Clinical trial NCT02330133: Mid-life Women: Preventing Unintended Pregnancy and STIs
Official title: Mid-life Women: Preventing Unintended Pregnancy and STIs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Reproductive Health
Keywords: mid-life women
unintended pregnancy
STI/HIV prevention
intervention
interactive
CD-ROM
multimedia
video
Lead sponsor: Oregon Center for Applied Science, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-01-01
Enrollment: 333
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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 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

Eligibility criteria: Inclusion Criteria:

* Women aged 25-55.

Exclusion Criteria:

* Males
* Women under 25 years of age and over 55

Primary outcomes:
measure: Knowledge of reproductive health issues
timeFrame: 7-day posttest and 30-day follow-up
Secondary outcomes:
measure: Attitudes about reproductive health and prevention
timeFrame: 7-day posttest and 30-day follow-up
measure: Self-efficacy for engaging in strategies to prevent pregnancy and communicate with partner about health risks
timeFrame: 7-day posttest and 30-day follow-up
measure: Intentions to engage in strategies to prevent pregnancy and communicate with
timeFrame: 7-day posttest and 30-day follow-up
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Center for Applied Science
state: Oregon
Study officials:
affiliation: Oregon Center for Applied Science
name: Lynne H Grilley Swartz, MPH, CHES
role: PRINCIPAL_INVESTIGATOR
References: