Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2017-11-29
2023-08-31
Brief Summary
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Detailed Description
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To date, very little research has been done to improve linkage to PrEP care among US women. The proposed study will examine the acceptability, feasibility, and preliminary efficacy of a psychoeducation and motivational interviewing intervention to promote PrEP initiation during incarceration, followed by a patient navigator intervention to facilitate linkage to community-based PrEP care upon release from incarceration. The long-term goal of this line of research is to disseminate an efficacious PrEP Care linkage intervention for at-risk women post-release from incarceration. The present proposal seeks to develop intervention materials and conduct a small randomized controlled trial (RCT) of the intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MI-NAV
A study therapist will deliver a motivational interviewing session with participants while they are incarcerated and serve as a role of patient navigator post-release.
Motivational Interviewing & Patient Navigator
The specific content, structure, and implementation approach for MI-NAV will be guided by IDIs conducted during Phase 1 and Phase 2. Our initial plan is to deliver MI-NAV in two waves. The first wave will be aimed at promoting uptake of PrEP at the prison, through the use of motivational interviewing. The second wave will be aimed at linking at-risk women to community-based PrEP care upon release from incarceration, by utilizing a patient navigator approach.
Standard of Care (SOC)
Approximates care currently provided at the prison.
Standard of Care (SOC)
SOC will consist of a pamphlet regarding PrEP during incarceration, an offer of PrEP while incarcerated, and referral to community-based PrEP care upon release.
Interventions
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Motivational Interviewing & Patient Navigator
The specific content, structure, and implementation approach for MI-NAV will be guided by IDIs conducted during Phase 1 and Phase 2. Our initial plan is to deliver MI-NAV in two waves. The first wave will be aimed at promoting uptake of PrEP at the prison, through the use of motivational interviewing. The second wave will be aimed at linking at-risk women to community-based PrEP care upon release from incarceration, by utilizing a patient navigator approach.
Standard of Care (SOC)
SOC will consist of a pamphlet regarding PrEP during incarceration, an offer of PrEP while incarcerated, and referral to community-based PrEP care upon release.
Eligibility Criteria
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Inclusion Criteria
18 Years
FEMALE
No
Sponsors
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Rhode Island Hospital
OTHER
Responsible Party
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Principal Investigators
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Susan E Ramsey, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Rhode Island Hospital
Locations
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Rhode Island Hospital
Providence, Rhode Island, United States
Countries
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References
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Ramsey SE, Ames EG, Brinkley-Rubinstein L, Teitelman AM, Clarke J, Kaplan C. Linking women experiencing incarceration to community-based HIV pre-exposure prophylaxis care: protocol of a pilot trial. Addict Sci Clin Pract. 2019 Mar 4;14(1):8. doi: 10.1186/s13722-019-0137-5.
Other Identifiers
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