Preventing Health Damaging Behaviors in Male and Female Army Recruits

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2010 by Department of Defense.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Department of Defense

ClinicalTrials.gov Identifier:

NCT01234103

First received: November 3, 2010

Last updated: NA

Last verified: September 2010

History: No changes posted

Purpose

Health damaging (risk) behaviors of young military personnel are reflections of health problems facing all young people in the U.S. Military life presents opportunities and challenges that may both protect against and place young troops at risk for health damaging behaviors. Challenges for maintaining a healthy armed force include high rates of sexually transmitted infections (STIs), unintended pregnancies (UIPs), misuse of alcohol and other substances. The common thread through these negative health outcomes is volitional behavior. Such behaviors do not only result in illness or injury, but also negatively impact performance of military duties and threaten military readiness. Despite military leadership in setting standards and policies regarding professional behavior and universal health care for preventing and eliminating such negative health outcomes, many health problems remain. Building on our previous military research, we will evaluate the effectiveness a cognitive-behavioral, skills-building intervention to prevent and reduce young troops' risk for and acquisition of STIs and UIPs and will seek to reduce a number of their associated risk factors including, alcohol misuse, other substance use, and victimization due to IPV in male and female U.S. Army soldiers who are receiving Advance Individual Training (AIT) in Fort Jackson, SC.

Condition	Intervention	Phase
Sexually Transmitted Infection (STI) Prevention Unintended Pregnancy Prevention Sexual Risk Reduction Alcohol and Other Substance Use Prevention Intimate Partner Violence Prevention	Behavioral: Staying Safe & In Control: Increasing Knowledge and Building Skills to Prevent STIs and Unintended Pregnancy	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Preventing Health Damaging Behaviors in Male and Female Army Recruits

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Sexually Transmitted Diseases

U.S. FDA Resources

Further study details as provided by Department of Defense:

Primary Outcome Measures:

incidence of sexually transmitted infections and the self-reported numbers of unintended pregnancies [ Time Frame: 6 to 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

self-reported behavioral measures related to STI/HIV prevention [ Time Frame: 6 to 9 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	1000
Study Start Date:	September 2010
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cognitive-behavioral intervention To prevent STIs, unintended pregnancies, and related behaviors including sexual risk and alcohol and other substance use	Behavioral: Staying Safe & In Control: Increasing Knowledge and Building Skills to Prevent STIs and Unintended Pregnancy Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors

Detailed Description:

The primary hypotheses to be tested in this research are as follows. AIT soldiers participating in the experimental STI/UIP prevention intervention will: (a) have increased knowledge about the risk factors for and prevention of STIs, UIPs, alcohol and other substances, and intimate partner violence (IPV); (b) be more highly motivated to change risk behaviors associated with STIs and UIPs; (c) have higher levels of skills to prevent risk behaviors associated with STIs and UIPs and skills; (d) engage in more health promoting behaviors and fewer risk behaviors associated with STIs and UIPs, and (e) have fewer STIs and UIPs post-intervention compared with AIT solders who participate in a comparable control intervention focused on increasing healthy eating, maintaining physical fitness, and preventing fitness-related injuries.

The overall goal of this research is to evaluate the effectiveness a cognitive-behavioral skills-building intervention to prevent risk for and acquisition of STIs and UIPs and will seek to reduce a number of their associated risk factors including, alcohol misuse, other substance use, IPV in AIT soldiers. Specifically, we will evaluate whether AIT soldiers who participate in the experimental intervention entitled, Staying Safe and in Control: Increasing Knowledge and Building Skills to Prevent Sexually Transmitted Infections and Unintended Pregnancies will reduce their risk for and acquisition of STIs, UIPs and their associated sexual and substance use behaviors compared with AIT soldiers who undergo the control intervention entitled, Fit You: Practical Tools for Healthy Eating, Physical Fitness, and Injury Prevention. This intervention will focus primarily on promoting healthy eating, maintaining physical fitness, and preventing work-related and exercise injury.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

All participants will be 18 years of age or older, will be fluent in English, and able to provide written, informed consent.

Exclusion Criteria:

AIT soldiers under the age of 18 will be excluded since it will be difficult to obtain parental consent. We anticipate that this exclusion will be rare.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234103

Contacts


Contact: Cherrie B Boyer, PhD	415-476-9620	boyerc@peds.ucsf.edu
Contact: Anthony Kung, BA	415-502-4689	kunga@peds.ucsf.edu

Locations


United States, South Carolina
Fort Jackson Advance Individual Training Units	Recruiting
Columbia, South Carolina, United States, 29044
Contact: Cherrie B Boyer, PhD 415-502-4689 BoyerC@peds.ucsf.edu
Principal Investigator: Cherrie B Boyer, PhD

Sponsors and Collaborators

Department of Defense

Investigators


Principal Investigator:	Cherrie B Boyer, PhD	University of California, San Francisco

More Information

Publications:

Gaydos CA, Howell MR, Pare B, Clark KL, Ellis DA, Hendrix RM, Gaydos JC, McKee KT Jr, Quinn TC. Chlamydia trachomatis infections in female military recruits. N Engl J Med. 1998 Sep 10;339(11):739-44.

Boyer CB, Shafer MA, Moncada J, Schachter J, Shaffer RA, Brodine SK. Sociodemographic, behavioral, and clinical factors associated with STDs in a national sample of women entering the US military. ISSTDR: Sexually Transmitted Infections. 2001:241-246.

Shafer MA, Moncada J, Boyer CB, Betsinger K, Flinn SD, Schachter J. Comparing first-void urine specimens, self-collected vaginal swabs, and endocervical specimens to detect Chlamydia trachomatis and Neisseria gonorrhoeae by a nucleic acid amplification test. J Clin Microbiol. 2003 Sep;41(9):4395-9.

Cecil JA, Howell MR, Tawes JJ, Gaydos JC, McKee KT Jr, Quinn TC, Gaydos CA. Features of Chlamydia trachomatis and Neisseria gonorrhoeae infection in male Army recruits. J Infect Dis. 2001 Nov 1;184(9):1216-9. Epub 2001 Sep 27.

Brodine SK, Shafer MA, Shaffer RA, Boyer CB, Putnam SD, Wignall FS, Thomas RJ, Bales B, Schachter J. Asymptomatic sexually transmitted disease prevalence in four military populations: application of DNA amplification assays for Chlamydia and gonorrhea screening. J Infect Dis. 1998 Oct;178(4):1202-4.

Shafer MA, Boyer CB, Shaffer RA, Schachter J, Ito SI, Brodine SK. Correlates of sexually transmitted diseases in a young male deployed military population. Mil Med. 2002 Jun;167(6):496-500.

Yen S, Shafer MA, Moncada J, Campbell CJ, Flinn SD, Boyer CB. Bacterial vaginosis in sexually experienced and non-sexually experienced young women entering the military. Obstet Gynecol. 2003 Nov;102(5 Pt 1):927-33.

Howell MR, Gaydos JC, McKee KT Jr, Quinn TC, Gaydos CA. Control of Chlamydia trachomatis infections in female army recruits: cost-effective screening and treatment in training cohorts to prevent pelvic inflammatory disease. Sex Transm Dis. 1999 Oct;26(9):519-26.

Shafer MA, Pantell RH, Schachter J. Is the routine pelvic examination needed with the advent of urine-based screening for sexually transmitted diseases? Arch Pediatr Adolesc Med. 1999 Feb;153(2):119-25.

Magann EF, Nolan TE. Pregnancy outcome in an active-duty population. Obstet Gynecol. 1991 Sep;78(3 Pt 1):391-3.

McNeary AM, Lomenick TS. Military duty: risk factor for preterm labor? A review. Mil Med. 2000 Aug;165(8):612-5. Review.

Clark JB, Holt VL, Miser F. Unintended pregnancy among female soldiers presenting for prenatal care at Madigan Army Medical Center. Mil Med. 1998 Jul;163(7):444-8.

Bray RM, Fairbank JA, Marsden ME. Stress and substance use among military women and men. Am J Drug Alcohol Abuse. 1999 May;25(2):239-56.

Martin L. Personality characteristics that increase vulnerability to sexual harassment among U.S. Army soldiers. Mil Med. 2000 Oct;165(10):709-13.

Martin L, Rosen LN, Durand DB, Stretch RH, Knudson KH. Prevalence and timing of sexual assaults in a sample of male and female U.S. Army soldiers. Mil Med. 1998 Apr;163(4):213-6.

Sadler AG, Booth BM, Cook BL, Doebbeling BN. Factors associated with women's risk of rape in the military environment. Am J Ind Med. 2003 Mar;43(3):262-73. Erratum in: Am J Ind Med. 2003 Jul;44(1):110.

Sadler AG, Booth BM, Nielson D, Doebbeling BN. Health-related consequences of physical and sexual violence: women in the military. Obstet Gynecol. 2000 Sep;96(3):473-80.

Boyer CB, Barrett DC, Peterman TA, Bolan G. Sexually transmitted disease (STD) and HIV risk in heterosexual adults attending a public STD clinic: evaluation of a randomized controlled behavioral risk-reduction intervention trial. AIDS. 1997 Mar;11(3):359-67.

Boyer CB, Shafer MA, Tschann JM. Evaluation of a knowledge- and cognitive-behavioral skills-building intervention to prevent STDs and HIV infection in high school students. Adolescence. 1997 Spring;32(125):25-42.

Jemmott JB 3rd, Jemmott LS, Fong GT. Abstinence and safer sex HIV risk-reduction interventions for African American adolescents: a randomized controlled trial. JAMA. 1998 May 20;279(19):1529-36.

The NIMH Multisite HIV Prevention Trial: reducing HIV sexual risk behavior. The National Institute of Mental Health (NIMH) Multisite HIV Prevention Trial Group. Science. 1998 Jun 19;280(5371):1889-94.

Shain RN, Piper JM, Newton ER, Perdue ST, Ramos R, Champion JD, Guerra FA. A randomized, controlled trial of a behavioral intervention to prevent sexually transmitted disease among minority women. N Engl J Med. 1999 Jan 14;340(2):93-100.

Boyer CB, Shafer MA, Shaffer RA, Brodine SK, Ito SI, Yniguez DL, Benas DM, Schachter J. Prevention of sexually transmitted diseases and HIV in young military men: evaluation of a cognitive-behavioral skills-building intervention. Sex Transm Dis. 2001 Jun;28(6):349-55.

Boyer CB, Shafer MA. Preventing STDs and unplanned pregnancies: a cognitive-behavioral intervention for young women entering the U.S. military. Journal of Adolescent Health. 2003;32(2):129.

Jenkins RA, Jenkins PR, Nannis ED, McKee KT Jr, Temoshok LR. Correlates of human immunodeficiency virus infection risk behavior in male attendees of a clinic for sexually transmitted disease. Clin Infect Dis. 2000 Apr;30(4):723-9.

Williams JO, Bell NS, Amoroso PJ. Drinking and other risk taking behaviors of enlisted male soldiers in the US Army. Work. 2002;18(2):141-50.

Fisher JD, Fisher WA, Williams SS, Malloy TE. Empirical tests of an information-motivation-behavioral skills model of AIDS-preventive behavior with gay men and heterosexual university students. Health Psychol. 1994 May;13(3):238-50.

Chernesky M, Jang D, Luinstra K, Chong S, Smieja M, Cai W, Hayhoe B, Portillo E, Macritchie C, Main C, Ewert R. High analytical sensitivity and low rates of inhibition may contribute to detection of Chlamydia trachomatis in significantly more women by the APTIMA Combo 2 assay. J Clin Microbiol. 2006 Feb;44(2):400-5.

Chernesky MA, Jang DE. APTIMA transcription-mediated amplification assays for Chlamydia trachomatis and Neisseria gonorrhoeae. Expert Rev Mol Diagn. 2006 Jul;6(4):519-25. Review.

Levett PN, Brandt K, Olenius K, Brown C, Montgomery K, Horsman GB. Evaluation of three automated nucleic acid amplification systems for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in first-void urine specimens. J Clin Microbiol. 2008 Jun;46(6):2109-11. doi: 10.1128/JCM.00043-08. Epub 2008 Apr 9.

Moncada J, Schachter J, Hook EW 3rd, Ferrero D, Gaydos C, Quinn TC, Willis D, Weissfeld A, Martin DH. The effect of urine testing in evaluations of the sensitivity of the Gen-Probe Aptima Combo 2 assay on endocervical swabs for Chlamydia trachomatis and neisseria gonorrhoeae: the infected patient standard reduces sensitivity of single site evaluation. Sex Transm Dis. 2004 May;31(5):273-7.

Masek BJ, Arora N, Quinn N, Aumakhan B, Holden J, Hardick A, Agreda P, Barnes M, Gaydos CA. Performance of three nucleic acid amplification tests for detection of Chlamydia trachomatis and Neisseria gonorrhoeae by use of self-collected vaginal swabs obtained via an Internet-based screening program. J Clin Microbiol. 2009 Jun;47(6):1663-7. doi: 10.1128/JCM.02387-08. Epub 2009 Apr 22.

Schachter J, Chernesky MA, Willis DE, Fine PM, Martin DH, Fuller D, Jordan JA, Janda W, Hook EW 3rd. Vaginal swabs are the specimens of choice when screening for Chlamydia trachomatis and Neisseria gonorrhoeae: results from a multicenter evaluation of the APTIMA assays for both infections. Sex Transm Dis. 2005 Dec;32(12):725-8.

Serlin M, Shafer MA, Tebb K, Gyamfi AA, Moncada J, Schachter J, Wibbelsman C. What sexually transmitted disease screening method does the adolescent prefer? Adolescents' attitudes toward first-void urine, self-collected vaginal swab, and pelvic examination. Arch Pediatr Adolesc Med. 2002 Jun;156(6):588-91.

Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2006. MMWR. 2006;55(No. RR-11):1-100.


Responsible Party:	Cherrie B. Boyer, PhD, University of California San Francisco
ClinicalTrials.gov Identifier:	NCT01234103 History of Changes
Other Study ID Numbers:	W81XWH-04-1-0159
Study First Received:	November 3, 2010
Last Updated:	November 3, 2010
Health Authority:	United States: Federal Government United States: Institutional Review Board

Keywords provided by Department of Defense:


sexually transmitted infection sexual risk HIV young adults cognitive-behavioral intervention

Additional relevant MeSH terms:


Sexually Transmitted Diseases Genital Diseases, Female Genital Diseases, Male Infection Virus Diseases

ClinicalTrials.gov processed this record on March 03, 2015

To Top