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Clinical Trials/NCT03651453
NCT03651453
Completed
Not Applicable

Developing and Testing the Effect of a Patient-Centered HIV Prevention Decision Aid on PrEP Uptake for Women With Substance Use in Treatment Settings

Yale University1 site in 1 country164 target enrollmentOctober 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Yale University
Enrollment
164
Locations
1
Primary Endpoint
PrEP Uptake
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2018
End Date
June 11, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

PrEP Uptake

Time Frame: 12 months

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

Secondary Outcomes

  • Changes in PrEP receptiveness(12 months)
  • PrEP Adherence by Self Report(12 months)
  • Changes in HIV risk behaviors(12 months)
  • PrEP Adherence by Pharmacy Refill(12 months)

Study Sites (1)

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