Trial record 16 of 666 for:    HIV transmission AND Treatment of sexually transmitted disease OR prevention of STD OR prevention of STI OR treatment of STD OR treatment of STI OR prevention of sexually transmitted disease | Open Studies

Keep It Up! 2.0: A Comparison of Two Online HIV Intervention Programs for Young Men Who Have Sex With Men (KIU!)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Northwestern University
Sponsor:
Collaborators:
Emory University
Hunter College
Information provided by (Responsible Party):
Brian Mustanski, Northwestern University
ClinicalTrials.gov Identifier:
NCT01836445
First received: April 17, 2013
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

Young men who have sex with men (YMSM) account for almost 70% of HIV diagnoses among all young people in the U.S. and are alone in facing an increasing rate of infections. Because YMSM are less likely to receive relevant sexual health education in traditional settings (e.g. schools, community), the Internet is a unique route of reaching and helping YMSM.

The purpose of this study is to compare two different versions of an online HIV prevention program for YMSM. The study is being conducted by researchers at Northwestern University in Chicago, Hunter College in New York City, and Emory University in Atlanta. A total of 750 YMSM will be enrolled into this study from the clinics of community partners in Chicago, New York, and Atlanta.

Participants will be randomly assigned to one of two versions of the program. Some topics in the program include HIV facts and myths, sexually transmitted infections (STIs), and condom use. All participants, regardless of the program version they receive, will also take at-home urine and rectal tests for the STIs chlamydia and gonorrhea. After completing the program, participants will be contacted three more times over the course of a year for follow-up sessions and surveys.

The research team hypothesizes that the YMSM-specific prevention program will lead to a significant reduction in the frequency of unprotected anal sex acts and new STI infections compared to the HIV knowledge program that is for a general audience. The YMSM-specific program will also lead to improvements in secondary knowledge, motivation, and skills outcomes.

In order for the research team to measure the effectiveness of the YMSM-specific prevention program and determine if the study hypothesis is correct, participants will be asked questions about themselves, including questions about their sexual orientation, sexual experiences, health practices, including drug use, health knowledge, and questions about their feelings and emotions. Based on this information, the research team hopes to later change, improve, or expand the program to better address the needs of YMSM.


Condition Intervention
HIV
Gonorrhea
Chlamydia
Behavioral: Keep It Up!
Behavioral: HIV Knowledge Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of Internet-based HIV Prevention

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Unprotected Anal Sex [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]
    Change in number of unprotected anal sex acts at three months.

  • Unprotected Anal Sex [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
    Change in number of unprotected anal sex acts at six months.

  • Unprotected Anal Sex [ Time Frame: Baseline, 12 Months ] [ Designated as safety issue: No ]
    Change in number of unprotected anal sex acts at twelve months.

  • Occurrence of Sexually Transmitted Infections (STIs) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at baseline.

  • Occurrence of Sexually Transmitted Infections (STIs) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at twelve months.


Secondary Outcome Measures:
  • Condom Errors [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]
    The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at three months.

  • HIV Knowledge [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]
    The change in number of HIV statements correctly labeled as true or false at three months.

  • Motivation and Behavioral Skills [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]

    At three months, the change in:

    • Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer)
    • Social Norms (for example, partners, friends, or family members opinions about condom use)
    • Behavioral Skills (for example, negotiating condom use)

  • Health Protective Communication Skills [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]
    The change in how frequently health protection (for example, condom use and regular STI testing) is discussed with sex partners at three months.

  • Drug Use before sex [ Time Frame: Baseline, 12 Month ] [ Designated as safety issue: No ]
    The change in frequency that illegal drugs or drugs not prescribed by a doctor are used before sex.

  • Condom Errors [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
    The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms)at six months.

  • HIV Knowledge [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
    The change in number of HIV statements correctly labeled as true or false at six months.

  • Motivation and Behavioral Skills [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]

    At six months, the change in:

    • Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer)
    • Social Norms (for example, partners, friends, or family members opinions about condom use)
    • Behavioral Skills (for example, negotiating condom use)

  • Health Protective Communication Skills [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
    The change in how frequently health protection (for example, condom use and regular STI testing) is discussed with sex partners at six months.

  • Condom Errors [ Time Frame: Baseline, 12 Months ] [ Designated as safety issue: No ]
    The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at twelve months.

  • HIV Knowledge [ Time Frame: Baseline, 12 Months ] [ Designated as safety issue: No ]
    The change in number of HIV statements correctly labeled as true or false at twelve months.

  • Motivation and Behavioral Skills [ Time Frame: Baseline, 12 Months ] [ Designated as safety issue: No ]

    At twelve months, the change in:

    • Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer)
    • Social Norms (for example, partners, friends, or family members opinions about condom use)
    • Behavioral Skills (for example, negotiating condom use)

  • Health Protective Communication Skills [ Time Frame: Baseline, 12 Months ] [ Designated as safety issue: No ]
    The change in how frequently health protection (for example, condom use and regular STI testing) is discussed with sex partners at twelve months.

  • Feelings of HIV Invulnerability [ Time Frame: Baseline, 12 Months ] [ Designated as safety issue: No ]
    The change in effect that HIV testing has on health beliefs (for example, "I cannot get HIV") and sexual behaviors at twelve months.


Other Outcome Measures:
  • Participant Demographics [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Age, ethnicity/race, education, and socioeconomic status

  • Participant Rating of Intervention Acceptability and Tolerability [ Time Frame: Immediately following completion of intervention (up to 3 weeks after intervention is started by participant) ] [ Designated as safety issue: No ]
    Participant rating of how much they enjoyed the intervention and participant feedback and suggestions for improvement.

  • Participant Location, Level of Privacy, and Experiences of Harm During Intervention [ Time Frame: Immediately following completion of intervention (up to 3 weeks after intervention is started by participant) ] [ Designated as safety issue: Yes ]
    Log of where participants completed the intervention, the level of privacy of this location, and any negative experiences or harm experienced by participant during the intervention.

  • Participant Experiences of Harm at 3 Month Follow-up [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
    Log of any negative experiences or harm experienced by participant at three months.

  • Participant Experiences of Harm at 6 Month Follow-up [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Log of any negative experiences or harm experienced by participant at six months.

  • Participant Experiences of Harm at 12 Month Follow-up [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Log of any negative experiences or harm experienced by participant at twelve months.


Estimated Enrollment: 750
Study Start Date: May 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Keep It Up! Intervention
The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-24 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete.
Behavioral: Keep It Up!
Other Names:
  • KIU!
  • KIU! 2.0
  • Keep It Up! 2.0
Active Comparator: HIV Knowledge Control
The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days).
Behavioral: HIV Knowledge Control

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Birth male who identifies as male and reports sexual contact with another male
  • Received an HIV negative test result from a participating clinic/recruitment site
  • Unprotected anal sex with another male in the last 6 months
  • Ability to read English at 8th grade level

Exclusion Criteria:

  • HIV positive
  • Female or Transgender
  • No email address for contact
  • Currently in a monogamous relationship lasting longer than 6 months
  • Participated in previous versions of KIU!
  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: NCT01836445

Contacts
Contact: Krystal L Madkins, MPH 312-503-6529 krystal.madkins@northwestern.edu
Contact: George J Greene, PhD 312-503-3603 george-greene@northwestern.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Patrick Sullivan, PhD    404-727-2038    pssulli@emory.edu   
Contact: Craig Sineath, MPH    404-712-9211    rsineat@emory.edu   
Principal Investigator: Patrick Sullivan, PhD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Krystal Madkins, MPH    312-503-6529    krystal.madkins@northwestern.edu   
Contact: George J Greene, PhD    312-503-3603    george-greene@northwestern.edu   
Principal Investigator: Brian Mustanski, PhD         
Sub-Investigator: George J Greene, PhD         
United States, New York
Hunter College Recruiting
New York, New York, United States, 10065
Contact: Jeffrey Parsons, PhD    212-772-5533    jeffrey.parsons@hunter.cuny.edu   
Contact: Ruben Jimenez    212-206-7919 ext 932    rjimenez@chestnyc.org   
Principal Investigator: Jeffrey Parsons, PhD         
Sponsors and Collaborators
Northwestern University
Emory University
Hunter College
Investigators
Principal Investigator: Brian Mustanski, PhD Northwestern University
  More Information

Publications:
Responsible Party: Brian Mustanski, Associate Professor, Department of Medical Social Sciences; Director, IMPACT Program, Northwestern University
ClinicalTrials.gov Identifier: NCT01836445     History of Changes
Other Study ID Numbers: 1R01DA035145-01, 1R01DA035145-01
Study First Received: April 17, 2013
Last Updated: December 4, 2013
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Additional relevant MeSH terms:
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Chlamydia Infections
Gonorrhea
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Neisseriaceae Infections

ClinicalTrials.gov processed this record on July 26, 2014