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Clinical Trials/NCT01111721
NCT01111721
Completed
Not Applicable

Adapting Project SAFE: Reducing STD/HIV Risk in Women Prisoners

University of North Carolina, Chapel Hill2 sites in 1 country598 target enrollmentMarch 2009
ConditionsHIV Infections

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
University of North Carolina, Chapel Hill
Enrollment
598
Locations
2
Primary Endpoint
STI Infection Rate
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Project POWER will test the efficacy of a multi-session HIV Prevention program, adapted from an existing program (Project SAFE), for incarcerated women in the rural South.

Detailed Description

Incarcerated women have a disproportionately high risk for both Sexually Transmitted Infections (STIs) and Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS)and the prevalence of HIV and STIs are higher among women than men prisoners. More than half of the HIV/AIDS cases reported by State and Federal prisons in 2005 were in the South. The second highest regional burden for HIV among women released from correction facilities is in the South. Working in collaboration, the staff of the North Carolina Department of Correction (NCDOC) and faculty at the University of North Carolina at Chapel Hill School of Nursing (SON), School of Medicine (SOM), Center for AIDS Research (CFAR) and the School of Social Work (SSW) will systematically adapt and test the efficacy of Project SAFE, an existing evidence-based intervention (EBI), to increase protective behaviors, reduce high-risk behaviors, and prevent STIs in HIV-negative incarcerated women in the Southern United States. Using Centers for Disease Control and Prevention (CDC) guidelines for adaptation (McKleroy, Galbraith, Cummings et al. 2006), we will: 1. Assess the fit between intervention delivery and the needs and resources of the NCDOC and the fit between intervention materials and the behavioral, social, and contextual conditions of incarcerated women's lives following release from prison that may contribute to continuing sexual risk behavior and explore their ideas regarding ways to prevent STI/HIV with the intent of strengthening the approach to sexual risk reduction. 2. Adapt and tailor the Project SAFE behavioral risk reduction intervention for women prisoners in the rural Southeastern U.S. who are HIV-negative and have sex with men. 3. Pilot the adapted Project SAFE intervention. 4. Test the adapted Project SAFE risk-reduction intervention with incarcerated women to determine its efficacy in decreasing risk for non-viral STI infections (Chlamydia, trichomoniasis or gonorrhea), decreasing sexual risk behaviors and increasing risk reduction practices after release. We will also determine whether participants maintain these changes over time.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
December 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Catherine Fogel, PhD

Professor-Principle Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

Inclusion Criteria

  • Age 18 and above
  • Ability to provide verbal and written consent
  • A plan to reside in North Carolina after release from prison and for the length of the study
  • Sentence length of 12 months or less with less than 6 months to serve
  • Anticipated sexual activity with a man
  • Access to a telephone after release
  • HIV negative status

Exclusion Criteria

  • Under age 18
  • Unable to speak and read English
  • Plan to live somewhere other than in North Carolina
  • Sentence lengths of more than 12 months, or 12 months but with more than 6 months to serve
  • Individuals who exhibit signs of acute intoxication or appear to be under the influence of drugs, or exhibit an inability to focus or understand explanations, or exhibit symptoms of acute psychosis
  • No access to a telephone after release
  • HIV-positive status (determined by self-report)
  • Participation in the pilot phase

Outcomes

Primary Outcomes

STI Infection Rate

Time Frame: 12 months after release from prison

Secondary Outcomes

  • Number of unprotected sex acts as a measure of enacting sexual protective practices.(12 months after release from prison.)

Study Sites (2)

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