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

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ClinicalTrials.gov Identifier: NCT03651453
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Yale University

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
HIV Infections Substance Abuse Behavioral: Decision aid Behavioral: Standard care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : October 15, 2018
Actual Primary Completion Date : June 11, 2020
Actual Study Completion Date : June 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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 Name: 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 Name: PrEP decision aid




Primary Outcome Measures :
  1. PrEP Uptake [ Time Frame: 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 [ Time Frame: 12 months ]
    Adherence to PrEP is measured by pill count

  2. PrEP Adherence by Pharmacy Refill [ Time Frame: 12 months ]
    Adherence to PrEP is measured by pharmacy refill data

  3. Changes in PrEP receptiveness [ Time Frame: 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 [ Time Frame: 12 months ]
    Changes in HIV risk is measured by a modified risk assessment form from NIDA



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   cis- or trans- female eligible
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651453


Locations
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United States, Connecticut
Yale AIDS Program
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Jaimie P Meyer, MD Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03651453    
Other Study ID Numbers: 2000021561
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders