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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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Yale University

Status

Completed

Conditions

Substance Abuse
HIV Infections

Treatments

Behavioral: Standard care
Behavioral: Decision aid

Study type

Interventional

Funder types

Other

Identifiers

NCT03651453
2000021561

Details and patient eligibility

About

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.

Full 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.

Enrollment

164 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

164 participants in 2 patient groups

Standard Care
Active Comparator group
Description:
Participants will receive standard information about harm reduction as available at the drug treatment centers.
Treatment:
Behavioral: Standard care
Decision aid
Experimental group
Description:
Participants in this arm will receive the adapted decision aid for PrEP.
Treatment:
Behavioral: Decision aid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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