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Clinical Trials/NCT03281343
NCT03281343
Active, Not Recruiting
N/A

Linkage to Community-Based HIV Pre-Exposure Prophylaxsis Care Among at Risk Women Upon Release From Incarceration

Rhode Island Hospital1 site in 1 country80 target enrollmentNovember 29, 2017
ConditionsPrevention

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prevention
Sponsor
Rhode Island Hospital
Enrollment
80
Locations
1
Primary Endpoint
Rates of linkage to community-based PrEP care
Status
Active, Not Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Pre-exposure prophylaxis (PrEP) can be very effective at preventing HIV infection among women at high-risk for HIV but is underused in this population. Periods of incarceration represent an opportunity to identify women at risk and link them to PrEP care as they leave jail or prison. This study aims to improve linkage to community-based PrEP care to reduce HIV acquisition in a high-need, underserved community.

Detailed Description

Incarcerated women engage in high rates of sex- and drug-related behavior that place them at risk for HIV. Pre-exposure prophylaxis (PrEP) is an efficacious means of reducing HIV acquisition. There is a general lack of knowledge regarding PrEP among women at elevated risk, and only a small percentage of at-risk women are currently engaged in PrEP care. The period of incarceration represents an opportunity to identify at-risk women, initiate PrEP during incarceration, and establish linkage to community-based PrEP care upon release from incarceration. Further, post-release is a time period that is particularly risky, and there are numerous barriers that may impede linkage to community-based care in the absence of intervention. 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.

Registry
clinicaltrials.gov
Start Date
November 29, 2017
End Date
August 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Female at birth; at least 18 years of age; not currently pregnant; risk behavior prior to incarceration that meets CDC indications for PrEP; likely to be incarcerated for less than 6 months; able to understand and speak English and to provide written and verbal informed consent

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Rates of linkage to community-based PrEP care

Time Frame: 3 Months post-release

Linkage to community-based care is operationalized as receipt of a prescription for PrEP from a community-based provider within 3 months of release from prison, confirmed through medical record data extraction.

Secondary Outcomes

  • PrEP Adherence(3 Months and 6 Months post-release)
  • Alcohol and Drug Use(6-months)
  • PrEP Care Retention(3 Month clinical appointments (+/- 1 month))
  • Depressive Symptoms(6-months)
  • HIV Risk Behavior(6-months)
  • Treatment Received and Medications/Pregnancies(6-months)

Study Sites (1)

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