Trial record 10 of 28 for:    " March 24, 2010":" April 23, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Catherine Fogel, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01111721
First received: April 5, 2010
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
HIV Infections
Behavioral: Project POWER HIV Risk-reduction Intervention
Behavioral: NC DOC Standard of Care for STIs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Adapting Project SAFE: Reducing STD/HIV Risk in Women Prisoners

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • STI Infection Rate [ Time Frame: 12 months after release from prison ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of unprotected sex acts as a measure of enacting sexual protective practices. [ Time Frame: 12 months after release from prison. ] [ Designated as safety issue: No ]

Enrollment: 598
Study Start Date: March 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Project POWER Intervention Group
Intervention group participants will attend the Project POWER intervention sessions, complete a pre-intervention assessment and participate in 3, 6, and 12 month follow-up interviews when they will be asked to provide urine specimens for STI testing. The intervention consists of eight bi-weekly, 1.5 hour sessions. Intervention group participants will also attend one booster group session four weeks after the intervention before being released. Intervention participants will receive booster phone calls from a nurse-interventionist at 2, 6, and 10 weeks after release from prison. Booster phone calls will reinforce intervention content and support participant efforts to reduce risky sex behaviors and make healthy choices.
Behavioral: Project POWER HIV Risk-reduction Intervention
Nine session group-based behavioral intervention for incarcerated female adults.
Active Comparator: NC DOC Standard of Care for STIs
Control group participants will receive the North Carolina Department of Correction standard of care for Sexually Transmitted Infections, complete one interview in prison and participate in 3, 6, and 12 month follow up interviews when they will be asked to provide urine specimens for STI testing.
Behavioral: NC DOC Standard of Care for STIs
Standard North Carolina Department of Correction intake STI testing and counseling.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111721

Locations
United States, North Carolina
North Carolina Correctional Institution for Women
Raleigh, North Carolina, United States, 27610
Fountain Correctional Center for Women
Rocky Mount, North Carolina, United States, 27802
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Catherine I. Fogel, PhD School of Nursing, The University of North Carolina at Chapel Hill
  More Information

No publications provided

Responsible Party: Catherine Fogel, PhD, Professor-Principle Investigator, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01111721     History of Changes
Other Study ID Numbers: 09-1433, 5UR6PS000670
Study First Received: April 5, 2010
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Sexually Transmitted Diseases
HIV Infections
Genital Diseases, Female
Acquired Immunodeficiency Syndrome
Risk Reduction Behavior
HIV prevention

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 10, 2014