Cervical CancerSHE ProjectNCT02128659
Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention
A study testing SHE Project in people with Cervical Cancer, run by Megha Ramaswamy, PhD, MPH at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- SHE Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2014to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women sentenced or anticipate a sentence of one year or less
- Ability to follow participants post-jail release
- Able to read and understand English
Who cannot join
- Women who have been treated for cervical cancer with procedures that would obviate the need for regular screening
- Exhibit severe psychological distress
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Wyandotte County Detention Center
Kansas City, Kansas, 66101
University of Kansas Medical Center
Kansas City, Kansas, 66160
Jackson County Detention/Regional Correctional Center
Kansas City, Missouri, 64106
About this study
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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- SHE Project
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHE ProjectBehavioural
Consists of five-sessions, starting on a Monday and ending Friday. Each day involves an approximately 2 hour session.
| Study group | Role | What they receive |
|---|---|---|
| SHE Project | Experimental | Receives SHE Project Intervention during Week 1 of enrollment Receives: Behavioral: SHE Project |
| Wait-List Control | Active comparator | Receive SHE Project intervention during Week 2 of Enrollment Receives: Behavioral: SHE Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of sexual health empowerment (SHE Project) intervention
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)
Measured: Change from Baseline to 5 days
Secondary outcomes (4)
Long-term health behavior
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)
Measured: 6 Months post-jail release
Long-term health behavior
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)
Measured: 12 Months post-jail release
Long-term health behavior
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)
Measured: 24 Months post-jail release
Long-term health behavior
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)
Measured: 36 months post-jail release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Megha Ramaswamy, PhD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Megha Ramaswamy, PhD, MPH, University of Kansas Medical Center
- Investigators
- Megha Ramaswamy, PhD, MPH, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128659
- Sponsor's protocol ID
- 13559
- Other IDs
- R01CA181047-01A1
- Acronym
- SHE Project
- Status last verified
- Jun 2019
- First submitted
- 29 Apr 2014
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Pickett ML, Allison M, Twist K, Klemp JR, Ramaswamy M. Breast Cancer Risk Among Women in Jail. Biores Open Access. 2018 Sep 20;7(1):139-144. doi: 10.1089/biores.2018.0018. eCollection 2018.
PubMed 30250761Kelly PJ, Emerson A, Fair C, Ramaswamy M. Assessing fidelity: balancing methodology and reality in jail interventions. BMC Womens Health. 2018 Jul 23;18(1):127. doi: 10.1186/s12905-018-0617-x.
PubMed 30037333Emerson AM. Narrative Inquiry Into Shelter-Seeking by Women With a History of Repeated Incarceration: Research and Nursing Practice Implications. ANS Adv Nurs Sci. 2018 Jul/Sep;41(3):260-274. doi: 10.1097/ANS.0000000000000216.
PubMed 29901467Emerson AM. Strategizing and Fatalizing: Self and Other in the Trauma Narratives of Justice-Involved Women. Qual Health Res. 2018 May;28(6):873-887. doi: 10.1177/1049732318758634. Epub 2018 Feb 24.
PubMed 29478403Kelly PJ, Ramaswamy M. Closing the cervical cancer disparity gap. Public Health Nurs. 2017 May;34(3):195-196. doi: 10.1111/phn.12336. No abstract available.
PubMed 28493356Ramaswamy M, Lee J, Wickliffe J, Allison M, Emerson A, Kelly PJ. Impact of a brief intervention on cervical health literacy: A waitlist control study with jailed women. Prev Med Rep. 2017 Apr 5;6:314-321. doi: 10.1016/j.pmedr.2017.04.003. eCollection 2017 Jun.
PubMed 28435785Kelly PJ, Hunter J, Daily EB, Ramaswamy M. Challenges to Pap Smear Follow-up among Women in the Criminal Justice System. J Community Health. 2017 Feb;42(1):15-20. doi: 10.1007/s10900-016-0225-3.
PubMed 27449030Ramaswamy M, Kelly PJ. "The Vagina is a Very Tricky Little Thing Down There": Cervical Health Literacy among Incarcerated Women. J Health Care Poor Underserved. 2015 Nov;26(4):1265-85. doi: 10.1353/hpu.2015.0130.
PubMed 26548678Ramaswamy M, Simmons R, Kelly PJ. The development of a brief jail-based cervical health promotion intervention. Health Promot Pract. 2015 May;16(3):432-42. doi: 10.1177/1524839914541658. Epub 2014 Jul 25.
PubMed 25063589
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention
- ClinicalTrials.gov ID
- NCT02128659
- Acronym / sponsor ID
- SHE Project / 13559
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Megha Ramaswamy, PhD, MPHUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHE Project | Experimental | Behavioral: SHE ProjectReceives SHE Project Intervention during Week 1 of enrollment |
| Wait-List Control | Active comparator | Behavioral: SHE ProjectReceive SHE Project intervention during Week 2 of Enrollment |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women sentenced or anticipate a sentence of one year or less
- Ability to follow participants post-jail release
- Able to read and understand English
Key exclusion criteria (2 listed)
- Women who have been treated for cervical cancer with procedures that would obviate the need for regular screening
- Exhibit severe psychological distress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHE ProjectConsists of five-sessions, starting on a Monday and ending Friday. Each day involves an approximately 2 hour session. | Behavioural | SHE Project, Wait-List Control |
Primary outcome
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)
4 secondary outcomes
Long-term health behavior
Time frame: 6 Months post-jail release
Long-term health behavior
Time frame: 12 Months post-jail release
Long-term health behavior
Time frame: 24 Months post-jail release
Long-term health behavior
Time frame: 36 months post-jail release
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Background: PubMed 30250761Pickett ML, Allison M, Twist K, Klemp JR, Ramaswamy M. Breast Cancer Risk Among Women in Jail. Biores Open Access. 2018 Sep 20;7(1):139-144. doi: 10.1089/biores.2018.0018. eCollection 2018.
- Background: PubMed 30037333Kelly PJ, Emerson A, Fair C, Ramaswamy M. Assessing fidelity: balancing methodology and reality in jail interventions. BMC Womens Health. 2018 Jul 23;18(1):127. doi: 10.1186/s12905-018-0617-x.
- Background: PubMed 29901467Emerson AM. Narrative Inquiry Into Shelter-Seeking by Women With a History of Repeated Incarceration: Research and Nursing Practice Implications. ANS Adv Nurs Sci. 2018 Jul/Sep;41(3):260-274. doi: 10.1097/ANS.0000000000000216.
- Background: PubMed 29478403Emerson AM. Strategizing and Fatalizing: Self and Other in the Trauma Narratives of Justice-Involved Women. Qual Health Res. 2018 May;28(6):873-887. doi: 10.1177/1049732318758634. Epub 2018 Feb 24.
- Background: PubMed 28493356Kelly PJ, Ramaswamy M. Closing the cervical cancer disparity gap. Public Health Nurs. 2017 May;34(3):195-196. doi: 10.1111/phn.12336. No abstract available.
- Background: PubMed 28435785Ramaswamy M, Lee J, Wickliffe J, Allison M, Emerson A, Kelly PJ. Impact of a brief intervention on cervical health literacy: A waitlist control study with jailed women. Prev Med Rep. 2017 Apr 5;6:314-321. doi: 10.1016/j.pmedr.2017.04.003. eCollection 2017 Jun.
- Background: PubMed 27449030Kelly PJ, Hunter J, Daily EB, Ramaswamy M. Challenges to Pap Smear Follow-up among Women in the Criminal Justice System. J Community Health. 2017 Feb;42(1):15-20. doi: 10.1007/s10900-016-0225-3.
- Background: PubMed 26548678Ramaswamy M, Kelly PJ. "The Vagina is a Very Tricky Little Thing Down There": Cervical Health Literacy among Incarcerated Women. J Health Care Poor Underserved. 2015 Nov;26(4):1265-85. doi: 10.1353/hpu.2015.0130.
- Background: PubMed 25063589Ramaswamy M, Simmons R, Kelly PJ. The development of a brief jail-based cervical health promotion intervention. Health Promot Pract. 2015 May;16(3):432-42. doi: 10.1177/1524839914541658. Epub 2014 Jul 25.
- Study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megha Ramaswamy, PhD, MPH principal investigator
University of Kansas Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHE Project in people with Cervical Cancer, run by Megha Ramaswamy, PhD, MPH at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of sexual health empowerment (SHE Project) intervention (time frame: Change from Baseline to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02128659, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.