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

Pregnancy Clinical Trial

— eSiHLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579617
• Other study ID #: 261904-1
• Secondary ID: TP2AH000013
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: December 16, 2016
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2016
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 637
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy
• Sexually Transmitted Diseases
• Sexually Transmitted Infections

Intervention

Behavioral:
• 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.
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.

Locations

Country	Name	City	State
United States	Community Intercept	New Orleans	Louisiana
United States	Delgado Community College	New Orleans	Louisiana
United States	Dillard University	New Orleans	Louisiana
United States	Southern University of New Orleans	New Orleans	Louisiana
United States	Tulane Drop In Clinic at Covenant House	New Orleans	Louisiana
United States	Xavier University	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University Health Sciences Center	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

References & Publications (34)

Bedimo AL, Bessinger R, Kissinger P. Reproductive choices among HIV-positive women. Soc Sci Med. 1998 Jan;46(2):171-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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

Ventura SJ, Mathews TJ, Hamilton BE. Births to teenagers in the United States, 1940-2000. Natl Vital Stat Rep. 2001 Sep 25;49(10):1-23. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No