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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections, Substance Abuse

Intervention / Treatment
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* Behavioral: Decision aid
* Behavioral: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A controlled un-blinded pilot study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care<br>Participants will receive standard information about harm reduction as available at the drug treatment centers. | Behavioral: Standard care<br>* Standard harm reduction information<br>* Other names: treatment as usual;|
| Experimental: Decision aid<br>Participants in this arm will receive the adapted decision aid for PrEP. | Behavioral: Decision aid<br>* Participants in the experimental arm will receive the PrEP decision aid.<br>* Other names: PrEP decision aid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Uptake | PrEP uptake is measured by attending an appointment with a provider for the purposes of starting PrEP. | 12 months | 

Secondary Outcome Measures

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