N/A
N=901
Keep It Up! 2.0: A Comparison of Two Online HIV Intervention Programs for Young Men Who Have Sex With Men
HIV · Gonorrhea · Chlamydia
Bottom Line
View on ClinicalTrials.gov: NCT01836445 ↗Enrolled (actual)
901
Serious AEs
2.7%
Results posted
Jul 2018
Primary outcome: Primary: Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months — 304; 312; 148; 184 Participants — p=0.20
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Keep It Up! (Behavioral); HIV Knowledge Control (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Northwestern University
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months |
304; 312; 148; 184 | 0.20 |
| PRIMARY Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months |
304; 312; 133; 156 | 0.60 |
| PRIMARY Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months |
304; 312; 136; 173 | 0.04 sig |
| PRIMARY Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline |
15; 7; 3; 4; 47; 30 | — |
| PRIMARY Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months |
4; 7; 1; 3; 22; 38 | 0.01 sig |
| SECONDARY Mean Score of Condom Errors at Baseline and 3 Months |
4.28; 4.05; 3.23; 3.45 | 0.150 |
| SECONDARY Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months |
85.93; 86.41; 89.11; 88.68 | 0.374 |
| SECONDARY Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months |
3.11; 3.02; 3.11; 3.03; 4.36; 4.33 | 0.919 |
| SECONDARY Mean Score of Health Protective Communication Skills at Baseline and 3 Months |
1.34; 1.36; 1.46; 1.37; 1.32; 1.10 | 0.067 |
| SECONDARY Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months |
100; 108; 92; 84 | 0.138 |
| SECONDARY Mean Score of Condom Errors at Baseline and 6 Months |
4.29; 3.96; 3.09; 3.12 | 0.173 |
| SECONDARY Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months |
85.78; 86.69; 88.96; 89.25 | 0.567 |
| SECONDARY Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months |
3.13; 3.03; 3.12; 3.04; 4.35; 4.34 | 0.861 |
| SECONDARY Mean Score of Health Protective Communication Skills at Baseline and 6 Months |
1.36; 1.35; 1.65; 1.39; 1.35; 1.06 | 0.001 sig |
| SECONDARY Mean Score of Condom Errors at Baseline and 12 Months |
4.31; 4.02; 3.30; 3.16 | 0.862 |
| SECONDARY Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months |
85.02; 86.76; 88.46; 89.94 | 0.762 |
| SECONDARY Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months |
3.13; 3.02; 2.93; 2.97; 4.32; 4.34 | 0.043 sig |
| SECONDARY Mean Score of Health Protective Communication Skills at Baseline and 12 Months |
1.32; 1.31; 1.65; 1.45; 1.32; 1.09 | 0.036 sig |
| SECONDARY Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months |
1.92; 1.84; 2.05; 1.95 | 0.719 |
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.
Eligibility Criteria
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!
Data sourced from ClinicalTrials.gov (NCT01836445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.