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HIV Prevention Peer Navigation for Justice Involved Women

kINSHIP: Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-justice Involved Women

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04680390
Acronym
kINSHIP
Enrollment
30
Registered
2020-12-23
Start date
2022-09-07
Completion date
2024-11-06
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Stigma, Social

Keywords

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

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.

Interventions

BEHAVIORALStandard 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).

BEHAVIORALPeer 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.

Sponsors

University of California, San Francisco
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Linkage to PrEP Services4 months post enrollmentThe primary outcome of PrEP linkage will be attendance at a PrEP services appointment, verified by medical records.

Secondary

MeasureTime frameDescription
Accepted PrEP Referral4 months post enrollmentSelf-report
Time to PrEP Linkage4 months post enrollmentReported by via medical record.
Accepted PrEP Prescription4 months post enrollmentSelf-report.
PrEP Initiation4 months post enrollmentSelf-report.
PrEP Adherence4 months post enrollmentSelf-report.
PrEP Persistence4 months post enrollmentSelf-report.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREmily Dauria, PhD, MPH

University of California, San Francisco

Participant flow

Recruitment details

Women were recruited from San Francisco Adult Probation, County Jail Health Services, and community-based organizations serving criminal legal system-involved women. Staff shared study information and flyers. Interested individuals contacted staff in person, by phone, link, or QR code to complete consent-to-contact and eligibility screening; UCSF staff also conducted in-person outreach and screening.

Pre-assignment details

Enrolled participants were only excluded from the analysis if they did not complete the baseline assessment or randomization.

Baseline characteristics

Characteristic
Age, Continuous33.6785714 Years
STANDARD_DEVIATION 10.6111527
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
White
3 Participants
Sex: Female, Male
Female
13 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 15
other
Total, other adverse events
0 / 130 / 15
serious
Total, serious adverse events
0 / 130 / 15

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026