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

NCT01836445 | Completed Results DMC

• 1 other identifier: 1R01DA035145-01
• Study Type: interventional
• Target: 901
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV; Gonorrhea; Chlamydia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (14)

• Mean Score of Condom Errors at Baseline and 3 Months

  Baseline, 3 Months

• 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 Health Protective Communication Skills at Baseline and 3 Months

  Baseline, 3 Months

• Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months

  Baseline, 12 Month

Other Outcomes (8)

• Participant Rating of Intervention Acceptability and Tolerability

  Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)

• Participant Location

  Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)

• Participant Experiences of Harm at 3 Month Follow-up

  3 Months

Study Arms (2)

Keep It Up! Intervention

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.

Behavioral: Keep It Up!

HIV Knowledge Control

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).

Behavioral: HIV Knowledge Control

Interventions

Keep It Up! BEHAVIORAL

Also known as: KIU!, KIU! 2.0, Keep It Up! 2.0

Keep It Up! Intervention

HIV Knowledge Control BEHAVIORAL

HIV Knowledge Control

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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!

Sponsors & Collaborators

• Northwestern University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Emory University: collaborator
• Hunter College of City University of New York: collaborator

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Hunter College

New York, New York, 10065, United States

Location

Related Publications (6)

• Centers for Disease Control and Prevention (CDC). HIV Surveillance in Adolescents and Young Adults. 2010.

  BACKGROUND

• 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.

  PMID: 18583954 BACKGROUND

• 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.

  PMID: 21826193 BACKGROUND

• 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.

  PMID: 20182787 BACKGROUND

• 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.

  PMID: 29937115 DERIVED

• 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.

  PMID: 28062389 DERIVED

MeSH Terms

Conditions

Gonorrhea; Chlamydia Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Chlamydiaceae Infections

Results Point of Contact

• Title: Dr. Brian Mustanski
• Organization: Northwestern University

brian@northwestern.edu

312-503-5421

Study Officials

• Brian Mustanski, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medical Social Sciences; Director, IMPACT Program

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 19, 2013
• Study Start: May 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 15, 2022
• Results First Posted: July 11, 2018

Record last verified: 2022-08

Locations

US (3)