Back to resultsOPTIONS: A Patient-Centered HIV Prevention Decision Aid for PrEP Uptake for Women With Substance Use in Treatment Settings
Primary Purpose
HIV Infections, Substance Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision aid
Standard care
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections
Eligibility Criteria
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
Sites / Locations
- Yale AIDS Program
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Care
Decision aid
Arm Description
Participants will receive standard information about harm reduction as available at the drug treatment centers.
Participants in this arm will receive the adapted decision aid for PrEP.
Outcomes
Primary Outcome Measures
PrEP Uptake
PrEP uptake is measured by attending an appointment with a provider for the purposes of starting PrEP.
Secondary Outcome Measures
PrEP Adherence by Self Report
Adherence to PrEP is measured by pill count
PrEP Adherence by Pharmacy Refill
Adherence to PrEP is measured by pharmacy refill data
Changes in PrEP receptiveness
Receptiveness to PrEP (pre- and post- decision aid) is measured on a receptiveness scale (Likert 1-5)
Changes in HIV risk behaviors
Changes in HIV risk is measured by a modified risk assessment form from NIDA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03651453
Brief Title
OPTIONS: A Patient-Centered HIV Prevention Decision Aid for PrEP Uptake for Women With Substance Use in Treatment Settings
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
June 11, 2020 (Actual)
Study Completion Date
June 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Substance Abuse
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A controlled un-blinded pilot study.
Masking
None (Open Label)
Masking Description
A controlled un-blinded pilot study.
Allocation
Non-Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Participants will receive standard information about harm reduction as available at the drug treatment centers.
Arm Title
Decision aid
Arm Type
Experimental
Arm Description
Participants in this arm will receive the adapted decision aid for PrEP.
Intervention Type
Behavioral
Intervention Name(s)
Decision aid
Other Intervention Name(s)
PrEP decision aid
Intervention Description
Participants in the experimental arm will receive the PrEP decision aid.
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Other Intervention Name(s)
treatment as usual
Intervention Description
Standard harm reduction information
Primary Outcome Measure Information:
Title
PrEP Uptake
Description
PrEP uptake is measured by attending an appointment with a provider for the purposes of starting PrEP.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
PrEP Adherence by Self Report
Description
Adherence to PrEP is measured by pill count
Time Frame
12 months
Title
PrEP Adherence by Pharmacy Refill
Description
Adherence to PrEP is measured by pharmacy refill data
Time Frame
12 months
Title
Changes in PrEP receptiveness
Description
Receptiveness to PrEP (pre- and post- decision aid) is measured on a receptiveness scale (Likert 1-5)
Time Frame
12 months
Title
Changes in HIV risk behaviors
Description
Changes in HIV risk is measured by a modified risk assessment form from NIDA
Time Frame
12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
cis- or trans- female eligible
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaimie P Meyer, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale AIDS Program
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Learn more about this trial
OPTIONS: A Patient-Centered HIV Prevention Decision Aid for PrEP Uptake for Women With Substance Use in Treatment Settings
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