Linking Women to PrEP Care

Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03281343
• Other study ID #: R34DA045621
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 29, 2017
• Est. completion date: August 31, 2023

Study information

• Verified date: April 2023
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: August 31, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prevention

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of linkage to community-based PrEP care	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.	3 Months post-release
Secondary	PrEP Adherence	PrEP adherence will be determined by drug concentrations in urine samples collected from participants who have been prescribed PrEP at 3 and 6 months. Presence of PrEP will be assessed with immunoassay developed by UrSure Inc.	3 Months and 6 Months post-release
Secondary	PrEP Care Retention	PrEP retention in care will be defined as attending 3-month clinical appointments (+/- 1 month) which is in accordance with current CDC guidelines. This will be verified with medical records.	3 Month clinical appointments (+/- 1 month)
Secondary	Alcohol and Drug Use	The Timeline Followback (TLFB) will be used to assess alcohol and drug use behavior at baseline, as well as during the follow-up interviews.	6-months
Secondary	HIV Risk Behavior	The TLFB will be used to assess drug and sex risk behavior at baseline and during the follow-up interviews. In addition, the HIV Risk Assessment Battery will serve as a measure of overall sex and drug risk behavior.	6-months
Secondary	Depressive Symptoms	The Center for Epidemiologic Studies Depression Scale (CES-D) will be administered at baseline and follow-up interviews to assess depressive symptoms	6-months
Secondary	Treatment Received and Medications/Pregnancies	The Treatment Services Review (TSR) and Use of Medications Questionnaire will be used to measure the number and types of treatment services utilized, medications prescribed, and pregnancies experienced during the follow-up period.	6-months