Clinical trial NCT03281343: Linking Women to PrEP Care
Official title: Linkage to Community-Based HIV Pre-Exposure Prophylaxsis Care Among at Risk Women Upon Release From Incarceration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prevention
Keywords: PrEP
Women
Linkage to Care
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rates of linkage to community-based PrEP care
timeFrame: 3 Months post-release
Secondary outcomes:
measure: PrEP Adherence
timeFrame: 3 Months and 6 Months post-release
measure: PrEP Care Retention
timeFrame: 3 Month clinical appointments (+/- 1 month)
measure: Alcohol and Drug Use
timeFrame: 6-months
measure: HIV Risk Behavior
timeFrame: 6-months
measure: Depressive Symptoms
timeFrame: 6-months
measure: Treatment Received and Medications/Pregnancies
timeFrame: 6-months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Susan E Ramsey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.