e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls (eSiHLE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01579617|
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : December 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Sexually Transmitted Infections||Behavioral: BUtiful. Behavioral: DIVAS.||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||637 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|