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OPTIONS: A Patient-Centered HIV Prevention Decision Aid for PrEP Uptake for Women With Substance Use in Treatment Settings

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT03651453
Collaborator
(none)
164
Enrollment
1
Location
2
Arms
19.9
Actual Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To develop and test the effect of a patient-centered HIV prevention decision aid on HIV pre-exposure prophylaxis (PrEP) uptake among women with substance use disorders (SUD) in treatment.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Decision aid
  • Behavioral: Standard care
 N/A

Detailed Description

To test the effect of the informed decision aid intervention on PrEP uptake among women with substance use disorders in treatment. Investigators hypothesize that compared to those receiving standard harm reduction information, women receiving the decision aid will have a significant increase in PrEP uptake at 6 and 12 months post-intervention.

Study Design

Study Type:
Interventional
Actual Enrollment :
164 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A controlled un-blinded pilot study.A controlled un-blinded pilot study.
Masking:
None (Open Label)
Masking Description:
A controlled un-blinded pilot study.
Primary Purpose:
Prevention
Official Title:
Developing and Testing the Effect of a Patient-Centered HIV Prevention Decision Aid on PrEP Uptake for Women With Substance Use in Treatment Settings
Actual Study Start Date :
Oct 15, 2018
Actual Primary Completion Date :
Jun 11, 2020
Actual Study Completion Date :
Jun 11, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard Care

Participants will receive standard information about harm reduction as available at the drug treatment centers.

Behavioral: Standard care
Standard harm reduction information
Other Names:
  • treatment as usual

    		•
    Experimental: Decision aid

    Participants in this arm will receive the adapted decision aid for PrEP.

    Behavioral: Decision aid
    Participants in the experimental arm will receive the PrEP decision aid.
    Other Names:
  • PrEP decision aid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PrEP Uptake [12 months]

      PrEP uptake is measured by attending an appointment with a provider for the purposes of starting PrEP.

    Secondary Outcome Measures

    1. PrEP Adherence by Self Report [12 months]

      Adherence to PrEP is measured by pill count

    2. PrEP Adherence by Pharmacy Refill [12 months]

      Adherence to PrEP is measured by pharmacy refill data

    3. Changes in PrEP receptiveness [12 months]

      Receptiveness to PrEP (pre- and post- decision aid) is measured on a receptiveness scale (Likert 1-5)

    4. Changes in HIV risk behaviors [12 months]

      Changes in HIV risk is measured by a modified risk assessment form from NIDA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Self- identification as female (i.e., cis- or trans- women), age ≥18, HIV negative status (confirmed with APT date from rapid testing procedures), and entering or receiving treatment at our partnering site, the APT Foundation, Inc. (a drug treatment center).
    Exclusion Criteria:
    • Women on PrEP at baseline, unable or unwilling to provide informed consent, threatening to staff, pregnant, or experiencing symptoms of physiological withdrawal that interfere with ability to provide informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale AIDS Program New Haven Connecticut United States 06519

    Sponsors and Collaborators

    • Yale University

    Investigators

    • Principal Investigator: Jaimie P Meyer, MD, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT03651453
    Other Study ID Numbers:
    • 2000021561
    First Posted:
    Aug 29, 2018
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Substance-Related Disorders

    Study Results

    No Results Posted as of Jul 28, 2021