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NCT03651453 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03651453
Other study ID # 2000021561
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date June 11, 2020

Study information
Verified date July 2021
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 164
Est. completion date June 11, 2020
Est. primary completion date June 11, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Decision aid
Participants in the experimental arm will receive the PrEP decision aid.
• Standard care
Standard harm reduction information

Locations
Country Name City State
United States Yale AIDS Program New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary PrEP Uptake PrEP uptake is measured by attending an appointment with a provider for the purposes of starting PrEP. 12 months
Secondary PrEP Adherence by Self Report Adherence to PrEP is measured by pill count 12 months
Secondary PrEP Adherence by Pharmacy Refill Adherence to PrEP is measured by pharmacy refill data 12 months
Secondary Changes in PrEP receptiveness Receptiveness to PrEP (pre- and post- decision aid) is measured on a receptiveness scale (Likert 1-5) 12 months
Secondary Changes in HIV risk behaviors Changes in HIV risk is measured by a modified risk assessment form from NIDA 12 months
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