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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project POWER HIV Risk-reduction Intervention
NC DOC Standard of Care for STIs
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Sexually Transmitted Diseases, HIV Infections, Genital Diseases, Female, Acquired Immunodeficiency Syndrome, Risk Reduction Behavior, HIV prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • North Carolina Correctional Institution for Women
  • Fountain Correctional Center for Women

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Project POWER Intervention Group

NC DOC Standard of Care for STIs

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

STI Infection Rate

Secondary Outcome Measures

Number of unprotected sex acts as a measure of enacting sexual protective practices.

Full Information

First Posted
April 5, 2010
Last Updated
March 13, 2013
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01111721
Brief Title
Project POWER, Adapting Project SAFE: Reducing STD/HIV Risk in Women Prisoners
Acronym
POWER
Official Title
Adapting Project SAFE: Reducing STD/HIV Risk in Women Prisoners
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Sexually Transmitted Diseases, HIV Infections, Genital Diseases, Female, Acquired Immunodeficiency Syndrome, Risk Reduction Behavior, HIV prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
598 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Project POWER Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
NC DOC Standard of Care for STIs
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Project POWER HIV Risk-reduction Intervention
Intervention Description
Nine session group-based behavioral intervention for incarcerated female adults.
Intervention Type
Behavioral
Intervention Name(s)
NC DOC Standard of Care for STIs
Intervention Description
Standard North Carolina Department of Correction intake STI testing and counseling.
Primary Outcome Measure Information:
Title
STI Infection Rate
Time Frame
12 months after release from prison
Secondary Outcome Measure Information:
Title
Number of unprotected sex acts as a measure of enacting sexual protective practices.
Time Frame
12 months after release from prison.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine I. Fogel, PhD
Organizational Affiliation
School of Nursing, The University of North Carolina at Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Carolina Correctional Institution for Women
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Fountain Correctional Center for Women
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27802
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27427925
Citation
Herbst JH, Branscomb-Burgess O, Gelaude DJ, Seth P, Parker S, Fogel CI. Risk Profiles of Women Experiencing Initial and Repeat Incarcerations: Implications for Prevention Programs. AIDS Educ Prev. 2016 Aug;28(4):299-311. doi: 10.1521/aeap.2016.28.4.299.
Results Reference
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Project POWER, Adapting Project SAFE: Reducing STD/HIV Risk in Women Prisoners

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