolescents
Other intervention name(s): Acceptance and commitment therapy; Discoverer, Noticer, Advisor-Values
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One group of adolescents (treatment group), will be exposed to a mindfulness and acceptance based psychotherapy on top of usual clinic care services, while the other group will keep receiving usual clinic care. Then comparison will be made at post intervention on experiences of depression, stigma, anxiety, psychological flexibility and then self-reported medical adherence at post intervention between the two groups, adjusting for baseline measures.
Masking: None (Open Label)
Primary purpose: Supportive Care