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

Efficacy of Internet-based HIV Prevention

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.

Study Overview

• Status: Completed
• Conditions: HIV; Chlamydia; Gonorrhea
• Intervention / Treatment: Behavioral: Keep It Up!; Behavioral: HIV Knowledge Control

• Study Type: Interventional
• Enrollment (Actual): 901
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • New York
    • New York, New York, United States, 10065
      • Hunter College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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!

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Keep It Up! Intervention; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months	Change in self-report of condomless anal sex acts at three months.	Baseline, 3 Months
Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months	Change in self-report of condomless anal sex acts at six months.	Baseline, 6 Months
Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months	Change in self-report of condomless anal sex acts at twelve months.	Baseline, 12 Months
Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline	The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at baseline.	Baseline
Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months	The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at twelve months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Score of Condom Errors at Baseline and 3 Months	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. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.	Baseline, 3 Months
Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months	The change in number of HIV statements (e.g. "Only the receptive/bottom partner is at risk of being infected with HIV during anal sex", "There is a vaccine that can stop people from getting HIV", and "A natural skin (lamb skin) condom works better against HIV than does a latex condom") correctly labeled as true or false at three months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.	Baseline, 3 Months
Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months	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) Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4	Baseline, 3 Months
Mean Score of Health Protective Communication Skills at Baseline and 3 Months	The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at three months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).	Baseline, 3 Months
Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months	The change in number of participants who report using illegal drugs or drugs not prescribed by a doctor before sex.	Baseline, 12 Month
Mean Score of Condom Errors at Baseline and 6 Months	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. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors	Baseline, 6 Months
Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months	The change in number of HIV statements (e.g. "Only the receptive/bottom partner is at risk of being infected with HIV during anal sex", "There is a vaccine that can stop people from getting HIV", and "A natural skin (lamb skin) condom works better against HIV than does a latex condom") correctly labeled as true or false at six months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.	Baseline, 6 Months
Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months	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) Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4	Baseline, 6 Months
Mean Score of Health Protective Communication Skills at Baseline and 6 Months	The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at six months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).	Baseline, 6 Months
Mean Score of Condom Errors at Baseline and 12 Months	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. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.	Baseline, 12 Months
Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months	The change in number of HIV statements (e.g. "Only the receptive/bottom partner is at risk of being infected with HIV during anal sex", "There is a vaccine that can stop people from getting HIV", and "A natural skin (lamb skin) condom works better against HIV than does a latex condom") correctly labeled as true or false at twelve months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.	Baseline, 12 Months
Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months	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) Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4	Baseline, 12 Months
Mean Score of Health Protective Communication Skills at Baseline and 12 Months	The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at twelve months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).	Baseline, 12 Months
Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months	The change in effect that HIV testing has on health beliefs (for example, "I cannot get HIV") and sexual behaviors at twelve months. Range 1-5; higher scores = more feelings of invulnerability	Baseline, 12 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Rating of Intervention Acceptability and Tolerability	Participant rating of how much they enjoyed the intervention and participant feedback and suggestions for improvement. Range 1-4; higher scores indicate greater acceptability.	Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)
Participant Location	Log of where participants completed the intervention sessions (participants can select multiple locations).	Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)
Participant Experiences of Harm at 3 Month Follow-up	Log of any negative experiences or harm experienced by participant at three months.	3 Months
Participant Experiences of Harm at 6 Month Follow-up	Log of any negative experiences or harm experienced by participant at six months.	6 Months
Participant Experiences of Harm at 12 Month Follow-up	Log of any negative experiences or harm experienced by participant at twelve months.	12 Months
Occurrence of Sexually Transmitted Infections (STIs) at 3 Months	The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 3 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline.	3 Months
Occurrence of Sexually Transmitted Infections (STIs) at 6 Months	The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 6 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline.	6 Months
Level of Privacy	Log of the levels of privacy of the locations where participants completed intervention.	Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute on Drug Abuse (NIDA); Emory University; Hunter College of City University of New York
• Investigators: Principal Investigator: Brian Mustanski, PhD, Northwestern University

Publications and helpful links

General Publications

• Centers for Disease Control and Prevention (CDC). HIV Surveillance in Adolescents and Young Adults. 2010.
• Centers for Disease Control and Prevention (CDC). Trends in HIV/AIDS diagnoses among men who have sex with men--33 states, 2001-2006. MMWR Morb Mortal Wkly Rep. 2008 Jun 27;57(25):681-6.
• Prejean J, Song R, Hernandez A, Ziebell R, Green T, Walker F, Lin LS, An Q, Mermin J, Lansky A, Hall HI; HIV Incidence Surveillance Group. Estimated HIV incidence in the United States, 2006-2009. PLoS One. 2011;6(8):e17502. doi: 10.1371/journal.pone.0017502. Epub 2011 Aug 3.
• Mustanski B, Lyons T, Garcia SC. Internet use and sexual health of young men who have sex with men: a mixed-methods study. Arch Sex Behav. 2011 Apr;40(2):289-300. doi: 10.1007/s10508-009-9596-1. Epub 2010 Feb 25.
• Mustanski B, Parsons JT, Sullivan PS, Madkins K, Rosenberg E, Swann G. Biomedical and Behavioral Outcomes of Keep It Up!: An eHealth HIV Prevention Program RCT. Am J Prev Med. 2018 Aug;55(2):151-158. doi: 10.1016/j.amepre.2018.04.026. Epub 2018 Jun 28.
• Mustanski B, Madkins K, Greene GJ, Parsons JT, Johnson BA, Sullivan P, Bass M, Abel R. Internet-Based HIV Prevention With At-Home Sexually Transmitted Infection Testing for Young Men Having Sex With Men: Study Protocol of a Randomized Controlled Trial of Keep It Up! 2.0. JMIR Res Protoc. 2017 Jan 7;6(1):e1. doi: 10.2196/resprot.5740.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: April 17, 2013
• First Submitted That Met QC Criteria: April 17, 2013
• First Posted (Estimate): April 19, 2013

Study Record Updates

• Last Update Posted (Actual): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Sexually Transmitted Diseases, Bacterial; Gonorrhea
• Other Study ID Numbers: 1R01DA035145-01 (U.S. NIH Grant/Contract)