Medication AdherenceNCT05010317
Mindfulness and Acceptance Based Therapy for Adolescents Living With HIV
A study testing Mindfulness and acceptance based therapy in people with Medication Adherence and Adjustment Reaction With Anxiety and Depression, run by Infectious Diseases Research Collaboration, Uganda at 2 sites in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Medication Adherence, Adjustment Reaction With Anxiety and Depression, Mental Health Issue
- What is being tested?
- Mindfulness and acceptance based therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesUganda
- Study dates
- 1 Nov 2022to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites
Kisenyi Health center iv
Kampala, Central Region, +256
Kitebi health center iii
Kampala, Non-US/Non-Canadian, +256
About this study
Official title: 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.
Read the 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.
- Conditions
- Medication Adherence, Adjustment Reaction With Anxiety and Depression, Mental Health Issue
- Being tested
- Mindfulness and acceptance based therapy, Standard of care
- Medical subject headings
- Medication Adherence, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and acceptance based therapyBehavioural
Also called Acceptance and commitment therapy, Discoverer, Noticer, Advisor-Values
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.
Standard of careBehavioural
Usual clinic based counselling offered as routine care to adolescents
| Study group | Role | What they receive |
|---|---|---|
| Group receiving the mindfulness and acceptance intervention | Experimental | 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). Receives: Behavioral: Mindfulness and acceptance based therapy; Behavioral: Standard of care |
| Control group | Active comparator | This group will continue receiving the usual clinic based care (counselling) only. Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of Depression; measured by Beck's Depression Inventory-ii
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.
Measured: pre-intervention and at four weeks post intervention assessment
Change in Health related anxiety; measured by the short health anxiety inventory
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.
Measured: 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)
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.
Measured: At pre-intervention and at four weeks post intervention assessment
Secondary outcomes (2)
Self-reported medication adherence; measured by the Morisky Medication Adherence scale-MMAS-8.
The 3 categorical Likert Scale is low adherence = <6, medium adherence = 6-<8 and high adherence is = 8.
Measured: At three months
Viral load
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.
Measured: At three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start1 Nov 2022
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infectious Diseases Research Collaboration, Uganda
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Moses R Kamya, Study chair, IDRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010317
- Sponsor's protocol ID
- D43TW011304
- Other IDs
- D43TW011304
- Status last verified
- May 2023
- First submitted
- 12 Jul 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be accessed through a public repository or upon reasonable request from the corresponding author
Publications
Soomro N, Fitzgerald G, Seeley J, Schatz E, Nachega JB, Negin J. Comparison of Antiretroviral Therapy Adherence Among HIV-Infected Older Adults with Younger Adults in Africa: Systematic Review and Meta-analysis. AIDS Behav. 2019 Feb;23(2):445-458. doi: 10.1007/s10461-018-2196-0.
PubMed 29971732Burckhardt R, Manicavasagar V, Batterham PJ, Hadzi-Pavlovic D, Shand F. Acceptance and commitment therapy universal prevention program for adolescents: a feasibility study. Child Adolesc Psychiatry Ment Health. 2017 May 25;11:27. doi: 10.1186/s13034-017-0164-5. eCollection 2017.
PubMed 28559924Casale M, Carlqvist A, Cluver L. Recent Interventions to Improve Retention in HIV Care and Adherence to Antiretroviral Treatment Among Adolescents and Youth: A Systematic Review. AIDS Patient Care STDS. 2019 Jun;33(6):237-252. doi: 10.1089/apc.2018.0320.
PubMed 31166783Vreeman RC, McCoy BM, Lee S. Mental health challenges among adolescents living with HIV. J Int AIDS Soc. 2017 May 16;20(Suppl 3):21497. doi: 10.7448/IAS.20.4.21497.
PubMed 28530045Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.
PubMed 24402217Kalichman SC, Simbayi LC, Cloete A, Mthembu PP, Mkhonta RN, Ginindza T. Measuring AIDS stigmas in people living with HIV/AIDS: the Internalized AIDS-Related Stigma Scale. AIDS Care. 2009 Jan;21(1):87-93. doi: 10.1080/09540120802032627.
PubMed 19085224Moon SJ, Lee WY, Hwang JS, Hong YP, Morisky DE. Accuracy of a screening tool for medication adherence: A systematic review and meta-analysis of the Morisky Medication Adherence Scale-8. PLoS One. 2017 Nov 2;12(11):e0187139. doi: 10.1371/journal.pone.0187139. eCollection 2017.
PubMed 29095870Greco LA, Lambert W, Baer RA. Psychological inflexibility in childhood and adolescence: development and evaluation of the Avoidance and Fusion Questionnaire for Youth. Psychol Assess. 2008 Jun;20(2):93-102. doi: 10.1037/1040-3590.20.2.93.
PubMed 18557686Abramowitz JS, Deacon BJ, Valentiner DP. The Short Health Anxiety Inventory: Psychometric Properties and Construct Validity in a Non-clinical Sample. Cognit Ther Res. 2007;31(6):871-883. doi: 10.1007/s10608-006-9058-1. Epub 2007 Feb 15.
PubMed 32214558Musanje K, Kasujja R, Camlin CS, Hooper N, Hope-Bell J, Sinclair DL, Kibanja GM, Mpirirwe R, Kalyango JN, Kamya MR. Effectiveness of a mindfulness and acceptance-based intervention for improving the mental health of adolescents with HIV in Uganda: An open-label trial. PLoS One. 2024 May 9;19(5):e0301988. doi: 10.1371/journal.pone.0301988. eCollection 2024.
PubMed 38722926
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability, Feasibility and Effectiveness of a Mindfulness Based Intervention to Promote Adherence to Antiretroviral Therapy Among Adolescents in Kampala.
- ClinicalTrials.gov ID
- NCT05010317
- Acronym / sponsor ID
- D43TW011304
- Conditions
- Medication Adherence, Adjustment Reaction With Anxiety and Depression, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Infectious Diseases Research Collaboration, UgandaUniversity, hospital or other
- Collaborators
- Makerere University, National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group receiving the mindfulness and acceptance intervention | Experimental | Behavioral: Mindfulness and acceptance based therapy, Behavioral: Standard of careThis 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). |
| Control group | Active comparator | Behavioral: Standard of careThis group will continue receiving the usual clinic based care (counselling) only. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness and acceptance based therapyAlso: Acceptance and commitment therapy, Discoverer, Noticer, Advisor-ValuesThis 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. | Behavioural | Group receiving the mindfulness and acceptance intervention |
| Standard of careUsual clinic based counselling offered as routine care to adolescents | Behavioural | Control group, Group receiving the mindfulness and acceptance intervention |
Primary outcome
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.
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.
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.
2 secondary outcomes
Self-reported medication adherence; measured by the Morisky Medication Adherence scale-MMAS-8.
Time frame: At three months
Viral load
Time frame: At three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 29971732Soomro N, Fitzgerald G, Seeley J, Schatz E, Nachega JB, Negin J. Comparison of Antiretroviral Therapy Adherence Among HIV-Infected Older Adults with Younger Adults in Africa: Systematic Review and Meta-analysis. AIDS Behav. 2019 Feb;23(2):445-458. doi: 10.1007/s10461-018-2196-0.
- Background: PubMed 28559924Burckhardt R, Manicavasagar V, Batterham PJ, Hadzi-Pavlovic D, Shand F. Acceptance and commitment therapy universal prevention program for adolescents: a feasibility study. Child Adolesc Psychiatry Ment Health. 2017 May 25;11:27. doi: 10.1186/s13034-017-0164-5. eCollection 2017.
- Background: PubMed 31166783Casale M, Carlqvist A, Cluver L. Recent Interventions to Improve Retention in HIV Care and Adherence to Antiretroviral Treatment Among Adolescents and Youth: A Systematic Review. AIDS Patient Care STDS. 2019 Jun;33(6):237-252. doi: 10.1089/apc.2018.0320.
- Background: PubMed 28530045Vreeman RC, McCoy BM, Lee S. Mental health challenges among adolescents living with HIV. J Int AIDS Soc. 2017 May 16;20(Suppl 3):21497. doi: 10.7448/IAS.20.4.21497.
- Background: PubMed 24402217Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.
- Background: PubMed 19085224Kalichman SC, Simbayi LC, Cloete A, Mthembu PP, Mkhonta RN, Ginindza T. Measuring AIDS stigmas in people living with HIV/AIDS: the Internalized AIDS-Related Stigma Scale. AIDS Care. 2009 Jan;21(1):87-93. doi: 10.1080/09540120802032627.
- Background: PubMed 29095870Moon SJ, Lee WY, Hwang JS, Hong YP, Morisky DE. Accuracy of a screening tool for medication adherence: A systematic review and meta-analysis of the Morisky Medication Adherence Scale-8. PLoS One. 2017 Nov 2;12(11):e0187139. doi: 10.1371/journal.pone.0187139. eCollection 2017.
- Background: PubMed 18557686Greco LA, Lambert W, Baer RA. Psychological inflexibility in childhood and adolescence: development and evaluation of the Avoidance and Fusion Questionnaire for Youth. Psychol Assess. 2008 Jun;20(2):93-102. doi: 10.1037/1040-3590.20.2.93.
- Background: PubMed 32214558Abramowitz JS, Deacon BJ, Valentiner DP. The Short Health Anxiety Inventory: Psychometric Properties and Construct Validity in a Non-clinical Sample. Cognit Ther Res. 2007;31(6):871-883. doi: 10.1007/s10608-006-9058-1. Epub 2007 Feb 15.
- Derived from this study: PubMed 38722926Musanje K, Kasujja R, Camlin CS, Hooper N, Hope-Bell J, Sinclair DL, Kibanja GM, Mpirirwe R, Kalyango JN, Kamya MR. Effectiveness of a mindfulness and acceptance-based intervention for improving the mental health of adolescents with HIV in Uganda: An open-label trial. PLoS One. 2024 May 9;19(5):e0301988. doi: 10.1371/journal.pone.0301988. eCollection 2024.
- UPHIA Uganda factsheetLink provided by the sponsor.
- UNAIDS report on the global AIDS epidemic 2020Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be accessed through a public repository or upon reasonable request from the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moses R Kamya study chair
IDRC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and acceptance based therapy in people with Medication Adherence and Adjustment Reaction With Anxiety and Depression, run by Infectious Diseases Research Collaboration, Uganda at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of Depression; measured by Beck's Depression Inventory-ii (time frame: pre-intervention and at four weeks post intervention assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05010317, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.