Clinical trial NCT01111721: Project POWER, Adapting Project SAFE: Reducing STD/HIV Risk in Women Prisoners
Official title: Adapting Project SAFE: Reducing STD/HIV Risk in Women Prisoners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Sexually Transmitted Diseases
HIV Infections
Genital Diseases, Female
Acquired Immunodeficiency Syndrome
Risk Reduction Behavior
HIV prevention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2010-04-28
Enrollment: 598
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.

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

Primary outcomes:
measure: STI Infection Rate
timeFrame: 12 months after release from prison
Secondary outcomes:
measure: Number of unprotected sex acts as a measure of enacting sexual protective practices.
timeFrame: 12 months after release from prison.
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: North Carolina Correctional Institution for Women
state: North Carolina
city: Rocky Mount
country: United States
facility: Fountain Correctional Center for Women
state: North Carolina
Study officials:
affiliation: School of Nursing, The University of North Carolina at Chapel Hill
name: Catherine I. Fogel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.