e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls (eSiHLE)

December 16, 2016 updated by: Patricia Kissinger, Tulane University Health Sciences Center
The purpose of this study is to evaluate the efficacy of an online pregnancy prevention intervention that was adapted from the evidence based small group intervention SiHLE.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will test the hypothesis that by the end of the study, women who receive the e-SIHLE intervention will have a 35% increase in reliable contraception use compared to attention control website, DIVAS, which is a health and nutrition education program.

Both arms of the study were designed for African-American women who are 18-19 years old.

Study Type

Interventional

Enrollment (Actual)

637

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Community Intercept
      • New Orleans, Louisiana, United States, 70116
        • Tulane Drop In Clinic at Covenant House
      • New Orleans, Louisiana, United States, 70119
        • Delgado Community College
      • New Orleans, Louisiana, United States, 70122
        • Dillard University
      • New Orleans, Louisiana, United States, 70125
        • Xavier University
      • New Orleans, Louisiana, United States, 70126
        • Southern University of New Orleans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 19 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 18 or 19 at enrollment
  • Female
  • Not currently pregnant or intending to become pregnant in the next 12 months
  • Live in Orleans or Jefferson Parish in Louisiana
  • English is your primary language
  • Access to a computer and internet connection
  • Does not have sex with women exclusively

Exclusion Criteria:

  • Age younger than 18 or older than 19
  • Male
  • Currently pregnant or intend to become pregnant in the next 12 months
  • Live outside of Orleans or Jefferson Parish
  • Hearing impairments that prevent listening to videos

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BUtiful
Intervention arm, 'BUtiful. Be yoU! Talented, Informed, Fearless, Uncompromised, Loved', has 8 website sessions focused on pregnancy and STI prevention
Behavioral: BUtiful.
8 website sessions include themes that teach: gender empowerment, assertive communication skills, goal setting, pregnancy and STI/HIV risk, safer sex behaviors, proper condom use, positive attitudes and norms towards consistent condom use, contraception, partner involvement in safer sex, and responsibility for their own health.
Other Names:
  • BUtiful
Other: DIVAS
Attention control arm, 'DIVAS. Diversity, Individuality, Vitality, Activity and Strong', has 8 website sessions focused on general health and nutrition
Behavioral: DIVAS.
Attention control arm: 8 website sessions that include topics on: healthy eating, choosing nutritional snacks, sugar and salt intake, physical activity, stress management, foods for beauty.
Other Names:
  • DIVAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change from baseline in the use of reliable contraceptives
Time Frame: Change from baseline measured at 3 and 7 and 13 months post baseline
Women who receive the BUtiful intervention will have a 35% increase in the use of reliable contraceptives compared to the DIVAS intervention. Reliable contraceptive use is defined as the consistent use of a condom with all sex partners, a hormonal birth control method, or an intrauterine device.
Change from baseline measured at 3 and 7 and 13 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tulane University Health Sciences Center

Collaborators

Department of Health and Human Services

Investigators

  • Principal Investigator: Patricia Kissinger, BSN MPH PhD, Tulane University Health Sciences Center, School of Public Health and Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (Estimate)

April 18, 2012

Study Record Updates

Last Update Posted (Estimate)

December 19, 2016

Last Update Submitted That Met QC Criteria

December 16, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 261904-1
  • TP2AH000013 (Other Grant/Funding Number: Department of Health and Human Services)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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