HIV Infections, Substance Abuse
Conditions
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.
Interventions
BEHAVIORALDecision aid
Participants in the experimental arm will receive the PrEP decision aid.
BEHAVIORALStandard care
Standard harm reduction information
Sponsors
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
A controlled un-blinded pilot study.
Intervention model description
A controlled un-blinded pilot study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Uptake | 12 months | PrEP uptake is measured by attending an appointment with a provider for the purposes of starting PrEP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Adherence by Self Report | 12 months | Adherence to PrEP is measured by pill count |
| PrEP Adherence by Pharmacy Refill | 12 months | Adherence to PrEP is measured by pharmacy refill data |
| Changes in PrEP receptiveness | 12 months | Receptiveness to PrEP (pre- and post- decision aid) is measured on a receptiveness scale (Likert 1-5) |
| Changes in HIV risk behaviors | 12 months | Changes in HIV risk is measured by a modified risk assessment form from NIDA |
Countries
United States
Outcome results
None listed