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Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention

Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02128659
Acronym
SHE Project
Enrollment
261
Registered
2014-05-01
Start date
2014-04-30
Completion date
2019-05-31
Last updated
2019-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Brief summary

The purpose of this study is to learn if a cervical health literacy program is a practical and helpful way of improving women's cervical health knowledge and improving cancer screening behaviors, and ultimately preventing cervical cancer.

Detailed description

Women in the criminal just system are 4-5 times more likely to have cervical cancer than non-incarcerated women. Little is known about how to close this gap. The few investigators that have studied cervical cancer risk and disease among women in jails and prisons have found that while many women get screened for cervical cancer, less than half get follow-up care. The investigator's pilot research suggests the most important contributor to cervical cancer risk, and perhaps lack of follow-up, is incarcerated women's low health literacy about both cervical cancer and broader reproductive health issues. This study is testing a sexual health empowerment intervention (SHE Project) to see if it improves incarcerated women's reproductive health literacy.

Interventions

BEHAVIORALSHE Project

Consists of five-sessions, starting on a Monday and ending Friday. Each day involves an approximately 2 hour session.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Megha Ramaswamy, PhD, MPH
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Women sentenced or anticipate a sentence of one year or less * Ability to follow participants post-jail release * Able to read and understand English

Exclusion criteria

* Women who have been treated for cervical cancer with procedures that would obviate the need for regular screening * Exhibit severe psychological distress

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of sexual health empowerment (SHE Project) interventionChange from Baseline to 5 daysChanges in knowledge, beliefs, and self-efficacy pre- and post-intervention measured using data collection instruments (Pap Knowledge Scale, Health Belief Model Scale for Cervical Cancer and Pap Smear Test, Self-Efficacy Scale for Pap Smear Screening Participation, Investigator developed study specific survey specific to women with criminal justice involvement, 10-question satisfaction survey)

Secondary

MeasureTime frameDescription
Long-term health behavior6 Months post-jail releaseParticipant screening behaviors (Paps or Sexually Transmitted Infections \[STIs\]), clinical follow-up of screening, and strategies for navigating health care encounters. Measured using self-report of screening and clinical follow-up survey, review of participant medical charts)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026