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Clinical Trials/NCT01836445
NCT01836445
Completed
Not Applicable

Efficacy of Internet-based HIV Prevention

Northwestern University3 sites in 1 country901 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
Northwestern University
Enrollment
901
Locations
3
Primary Endpoint
Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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 900 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.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
March 2017
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brian Mustanski

Associate Professor, Department of Medical Social Sciences; Director, IMPACT Program

Northwestern University

Eligibility 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!

Outcomes

Primary Outcomes

Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months

Time Frame: Baseline, 3 Months

Change in self-report of condomless anal sex acts at three months.

Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months

Time Frame: Baseline, 6 Months

Change in self-report of condomless anal sex acts at six months.

Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months

Time Frame: 12 months

The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at twelve months.

Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline

Time Frame: Baseline

The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at baseline.

Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months

Time Frame: Baseline, 12 Months

Change in self-report of condomless anal sex acts at twelve months.

Secondary Outcomes

  • Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months(Baseline, 3 Months)
  • Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months(Baseline, 3 Months)
  • Mean Score of Condom Errors at Baseline and 3 Months(Baseline, 3 Months)
  • Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months(Baseline, 12 Month)
  • Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months(Baseline, 6 Months)
  • Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months(Baseline, 6 Months)
  • Mean Score of Health Protective Communication Skills at Baseline and 6 Months(Baseline, 6 Months)
  • Mean Score of Condom Errors at Baseline and 12 Months(Baseline, 12 Months)
  • Mean Score of Condom Errors at Baseline and 6 Months(Baseline, 6 Months)
  • Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months(Baseline, 12 Months)
  • Mean Score of Health Protective Communication Skills at Baseline and 3 Months(Baseline, 3 Months)
  • Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months(Baseline, 12 Months)
  • Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months(Baseline, 12 Months)
  • Mean Score of Health Protective Communication Skills at Baseline and 12 Months(Baseline, 12 Months)

Study Sites (3)

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