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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA035145-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Emory University | OTHER |
| Hunter College of City University of New York | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Keep It Up! | Behavioral |
|
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Mustanski, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Centers for Disease Control and Prevention (CDC). HIV Surveillance in Adolescents and Young Adults. 2010. | ||
| 18583954 | 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. | |
| 21826193 |
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Participants were randomized after completing a baseline assessment and STI testing.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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! |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Modules |
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| 3 Month Follow-up Assessment |
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| 6 Month Follow-up Assessment |
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| 12 Month Follow-up Assessment |
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| 12 Month STI Testing |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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! |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months | Change in self-report of condomless anal sex acts at three months. | Enrolled participants who completed assessments on their sexual risk behaviors (e.g. condomless anal sex (CAS) acts) at baseline and 3 month follow-up. | Posted | Count of Participants | Participants | Baseline, 3 Months |
|
Adverse event data collected for nearly 4 years (May 2013 - March 2017)
The adverse events that are reported differ from the clinicaltrials.gov definitions.
Serious Non-compliance: Failure to follow the regulations, requirements and/or determinations of the IRB that adversely affects the rights or welfare of subjects.
UPIRSO: Any incident that meets ALL of the following conditions:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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! |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Confidentiality Breach 3.27.14 | Social circumstances | Non-systematic Assessment | On March 27, 2014, a group email was sent to study participants using the carbon copy (cc:) field instead of blind carbon copy (bcc:) field. IRB determined to be a UPIRSO. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Mustanski | Northwestern University | 312-503-5421 | brian@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 12, 2016 | Feb 26, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2016 | Feb 26, 2018 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 24, 2014 | Feb 26, 2018 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| D002690 | Chlamydia Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| HIV Knowledge Control |
| Behavioral |
|
| 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:
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:
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:
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 |
| 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) |
| Participant Experiences of Harm at 3 Month Follow-up | Log of any negative experiences or harm experienced by participant at three months. | 3 Months |
| Participant Experiences of Harm at 6 Month Follow-up | Log of any negative experiences or harm experienced by participant at six months. | 6 Months |
| Participant Experiences of Harm at 12 Month Follow-up | Log of any negative experiences or harm experienced by participant at twelve months. | 12 Months |
| 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 |
| 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 |
| 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) |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Hunter College | New York | New York | 10065 | United States |
| 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. |
| 20182787 | 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. |
| 29937115 | Derived | 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. |
| 28062389 | 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. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Condomless Anal Sex | Mean | Standard Deviation | condomless anal sex acts |
|
| Sexually Transmitted Infections | Enrolled participants who returned STI test kits for analysis at Baseline (n = 896) | 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) | Count of Participants | Participants | No |
|
| Education | Enrolled participants who completed questions on educational background at baseline | Count of Participants | Participants |
|
| Employment | Enrolled participants who were employed and answered follow-up questions on employment status at baseline | Only participants who were employed and answered the follow-up questions on employment are included in the analysis population. | Count of Participants | Participants |
|
| OG001 | 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 |
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| Primary | Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months | Change in self-report of condomless anal sex acts at six months. | Enrolled participants who completed assessments on their sexual risk behaviors (e.g. condomless anal sex (CAS) acts) at baseline and 6 month follow-up. | Posted | Count of Participants | Participants | Baseline, 6 Months |
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| Primary | Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months | Change in self-report of condomless anal sex acts at twelve months. | Enrolled participants who completed assessments on their sexual risk behaviors (e.g. condomless anal sex (CAS) acts) at baseline and 12 month follow-up. | Posted | Count of Participants | Participants | Baseline, 12 Months |
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| 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. | 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) | Posted | Count of Participants | Participants | Baseline |
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| 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. | Enrolled participants who returned STI test kits for analysis at 12 month follow-up. Denominator varies by testing site and study arm: urethral (control - 374; intervention - 359) rectal (control - 374; intervention - 356) | Posted | Count of Participants | Participants | 12 months |
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| 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. | Enrolled participants who completed assessments on condom errors at baseline and 3 month follow-up. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 Months |
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| 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. | Enrolled participants who completed assessments on HIV knowledge at baseline and 3 month follow-up. | Posted | Mean | Standard Deviation | percentage of correct responses | Baseline, 3 Months |
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| Secondary | Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months | At three months, the change in:
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 | Enrolled participants who completed assessments on motivation & behavioral skills at baseline and 3 month. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 Months |
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| 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). | Enrolled participants who completed assessments on health protective communication (HPC) Relationship & condom items: must have reported vaginal/anal sex partner in prev. 3 months at both time points HIV testing items: must have reported NEW vaginal/anal sex partner in prev. 3 months at both time points | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 Months |
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| 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. | Enrolled participants who completed assessments on drug use before sex at baseline and 12 month. | Posted | Count of Participants | Participants | No | Baseline, 12 Month |
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| 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 | Enrolled participants who completed assessments on condom errors at baseline and 6 month. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Months |
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| 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. | Enrolled participants who completed assessments on HIV Knowledge at baseline and 6 month. | Posted | Mean | Standard Deviation | percentage of correct responses | Baseline, 6 Months |
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| Secondary | Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months | At six months, the change in:
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 | Enrolled participants who completed assessments on motivation & behavioral skills at baseline and 6 month. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Months |
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| 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). | Enrolled participants who completed assessments on health protective communication (HPC) Relationship & condom items: must have reported vaginal/anal sex partner in prev. 3 months at both time points HIV testing items: must have reported NEW vaginal/anal sex partner in prev. 3 months at both time points | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Months |
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| 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. | Enrolled participants who completed assessments on their condom errors at baseline and 12 month follow-up. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 Months |
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| 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. | Enrolled participants who completed assessments on their HIV Knowledge at baseline and 12 month follow-up. | Posted | Mean | Standard Deviation | percentage of correct responses | Baseline, 12 Months |
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| Secondary | Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months | At twelve months, the change in:
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 | Enrolled participants who completed assessments on motivation & behavioral skills at baseline and 12 month. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 Months |
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| 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). | Enrolled participants who completed assessments on health protective communication (HPC) Relationship & condom items: must have reported vaginal/anal sex partner in prev. 3 months at both time points HIV testing items: must have reported NEW vaginal/anal sex partner in prev. 3 months at both time points Higher score = less HPC skills; range 1-4 | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 Months |
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| 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 | Enrolled participants who completed assessments on HIV invulnerability at baseline and 12 month. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 Months |
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| Other Pre-specified | 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. | Enrolled participants who completed assessments on intervention acceptability immediately following completion of intervention. | Posted | Mean | Standard Deviation | units on a scale | Immediately following completion of intervention (up to 3 weeks after intervention is started by participant) |
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| Other Pre-specified | Participant Location | Log of where participants completed the intervention sessions (participants can select multiple locations). | Participants who reported information about the locations where they completed the intervention sessions. | Posted | Count of Participants | Participants | No | Immediately following completion of intervention (up to 3 weeks after intervention is started by participant) |
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| Other Pre-specified | Participant Experiences of Harm at 3 Month Follow-up | Log of any negative experiences or harm experienced by participant at three months. | Number of participants who reported negative health experiences at 3 Month Follow-up | Posted | Count of Participants | Participants | 3 Months |
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| Other Pre-specified | Participant Experiences of Harm at 6 Month Follow-up | Log of any negative experiences or harm experienced by participant at six months. | Number of participants who reported negative health experiences at 6 Month Follow-up | Posted | Count of Participants | Participants | 6 Months |
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| Other Pre-specified | Participant Experiences of Harm at 12 Month Follow-up | Log of any negative experiences or harm experienced by participant at twelve months. | Number of participants who reported negative health experiences at 12 Month Follow-up as a result of participating in the study | Posted | Count of Participants | Participants | 12 Months |
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| Other Pre-specified | 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. | Participants who were positive for an STI at baseline, were sent a follow-up test kit at 3 Month Follow-up, and tested positive again. | Posted | Count of Participants | Participants | 3 Months |
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| Other Pre-specified | 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. | Participants who were positive for an STI at baseline, were sent a follow-up test kit at 6 Month Follow-up, and tested positive again. | Posted | Count of Participants | Participants | 6 Months |
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| Other Pre-specified | Level of Privacy | Log of the levels of privacy of the locations where participants completed intervention. | Participants who reported information about the locations where they completed the intervention sessions. | Posted | Count of Participants | Participants | Immediately following completion of intervention (up to 3 weeks after intervention is started by participant) |
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|
| 0 |
| 445 |
| 11 |
| 445 |
| 0 |
| 445 |
| EG001 | 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 | 0 | 456 | 13 | 456 | 0 | 456 |
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| Confidentiality Breach 9.11.15 | Social circumstances | Non-systematic Assessment | On September 11, 2015, a study participant received an email from a project research assistant that contained the assessment login information and email address of another participant. IRB determined to be serious non-compliance. |
|
Not provided
Not provided
Not provided
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D002694 | Chlamydiaceae Infections |
| 6 Month Follow-up |
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| 12 Month Follow-up |
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| Urethral Gonorrhea |
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| Rectal Chlamydia |
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| Rectal Gonorrhea |
|
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| Any STI |
|
|
| Urethral Gonorrhea |
|
|
| Rectal Chlamydia |
|
|
| Rectal Gonorrhea |
|
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| Any STI |
|
|
| Baseline - Social Norms |
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| 3 Month Follow-up - Social Norms |
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| Baseline - Behavioral Skills |
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| 3 Month Follow-up - Behavioral Skills |
|
| Regression, Linear |
| 0.493 |
| Other |
Generalized Linear Mixed Model statistical test used |
| Analysis for Behavioral Skills items | Regression, Linear | 0.002 | Other | Generalized Linear Mixed Model statistical test used |
| 3 Month Follow-up - HPC Relationship Maintenance |
|
|
| Baseline - HPC Condom Use |
|
|
| 3 Month Follow-up - HPC Condom Use |
|
|
| Baseline - HPC HIV Testing |
|
|
| 3 Month Follow-up - HPC HIV Testing |
|
|
| Regression, Linear |
| 0.135 |
| Other |
Generalized Linear Mixed Model statistical test used |
| Analysis for HIV Testing items | Regression, Linear | 0.025 | Other | Generalized Linear Mixed Model statistical test used |
| Baseline - Social Norms |
|
| 6 Month Follow-up - Social Norms |
|
| Baseline - Behavioral Skills |
|
| 6 Month Follow-up - Behavioral Skills |
|
| Regression, Linear |
| 0.628 |
| Other |
Generalized Linear Mixed Model statistical test used |
| Analysis for behavioral skills items | Regression, Linear | 0.151 | Other | Generalized Linear Mixed Model statistical test used |
| 6 Month Follow-up - HPC Relationship Maintenance |
|
|
| Baseline - HPC Condom Use |
|
|
| 6 Month Follow-up - HPC Condom Use |
|
|
| Baseline - HPC HIV Testing |
|
|
| 6 Month Follow-up - HPC HIV Testing |
|
|
| Regression, Linear |
| 0.067 |
| Other |
Generalized Linear Mixed Model statistical test used |
| Analysis for HIV Testing items | Regression, Linear | 0.637 | Other | Generalized Linear Mixed Model statistical test used |
| Baseline - Social Norms |
|
| 12 Month Follow-up - Social Norms |
|
| Baseline - Behavioral Skills |
|
| 12 Month Follow-up - Behavioral Skills |
|
| 0.617 |
| Superiority |
| Analysis for Behavioral Skills items | Regression, Linear | 0.570 | Superiority |
| 12 Month Follow-up - HPC Relationship Maintenance |
|
|
| Baseline - HPC Condom Use |
|
|
| 12 Month Follow-up - HPC Condom Use |
|
|
| Baseline - HPC HIV Testing |
|
|
| 12 Month Follow-up - HPC HIV Testing |
|
|
| 0.837 |
| Superiority |
| Analysis for HIV Testing items | Regression, Linear | 0.953 | Superiority |
| Coffee Shop |
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| Community Center |
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| Library |
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| Friend's House |
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| Other |
|
| Rectal Chlamydia |
|
| Rectal Gonorrhea |
|
| Any STI |
|
| Rectal Chlamydia |
|
| Rectal Gonorrhea |
|
| Any STI |
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| Moderately Private |
|
| Completely Private |
|