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Preventing Health Damaging Behaviors in Male and Female Army Recruits

Primary Purpose

Sexually Transmitted Infection (STI) Prevention, Unintended Pregnancy Prevention, Sexual Risk Reduction

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits
Sponsored by
United States Department of Defense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Infection (STI) Prevention focused on measuring sexually transmitted infection, sexual risk, HIV, young adults, cognitive-behavioral intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fort Jackson Advance Individual Training Units

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Preventing sexual health risks

Improving nutrition, fitness and injury prevention

Arm Description

The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse

The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress

Outcomes

Primary Outcome Measures

Incidence of Sexually Transmitted Infections and the Self-reported Numbers of Unintended Pregnancies

Secondary Outcome Measures

Self-reported Behavioral Measures Related to STI/HIV Prevention

Full Information

First Posted
November 3, 2010
Last Updated
August 24, 2017
Sponsor
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT01234103
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to lack of continue funding
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Department of Defense

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
933 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preventing sexual health risks
Arm Type
Experimental
Arm Description
The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse
Arm Title
Improving nutrition, fitness and injury prevention
Arm Type
Other
Arm Description
The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress
Intervention Type
Behavioral
Intervention Name(s)
Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits
Intervention Description
Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk 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.
Primary Outcome Measure Information:
Title
Incidence of Sexually Transmitted Infections and the Self-reported Numbers of Unintended Pregnancies
Time Frame
6 to 9 months
Secondary Outcome Measure Information:
Title
Self-reported Behavioral Measures Related to STI/HIV Prevention
Time Frame
6 to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cherrie B Boyer, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fort Jackson Advance Individual Training Units
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29044
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Preventing Health Damaging Behaviors in Male and Female Army Recruits

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