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

This study is currently recruiting participants.
Verified January 2013 by Tulane University Health Sciences Center
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01579617
First received: March 6, 2012
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Pregnancy
Sexually Transmitted Infections
 Behavioral: BUtiful. Be yoU! Talented, Informed, Fearless, Uncompromised, Loved
Behavioral: DIVAS. Diversity, Individuality, Vitality, Activity and Strong.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tulane University Health Sciences Center:

Primary Outcome Measures:
  • Percent change from baseline in the use of reliable contraceptives [ Time Frame: Change from baseline measured at 3 and 9 months post baseline ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 700
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BUtiful
Intervention arm, 'BUtiful. Be yoU! Talented, Informed, Fearless, Uncompromised, Loved', has 8 website sessions focused on pregnancy and STI prevention
 Behavioral: BUtiful. Be yoU! Talented, Informed, Fearless, Uncompromised, Loved
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 Name: BUtiful
DIVAS
Attention control arm, 'DIVAS. Diversity, Individuality, Vitality, Activity and Strong', has 8 website sessions focused on general health and nutrition
 Behavioral: DIVAS. Diversity, Individuality, Vitality, Activity and Strong.
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 Name: DIVAS

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% reduction in pregnancy and a 35% increase in knowledge and attitudes regarding pregnancy prevention 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.

  Eligibility

Ages Eligible for Study:   18 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579617

Contacts
Contact: Patricia Kissinger, BSN MPH PhD (504) 988-7320 kissing@tulane.edu
Contact: Norine Schmidt, MPH 504.988.8268 nschmid1@tulane.edu

Locations
United States, Louisiana
Delgado Community College Recruiting
New Orleans, Louisiana, United States, 70119
Tulane Drop In Clinic at Covenant House Recruiting
New Orleans, Louisiana, United States, 70116
Southern University of New Orleans Recruiting
New Orleans, Louisiana, United States, 70126
Community Intercept Recruiting
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Tulane University Health Sciences Center
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
  More Information

Publications:

Responsible Party: Patricia Kissinger, Professor, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01579617     History of Changes
Other Study ID Numbers: 261904-1, TP2AH000013
Study First Received: March 6, 2012
Last Updated: January 17, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Tulane University Health Sciences Center:
pregnancy
STI
STD

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013