Sexual Health Empowerment for Women's Health

Sexual Health Empowerment for Jail-Involved Women's Health Literacy and Prevention

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03984695

Acronym

SHE-WOMEN

Enrollment

279

Registered

2019-06-13

Start date

2019-09-11

Completion date

2026-03-31

Last updated

2026-01-28

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

Conditions

Breast Cancer, Cervical Cancer, Contraceptive Usage, Sexually Transmitted Diseases

Keywords

Jail, Vulnerable Populations, STD Screening, unintended pregnancy

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALSHE-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Intervention model description

Randomized clinical trial.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

-Scheduled to leave jail within 3 days

Exclusion criteria

* not actively intoxicated * not show severe psychological distress

Design outcomes

Primary

Measure	Time frame	Description
Cervical Cancer Literacy	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	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).
Breast Cancer Literacy	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 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
Knowledge of Contraception	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	-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.
Beliefs About Acquisition and Use of Contraception	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 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).
Confidence in Use of Contraception	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 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).
Knowledge of Sexually Transmitted Diseases	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.	-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.
Confidence Using Condoms	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.	-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.
Attitudes Related to Condom Use	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.	-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.

Secondary

Measure	Time frame	Description
HPV Vaccination Receipt	Only at baseline	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).
Up to Date Pap Screening	Only at baseline	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.
Up to Date Mammography	Only at baseline	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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJason Glenn, PhD

University of Kansas Medical Center

Participant flow

Participants by arm

Arm	Count
Control * 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	127
Intervention 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. 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.	128
Total	255

Baseline characteristics

Characteristic	Control	Intervention	Total
Age, Continuous	39.83 years	39.1 years	39.45 years
Race/Ethnicity, Customized Black	9 Participants	9 Participants	18 Participants
Race/Ethnicity, Customized Hispanic	9 Participants	12 Participants	21 Participants
Race/Ethnicity, Customized Other	6 Participants	10 Participants	16 Participants
Race/Ethnicity, Customized White	84 Participants	81 Participants	165 Participants
Sex: Female, Male Female	127 Participants	128 Participants	255 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants
Time Served in Jail or Prison (Lifetime) Jail	21.33 Months STANDARD_DEVIATION 23.34	19.68 Months STANDARD_DEVIATION 28.2	20.49 Months STANDARD_DEVIATION 28.85
Time Served in Jail or Prison (Lifetime) Prison	33.35 Months STANDARD_DEVIATION 47.63	30.95 Months STANDARD_DEVIATION 47.06	32.16 Months STANDARD_DEVIATION 47.23

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0

Outcome results

Primary

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.