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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Internet-based HIV Prevention

Conditions
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HIV, Gonorrhea, Chlamydia

Intervention / Treatment
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* Behavioral: Keep It Up!
* Behavioral: HIV Knowledge Control


Participation Criteria
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Eligibility Criteria
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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!

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Keep It Up! Intervention<br>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!<br> <br> * Other names: Keep It Up! 2.0;|
| Active Comparator: HIV Knowledge Control<br>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<br> <br> |

What is the study measuring?
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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 |