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

HIV Clinical Trial

— KIU!  

Official title:

Efficacy of Internet-based HIV Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836445
• Other study ID #: 1R01DA035145-01
• Secondary ID: 1R01DA035145-01
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: March 2017

Study information

• Verified date: August 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 901
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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!

Related Conditions & MeSH terms

• Chlamydia
• Gonorrhea
• HIV

Intervention

Behavioral:
• Keep It Up!

• HIV Knowledge Control

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Northwestern University	Chicago	Illinois
United States	Hunter College	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	Emory University, Hunter College of City University of New York, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	Participant Experiences of Harm at 3 Month Follow-up	Log of any negative experiences or harm experienced by participant at three months.	3 Months
Other	Participant Experiences of Harm at 6 Month Follow-up	Log of any negative experiences or harm experienced by participant at six months.	6 Months
Other	Participant Experiences of Harm at 12 Month Follow-up	Log of any negative experiences or harm experienced by participant at twelve months.	12 Months
Other	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
Other	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
Other	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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