Linking Women to PrEP Care

Not Applicable

Active, not recruiting

• Conditions: Prevention
• Interventions: Behavioral: Standard of Care (SOC); Behavioral: Motivational Interviewing & Patient Navigator

• Registration Number: NCT03281343
• Lead Sponsor: Rhode Island Hospital

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.

Study Timeline

• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-13
• Study Start: 2017-11-29
• Primary Completion: 2022-10-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-05
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care (SOC)	Standard of Care (SOC)	Approximates care currently provided at the prison.
MI-NAV	Motivational Interviewing & Patient Navigator	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.

Primary Outcome Measures

Name	Time	Method
Rates of linkage to community-based PrEP care	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 Outcome Measures

Name	Time	Method
PrEP Adherence	3 Months and 6 Months post-release	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.
Alcohol and Drug Use	6-months	The Timeline Followback (TLFB) will be used to assess alcohol and drug use behavior at baseline, as well as during the follow-up interviews.
PrEP Care Retention	3 Month clinical appointments (+/- 1 month)	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.
Depressive Symptoms	6-months	The Center for Epidemiologic Studies Depression Scale (CES-D) will be administered at baseline and follow-up interviews to assess depressive symptoms
HIV Risk Behavior	6-months	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.
Treatment Received and Medications/Pregnancies	6-months	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.

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States