Project POWER, Adapting Project SAFE: Reducing STD/HIV Risk in Women Prisoners
POWER
Adapting Project SAFE: Reducing STD/HIV Risk in Women Prisoners
2 other identifiers
interventional
598
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Mar 2009
Typical duration for not_applicable hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 5, 2010
CompletedFirst Posted
Study publicly available on registry
April 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMarch 14, 2013
March 1, 2013
3.8 years
April 5, 2010
March 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
STI Infection Rate
12 months after release from prison
Secondary Outcomes (1)
Number of unprotected sex acts as a measure of enacting sexual protective practices.
12 months after release from prison.
Study Arms (2)
Project POWER Intervention Group
EXPERIMENTALIntervention 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.
NC DOC Standard of Care for STIs
ACTIVE COMPARATORControl 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.
Interventions
Nine session group-based behavioral intervention for incarcerated female adults.
Standard North Carolina Department of Correction intake STI testing and counseling.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
North Carolina Correctional Institution for Women
Raleigh, North Carolina, 27610, United States
Fountain Correctional Center for Women
Rocky Mount, North Carolina, 27802, United States
Related Publications (1)
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.
PMID: 27427925DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine I. Fogel, PhD
School of Nursing, The University of North Carolina at Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor-Principle Investigator
Study Record Dates
First Submitted
April 5, 2010
First Posted
April 28, 2010
Study Start
March 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
March 14, 2013
Record last verified: 2013-03