e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls (eSiHLE)
Sexually Transmitted Infections
|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|
- 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 ] [ 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.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Intervention arm, 'BUtiful. Be yoU! Talented, Informed, Fearless, Uncompromised, Loved', has 8 website sessions focused on pregnancy and STI prevention
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
Attention control arm, 'DIVAS. Diversity, Individuality, Vitality, Activity and Strong', has 8 website sessions focused on general health and nutrition
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579617
|United States, Louisiana|
|New Orleans, Louisiana, United States, 70112|
|Tulane Drop In Clinic at Covenant House|
|New Orleans, Louisiana, United States, 70116|
|Delgado Community College|
|New Orleans, Louisiana, United States, 70119|
|New Orleans, Louisiana, United States, 70122|
|New Orleans, Louisiana, United States, 70125|
|Southern University of New Orleans|
|New Orleans, Louisiana, United States, 70126|
|Principal Investigator:||Patricia Kissinger, BSN MPH PhD||Tulane University Health Sciences Center, School of Public Health and Tropical Medicine|