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PregnancyeSiHLENCT01579617

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

A study testing BUtiful. and DIVAS. in people with Pregnancy and Sexually Transmitted Infections, run by Tulane University Health Sciences Center at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 19 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Sexually Transmitted Infections
What is being tested?
BUtiful. and DIVAS.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
637 participants
Where
6 sitesUnited States
Study dates
Aug 2012to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 19 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Community Intercept

    New Orleans, Louisiana, 70112

  • Tulane Drop In Clinic at Covenant House

    New Orleans, Louisiana, 70116

  • Delgado Community College

    New Orleans, Louisiana, 70119

  • Dillard University

    New Orleans, Louisiana, 70122

  • Xavier University

    New Orleans, Louisiana, 70125

  • Southern University of New Orleans

    New Orleans, Louisiana, 70126

Other trials in United States

About this study

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.

Read the detailed 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.

Being tested
BUtiful., DIVAS.
Keywords
pregnancy, STI, STD
Medical subject headings
Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BUtiful.Behavioural

    Also called 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.

  • DIVAS.Behavioural

    Also called 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.

Study groups in NCT01579617
Study groupRoleWhat they receive
BUtifulExperimentalIntervention arm, 'BUtiful. Be yoU! Talented, Informed, Fearless, Uncompromised, Loved', has 8 website sessions focused on pregnancy and STI prevention
Receives: Behavioral: BUtiful.
DIVASOtherAttention control arm, 'DIVAS. Diversity, Individuality, Vitality, Activity and Strong', has 8 website sessions focused on general health and nutrition
Receives: Behavioral: DIVAS.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline measured at 3 and 7 and 13 months post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
637 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01579617
Sponsor's protocol ID
261904-1
Other IDs
TP2AH000013
Acronym
eSiHLE
Status last verified
Dec 2016
First submitted
6 Mar 2012
Last updated
19 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Singh S, Darroch JE. Adolescent pregnancy and childbearing: levels and trends in developed countries. Fam Plann Perspect. 2000 Jan-Feb;32(1):14-23.

    PubMed 10710702

  • Kost, K., Henshaw, S., & Carlin, L. , U.S. Teenage Pregnancies, Births and Abortions: National and State Trends and Trends by Race and Ethnicity. . 2010, Guttmacher: New York.

  • Guttmacher Institute, Facts on American Teens' Sexual and Reproductive Health. 2010, Guttmacher Institute New York.

  • Guttmacher Institute, U.S. Teenage Pregnancy Statistics: National and State Trends and Trends by Race and Ethnicity. . 2006, Guttmacher Institute: New York.

  • Prevention, C.f.D.C.a., Youth Risk Behavior Surveillance Survey. 2007, Centers for Disease Control and Prevention

  • Hamilton, B.E., Martin, J. A., & Ventura, S. J., National Vital Statistics Reports. 2007, Centers for Disease Control and Prevention.

  • Mosher WD, Martinez GM, Chandra A, Abma JC, Willson SJ. Use of contraception and use of family planning services in the United States: 1982-2002. Adv Data. 2004 Dec 10;(350):1-36.

    PubMed 15633582

  • Foundation, T.A.E.C., Kids Count 2008 data book 2008, The Annie E. Casey Foundation Baltimore.

  • Frost JJ, Darroch JE. Factors associated with contraceptive choice and inconsistent method use, United States, 2004. Perspect Sex Reprod Health. 2008 Jun;40(2):94-104. doi: 10.1363/4009408.

    PubMed 18577142

  • Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health. 2006 Jun;38(2):90-6. doi: 10.1363/psrh.38.090.06.

    PubMed 16772190

  • Zill, N., & O'Donnell, K., Child poverty rates by maternal risk factors: An update. 2004, WESTAT.

  • Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Menacker F, Kirmeyer S, Munson ML; Centers for Disease Control and Prevention National Center for Health Statistics National Vital Statistics System. Births: final data for 2005. Natl Vital Stat Rep. 2007 Dec 5;56(6):1-103.

    PubMed 18277471

  • Hoffman, S.D., By the numbers: The public costs of adolescent childbearing. 2006, The National Campaign to Prevent Teen Pregnancy.: Washington, DC.

  • The National Campaign to Prevent Teen Pregnancy, Why it matters: Linking teen pregnancy prevention to other critical social issues. 2010: Washington, DC.

  • Kissinger P, Clark R, Rice J, Kutzen H, Morse A, Brandon W. Evaluation of a program to remove barriers to public health care for women with HIV infection. South Med J. 1995 Nov;88(11):1121-5. doi: 10.1097/00007611-199511000-00007.

    PubMed 7481982

Questions about this trial

What is this clinical trial studying?

A study testing BUtiful. and DIVAS. in people with Pregnancy and Sexually Transmitted Infections, run by Tulane University Health Sciences Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01579617, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016.

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