Linking Women to PrEP Care
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|ClinicalTrials.gov Identifier: NCT03281343|
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prevention||Behavioral: Motivational Interviewing & Patient Navigator Behavioral: Standard of Care (SOC)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Linkage to Community-Based HIV Pre-Exposure Prophylaxsis Care Among at Risk Women Upon Release From Incarceration|
|Actual Study Start Date :||November 29, 2017|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||May 2021|
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.
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.
Active Comparator: Standard of Care (SOC)
Approximates care currently provided at the prison.
Behavioral: 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.
- 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.
- PrEP Adherence [ Time Frame: 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.
- PrEP Care Retention [ Time Frame: 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.
- Alcohol and Drug Use [ Time Frame: 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.
- HIV Risk Behavior [ Time Frame: 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.
- Depressive Symptoms [ Time Frame: 6-months ]The Center for Epidemiologic Studies Depression Scale (CES-D) will be administered at baseline and follow-up interviews to assess depressive symptoms
- Treatment Received and Medications/Pregnancies [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281343
|Contact: Susan E Ramsey, Ph.D.||firstname.lastname@example.org|
|United States, Rhode Island|
|Rhode Island Hospital||Recruiting|
|Providence, Rhode Island, United States, 02903|
|Contact: Susan E Ramsey, Ph.D. 401-444-7831 email@example.com|
|Principal Investigator:||Susan E Ramsey, Ph.D.||Rhode Island Hospital|