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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls

Conditions
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Pregnancy, Sexually Transmitted Infections

Intervention / Treatment
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* Behavioral: BUtiful.
* Behavioral: DIVAS.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BUtiful<br>Intervention arm, 'BUtiful. Be yoU! Talented, Informed, Fearless, Uncompromised, Loved', has 8 website sessions focused on pregnancy and STI prevention | Behavioral: BUtiful.<br>* 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.<br>* Other names: BUtiful;|
| Other: DIVAS<br>Attention control arm, 'DIVAS. Diversity, Individuality, Vitality, Activity and Strong', has 8 website sessions focused on general health and nutrition | Behavioral: DIVAS.<br>* 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.<br>* Other names: DIVAS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in the use of reliable contraceptives | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, STD, STI