This trial has been completed.

Conditions pregnancy, sexually transmitted infections
Treatments butiful., divas.
Sponsor Tulane University Health Sciences Center
Collaborator Department of Health and Human Services
Start date August 2012
End date December 2015
Trial size 637 participants
Trial identifier NCT01579617, 261904-1, TP2AH000013


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Intervention arm, 'BUtiful. Be yoU! Talented, Informed, Fearless, Uncompromised, Loved', has 8 website sessions focused on pregnancy and STI prevention
butiful. 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.
Attention control arm, 'DIVAS. Diversity, Individuality, Vitality, Activity and Strong', has 8 website sessions focused on general health and nutrition
divas. 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.

Primary Outcomes

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

Eligibility Criteria

Female participants from 18 years up to 19 years old.

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

Additional Information

Official title e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls
Principal investigator Patricia Kissinger, BSN MPH PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Tulane University.