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

HIV Infections Clinical Trial

— POWER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111721
• Other study ID #: 09-1433
• Secondary ID: 5UR6PS000670
• Status: Completed
• Phase: N/A
• First received: April 5, 2010
• Last updated: March 13, 2013
• Start date: March 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Project POWER HIV Risk-reduction Intervention
Nine session group-based behavioral intervention for incarcerated female adults.
• NC DOC Standard of Care for STIs
Standard North Carolina Department of Correction intake STI testing and counseling.

Locations

Country	Name	City	State
United States	North Carolina Correctional Institution for Women	Raleigh	North Carolina
United States	Fountain Correctional Center for Women	Rocky Mount	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	STI Infection Rate		12 months after release from prison	No
Secondary	Number of unprotected sex acts as a measure of enacting sexual protective practices.		12 months after release from prison.	No