Trial record 17 of 30 for:    HIV [CONDITION] AND (pregnancy OR perinatal) [TREATMENT] | Open Studies

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:


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

Publications:
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.
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.
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:
Infection
Sexually Transmitted Diseases
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014