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Completed

NCT Number: NCT02128659

Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHE Project

Behavioral

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

Primary outcomes

  1. Effectiveness of sexual health empowerment (SHE Project) intervention

    Time frame: Change from Baseline to 5 days

    Changes 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 outcomes

  1. Long-term health behavior

    Time frame: 6 Months post-jail release

    Participant 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)

  2. Long-term health behavior

    Time frame: 12 Months post-jail release

    Participant screening behaviors (Paps or 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)

  3. Long-term health behavior

    Time frame: 24 Months post-jail release

    Participant screening behaviors (Paps or 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)

  4. Long-term health behavior

    Time frame: 36 months post-jail release

    Participant screening behaviors (Paps or 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)

Sponsors and collaborators

Lead sponsor

Megha Ramaswamy, PhD, MPH

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: SHE Project

Important dates

Study start
2014
Primary completion
2016
Study completion
2019
First posted
May 1, 2014
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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