NCT03281343

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 29, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

April 5, 2023

Status Verified

April 1, 2023

Enrollment Period

4.9 years

First QC Date

September 11, 2017

Last Update Submit

April 3, 2023

Conditions

Prevention

Keywords

PrEPWomenLinkage to Care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • PrEP Adherence

    3 Months and 6 Months post-release

  • PrEP Care Retention

    3 Month clinical appointments (+/- 1 month)

  • Alcohol and Drug Use

    6-months

  • HIV Risk Behavior

    6-months

  • Depressive Symptoms

    6-months

  • +1 more secondary outcomes

Study Arms (2)

MI-NAV

EXPERIMENTAL

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

Standard of Care (SOC)

ACTIVE COMPARATOR

Approximates care currently provided at the prison.

Behavioral: Standard of Care (SOC)

Interventions

Motivational Interviewing & Patient NavigatorBEHAVIORAL

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.

MI-NAV
Standard of Care (SOC)BEHAVIORAL

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.

Standard of Care (SOC)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • 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.

    PMID: 30832717DERIVED

MeSH Terms

Interventions

Motivational InterviewingPatient NavigationStandard of Care

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesPatient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services AdministrationQuality Indicators, Health CareQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Susan E Ramsey, Ph.D.

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

November 29, 2017

Primary Completion

October 31, 2022

Study Completion

August 31, 2023

Last Updated

April 5, 2023

Record last verified: 2023-04

Locations

US(1)