HIV/AIDS Clinical Trial
— ACES PilotOfficial title:
Development and Pilot of Positive Self-Reappraisal Emotion Regulation Intervention to Improve Self-Care Among HIV+ Substance Users
Verified date | June 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 31, 2016 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - Endorsement of active suicidality or psychosis on initial clinical interview. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of California, San Francisco |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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). | |
Primary | 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. | 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 | 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. | Collected at baseline and approximately 21 months post-baseline at final research visit. | |
Secondary | Change in substance use | The ASSIST measures substance use. | Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline. | |
Secondary | 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. | ssessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline. | |
Secondary | Change in HIV and Abuse Related Shame (HARSI) | The HARSI is a self report measure that assesses HIV and abuse related shame | Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline. | |
Secondary | Change in depression (CES-D) | The CES-D will be used to assess self-reported depressive symptoms | Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline. | |
Secondary | Change in Self-Compassion (Self-Compassion Scale) | The Self-Compassion Scale will be used to assess self-reported self compassion | Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline. | |
Secondary | Change in mindfulness (Five Facet Mindfulness Questionnaire) | The Five Facet Mindfulness Questionnaire will be use to assess self-reported mindfulness | Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline. |
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