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Completed

NCT Number: NCT01579617

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

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.

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Key information

Age range

18 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Community Intercept, New Orleans, Louisiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BUtiful.

Behavioral

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 names: BUtiful

DIVAS.

Behavioral

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 names: DIVAS

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Tulane University Health Sciences Center

Other

Collaborators

  • Department of Health and Human Services

Registry information

Acronym: eSiHLE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 18, 2012
Registry last updated
Dec 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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