An interventional study of SHE-WOMEN in Cervical Cancer, Breast Cancer and Contraceptive Usage, sponsored by University of Kansas Medical Center. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Screening
The purpose of this study is to expand the reach of an existing cervical cancer literacy and prevention intervention- the Sexual Health Empowerment (SHE) Project . As a logical extension of the investigators earlier work, the objective of this renewal is to expand reach of SHE to address women's health disparities more broadly to create a sustainable model for dissemination of health promotion interventions for vulnerable populations.
Over the last 35 years, there has been a 700% increase in the number of women in prisons and jails. These women, mostly women of color, have pervasive trauma histories, mental health problems, and drug use, all of which compromise their ability to engage in preventive health behaviors. For the last eight years, the research team has studied women leaving jail and why they are 4-5 times more likely to develop cervical cancer, a disparity that has remained unchanged for over 50 years. The original objective of the Sexual Health Empowerment (SHE) for Cervical Health Literacy and Prevention program (R01 CA181047) was to assess the effectiveness of a jail-based intervention to increase cervical health literacy and screening. SHE increased jailed women's cervical health literacy and rates of cancer screening after the women left jail.
While delivering SHE, researchers observed: 1) the cross-cutting nature of women's health risk factors, i.e. the risks that jailed women faced for cervical cancer also could lead to other women's health problems; and 2) opportunity for taking an evidence-based intervention, with a rich theoretical framing, to expand to other women's health issues faced by this group, around, not only cervical cancer prevention, but also breast cancer, unintended pregnancy, and STI prevention. While following women after release from jail (85% follow-up rate after 3 years), investigators also identified strategies for reaching this high-risk population through electronic communication. SHE participants were high users of mobile phones (88%), text (76%), Web (79%), and Facebook (70%). This renewal application presents an opportunity to holistically address health disparities experienced by women leaving jail and test new modalities for intervention delivery given use of electronic communication and social media.
The first aim uses an RCT to test the effectiveness of SHE-Women with women leaving jail on increasing women's health literacy, screening, and risk reduction practices (for cervical, breast cancer, unintended pregnancy, and STIs) against a standard of care. The second aim will be to understand the role and impact of human interaction in electronic interventions by tracking participants and interviewing key stakeholders.
Knowledge gained from this study will lead to an understanding of: 1) how a comprehensive women's health literacy intervention can narrow health disparities among justice-involved women and 2) the role of human interaction in successful electronic interventions, thereby creating a sustainable model for dissemination of health promotion interventions.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's enrollment of 279 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-Scheduled to leave jail within 3 days
Exclusion Criteria:
* 15 minute discharge planning session with health educator * Health education booklet containing SHE-Women intervention content in print form(N\~100) * access to health educator via text message
Deliver text-Web intervention to (N \~100) women Researchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \~10 hours pushed to participants over approximately a 5-day period.
Behavioral: SHE-WOMEN
SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections.
Cervical Cancer Literacy
Cervical Cancer Literacy Assessment Tool (C-CLAT) (PMID: 19299678) Adopted 16-items C-CLAT, the sum of scores on all 16 items reflects participants cervical cancer literacy with a possible total score ranges from 0 (minimum) to 16 (maximum). A higher score represents a higher level of cervical cancer literacy (i.e., better outcome).
Time frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment
Breast Cancer Literacy
Breast Cancer Literacy Assessment Tool (B-CLAT) (PMID:23905580) Revised 22-items from B-CLAT (with an added item ask "At what age are most women supposed to start having mammograms?") The sum of scores on all 22 items reflects participants breast cancer literacy with a possible total score ranges from 0 (minimum) to 22 (maximum). A higher score represents a higher level of cervical cancer literacy (i.e., better outcome). ...items from revised Breast Cancer Literacy Assessment Tool (B-CLAT) (PMID:23905580) disagree or agree options: higher mean score = higher perception of risk
Time frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment
Knowledge of Contraception
-Contraceptive knowledge assessment (PMID:27621043) Adopted 8-items Contraceptive knowledge assessment, the sum of scores on all 8 items reflects participants cervical cancer literacy with a possible total score ranges from 0 (minimum) to 8 (maximum). A higher score represents a higher level of knowledge of contraception.
Time frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment
Beliefs About Acquisition and Use of Contraception
-Beliefs about acquisition and use of contraceptive items from self-efficacy scale (PMID:18926726) Each item was on 5-point Likert scale range from 1 (Strongly Disagree) to 5 (Strongly Agree) A mean score of 10 items represent participants' beliefs of contraceptive barriers, ranges from 1 (minimum) to 5 (maximum). A higher score represents a higher level of perceived barriers (i.e., worse outcome).
Time frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.
Confidence in Use of Contraception
-Beliefs about acquisition and use of contraceptive items from self-efficacy scale (PMID:18926726) Each item was on 5-point Likert scale range from 1 (Very confident) to 5 (Not at all confident). A mean score of reverse-coded 6 items represent participants' beliefs of contraceptive self-efficacy, ranges from 1 (minimum) to 5 (maximum). A higher score represents a higher level of contraceptive self-efficacy (i.e., better outcome).
Time frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.
Knowledge of Sexually Transmitted Diseases
-STD knowledge questionnaire (PMID: 17016760) Adopted 8-items STD knowledge questionnaire , the sum of scores on all 8 items reflects participants STD knowledge level with a possible total score ranges from 0 (minimum) to 8 (maximum). A higher score represents a higher level of knowledge of STD.
Time frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.
Confidence Using Condoms
-Condom self-efficacy scale (PMID: 1783705) A mean score of 15 items were calculated with a possible range of 1 (minimum) to 7 (maximum). Higher scores represent a higher level of condom self-efficacy.
Time frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.
Attitudes Related to Condom Use
-Multidimensional condom attitudes scale (PMID: 8055858) A mean score of 20-items was calculated with possible values range from 1 (minimum) to 7 (maximum). Items were rated on a 7-point scale ranging from strongly disagree to strongly agree. Higher mean score indicate more positive attitudes toward condoms.
Time frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.
HPV Vaccination Receipt
Behavioral Risk Factor Surveillance System (BRFSS) Human papillomavirus (HPV) vaccine question: have you ever had an HPV vaccination? A dichotomized score reflects participants' HPV vaccination receipt with 0 (no) and 1 (yes).
Time frame: Only at baseline
Up to Date Pap Screening
Health Information National Trends Survey-cervical cancer screening question: "When was your last pap screen?" A categorical items with four levels: 1) never; 2) within the past 3 years; 3) between 3 to 5 years; 4) 5 or more years ago.
Time frame: Only at baseline
Up to Date Mammography
Health Information National Trends Survey-breast cancer screening question: "When did you have your most recent mammogram to check for breast cancer? The items is only asked for participants over 50 years old. A categorical outcome with five levels: 1) never had a mammogram; 2) a year ago or less; 3) more than 1, up to 2 years ago; 4) more than 2 but no more than 5 years ago; 5) more than 5 years ago
Time frame: Only at baseline
| Milestone | Control | Intervention | Pilot |
|---|---|---|---|
| Started | 127 | 128 | 24 |
| Completed | 102 | 102 | 21 |
| Not completed | 25 | 26 | 3 |
Cervical Cancer Literacy Assessment Tool (C-CLAT) (PMID: 19299678) Adopted 16-items C-CLAT, the sum of scores on all 16 items reflects participants cervical cancer literacy with a possible total score ranges from 0 (minimum) to 16 (maximum). A higher score represents a higher level of cervical cancer literacy (i.e., better outcome).
| score on a scale | Control | Intervention |
|---|---|---|
| Pre-Intervention assessment | 9.53 ± 2.95 | 9.05 ± 3.29 |
| Post-intervention assessment | 10.98 ± 2.67 | 11.51 ± 3.03 |
| 12-month assessment | 10.99 ± 2.41 | 11.07 ± 2.61 |
| 24-month assessment | 10.80 ± 2.09 | 11.38 ± 2.01 |
| 36-month assessment | 11.20 ± 2.12 | 11.21 ± 1.78 |
Breast Cancer Literacy Assessment Tool (B-CLAT) (PMID:23905580) Revised 22-items from B-CLAT (with an added item ask "At what age are most women supposed to start having mammograms?") The sum of scores on all 22 items reflects participants breast cancer literacy with a possible total score ranges from 0 (minimum) to 22 (maximum). A higher score represents a higher level of cervical cancer literacy (i.e., better outcome). ...items from revised Breast Cancer Literacy Assessment Tool (B-CLAT) (PMID:23905580) disagree or agree options: higher mean score = higher perception of risk
| score on a scale | Control | Intervention |
|---|---|---|
| Pre-Intervention assessment | 11.44 ± 3.99 | 10.92 ± 5.13 |
| Post-Intervention assessment | 14.54 ± 3.75 | 15.45 ± 3.61 |
| 12-month assessment | 14.20 ± 3.48 | 15.04 ± 3.00 |
| 24-month assessment | 14.13 ± 2.84 | 14.53 ± 3.89 |
| 36-month assessment | 15.42 ± 2.62 | 14.84 ± 1.98 |
-Contraceptive knowledge assessment (PMID:27621043) Adopted 8-items Contraceptive knowledge assessment, the sum of scores on all 8 items reflects participants cervical cancer literacy with a possible total score ranges from 0 (minimum) to 8 (maximum). A higher score represents a higher level of knowledge of contraception.
| score on a scale | Control | Intervention |
|---|---|---|
| Pre-Intervention assessment | 5.33 ± 1.92 | 5.51 ± 1.96 |
| Post-Intervention assessment | 6.53 ± 1.38 | 6.32 ± 1.68 |
| 12-month assessment | 6.55 ± 1.47 | 6.53 ± 1.55 |
| 24-month assessment | 6.59 ± 1.56 | 6.29 ± 1.74 |
| 36-month assessment | 6.88 ± 1.23 | 6.58 ± 1.26 |
-Beliefs about acquisition and use of contraceptive items from self-efficacy scale (PMID:18926726) Each item was on 5-point Likert scale range from 1 (Strongly Disagree) to 5 (Strongly Agree) A mean score of 10 items represent participants' beliefs of contraceptive barriers, ranges from 1 (minimum) to 5 (maximum). A higher score represents a higher level of perceived barriers (i.e., worse outcome).
| score on a scale | Control | Intervention |
|---|---|---|
| Pre-Intervention assessment | 2.05 ± 0.75 | 2.05 ± 0.69 |
| Post-Intervention assessment | 2.07 ± 0.82 | 1.94 ± 0.80 |
| 12-month assessment | 2.02 ± 0.75 | 1.92 ± 0.88 |
| 24-month assessment | 1.85 ± 0.81 | 1.88 ± 0.78 |
| 36-month assessment | 1.68 ± 0.55 | 1.93 ± 0.91 |
-Beliefs about acquisition and use of contraceptive items from self-efficacy scale (PMID:18926726) Each item was on 5-point Likert scale range from 1 (Very confident) to 5 (Not at all confident). A mean score of reverse-coded 6 items represent participants' beliefs of contraceptive self-efficacy, ranges from 1 (minimum) to 5 (maximum). A higher score represents a higher level of contraceptive self-efficacy (i.e., better outcome).
| score on a scale | Control | Intervention |
|---|---|---|
| Pre-Intervention assessment | 2.92 ± 0.89 | 2.91 ± 0.96 |
| Post-Intervention assessment | 3.13 ± 0.87 | 3.25 ± 0.77 |
| 12-month assessment | 3.08 ± 0.85 | 3.44 ± 0.68 |
| 24-month assessment | 3.26 ± 0.85 | 3.45 ± 0.73 |
| 36-month assessment | 3.24 ± 0.85 | 3.58 ± 0.48 |
-STD knowledge questionnaire (PMID: 17016760) Adopted 8-items STD knowledge questionnaire , the sum of scores on all 8 items reflects participants STD knowledge level with a possible total score ranges from 0 (minimum) to 8 (maximum). A higher score represents a higher level of knowledge of STD.
| score on a scale | Control | Intervention |
|---|---|---|
| Pre-Intervention assessment | 4.28 ± 1.62 | 4.43 ± 1.63 |
| Post-Intervention assessment | 5.24 ± 1.78 | 5.16 ± 1.33 |
| 12-month assessment | 4.82 ± 1.69 | 4.96 ± 1.46 |
| 24-month assessment | 4.67 ± 1.46 | 5.06 ± 1.69 |
| 36-month assessment | 5.46 ± 1.47 | 5.37 ± 1.61 |
-Condom self-efficacy scale (PMID: 1783705) A mean score of 15 items were calculated with a possible range of 1 (minimum) to 7 (maximum). Higher scores represent a higher level of condom self-efficacy.
| score on a scale | Control | Intervention |
|---|---|---|
| Pre-Intervention assessment | 4.24 ± 0.80 | 4.38 ± 0.72 |
| Post-Intervention assessment | 4.35 ± 0.78 | 4.46 ± 0.69 |
| 12-month assessment | 4.45 ± 0.64 | 4.65 ± 0.53 |
| 24-month assessment | 4.53 ± 0.65 | 4.53 ± 0.65 |
| 36-month assessment | 4.64 ± 0.47 | 4.70 ± 0.38 |
-Multidimensional condom attitudes scale (PMID: 8055858) A mean score of 20-items was calculated with possible values range from 1 (minimum) to 7 (maximum). Items were rated on a 7-point scale ranging from strongly disagree to strongly agree. Higher mean score indicate more positive attitudes toward condoms.
| score on a scale | Control | Intervention |
|---|---|---|
| Pre-Intervention assessment | 4.74 ± 0.84 | 4.77 ± 0.86 |
| Post-Intervention assessment | 5.03 ± 0.84 | 5.08 ± 0.81 |
| 12-month assessment | 4.85 ± 0.72 | 5.09 ± 0.77 |
| 24-month assessment | 4.83 ± 0.89 | 5.13 ± 0.76 |
| 36-month assessment | 4.96 ± 0.59 | 5.21 ± 0.84 |
Behavioral Risk Factor Surveillance System (BRFSS) Human papillomavirus (HPV) vaccine question: have you ever had an HPV vaccination? A dichotomized score reflects participants' HPV vaccination receipt with 0 (no) and 1 (yes).
| Participants | Control | Intervention |
|---|---|---|
| Not vaccinated | 70 | 62 |
| Vaccinated | 19 | 25 |
Health Information National Trends Survey-cervical cancer screening question: "When was your last pap screen?" A categorical items with four levels: 1) never; 2) within the past 3 years; 3) between 3 to 5 years; 4) 5 or more years ago.
| Participants | Control | Intervention |
|---|---|---|
| Never | 1 | 2 |
| Within 3 years | 75 | 73 |
| 3 to 5 years | 10 | 13 |
| Over 5 years | 14 | 14 |
Health Information National Trends Survey-breast cancer screening question: "When did you have your most recent mammogram to check for breast cancer? The items is only asked for participants over 50 years old. A categorical outcome with five levels: 1) never had a mammogram; 2) a year ago or less; 3) more than 1, up to 2 years ago; 4) more than 2 but no more than 5 years ago; 5) more than 5 years ago
| Participants | Control | Intervention |
|---|---|---|
| Never | 1 | 1 |
| Less than a year | 2 | 5 |
| 1 to 2 years | 4 | 1 |
| 2 to 5 years | 5 | 2 |
| Over 5 years | 1 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | — | — |
| Intervention | — | — | — |
| Pilot | — | — | — |
| Age, Continuous(years) | Control | Intervention | Total |
|---|---|---|---|
| Mean | 39.83 (20 to 62) | 39.1 (23 to 67) | 39.45 (20 to 67) |
| Sex: Female, Male(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Female | 127 | 128 | 255 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Control | Intervention | Total |
|---|---|---|---|
| White | 84 | 81 | 165 |
| Black | 9 | 9 | 18 |
| Hispanic | 9 | 12 | 21 |
| Other | 6 | 10 | 16 |
| Time Served in Jail or Prison (Lifetime)(Months) | Control | Intervention | Total |
|---|---|---|---|
| Jail | 21.33 ± 23.34 | 19.68 ± 28.20 | 20.49 ± 28.85 |
| Prison | 33.35 ± 47.63 | 30.95 ± 47.06 | 32.16 ± 47.23 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2019 to primary completion in Sep 2023, 47 months.
Results were first posted in Feb 2025, 1 year 5 months after primary completion.
Of 445 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's 47 months is above that.
Counting every sponsor, half of 461 studies reached it within 33 months; a quarter within 15 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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