Summary

Eligibility
for females ages 18-49 (full criteria)
Healthy Volunteers
healthy people welcome
Dates
study started
estimated completion
Principal Investigator
by Emily Dauria, PhD, MPH
Photo of Emily Dauria
Emily Dauria

Description

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.

Official Title

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

Details

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.

Keywords

HIV Infections Stigma, Social Justice-involved population Women's health HIV prevention Substance use Intersectional stigma Navigator Peer Navigators Addressing INtersectional Stigma to Improve HIV Prevention Among Criminal-Justice Involved Women

Eligibility

You can join if…

Open to females ages 18-49

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 CAN'T join if...

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

Lead Scientist at UCSF

  • Emily Dauria, PhD, MPH
    Assistant Professor, Psychiatry. Authored (or co-authored) 31 research publications. Research interests: Social determinants of health · mixed methods research · qualitative research · health disparities · HIV/AIDS · sexually transmitted infections · incarceration · women's health · substance abuse · geospatial analyses.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04680390
Study Type
Interventional
Last Updated