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Trial record 16 of 200 for:    nichd Sexually Transmitted Diseases

Mid-life Women: Preventing Unintended Pregnancy and STIs (FemRepro_2)

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Lynne Swartz, Oregon Center for Applied Science, Inc.
ClinicalTrials.gov Identifier:
NCT02330133
First received: May 4, 2010
Last updated: December 30, 2014
Last verified: December 2014
  Purpose
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.

Condition Intervention Phase
Reproductive Health
Behavioral: Women's Reproductive Health
Behavioral: Online sexual health content
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Mid-life Women: Preventing Unintended Pregnancy and STIs

Further study details as provided by Oregon Center for Applied Science, Inc.:

Primary Outcome Measures:
  • Knowledge of reproductive health issues [ Time Frame: 7-day posttest and 30-day follow-up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Attitudes about reproductive health and prevention [ Time Frame: 7-day posttest and 30-day follow-up ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • Intentions to engage in strategies to prevent pregnancy and communicate with [ Time Frame: 7-day posttest and 30-day follow-up ] [ Designated as safety issue: No ]
    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).


Enrollment: 333
Study Start Date: May 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Women's Reproductive Health
Targeted text and video information on website for women aged 25-55 to avoid unplanned pregnancy and sexually transmitted infections
Behavioral: Women's Reproductive Health
Targeted text and video information on website for women aged 25-55 to avoid unplanned pregnancy and sexually transmitted infections
Other Name: Women's Reproductive Health: A Guide to Staying Healthy
Active Comparator: Online sexual health content
Online general text-based information about reproductive health issues and STD prevention strategies
Behavioral: Online sexual health content
Online general text-based information about reproductive health issues and strategies for preventing sexually transmitted infections

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

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women aged 25-55.

Exclusion Criteria:

  • Males
  • Women under 25 years of age and over 55
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02330133

Locations
United States, Oregon
Oregon Center for Applied Science
Eugene, Oregon, United States, 97401
Sponsors and Collaborators
Oregon Center for Applied Science, Inc.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Lynne H Grilley Swartz, MPH, CHES Oregon Center for Applied Science
  More Information

Responsible Party: Lynne Swartz, Research Scientist, Oregon Center for Applied Science, Inc.
ClinicalTrials.gov Identifier: NCT02330133     History of Changes
Other Study ID Numbers: SBIR64R-2  R44HD044374 
Study First Received: May 4, 2010
Last Updated: December 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Center for Applied Science, Inc.:
mid-life women
unintended pregnancy
STI/HIV prevention
intervention
interactive
CD-ROM
multimedia
video

ClinicalTrials.gov processed this record on December 02, 2016