HIV Prevention Peer Navigation for Justice Involved Women

NCT04680390 | Completed Results

• 2 other identifiers: 20-30358R34DA050480
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Stigma, Social

Keywords

Justice-involved population; Women's health; HIV prevention; Substance use; Intersectional stigma; Navigator

Outcome Measures

Primary Outcomes (1)

• Linkage to PrEP Services

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

  4 months post enrollment

Secondary Outcomes (6)

• Accepted PrEP Referral

  4 months post enrollment

• Time to PrEP Linkage

  4 months post enrollment

• Accepted PrEP Prescription

  4 months post enrollment

• PrEP Initiation

  4 months post enrollment

• PrEP Adherence

  4 months post enrollment

Study Arms (2)

Active-kINSHIP navigation intervention

EXPERIMENTAL

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

Control-Standard Care

ACTIVE COMPARATOR

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

Behavioral: Standard of care engagement practices

Interventions

Standard of care engagement practices BEHAVIORAL

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).

Control-Standard Care

Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-Justice Involved Women BEHAVIORAL

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-kINSHIP navigation intervention

Eligibility Criteria

• Age: 18 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

HIV Infections; Social Stigma; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Social Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

This study experienced delays due to COVID-19, which limited recruitment involving criminal legal system partners. Implementation challenges included turnover in the project coordinator role (three individuals within one year). Adaptations led to collaboration with the San Francisco County Jail, which improved enrollment but required unanticipated ethical and administrative processes. Jail-based recruitment was inconsistent due to frequent facility lockdowns limiting research access.

Results Point of Contact

• Title: Emily Dauria
• Organization: University of Pittsburg

efd16@pitt.edu

412-383-0732

Study Officials

• Emily Dauria, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 23, 2020
• Study Start: September 7, 2022
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: August 3, 2026
• Results First Posted: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)