NCT01111721

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
598

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2010

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 14, 2013

Status Verified

March 1, 2013

Enrollment Period

3.8 years

First QC Date

April 5, 2010

Last Update Submit

March 13, 2013

Conditions

Keywords

Sexually Transmitted DiseasesHIV InfectionsGenital Diseases, FemaleAcquired Immunodeficiency SyndromeRisk Reduction BehaviorHIV prevention

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

EXPERIMENTAL

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

NC DOC Standard of Care for STIs

ACTIVE COMPARATOR

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

Interventions

Nine session group-based behavioral intervention for incarcerated female adults.

Project POWER Intervention Group

Standard North Carolina Department of Correction intake STI testing and counseling.

NC DOC Standard of Care for STIs

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Fountain Correctional Center for Women

Rocky Mount, North Carolina, 27802, United States

Location

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.

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted DiseasesGenital Diseases, FemaleAcquired Immunodeficiency SyndromeRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsSlow Virus DiseasesBehavior

Study Officials

  • Catherine I. Fogel, PhD

    School of Nursing, The University of North Carolina at Chapel Hill

    PRINCIPAL INVESTIGATOR

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

Locations