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HIV Prevention Peer Navigation for Justice Involved Women (kINSHIP)

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ClinicalTrials.gov Identifier: NCT04680390
Recruitment Status : Not yet recruiting
First Posted : December 23, 2020
Last Update Posted : January 13, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
HIV Infections Stigma, Social Behavioral: Standard of care engagement practices Behavioral: Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-Justice Involved Women Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: kINSHIP: Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-justice Involved Women
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Active-kINSHIP navigation intervention
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.
Behavioral: Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-Justice Involved Women
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.

Active Comparator: Control-Standard Care
The control arm will be standard-of-care, which is as-needed case management for justice-involved women.
Behavioral: Standard of care engagement practices
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).




Primary Outcome Measures :
  1. Linkage to PrEP services [ Time Frame: 4 months post enrollment ]
    The primary outcome of PrEP linkage will be attendance at a PrEP services appointment, verified by medical records.


Secondary Outcome Measures :
  1. Accepted PrEP referral [ Time Frame: 4 months post enrollment ]
    Reported by the kINSHIP navigator.

  2. Time to PrEP linkage [ Time Frame: 4 months post enrollment ]
    Reported by the kINSHIP navigator and via medical record.

  3. Accepted PrEP prescription [ Time Frame: 4 months post enrollment ]
    Self-report and pharmacy collateral (if participant agrees).

  4. PrEP initiation [ Time Frame: 4 months post enrollment ]
    Self-report.

  5. PrEP adherence [ Time Frame: 4 months post enrollment ]
    Self-report.

  6. PrEP persistence [ Time Frame: 4 months post enrollment ]
    Self-report.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04680390


Contacts
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Contact: Emily Dauria, PhD, MPH (628) 206-8306 emily.dauria@ucsf.edu
Contact: Cristina M Brentley cristina.brentley@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Emily Dauria, PhD, MPH University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04680390    
Other Study ID Numbers: 20-30358
R34DA050480 ( U.S. NIH Grant/Contract )
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Justice-involved population
Women's health
HIV prevention
Substance use
Intersectional stigma
Navigator
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases