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HIV Prevention Peer Navigation for Justice Involved Women (kINSHIP)

Primary Purpose

HIV Infections, Stigma, Social

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of care engagement practices
Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-Justice Involved Women
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Justice-involved population, Women's health, HIV prevention, Substance use, Intersectional stigma, Navigator

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Women in San Francisco Adult Probation, ages 18-49 will be eligible if they:

  • self-identify as HIV-negative;
  • endorse risk behaviors in the past 6 months that call for consideration of PrEP per the Centers of Disease Control and Prevention risk indices;
  • are English-Speaking.

Exclusion Criteria:

  • Self-reported HIV infection;
  • already on PrEP;
  • observable cognitive/developmental delays or severe mental illness that would interfere with consent or participation.

Sites / Locations

  • University of California San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active-kINSHIP navigation intervention

Control-Standard Care

Arm Description

kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.

The control arm will be standard-of-care, which is as-needed case management for justice-involved women.

Outcomes

Primary Outcome Measures

Linkage to PrEP services
The primary outcome of PrEP linkage will be attendance at a PrEP services appointment, verified by medical records.

Secondary Outcome Measures

Accepted PrEP referral
Reported by the kINSHIP navigator.
Time to PrEP linkage
Reported by the kINSHIP navigator and via medical record.
Accepted PrEP prescription
Self-report and pharmacy collateral (if participant agrees).
PrEP initiation
Self-report.
PrEP adherence
Self-report.
PrEP persistence
Self-report.

Full Information

First Posted
December 17, 2020
Last Updated
February 1, 2022
Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04680390
Brief Title
HIV Prevention Peer Navigation for Justice Involved Women
Acronym
kINSHIP
Official Title
kINSHIP: Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-justice Involved Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2022 (Anticipated)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Women involved in the criminal justice system have complex and highly stigmatized sexual and substance use risk profiles and are particularly vulnerable to, and experience, high rates of HIV. Criminal justice settings represent an important opportunity to address health disparities in HIV by linking women, who experience multiple, intersecting stigmas with innovative biomedical HIV prevention strategies, like pre-exposure prophylaxis (PrEP). The investigators propose to develop and test a peer-led patient navigation intervention for criminal-justice involved (CJI) women at risk of HIV acquisition to reduce intersectional stigma and improve uptake and linkage to PrEP services, thereby increasing access to PrEP and decreasing PrEP-related disparities.
Detailed Description
Stigma persists as a principal factor shaping HIV risk. Women involved in the criminal justice system have complex and highly stigmatized sexual and substance use risk profiles and are particularly vulnerable to, and experience, high rates of HIV. Pre-exposure prophylaxis, or PrEP, is an efficacious HIV prevention strategy, however, women at high-risk of HIV infection in the United States (US) are largely absent from national efforts to improve PrEP awareness and uptake. Criminal justice settings represent an important opportunity to address disparities in HIV by linking high-risk women, who experience multiple, intersecting stigmas with innovative biomedical HIV prevention strategies, like PrEP. Peer-led patient navigation interventions have demonstrated efficacy in building trust and reducing stigma and discrimination-related barriers to healthcare engagement, and hold strong potential to address multiple, intersecting stigmas and other multifactorial and complex barriers to PrEP acceptability, linkage, and uptake for criminal justice-involved women. The investigators propose to develop and test a peer-led patient navigator PrEP linkage intervention for women at risk for HIV acquisition who are on probation in San Francisco. Intervention development and study design will be guided by our team's pilot research, the Stigma and HIV Disparities Framework, and the PrEP Continuum of Care model. Study aims are to:1) Determine the content and structure of a peer-led PrEP screening and linkage navigation intervention (Project kINSHIP) for high-risk criminal justice-involved (CJI)-women; 2) Refine and test the content and structure of the kINSHIP intervention for CJI-women; and 3) Assess the feasibility, acceptability, and preliminary impact of the kINSHIP intervention on internalized stigma and the PrEP continuum of care in a pilot randomized trial. Formative qualitative work with key stakeholders, including women on probation, probation staff, and medical/public health staff in Aim1 will guide intervention development and testing in Aim 2. In Aim 3, the investigators will examine the primary outcome of PrEP service linkage and secondary outcomes such as time to linkage, PrEP prescription/initiation, and PrEP adherence/persistence. The investigators will explore how intersectional stigma may moderate intervention effects on linkage to PrEP. The proposed study has the potential to: 1) reduce the impact of intersectional stigma as a barrier to service care engagement, 2) inform PrEP care continuum estimates for criminal justice-involved women as well as identify barriers, and 3) create an intervention suitable for large-scale efficacy testing and translation to other criminal justice settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Stigma, Social
Keywords
Justice-involved population, Women's health, HIV prevention, Substance use, Intersectional stigma, Navigator

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active-kINSHIP navigation intervention
Arm Type
Experimental
Arm Description
kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
Arm Title
Control-Standard Care
Arm Type
Active Comparator
Arm Description
The control arm will be standard-of-care, which is as-needed case management for justice-involved women.
Intervention Type
Behavioral
Intervention Name(s)
Standard of care engagement practices
Intervention Description
The control arm will be standard-of-care, which is as-needed case management for justice-involved women. The goals of case management services are to reduce recidivism, mitigate behavioral challenges, strengthen public safety, and build self-sufficiency skills. Case managers refer clients to appropriate services in the community (e.g., housing, food).
Intervention Type
Behavioral
Intervention Name(s)
Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-Justice Involved Women
Intervention Description
kINSHIP is a peer-led navigator intervention to address intersectional stigma and improve PrEP treatment initiation and engagement for justice-involved women. The key components of the kINSHIP intervention are to: 1) increase social support; 2) increase self-efficacy in accessing PrEP services; 3) enhance access to healthcare services; 4) improve adaptive coping skills to manage experiences of intersectional stigma.
Primary Outcome Measure Information:
Title
Linkage to PrEP services
Description
The primary outcome of PrEP linkage will be attendance at a PrEP services appointment, verified by medical records.
Time Frame
4 months post enrollment
Secondary Outcome Measure Information:
Title
Accepted PrEP referral
Description
Reported by the kINSHIP navigator.
Time Frame
4 months post enrollment
Title
Time to PrEP linkage
Description
Reported by the kINSHIP navigator and via medical record.
Time Frame
4 months post enrollment
Title
Accepted PrEP prescription
Description
Self-report and pharmacy collateral (if participant agrees).
Time Frame
4 months post enrollment
Title
PrEP initiation
Description
Self-report.
Time Frame
4 months post enrollment
Title
PrEP adherence
Description
Self-report.
Time Frame
4 months post enrollment
Title
PrEP persistence
Description
Self-report.
Time Frame
4 months post enrollment

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women in San Francisco Adult Probation, ages 18-49 will be eligible if they: self-identify as HIV-negative; endorse risk behaviors in the past 6 months that call for consideration of PrEP per the Centers of Disease Control and Prevention risk indices; are English-Speaking. Exclusion Criteria: Self-reported HIV infection; already on PrEP; observable cognitive/developmental delays or severe mental illness that would interfere with consent or participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Dauria, PhD, MPH
Phone
(628) 206-8306
Email
efd16@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Priyanka Kulkarni
Email
priyanka.kulkarni2@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Dauria, PhD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priyanka Kulkarni
Email
priyanka.kulkarni2@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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HIV Prevention Peer Navigation for Justice Involved Women

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