NCT02330133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
333

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2010

Completed
4.7 years until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
Last Updated

January 1, 2015

Status Verified

December 1, 2014

Enrollment Period

1.3 years

First QC Date

May 4, 2010

Last Update Submit

December 30, 2014

Conditions

Reproductive Health

Keywords

mid-life womenunintended pregnancySTI/HIV preventioninterventioninteractiveCD-ROMmultimediavideo

Outcome Measures

Primary Outcomes (1)

  • 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.

    7-day posttest and 30-day follow-up

Secondary Outcomes (3)

  • Attitudes about reproductive health and prevention

    7-day posttest and 30-day follow-up

  • Self-efficacy for engaging in strategies to prevent pregnancy and communicate with partner about health risks

    7-day posttest and 30-day follow-up

  • Intentions to engage in strategies to prevent pregnancy and communicate with

    7-day posttest and 30-day follow-up

Study Arms (2)

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

Behavioral: Women's Reproductive Health

Online sexual health content

ACTIVE COMPARATOR

Online general text-based information about reproductive health issues and STD prevention strategies

Behavioral: Online sexual health content

Interventions

Women's Reproductive HealthBEHAVIORAL

Targeted text and video information on website for women aged 25-55 to avoid unplanned pregnancy and sexually transmitted infections

Also known as: Women's Reproductive Health: A Guide to Staying Healthy
Women's Reproductive Health
Online sexual health contentBEHAVIORAL

Online general text-based information about reproductive health issues and strategies for preventing sexually transmitted infections

Online sexual health content

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 25-55.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Center for Applied Science

Eugene, Oregon, 97401, United States

Location

Study Officials

  • Lynne H Grilley Swartz, MPH, CHES

    Oregon Center for Applied Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

May 4, 2010

First Posted

January 1, 2015

Study Start

May 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

January 1, 2015

Record last verified: 2014-12

Locations

US(1)