HIV/AIDSACES PilotNCT02535455
Acceptance and Compassion to Enhance Self-care Pilot
A study testing ACES Pilot in people with HIV/AIDS and Substance Use Disorder, run by University of California, San Francisco.
Trial summary
Innovative approaches are needed to optimize the benefits of treatment as prevention (TasP) among HIV+ substance users, who experience profound health disparities that amplify onward transmission risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Substance Use Disorder
- What is being tested?
- ACES Pilot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2015to 31 Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- HIV+
- ≥18 years old
- Able to complete informed consent
- Endorse polysubstance use in the past 2 months, excluding cannabis and tobacco
- Participants must own a cell phone with text message capacity and be willing to work with a study staff member to add minutes or money to their cell phone plan to cover the text-message component of the intervention (at no cost to participants).
- Consent to release their medical records, in order to assess engagement in HIV-care (i.e., attended/scheduled appointments).
Who cannot join
- Endorsement of active suicidality or psychosis on initial clinical interview.
About this study
Official title: Development and Pilot of Positive Self-Reappraisal Emotion Regulation Intervention to Improve Self-Care Among HIV+ Substance Users
Innovative approaches are needed to optimize the benefits of treatment as prevention (TasP) among HIV+ substance users, who experience profound health disparities that amplify onward transmission risk. This project will systematically develop, refine and conduct an open pilot to assess the feasibility and acceptability of a two-phase emotion regulation intervention that targets emotional barriers to HIV-related self-care among individuals who endorse active substance use. Emotional barriers such as shame and internalized stigma have been identified as barriers to optimal HIV care among individuals struggling with HIV and substance use. To effectively implement TasP, strategies for addressing these barriers are needed. Utilizing transdiagnostic approaches (e.g., positive affect-focused emotional regulation, mindfulness and self-compassion) investigators will develop, refine and pilot a two-phase emotional regulation intervention that requires only 5 face-to-face hours and can ultimately be implemented by a case-management-level staff person or trained peer educator. The first phase of the intervention will be a multicomponent in-person intervention targeting emotional, cognitive and behavioral barriers to HIV self-care behaviors among HIV+ substance users. The second phase of the intervention will extend the intervention benefits by sending personalized positive self-reappraisal text messages in response to text message queries about participants' mood. This phase will use an innovative personalized bi-directional platform, which will leverage an existing text message delivery system. This project will be instrumental in developing a relatively low-resource intervention strategy to address unmet emotional barriers to optimal HIV-care among individuals who are actively using substances. This work will provide the necessary pilot data for a subsequent grant submission to assess the preliminary efficacy of the intervention. The resulting intervention has the potential to address emotional barriers to self-care along the HIV care cascade: including retention in care, antiretroviral treatment adherence and persistence, and ultimately viral suppression.
Read the detailed description
Investigators will develop and refine a two-phase emotion regulation intervention. This process will involve 5 steps: 1) conducting 5-8 key informant interviews, including obtaining feedback on a drafted manual and materials from providers and case managers, 2) integrating the qualitative data, 3) running 2 participants through a condensed version of the intervention and obtaining feedback on the content, language, and text message interface, 4) integrating the additional feedback, and 5) conducting an open pilot with 10 participants to assess feasibility and acceptability of the revised intervention. The pilot will include 3 research assessment visits which will involve completion of self-report questionnaires using Qualtrics at baseline, within one week of completion of phase 1, and within one week of completing phase 2. Viral load (VL) will be assessed at baseline and at the final follow up.
Qualitative interviews. The investigators will conduct 5-8 semi-structured qualitative interviews with providers and case managers. Interviews will inquire about unmet psychological barriers to HIV-care, perceptions of proposed domains and text message questions and response options. All interviews will be recorded, transcribed and analyzed using thematic analysis. Prominent themes and suggestions brought up in the interviews will be integrated into the intervention materials and implementation.
Trial run of pilot. After integrating the feedback from the key informant interviews, investigators will recruit two participants to complete a condensed version of the intervention. After each of the 5 sessions, participants will be asked to complete perceived usefulness surveys. Both participants will then be interviewed to obtain feedback on the intervention. These interviews will be recorded, transcribed and analyzed using thematic analysis. Prominent themes and suggestions brought up in these interviews as well as logistic challenges will be integrated into the intervention materials and implementation procedures.
Text messages. Investigators will use questions adapted from a previously published personalized bi-directional text message intervention involving HIV+ substance users (TxText) to assess mood, adherence and substance use. Each participant will receive 3 texts/week inquiring about current mood over the course of the intervention. Additionally, in phase 2 each participant will receive weekly texts asking about their medication adherence. Given the stigmatized nature of substance use, investigators will use a coded query, adapted from TxText, which assess substance use in the form of a weather question. This coded query strategy has demonstrated feasibility and acceptability among a similar population of HIV+ active substance users. All participants will be reminded of the meaning of this question during phase 1. During the last in-person intervention visit, participants will identify 5 positive self-reappraisal statements and link them to response options to the mood query based on when they feel each would be most helpful in regulating their emotions. Throughout phase 2, participants will then receive their linked positive-self reappraisal statements in response to mood queries. Participants will then be asked to respond on a 6-point scale indicating how helpful the positive self-reappraisal was (0=extremely unhelpful to 5= extremely helpful), which will be used to assess engagement in phase 2 of the intervention.
- Conditions
- HIV/AIDS, Substance Use Disorder
- Being tested
- ACES Pilot
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACES PilotBehavioural
Also called Acceptance and Compassion to Enhance Self-care
This pilot will consist of 5 individual sessions and an innovative bi-directional text message component that uses participant-written positive self-statements informed by the intervention content (e.g., self-compassion, positive self-reappraisal and nonjudgmental acceptance).
| Study group | Role | What they receive |
|---|---|---|
| ACES Pilot | Experimental | This pilot will consist of 5 individual sessions and an innovative bi-directional text message component that uses participant-written positive self-statements informed by the intervention content (e.g., self-compassion, positive self-reappraisal and nonjudgmental acceptance). Receives: Behavioral: ACES Pilot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline antiretroviral adherence to post intervention follow up visits
Participants will be asked to complete the Visual Analogue Scale (VAS) in person at baseline and subsequent research visits.
Measured: Collected at baseline, research visit after face-to-face intervention component (approximately 5 weeks post-baseline) and research visit after text-message component (approximately 13 months post-baseline).
Change from baseline engagement in HIV-related Care (number of HIV-related health visits scheduled and attended) to follow up visits.
Participants will be asked to report the number of HIV-related health visits scheduled and attended. Additionally, chart reviews will be conducted at the end of the study to determine the number of attended compared to scheduled HIV-related health visits.
Measured: Collected at baseline, research visit after face-to-face intervention component (approximately 5 weeks post-baseline) and research visit after text-message component (approximately 13 months post-baseline).
Secondary outcomes (7)
Change from baseline viral load to final follow up visit.
Participants will have blood drawn for viral load tests at baseline and their final follow up visit. The values will be compared.
Measured: Collected at baseline and approximately 21 months post-baseline at final research visit.
Change in substance use
The ASSIST measures substance use.
Measured: Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
Change in baseline sexual risk behaviors to research visit after face-to-face intervention component (approximately 5 weeks post-baseline) and research visit after text-message component (approximately 11 months post-baseline).
Self-report questions to assess recent sexual risk behaviors.
Measured: ssessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
Change in HIV and Abuse Related Shame (HARSI)
The HARSI is a self report measure that assesses HIV and abuse related shame
Measured: Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
Change in depression (CES-D)
The CES-D will be used to assess self-reported depressive symptoms
Measured: Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
Change in Self-Compassion (Self-Compassion Scale)
The Self-Compassion Scale will be used to assess self-reported self compassion
Measured: Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
Change in mindfulness (Five Facet Mindfulness Questionnaire)
The Five Facet Mindfulness Questionnaire will be use to assess self-reported mindfulness
Measured: Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study start1 Aug 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abigail W Batchelder, PhD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535455
- Sponsor's protocol ID
- A118121
- Acronym
- ACES Pilot
- Status last verified
- Jun 2020
- First submitted
- 20 Aug 2015
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot of Positive Self-Reappraisal Emotion Regulation Intervention to Improve Self-Care Among HIV+ Substance Users
- ClinicalTrials.gov ID
- NCT02535455
- Acronym / sponsor ID
- ACES Pilot / A118121
- Conditions
- HIV/AIDS, Substance Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 28 Aug 2015 (estimated)
- 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.
Innovative approaches are needed to optimize the benefits of treatment as prevention (TasP) among HIV+ substance users, who experience profound health disparities that amplify onward transmission risk. This project will systematically develop, refine and conduct an open pilot to assess the feasibility and acceptability of a two-phase emotion regulation intervention that targets emotional barriers to HIV-related self-care among individuals who endorse active substance use. Emotional barriers such as shame and internalized stigma have been identified as barriers to optimal HIV care among individuals struggling with HIV and substance use. To effectively implement TasP, strategies for addressing these barriers are needed. Utilizing transdiagnostic approaches (e.g., positive affect-focused emotional regulation, mindfulness and self-compassion) investigators will develop, refine and pilot a two-phase emotional regulation intervention that requires only 5 face-to-face hours and can ultimately be implemented by a case-management-level staff person or trained peer educator. The first phase of the intervention will be a multicomponent in-person intervention targeting emotional, cognitive and behavioral barriers to HIV self-care behaviors among HIV+ substance users. The second phase of the intervention will extend the intervention benefits by sending personalized positive self-reappraisal text messages in response to text message queries about participants' mood. This phase will use an innovative personalized bi-directional platform, which will leverage an existing text message delivery system. This project will be instrumental in developing a relatively low-resource intervention strategy to address unmet emotional barriers to optimal HIV-care among individuals who are actively using substances. This work will provide the necessary pilot data for a subsequent grant submission to assess the preliminary efficacy of the intervention. The resulting intervention has the potential to address emotional barriers to self-care along the HIV care cascade: including retention in care, antiretroviral treatment adherence and persistence, and ultimately viral suppression.
Detailed description
Investigators will develop and refine a two-phase emotion regulation intervention. This process will involve 5 steps: 1) conducting 5-8 key informant interviews, including obtaining feedback on a drafted manual and materials from providers and case managers, 2) integrating the qualitative data, 3) running 2 participants through a condensed version of the intervention and obtaining feedback on the content, language, and text message interface, 4) integrating the additional feedback, and 5) conducting an open pilot with 10 participants to assess feasibility and acceptability of the revised intervention. The pilot will include 3 research assessment visits which will involve completion of self-report questionnaires using Qualtrics at baseline, within one week of completion of phase 1, and within one week of completing phase 2. Viral load (VL) will be assessed at baseline and at the final follow up.
Qualitative interviews. The investigators will conduct 5-8 semi-structured qualitative interviews with providers and case managers. Interviews will inquire about unmet psychological barriers to HIV-care, perceptions of proposed domains and text message questions and response options. All interviews will be recorded, transcribed and analyzed using thematic analysis. Prominent themes and suggestions brought up in the interviews will be integrated into the intervention materials and implementation.
Trial run of pilot. After integrating the feedback from the key informant interviews, investigators will recruit two participants to complete a condensed version of the intervention. After each of the 5 sessions, participants will be asked to complete perceived usefulness surveys. Both participants will then be interviewed to obtain feedback on the intervention. These interviews will be recorded, transcribed and analyzed using thematic analysis. Prominent themes and suggestions brought up in these interviews as well as logistic challenges will be integrated into the intervention materials and implementation procedures.
Text messages. Investigators will use questions adapted from a previously published personalized bi-directional text message intervention involving HIV+ substance users (TxText) to assess mood, adherence and substance use. Each participant will receive 3 texts/week inquiring about current mood over the course of the intervention. Additionally, in phase 2 each participant will receive weekly texts asking about their medication adherence. Given the stigmatized nature of substance use, investigators will use a coded query, adapted from TxText, which assess substance use in the form of a weather question. This coded query strategy has demonstrated feasibility and acceptability among a similar population of HIV+ active substance users. All participants will be reminded of the meaning of this question during phase 1. During the last in-person intervention visit, participants will identify 5 positive self-reappraisal statements and link them to response options to the mood query based on when they feel each would be most helpful in regulating their emotions. Throughout phase 2, participants will then receive their linked positive-self reappraisal statements in response to mood queries. Participants will then be asked to respond on a 6-point scale indicating how helpful the positive self-reappraisal was (0=extremely unhelpful to 5= extremely helpful), which will be used to assess engagement in phase 2 of the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACES Pilot | Experimental | Behavioral: ACES PilotThis pilot will consist of 5 individual sessions and an innovative bi-directional text message component that uses participant-written positive self-statements informed by the intervention content (e.g., self-compassion, positive self-reappraisal and nonjudgmental acceptance). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- English-speaking
- HIV+
- ≥18 years old
- Able to complete informed consent
- Endorse polysubstance use in the past 2 months, excluding cannabis and tobacco
Key exclusion criteria (1 listed)
- Endorsement of active suicidality or psychosis on initial clinical interview.
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 |
|---|---|---|
| ACES PilotAlso: Acceptance and Compassion to Enhance Self-careThis pilot will consist of 5 individual sessions and an innovative bi-directional text message component that uses participant-written positive self-statements informed by the intervention content (e.g., self-compassion, positive self-reappraisal and nonjudgmental acceptance). | Behavioural | ACES Pilot |
Primary outcome
Change from baseline antiretroviral adherence to post intervention follow up visits
Time frame: Collected at baseline, research visit after face-to-face intervention component (approximately 5 weeks post-baseline) and research visit after text-message component (approximately 13 months post-baseline).
Participants will be asked to complete the Visual Analogue Scale (VAS) in person at baseline and subsequent research visits.
Change from baseline engagement in HIV-related Care (number of HIV-related health visits scheduled and attended) to follow up visits.
Time frame: Collected at baseline, research visit after face-to-face intervention component (approximately 5 weeks post-baseline) and research visit after text-message component (approximately 13 months post-baseline).
Participants will be asked to report the number of HIV-related health visits scheduled and attended. Additionally, chart reviews will be conducted at the end of the study to determine the number of attended compared to scheduled HIV-related health visits.
7 secondary outcomes
Change from baseline viral load to final follow up visit.
Time frame: Collected at baseline and approximately 21 months post-baseline at final research visit.
Change in substance use
Time frame: Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
Change in baseline sexual risk behaviors to research visit after face-to-face intervention component (approximately 5 weeks post-baseline) and research visit after text-message component (approximately 11 months post-baseline).
Time frame: ssessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
Change in HIV and Abuse Related Shame (HARSI)
Time frame: Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
Change in depression (CES-D)
Time frame: Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
Change in Self-Compassion (Self-Compassion Scale)
Time frame: Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
Change in mindfulness (Five Facet Mindfulness Questionnaire)
Time frame: Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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 19 Jun 2020.
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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.
Abigail W Batchelder, PhD, MPH principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing ACES Pilot in people with HIV/AIDS and Substance Use Disorder, run by University of California, San Francisco.
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 1 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 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 from baseline antiretroviral adherence to post intervention follow up visits (time frame: Collected at baseline, research visit after face-to-face intervention component (approximately 5 weeks post-baseline) and research visit after text-message component (approximately 13 months post-baseline).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2020.