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OpenTrials
Completed

NCT Number: NCT03651453

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance Abuse Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale AIDS Program

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision aid

Behavioral

Participants in the experimental arm will receive the PrEP decision aid.

Other names: PrEP decision aid

Standard Care

Behavioral

Standard harm reduction information

Other names: treatment as usual

Primary outcomes

  1. 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

  1. PrEP Adherence by Self Report

    Time frame: 12 months

    Adherence to PrEP is measured by pill count

  2. PrEP Adherence by Pharmacy Refill

    Time frame: 12 months

    Adherence to PrEP is measured by pharmacy refill data

  3. Changes in PrEP receptiveness

    Time frame: 12 months

    Receptiveness to PrEP (pre- and post- decision aid) is measured on a receptiveness scale (Likert 1-5)

  4. Changes in HIV risk behaviors

    Time frame: 12 months

    Changes in HIV risk is measured by a modified risk assessment form from NIDA

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 29, 2018
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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