Clinical trial NCT01234103: Preventing Health Damaging Behaviors in Male and Female Army Recruits
Official title: Preventing Health Damaging Behaviors in Male and Female Army Recruits
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sexually Transmitted Infection (STI) Prevention
Unintended Pregnancy Prevention
Sexual Risk Reduction
Alcohol and Other Substance Use Prevention
Intimate Partner Violence Prevention
Keywords: sexually transmitted infection
sexual risk
HIV
young adults
cognitive-behavioral intervention
Lead sponsor: United States Department of Defense
Sponsor class: FED
First posted: 2010-11-04
Enrollment: 933
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
measure: Incidence of Sexually Transmitted Infections and the Self-reported Numbers of Unintended Pregnancies
timeFrame: 6 to 9 months
Secondary outcomes:
measure: Self-reported Behavioral Measures Related to STI/HIV Prevention
timeFrame: 6 to 9 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Fort Jackson Advance Individual Training Units
state: South Carolina
Study officials:
affiliation: University of California, San Francisco
name: Cherrie B Boyer, PhD
role: PRINCIPAL_INVESTIGATOR
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