Overview

This trial is active, not recruiting.

Conditions hiv, gonorrhea, chlamydia
Treatments keep it up!, hiv knowledge control
Sponsor Northwestern University
Collaborator National Institute on Drug Abuse (NIDA)
Start date May 2013
End date December 2016
Trial size 901 participants
Trial identifier NCT01836445, 1R01DA035145-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 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.
keep it up! KIU!
(Active Comparator)
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).
hiv knowledge control

Primary Outcomes

Measure
Unprotected Anal Sex
time frame: Baseline, 3 Months
Unprotected Anal Sex
time frame: Baseline, 6 Months
Unprotected Anal Sex
time frame: Baseline, 12 Months
Occurrence of Sexually Transmitted Infections (STIs)
time frame: Baseline
Occurrence of Sexually Transmitted Infections (STIs)
time frame: 12 months

Secondary Outcomes

Measure
Condom Errors
time frame: Baseline, 3 Months
HIV Knowledge
time frame: Baseline, 3 Months
Motivation and Behavioral Skills
time frame: Baseline, 3 Months
Health Protective Communication Skills
time frame: Baseline, 3 Months
Drug Use before sex
time frame: Baseline, 12 Month
Condom Errors
time frame: Baseline, 6 Months
HIV Knowledge
time frame: Baseline, 6 Months
Motivation and Behavioral Skills
time frame: Baseline, 6 Months
Health Protective Communication Skills
time frame: Baseline, 6 Months
Condom Errors
time frame: Baseline, 12 Months
HIV Knowledge
time frame: Baseline, 12 Months
Motivation and Behavioral Skills
time frame: Baseline, 12 Months
Health Protective Communication Skills
time frame: Baseline, 12 Months
Feelings of HIV Invulnerability
time frame: Baseline, 12 Months

Eligibility Criteria

Male participants from 18 years up to 29 years old.

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!

Additional Information

Official title Efficacy of Internet-based HIV Prevention
Principal investigator Brian Mustanski, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Northwestern University.