Reproductive HealthPhase 2FemRepro_2NCT02330133
Mid-life Women: Preventing Unintended Pregnancy and STIs
A Phase 2 study testing Women's Reproductive Health and Online sexual health content in people with Reproductive Health, run by Oregon Center for Applied Science, Inc. at 1 site in United States.
Trial summary
Mid-life women, aged 35-50, are currently an underserved population in the areas of unintended pregnancy and STI prevention interventions. Common perception is that women in this age range are no longer sexually active, or are past the menopause transition, but in reality, sexual activity remains stable through… Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive Health
- What is being tested?
- Women's Reproductive Health and Online sexual health content
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Sep 2009
- Phase
- Phase 2
- 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 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 25-55.
Who cannot join
- Males
- Women under 25 years of age and over 55
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Center for Applied Science
Eugene, Oregon, 97401
About this study
Mid-life women, aged 35-50, are currently an underserved population in the areas of unintended pregnancy and STI prevention interventions. Common perception is that women in this age range are no longer sexually active, or are past the menopause transition, but in reality, sexual activity remains stable through mid-life and into the post-menopausal years. Additionally, physiological and relationship status changes (e.g. divorce or death of a partner) put these women at increased risk for both unintended pregnancy and STI's. This project developed and evaluated a theoretically-based multimedia intervention designed to assist mid-life women in protecting themselves from sexually transmitted infections and unintended pregnancy.
Read the detailed description
The primary aim of this project was to create and evaluate a theoretically-based, interactive multimedia program for women aged 35-55 to assist them in avoiding unintended pregnancy and sexually transmitted infections (STIs). The intervention, titled "Women's Reproductive Health: A guide to staying healthy," addressed these concerns across the life span and was designed to increase knowledge about (a) pregnancy risk; (b) STI risk; (c) strategies to prevent STIs and unintended pregnancy; (d) influences of sexual partners on risk reduction decisions and behaviors; (e) partner communication techniques; and (f) health care provider communication techniques.Overall features of the program include video, interactive tools, animations, text information pages, and various links both across and within specific modules to link related information. A feature titled "My Notes" allowed the user to save content from the program into an easily retrievable repository.
Motivational videos featuring friendly mid-life hosts could be viewed on the first page of each module, as well as on the home page and topic introduction pages. These videos not only provided specific information about the content, they also provided message framing and set the tone of the program segment. Other videos included testimonials on topics such as contraceptive methods, sexually transmitted infections, and other health information. Interactive materials include an assessment checklist for STI risk, a quiz to help the user identify the types of birth control methods that best fit her lifestyle and preferences, as well as several checklists
- Conditions
- Reproductive Health
- Being tested
- Women's Reproductive Health, Online sexual health content
- Keywords
- mid-life women, unintended pregnancy, STI/HIV prevention, intervention, interactive, CD-ROM, multimedia, video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women's Reproductive HealthBehavioural
Also called Women's Reproductive Health: A Guide to Staying Healthy
Targeted text and video information on website for women aged 25-55 to avoid unplanned pregnancy and sexually transmitted infections
Online sexual health contentBehavioural
Online general text-based information about reproductive health issues and strategies for preventing sexually transmitted infections
| Study group | Role | What they receive |
|---|---|---|
| Women's Reproductive Health | Experimental | Targeted text and video information on website for women aged 25-55 to avoid unplanned pregnancy and sexually transmitted infections Receives: Behavioral: Women's Reproductive Health |
| Online sexual health content | Active comparator | Online general text-based information about reproductive health issues and STD prevention strategies Receives: Behavioral: Online sexual health content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of reproductive health issues
A 22-item knowledge scale was created to assess content areas of the program (e.g., 3 items on anatomy \& physiology, 16 items on pregnancy prevention, and 4 items on STI prevention). For example, users were asked to answer the question "A women is most likely to become pregnant (no matter how long or short her menstrual cycle) if she has sexual intercourse about:" with choices being (a) 1 week before menstruation beings, (b) 2 weeks after menstruation begins, (c) 2 weeks before menstruation begins, (d) 1 week after menstruation begins, or (e) do not know.
Measured: 7-day posttest and 30-day follow-up
Secondary outcomes (3)
Attitudes about reproductive health and prevention
Participant attitudes were measured using scales that assessed the perceived importance of using a contraceptive method to prevent pregnancy (6 items), the perceived importance of talking with your partner about contraception (4 items) and two additional items measuring the perceived importance of using a contraceptive method to prevent STIs (1 item), and the perceived importance of talking with your healthcare provider (1 item) (alpha =.74, test- retest reliability=.73).
Measured: 7-day posttest and 30-day follow-up
Self-efficacy for engaging in strategies to prevent pregnancy and communicate with partner about health risks
Participant self-efficacy was measured using scales that assessed confidence in preventing pregnancy (6 items), and talking with the partner (2 items) (alpha=84, test-retest reliability=.68).
Measured: 7-day posttest and 30-day follow-up
Intentions to engage in strategies to prevent pregnancy and communicate with
Participant behavioral intentions were measured using scales that assessed intention of using a contraceptive method (2 items), preventing an STI (4 items), and talking with a sexual partner (4 items) (alpha=.74, test-retest reliability=.69).
Measured: 7-day posttest and 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startMay 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive HealthStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Center for Applied Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Lynne Swartz, Oregon Center for Applied Science, Inc.
- Investigators
- Lynne H Grilley Swartz, MPH, CHES, Principal investigator, Oregon Center for Applied Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330133
- Sponsor's protocol ID
- SBIR64R-2
- Other IDs
- R44HD044374
- Acronym
- FemRepro_2
- Status last verified
- Dec 2014
- First submitted
- 4 May 2010
- Last updated
- 1 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-life Women: Preventing Unintended Pregnancy and STIs
- ClinicalTrials.gov ID
- NCT02330133
- Acronym / sponsor ID
- FemRepro_2 / SBIR64R-2
- Conditions
- Reproductive Health
- Keywords
- mid-life women, unintended pregnancy, STI/HIV prevention, intervention, interactive, CD-ROM, multimedia, video
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Oregon Center for Applied Science, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 1 Jan 2015 (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.
Mid-life women, aged 35-50, are currently an underserved population in the areas of unintended pregnancy and STI prevention interventions. Common perception is that women in this age range are no longer sexually active, or are past the menopause transition, but in reality, sexual activity remains stable through mid-life and into the post-menopausal years. Additionally, physiological and relationship status changes (e.g. divorce or death of a partner) put these women at increased risk for both unintended pregnancy and STI's. This project developed and evaluated a theoretically-based multimedia intervention designed to assist mid-life women in protecting themselves from sexually transmitted infections and unintended pregnancy.
Detailed description
The primary aim of this project was to create and evaluate a theoretically-based, interactive multimedia program for women aged 35-55 to assist them in avoiding unintended pregnancy and sexually transmitted infections (STIs). The intervention, titled "Women's Reproductive Health: A guide to staying healthy," addressed these concerns across the life span and was designed to increase knowledge about (a) pregnancy risk; (b) STI risk; (c) strategies to prevent STIs and unintended pregnancy; (d) influences of sexual partners on risk reduction decisions and behaviors; (e) partner communication techniques; and (f) health care provider communication techniques.Overall features of the program include video, interactive tools, animations, text information pages, and various links both across and within specific modules to link related information. A feature titled "My Notes" allowed the user to save content from the program into an easily retrievable repository.
Motivational videos featuring friendly mid-life hosts could be viewed on the first page of each module, as well as on the home page and topic introduction pages. These videos not only provided specific information about the content, they also provided message framing and set the tone of the program segment. Other videos included testimonials on topics such as contraceptive methods, sexually transmitted infections, and other health information. Interactive materials include an assessment checklist for STI risk, a quiz to help the user identify the types of birth control methods that best fit her lifestyle and preferences, as well as several checklists
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women's Reproductive Health | Experimental | Behavioral: Women's Reproductive HealthTargeted text and video information on website for women aged 25-55 to avoid unplanned pregnancy and sexually transmitted infections |
| Online sexual health content | Active comparator | Behavioral: Online sexual health contentOnline general text-based information about reproductive health issues and STD prevention strategies |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged 25-55.
Key exclusion criteria (2 listed)
- Males
- Women under 25 years of age and over 55
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 |
|---|---|---|
| Women's Reproductive HealthAlso: Women's Reproductive Health: A Guide to Staying HealthyTargeted text and video information on website for women aged 25-55 to avoid unplanned pregnancy and sexually transmitted infections | Behavioural | Women's Reproductive Health |
| Online sexual health contentOnline general text-based information about reproductive health issues and strategies for preventing sexually transmitted infections | Behavioural | Online sexual health content |
Primary outcome
Knowledge of reproductive health issues
Time frame: 7-day posttest and 30-day follow-up
A 22-item knowledge scale was created to assess content areas of the program (e.g., 3 items on anatomy \& physiology, 16 items on pregnancy prevention, and 4 items on STI prevention). For example, users were asked to answer the question "A women is most likely to become pregnant (no matter how long or short her menstrual cycle) if she has sexual intercourse about:" with choices being (a) 1 week before menstruation beings, (b) 2 weeks after menstruation begins, (c) 2 weeks before menstruation begins, (d) 1 week after menstruation begins, or (e) do not know.
3 secondary outcomes
Attitudes about reproductive health and prevention
Time frame: 7-day posttest and 30-day follow-up
Self-efficacy for engaging in strategies to prevent pregnancy and communicate with partner about health risks
Time frame: 7-day posttest and 30-day follow-up
Intentions to engage in strategies to prevent pregnancy and communicate with
Time frame: 7-day posttest and 30-day follow-up
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 1 Jan 2015.
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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.
Lynne H Grilley Swartz, MPH, CHES principal investigator
Oregon Center for Applied Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Women's Reproductive Health and Online sexual health content in people with Reproductive Health, run by Oregon Center for Applied Science, Inc. at 1 site 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 1 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 1 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Knowledge of reproductive health issues (time frame: 7-day posttest and 30-day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2015.