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

NCT01579617 | Completed

• 2 other identifiers: 261904-1TP2AH000013
• Study Type: interventional
• Target: 637
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Pregnancy; Sexually Transmitted Infections

Keywords

pregnancy; STI; STD

Outcome Measures

Primary Outcomes (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.

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

Study Arms (2)

BUtiful

EXPERIMENTAL

Intervention arm, 'BUtiful. Be yoU! Talented, Informed, Fearless, Uncompromised, Loved', has 8 website sessions focused on pregnancy and STI prevention

Behavioral: BUtiful.

DIVAS

OTHER

Attention control arm, 'DIVAS. Diversity, Individuality, Vitality, Activity and Strong', has 8 website sessions focused on general health and nutrition

Behavioral: DIVAS.

Interventions

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.

Also known as: BUtiful

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.

Also known as: DIVAS

DIVAS

Eligibility Criteria

• Age: 18 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University Health Sciences Center: lead
• Department of Health and Human Services: collaborator

Study Sites (6)

Community Intercept

New Orleans, Louisiana, 70112, United States

Location

Tulane Drop In Clinic at Covenant House

New Orleans, Louisiana, 70116, United States

Location

Delgado Community College

New Orleans, Louisiana, 70119, United States

Location

Dillard University

New Orleans, Louisiana, 70122, United States

Location

Xavier University

New Orleans, Louisiana, 70125, United States

Location

Southern University of New Orleans

New Orleans, Louisiana, 70126, United States

Location

Related Publications (34)

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

  PMID: 10710702 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 15633582 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 18577142 BACKGROUND

• 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.

  PMID: 16772190 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 18277471 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 7481982 BACKGROUND

• Bedimo AL, Bessinger R, Kissinger P. Reproductive choices among HIV-positive women. Soc Sci Med. 1998 Jan;46(2):171-9. doi: 10.1016/s0277-9536(97)00157-3.

  PMID: 9447641 BACKGROUND

• Fuller C, Clark RA, Kissinger P, Abdalian SE. Clinical manifestations of infection with human immunodeficiency virus among adolescents in Louisiana. J Adolesc Health. 1996 Jun;18(6):422-8. doi: 10.1016/1054-139X(95)00235-K.

  PMID: 8803734 BACKGROUND

• Bessinger R, Clark R, Kissinger P, Rice J, Coughlin S. Pregnancy is not associated with the progression of HIV disease in women attending an HIV outpatient program. Am J Epidemiol. 1998 Mar 1;147(5):434-40. doi: 10.1093/oxfordjournals.aje.a009468.

  PMID: 9525529 BACKGROUND

• Kissinger P, Fuller C, Clark RA, Abdalian SE. Psychosocial characteristics of HIV-infected adolescents in New Orleans. J Adolesc Health. 1997 Apr;20(4):258. doi: 10.1016/S1054-139X(97)00029-3. No abstract available.

  PMID: 9098727 BACKGROUND

• Kissinger P, Mohammed H, Richardson-Alston G, Leichliter JS, Taylor SN, Martin DH, Farley TA. Patient-delivered partner treatment for male urethritis: a randomized, controlled trial. Clin Infect Dis. 2005 Sep 1;41(5):623-9. doi: 10.1086/432476. Epub 2005 Jul 19.

  PMID: 16080084 BACKGROUND

• Kissinger P, Schmidt N, Mohammed H, Leichliter JS, Gift TL, Meadors B, Sanders C, Farley TA. Patient-delivered partner treatment for Trichomonas vaginalis infection: a randomized controlled trial. Sex Transm Dis. 2006 Jul;33(7):445-50. doi: 10.1097/01.olq.0000204511.84485.4c.

  PMID: 16531939 BACKGROUND

• Schillinger JA, Kissinger P, Calvet H, Whittington WL, Ransom RL, Sternberg MR, Berman SM, Kent CK, Martin DH, Oh MK, Handsfield HH, Bolan G, Markowitz LE, Fortenberry JD. Patient-delivered partner treatment with azithromycin to prevent repeated Chlamydia trachomatis infection among women: a randomized, controlled trial. Sex Transm Dis. 2003 Jan;30(1):49-56. doi: 10.1097/00007435-200301000-00011.

  PMID: 12514443 BACKGROUND

• Kissinger P, Brown R, Reed K, Salifou J, Drake A, Farley TA, Martin DH. Effectiveness of patient delivered partner medication for preventing recurrent Chlamydia trachomatis. Sex Transm Infect. 1998 Oct;74(5):331-3. doi: 10.1136/sti.74.5.331.

  PMID: 10195027 BACKGROUND

• Kissinger, P., et al. Recurrent Trichomonas vaginalis among HIV positive and negative women. in 16th ISSTDR. 2005. Amsterdam, Netherlands.

  BACKGROUND

• Kissinger P, Amedee A, Clark RA, Dumestre J, Theall KP, Myers L, Hagensee ME, Farley TA, Martin DH. Trichomonas vaginalis treatment reduces vaginal HIV-1 shedding. Sex Transm Dis. 2009 Jan;36(1):11-6. doi: 10.1097/OLQ.0b013e318186decf.

  PMID: 19008776 BACKGROUND

• Kissinger P, Secor WE, Leichliter JS, Clark RA, Schmidt N, Curtin E, Martin DH. Early repeated infections with Trichomonas vaginalis among HIV-positive and HIV-negative women. Clin Infect Dis. 2008 Apr 1;46(7):994-9. doi: 10.1086/529149.

  PMID: 18444815 BACKGROUND

• Chaturvedi AK, Dumestre J, Gaffga AM, Mire KM, Clark RA, Braly PS, Dunlap K, Beckel TE, Hammons AF, Kissinger PJ, Hagensee ME. Prevalence of human papillomavirus genotypes in women from three clinical settings. J Med Virol. 2005 Jan;75(1):105-13. doi: 10.1002/jmv.20244.

  PMID: 15543579 BACKGROUND

• Magnus M, Schillinger JA, Fortenberry JD, Berman SM, Kissinger P. Partner age not associated with recurrent Chlamydia trachomatis infection, condom use, or partner treatment and referral among adolescent women. J Adolesc Health. 2006 Sep;39(3):396-403. doi: 10.1016/j.jadohealth.2006.01.005. Epub 2006 Jul 10.

  PMID: 16919802 BACKGROUND

• Kissinger P, Clark R, Dumestre J, Bessinger R. Incidence of three sexually transmitted diseases during a safer sex promotion program for HIV-infected women. J Gen Intern Med. 1996 Dec;11(12):750-2. doi: 10.1007/BF02598989.

  PMID: 9016422 BACKGROUND

• Yoo S, Johnson CC, Rice J, Manuel P. A qualitative evaluation of the Students of Service (SOS) program for sexual abstinence in Louisiana. J Sch Health. 2004 Oct;74(8):329-34. doi: 10.1111/j.1746-1561.2004.tb06623.x.

  PMID: 15554119 BACKGROUND

• Card JJ, Kuhn T, Solomon J, Benner TA, Wingood GM, DiClemente RJ. Translating an effective group-based HIV prevention program to a program delivered primarily by a computer: methods and outcomes. AIDS Educ Prev. 2011 Apr;23(2):159-74. doi: 10.1521/aeap.2011.23.2.159.

  PMID: 21517664 BACKGROUND

• Latham TP, Sales JM, Boyce LS, Renfro TL, Wingood GM, DiClemente RJ, Rose E. Application of ADAPT-ITT: adapting an evidence-based HIV prevention intervention for incarcerated African American adolescent females. Health Promot Pract. 2010 May;11(3 Suppl):53S-60S. doi: 10.1177/1524839910361433.

  PMID: 20488969 BACKGROUND

• Wingood GM, DiClemente RJ. The ADAPT-ITT model: a novel method of adapting evidence-based HIV Interventions. J Acquir Immune Defic Syndr. 2008 Mar 1;47 Suppl 1:S40-6. doi: 10.1097/QAI.0b013e3181605df1.

  PMID: 18301133 BACKGROUND

• DiClemente RJ, Wingood GM, Harrington KF, Lang DL, Davies SL, Hook EW 3rd, Oh MK, Crosby RA, Hertzberg VS, Gordon AB, Hardin JW, Parker S, Robillard A. Efficacy of an HIV prevention intervention for African American adolescent girls: a randomized controlled trial. JAMA. 2004 Jul 14;292(2):171-9. doi: 10.1001/jama.292.2.171.

  PMID: 15249566 BACKGROUND

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia Kissinger, BSN MPH PhD

  Tulane University Health Sciences Center, School of Public Health and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: April 18, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 19, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)