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

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ClinicalTrials.gov Identifier: NCT01836445
Recruitment Status : Completed
First Posted : April 19, 2013
Results First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Emory University
Hunter College of City University of New York
Information provided by (Responsible Party):
Brian Mustanski, Northwestern University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: HIV
Gonorrhea
Chlamydia
Interventions: Behavioral: Keep It Up!
Behavioral: HIV Knowledge Control

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From May 2013 to December 2015, 901 participants were recruited and enrolled from (1) community-based HIV testing organizations in Atlanta, Chicago, and New York; (2) local health department clinics in Chicago; (3) street outreach in Atlanta, Chicago, and New York; and (4) local and national advertising.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized after completing a baseline assessment and STI testing.

Reporting Groups
  Description
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.

Keep It Up!

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).

HIV Knowledge Control


Participant Flow for 5 periods

Period 1:   Intervention Modules
    Keep It Up! Intervention   HIV Knowledge Control
STARTED   445   456 
COMPLETED   375   434 
NOT COMPLETED   70   22 

Period 2:   3 Month Follow-up Assessment
    Keep It Up! Intervention   HIV Knowledge Control
STARTED   445 [1]   456 [1] 
COMPLETED   348   409 
NOT COMPLETED   97   47 
[1] All enrolled participants allowed to complete follow-up regardless of if they completed intervention

Period 3:   6 Month Follow-up Assessment
    Keep It Up! Intervention   HIV Knowledge Control
STARTED   445 [1]   455 [1] 
COMPLETED   342   380 
NOT COMPLETED   103   75 
[1] All enrolled participants allowed to complete follow-up regardless of if they completed intervention

Period 4:   12 Month Follow-up Assessment
    Keep It Up! Intervention   HIV Knowledge Control
STARTED   445 [1]   455 [1] 
COMPLETED   370   391 
NOT COMPLETED   75   64 
[1] All enrolled participants allowed to complete follow-up regardless of if they completed intervention

Period 5:   12 Month STI Testing
    Keep It Up! Intervention   HIV Knowledge Control
STARTED   445 [1]   455 [1] 
COMPLETED   365   378 
NOT COMPLETED   80   77 
[1] All enrolled participants allowed to complete follow-up regardless of if they completed intervention



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Keep It Up!

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).

HIV Knowledge Control

Total Total of all reporting groups

Baseline Measures
   Keep It Up! Intervention   HIV Knowledge Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 445   456   901 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   445   456   901 
   24.27  (3.02)   24.15  (2.89)   24.21  (2.95) 
Age, Customized 
[Units: Participants]
Count of Participants
     
18 - 24       
Participants Analyzed   445   456   901 
18 - 24   233   244   477 
25 - 29       
Participants Analyzed   445   456   901 
25 - 29   211   212   423 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   445   456   901 
Female      0   0.0%      0   0.0%      0   0.0% 
Male      445 100.0%      456 100.0%      901 100.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Native American       
Participants Analyzed   445   456   901 
Native American   1   4   5 
Asian       
Participants Analyzed   445   456   901 
Asian   15   22   37 
Black or African American       
Participants Analyzed   445   456   901 
Black or African American   106   113   219 
Hispanic or Latino       
Participants Analyzed   445   456   901 
Hispanic or Latino   135   125   260 
White       
Participants Analyzed   445   456   901 
White   165   165   330 
More than one race       
Participants Analyzed   445   456   901 
More than one race   15   17   32 
Unknown or Not Reported       
Participants Analyzed   445   456   901 
Unknown or Not Reported   8   10   18 
Condomless Anal Sex 
[Units: Condomless anal sex acts]
Mean (Standard Deviation)
     
Participants Analyzed   445   456   901 
   4.3  (13.1)   3.4  (6.7)   3.9  (9.9) 
Sexually Transmitted Infections [1] [2] 
[Units: Participants]
Count of Participants
     
Urethral Chlamydia       
Participants Analyzed   441   452   893 
Urethral Chlamydia   15   7   22 
Urethral Gonorrhea       
Participants Analyzed   441   452   893 
Urethral Gonorrhea   3   4   7 
Rectal Chlamydia       
Participants Analyzed   442   449   891 
Rectal Chlamydia   47   30   77 
Rectal Gonorrhea       
Participants Analyzed   442   449   891 
Rectal Gonorrhea   29   16   45 
Any STI       
Participants Analyzed   443   453   896 
Any STI   82   50   132 
[1] Enrolled participants who returned STI test kits for analysis at Baseline (n = 896)
[2] Enrolled participants who returned STI test kits for analysis at baseline. Denominator varies by testing site and study arm: urethral (control - 452; intervention - 441) rectal (control - 449; intervention - 442)
Education [1] 
[Units: Participants]
Count of Participants
     
Junior High School       
Participants Analyzed   445   456   901 
Junior High School   0   1   1 
Partial High School       
Participants Analyzed   445   456   901 
Partial High School   10   7   17 
High School Graduate/GED       
Participants Analyzed   445   456   901 
High School Graduate/GED   60   35   95 
Partial College (at Least One Year)       
Participants Analyzed   445   456   901 
Partial College (at Least One Year)   116   136   252 
College Education       
Participants Analyzed   445   456   901 
College Education   203   215   418 
Graduate Degree       
Participants Analyzed   445   456   901 
Graduate Degree   56   62   118 
[1] Enrolled participants who completed questions on educational background at baseline
Employment [1] [2] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   338   363   701 
Full Time      223  66.0%      228  62.8%      451  64.3% 
Part Time      115  34.0%      135  37.2%      250  35.7% 
[1] Enrolled participants who were employed and answered follow-up questions on employment status at baseline
[2] Only participants who were employed and answered the follow-up questions on employment are included in the analysis population.


  Outcome Measures

1.  Primary:   Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months   [ Time Frame: Baseline, 3 Months ]

2.  Primary:   Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months   [ Time Frame: Baseline, 6 Months ]

3.  Primary:   Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months   [ Time Frame: Baseline, 12 Months ]

4.  Primary:   Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline   [ Time Frame: Baseline ]

5.  Primary:   Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months   [ Time Frame: 12 months ]

6.  Secondary:   Mean Score of Condom Errors at Baseline and 3 Months   [ Time Frame: Baseline, 3 Months ]

7.  Secondary:   Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months   [ Time Frame: Baseline, 3 Months ]

8.  Secondary:   Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months   [ Time Frame: Baseline, 3 Months ]

9.  Secondary:   Mean Score of Health Protective Communication Skills at Baseline and 3 Months   [ Time Frame: Baseline, 3 Months ]

10.  Secondary:   Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months   [ Time Frame: Baseline, 12 Month ]

11.  Secondary:   Mean Score of Condom Errors at Baseline and 6 Months   [ Time Frame: Baseline, 6 Months ]

12.  Secondary:   Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months   [ Time Frame: Baseline, 6 Months ]

13.  Secondary:   Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months   [ Time Frame: Baseline, 6 Months ]

14.  Secondary:   Mean Score of Health Protective Communication Skills at Baseline and 6 Months   [ Time Frame: Baseline, 6 Months ]

15.  Secondary:   Mean Score of Condom Errors at Baseline and 12 Months   [ Time Frame: Baseline, 12 Months ]

16.  Secondary:   Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months   [ Time Frame: Baseline, 12 Months ]

17.  Secondary:   Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months   [ Time Frame: Baseline, 12 Months ]

18.  Secondary:   Mean Score of Health Protective Communication Skills at Baseline and 12 Months   [ Time Frame: Baseline, 12 Months ]

19.  Secondary:   Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months   [ Time Frame: Baseline, 12 Months ]

20.  Other Pre-specified:   Participant Rating of Intervention Acceptability and Tolerability   [ Time Frame: Immediately following completion of intervention (up to 3 weeks after intervention is started by participant) ]

21.  Other Pre-specified:   Participant Location   [ Time Frame: Immediately following completion of intervention (up to 3 weeks after intervention is started by participant) ]

22.  Other Pre-specified:   Participant Experiences of Harm at 3 Month Follow-up   [ Time Frame: 3 Months ]

23.  Other Pre-specified:   Participant Experiences of Harm at 6 Month Follow-up   [ Time Frame: 6 Months ]

24.  Other Pre-specified:   Participant Experiences of Harm at 12 Month Follow-up   [ Time Frame: 12 Months ]

25.  Other Pre-specified:   Occurrence of Sexually Transmitted Infections (STIs) at 3 Months   [ Time Frame: 3 Months ]

26.  Other Pre-specified:   Occurrence of Sexually Transmitted Infections (STIs) at 6 Months   [ Time Frame: 6 Months ]

27.  Other Pre-specified:   Level of Privacy   [ Time Frame: Immediately following completion of intervention (up to 3 weeks after intervention is started by participant) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Brian Mustanski
Organization: Northwestern University
phone: 312-503-5421
e-mail: brian@northwestern.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Brian Mustanski, Northwestern University
ClinicalTrials.gov Identifier: NCT01836445     History of Changes
Other Study ID Numbers: 1R01DA035145-01 ( U.S. NIH Grant/Contract )
1R01DA035145-01 ( U.S. NIH Grant/Contract )
First Submitted: April 17, 2013
First Posted: April 19, 2013
Results First Submitted: March 26, 2018
Results First Posted: July 11, 2018
Last Update Posted: July 11, 2018