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Acceptance and Compassion to Enhance Self-care Pilot (ACES Pilot)

17 juni 2020 bijgewerkt door: University of California, San Francisco

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

10

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: ACES Pilot
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).
Gedragsmatig: ACES Pilot
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).
Andere namen:
  • Acceptance and Compassion to Enhance Self-care

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline antiretroviral adherence to post intervention follow up visits
Tijdsspanne: 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.
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.
Tijdsspanne: 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.
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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline viral load to final follow up visit.
Tijdsspanne: Collected at baseline and approximately 21 months post-baseline at final research 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.
Change in substance use
Tijdsspanne: Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
The ASSIST measures substance use.
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).
Tijdsspanne: ssessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 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.
Change in HIV and Abuse Related Shame (HARSI)
Tijdsspanne: Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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.
Change in depression (CES-D)
Tijdsspanne: Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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.
Change in Self-Compassion (Self-Compassion Scale)
Tijdsspanne: Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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.
Change in mindfulness (Five Facet Mindfulness Questionnaire)
Tijdsspanne: Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, San Francisco

Onderzoekers

  • Hoofdonderzoeker: Abigail W Batchelder, PhD, MPH, University of California, San Francisco

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2015

Primaire voltooiing (Werkelijk)

31 december 2016

Studie voltooiing (Werkelijk)

31 december 2016

Studieregistratiedata

Eerst ingediend

20 augustus 2015

Eerst ingediend dat voldeed aan de QC-criteria

27 augustus 2015

Eerst geplaatst (Schatting)

28 augustus 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 juni 2020

Laatste update ingediend die voldeed aan QC-criteria

17 juni 2020

Laatst geverifieerd

1 juni 2020

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • A118121

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Klinische onderzoeken op ACES Pilot

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