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

Not Applicable

Completed

• Conditions: Substance Abuse; HIV Infections
• Interventions: Behavioral: Standard care; Behavioral: Decision aid

• Registration Number: NCT03651453
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-29
• Study Start: 2018-10-15
• Primary Completion: 2020-06-11
• Study Completion: 2020-06-11
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 164

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).

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard care	Participants will receive standard information about harm reduction as available at the drug treatment centers.
Decision aid	Decision aid	Participants in this arm will receive the adapted decision aid for PrEP.

Primary Outcome Measures

Name	Time	Method
PrEP Uptake	12 months	PrEP uptake is measured by attending an appointment with a provider for the purposes of starting PrEP.

Secondary Outcome Measures

Name	Time	Method
Changes in PrEP receptiveness	12 months	Receptiveness to PrEP (pre- and post- decision aid) is measured on a receptiveness scale (Likert 1-5)
PrEP Adherence by Self Report	12 months	Adherence to PrEP is measured by pill count
Changes in HIV risk behaviors	12 months	Changes in HIV risk is measured by a modified risk assessment form from NIDA
PrEP Adherence by Pharmacy Refill	12 months	Adherence to PrEP is measured by pharmacy refill data

Trial Locations

Locations (1)

Yale AIDS Program; 🇺🇸 New Haven, Connecticut, United States