Project POWER, Adapting Project SAFE: Reducing STD/HIV Risk in Women Prisoners (POWER)
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|ClinicalTrials.gov Identifier: NCT01111721|
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : March 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: Project POWER HIV Risk-reduction Intervention Behavioral: NC DOC Standard of Care for STIs||Not Applicable|
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:
- 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.
- 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.
- Pilot the adapted Project SAFE intervention.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||598 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Adapting Project SAFE: Reducing STD/HIV Risk in Women Prisoners|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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.
- STI Infection Rate [ Time Frame: 12 months after release from prison ]
- Number of unprotected sex acts as a measure of enacting sexual protective practices. [ Time Frame: 12 months after release from prison. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111721
|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|
|Principal Investigator:||Catherine I. Fogel, PhD||School of Nursing, The University of North Carolina at Chapel Hill|