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| ID | Type | Description | Link |
|---|---|---|---|
| U01MD011279 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Washington | OTHER |
| New York Blood Center | OTHER |
| University of Alabama at Birmingham | OTHER |
| Ann & Robert H Lurie Children's Hospital of Chicago |
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The proposed MyPEEPS Mobile intervention is a novel and evidence-driven intervention using mobile technology to deliver HIV prevention information specifically developed for at-risk young men who have sex with men (YMSM). This will be the one of the first studies to test the efficacy of a scaled-up, mobile version of an existing human immunodeficiency virus (HIV) prevention intervention originally developed for, designed by, and piloted for, a diverse group of YMSM.
MyPEEPS Mobile will be tested in an randomized controlled trial with racially and ethnically diverse HIV-negative or unknown status YMSM aged 13-18 at four geographically diverse sites: Birmingham, Chicago, New York City, and Seattle, allowing for increased generalizability of findings.
Men who have sex with men (MSM) bear a greater burden of HIV/AIDS than any other population group in the US, comprising only 2% of the population but 56% of individuals living with HIV/AIDS. Although much of the increased incidence in HIV has been reported among YMSM, especially among racial and ethnic minority groups, and is linked to high-risk sexual behavior, there remains a dearth of evidence-based HIV prevention interventions for YMSM - and none that address racially/ethnically diverse YMSM. To address this need, this study leverages mobile technology and MyPEEPS, an existing theory-driven, multi-ethnic, group-level, evidence-based intervention for diverse YMSM. MyPEEPS is a manualized curriculum, comprised of 6 modules focusing on key intermediate social and personal factors, including knowledge (e.g., correct way to use a condom), self-efficacy for safer sex, interpersonal communication skills and behavioral skills. MyPEEPS is one of the only HIV prevention interventions in the literature that focuses on diverse adolescent MSM. Long-term sustainability of face-to face, group-level behavioral interventions, such as MyPEEPS, have been problematic for dissemination in at-risk populations, particularly among young racial and ethnic minority groups. In response to this challenge, the investigators propose to translate MyPEEPS from a face-to-face, group-based curriculum to a mobile, responsive-driven web-based platform, accessible by smartphone or other web-enabled devices, to increase accessibility and scalability for diverse YMSM. The ubiquitous nature of mobile phones in daily life, especially among 13-18 year olds, has created opportunities for health interventions in a portable format with enhanced privacy. Using a participatory approach, this study will incorporate user-centered design in the translation of the MyPEEPS intervention onto a mobile platform.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention | Experimental | Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit. |
|
| Delayed Intervention | Experimental | Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyPEEPS Mobile | Behavioral | Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Condomless Anal Sex Acts | The number of condomless anal sex acts (CASA) will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. At each timepoint, participants were asked to report the past 3 month number of insertive and receptive anal sex acts during which condoms were not used. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
| Number of Anal Sex Partners | The number of anal sex partners will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. Participants are asked to report the number of insertive and receptive anal sex partners in their lifetime at the baseline timepoint and then asked to report the number of insertive and receptive anal sex partners in the past 3 months at each of the follow-up timepoints. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
| Number of Condomless Anal Sex Partners | The number of condomless anal sex (CAS) partners will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. Participants are asked to report the number of insertive and receptive anal sex partners with whom condoms were not used in their lifetime at the baseline timepoint and then asked to report the number of insertive and receptive anal sex partners with whom condoms were not used in the past 3 months at each of the follow-up timepoints. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
| Number of Anal Sex Acts Under the Influence of Drugs/Alcohol | The number of anal sex acts under the influence of drugs/alcohol will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. At each timepoint, participants were asked to report the past 3 month number of insertive and receptive anal sex acts during which they had been drinking alcohol or using drugs. |
| Measure | Description | Time Frame |
|---|---|---|
| Intent to Have Anal Sex | Participants were presented with the statement "During the next 3 months, I am not planning to have anal sex" with response options ranging from 1=Very true to 4=Very untrue. The mean value was calculated per group and per timepoint. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
| Measure | Description | Time Frame |
|---|---|---|
| Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex | Participants were asked to respond to 10 questions assessing self-efficacy in practicing condom use and safer sex communication with a partner. A sample item is "if I didn't want to have sex with my partner, I would be able to say no." Response options ranged from 1=Strongly agree to 4=Strongly disagree. Question scores ranged 1-4, values averaged and total scores ranged from 1 to 4, with lower values indicating higher self-efficacy |
Inclusion Criteria:
Exclusion Criteria:
Participants must identify as male, nonbinary, or genderqueer
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Schnall, PhD | Columbia University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Aids Outreach | Birmingham | Alabama | 35233 | United States | ||
| Lurie Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37129475 | Derived | Cordoba E, Garofalo R, Kuhns LM, Pearson CR, Batey DS, Bruce J, Radix A, Belkind U, Hidalgo MA, Hirshfield S, Schnall R. A Cross-sectional Study of Perceived Stress and Racial Discrimination Among a National Sample of Young Men Who Have Sex With Men. J Assoc Nurses AIDS Care. 2023 May-Jun 01;34(3):226-237. doi: 10.1097/JNC.0000000000000407. | |
| 36129712 | Derived | Schnall R, Kuhns LM, Pearson C, Batey DS, Bruce J, Hidalgo MA, Hirshfield S, Janulis P, Jia H, Radix A, Belkind U, Rodriguez RG, Garofalo R. Efficacy of MyPEEPS Mobile, an HIV Prevention Intervention Using Mobile Technology, on Reducing Sexual Risk Among Same-Sex Attracted Adolescent Males: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231853. doi: 10.1001/jamanetworkopen.2022.31853. |
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One participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Intervention | Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit. MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk young men who have sex with men (YMSM). |
| FG001 | Delayed Intervention | Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit. MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Intervention | Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit. MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM. |
| 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 | Number of Condomless Anal Sex Acts | The number of condomless anal sex acts (CASA) will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. At each timepoint, participants were asked to report the past 3 month number of insertive and receptive anal sex acts during which condoms were not used. | The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data. | Posted | Mean | Standard Error | condomless anal sex acts | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
|
Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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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 | Immediate Intervention | Study participants randomized to the immediate intervention arm will have access to the MyPEEPS Mobile from the baseline visit to 3-month follow-up visit. They will continue with follow-up visits at 6 months and 9 months, but will no longer have access to the MyPEEPS Mobile past the 3-month follow-up visit. MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rebecca Schnall, RN, MPH, PhD, Professor of Disease Prevention and Health Promotion (in Nursing) | Columbia University | 212-342-6886 | rb897@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2022 | Aug 12, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
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| OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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| Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
| Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use | Participants were asked if they have ever used Pre-exposure Prophylaxis (PrEP) at baseline, if they have used PrEP in the prior 3 months at all timepoints, and if they are currently using PrEP at the time of study visit at all timepoints. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
| Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use | Participants were asked if they've ever used Non-occupational Post-Exposure Prophylaxis (nPEP) at baseline and if they've used nPEP in the 3 months prior to each study visit timepoint. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
| Number of Participants With Self-Reported HIV Testing | Participants were asked to report how many times they've ever been tested for HIV at baseline and at each follow-up timepoint they were asked how many times they've tested for HIV in the prior 3 months. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
| Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing | Participants were asked to report past 3-month testing for sexually transmitted infections (STIs) at each timepoint. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
| Intent to Always Use Condoms During Anal Sex With All Sex Partners | Participants responded to the statement "During the next 3 months, I plan to always use condoms during anal sex with all of my sex partners" with response options ranging from 1=Very true to 4=Very untrue. Mean values were calculated by group for each timepoint. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
| Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk | Participants responded to the statement "I plan to use PrEP as a strategy to reduce my risk for HIV infection during the next three months" with response values ranging from 1=Very true to 4=Very untrue. Mean values were calculated for each group at each timepoint. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
| Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
| Condom Use Errors | The condom errors survey is a 12-item questionnaire was adapted to reflect a 6-week recall period. A sample question is "when you used condoms during the last six weeks, how often was the condom put on the wrong side up so that it had to be flipped over?" Response options ranged from 0=Never to 2=Always. Question scores ranged 0-2, values averaged and total scores ranged from 0 to 2, with lower values indicating fewer condom use errors. | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Columbia University School of Nursing | New York | New York | 10032 | United States |
| University of Washington | Seattle | Washington | 98105 | United States |
| 35867076 | Derived | Diaz JE, Sandh S, Schnall R, Garofalo R, Kuhns LM, Pearson CR, Bruce J, Batey DS, Radix A, Belkind U, Hidalgo MA, Hirshfield S. Predictors of Past-Year Health Care Utilization Among Young Men Who Have Sex with Men Using Andersen's Behavioral Model of Health Service Use. LGBT Health. 2022 Oct;9(7):471-478. doi: 10.1089/lgbt.2021.0488. Epub 2022 Jul 22. |
| 35241362 | Derived | Cordoba E, Kuizon CM, Garofalo R, Kuhns LM, Pearson C, Batey DS, Bruce J, Radix A, Belkind U, Hidalgo MA, Hirshfield S, Jia H, Schnall R. Are State-Level HIV Testing Policies for Minors Associated With HIV Testing Behavior and Awareness of Home-Based HIV Testing in Young Men Who Have Sex With Men? J Adolesc Health. 2022 Jun;70(6):902-909. doi: 10.1016/j.jadohealth.2021.12.023. Epub 2022 Feb 28. |
| 34855787 | Derived | Cordoba E, Garofalo R, Kuhns LM, Pearson C, Bruce J, Batey DS, Radix A, Belkind U, Hidalgo MA, Hirshfield S, Garibay Rodriguez R, Schnall R. Risk-taking behaviors in adolescent men who have sex with men (MSM): An association between homophobic victimization and alcohol consumption. PLoS One. 2021 Dec 2;16(12):e0260083. doi: 10.1371/journal.pone.0260083. eCollection 2021. |
| 31941475 | Derived | Kuhns LM, Garofalo R, Hidalgo M, Hirshfield S, Pearson C, Bruce J, Batey DS, Radix A, Belkind U, Jia H, Schnall R. A randomized controlled efficacy trial of an mHealth HIV prevention intervention for sexual minority young men: MyPEEPS mobile study protocol. BMC Public Health. 2020 Jan 15;20(1):65. doi: 10.1186/s12889-020-8180-4. |
| Withdrawal by Investigator |
|
| BG001 | Delayed Intervention | Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit. MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Any Anal Sex Acts With Another Male | Count of Participants | Participants |
|
| OG001 | Delayed Intervention | Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit. MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM. |
|
|
| Primary | Number of Anal Sex Partners | The number of anal sex partners will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. Participants are asked to report the number of insertive and receptive anal sex partners in their lifetime at the baseline timepoint and then asked to report the number of insertive and receptive anal sex partners in the past 3 months at each of the follow-up timepoints. | The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data. | Posted | Mean | Standard Error | Anal sex partners | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
|
|
|
| Primary | Number of Condomless Anal Sex Partners | The number of condomless anal sex (CAS) partners will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. Participants are asked to report the number of insertive and receptive anal sex partners with whom condoms were not used in their lifetime at the baseline timepoint and then asked to report the number of insertive and receptive anal sex partners with whom condoms were not used in the past 3 months at each of the follow-up timepoints. | The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data. | Posted | Mean | Standard Error | Condomless anal sex partners | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
|
|
|
| Primary | Number of Anal Sex Acts Under the Influence of Drugs/Alcohol | The number of anal sex acts under the influence of drugs/alcohol will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. At each timepoint, participants were asked to report the past 3 month number of insertive and receptive anal sex acts during which they had been drinking alcohol or using drugs. | The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data. | Posted | Mean | Standard Error | Anal sex acts under the influence | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
|
|
|
| Primary | Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use | Participants were asked if they have ever used Pre-exposure Prophylaxis (PrEP) at baseline, if they have used PrEP in the prior 3 months at all timepoints, and if they are currently using PrEP at the time of study visit at all timepoints. | The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data. | Posted | Count of Participants | Participants | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
|
|
|
| Primary | Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use | Participants were asked if they've ever used Non-occupational Post-Exposure Prophylaxis (nPEP) at baseline and if they've used nPEP in the 3 months prior to each study visit timepoint. | The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data. | Posted | Count of Participants | Participants | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
|
|
|
| Primary | Number of Participants With Self-Reported HIV Testing | Participants were asked to report how many times they've ever been tested for HIV at baseline and at each follow-up timepoint they were asked how many times they've tested for HIV in the prior 3 months. | The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data. | Posted | Count of Participants | Participants | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
|
|
|
| Primary | Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing | Participants were asked to report past 3-month testing for sexually transmitted infections (STIs) at each timepoint. | The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data. | Posted | Count of Participants | Participants | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
|
|
|
| Secondary | Intent to Have Anal Sex | Participants were presented with the statement "During the next 3 months, I am not planning to have anal sex" with response options ranging from 1=Very true to 4=Very untrue. The mean value was calculated per group and per timepoint. | The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data. | Posted | Mean | Standard Error | score on a scale | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
|
|
|
| Secondary | Intent to Always Use Condoms During Anal Sex With All Sex Partners | Participants responded to the statement "During the next 3 months, I plan to always use condoms during anal sex with all of my sex partners" with response options ranging from 1=Very true to 4=Very untrue. Mean values were calculated by group for each timepoint. | The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data. | Posted | Mean | Standard Error | units on a scale | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
|
|
|
| Secondary | Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk | Participants responded to the statement "I plan to use PrEP as a strategy to reduce my risk for HIV infection during the next three months" with response values ranging from 1=Very true to 4=Very untrue. Mean values were calculated for each group at each timepoint. | The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data. | Posted | Mean | Standard Error | units on a scale | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
|
|
|
| Other Pre-specified | Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex | Participants were asked to respond to 10 questions assessing self-efficacy in practicing condom use and safer sex communication with a partner. A sample item is "if I didn't want to have sex with my partner, I would be able to say no." Response options ranged from 1=Strongly agree to 4=Strongly disagree. Question scores ranged 1-4, values averaged and total scores ranged from 1 to 4, with lower values indicating higher self-efficacy | The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data. | Posted | Mean | Standard Error | units on a scale | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
|
|
|
| Other Pre-specified | Condom Use Errors | The condom errors survey is a 12-item questionnaire was adapted to reflect a 6-week recall period. A sample question is "when you used condoms during the last six weeks, how often was the condom put on the wrong side up so that it had to be flipped over?" Response options ranged from 0=Never to 2=Always. Question scores ranged 0-2, values averaged and total scores ranged from 0 to 2, with lower values indicating fewer condom use errors. | The analytic sample included 760 of the 764 participants enrolled because 1 participant was enrolled in error (ineligible age) and withdrawn from the study prior to randomization and 3 participants were excluded from the analytic sample due to missing or invalid data. | Posted | Mean | Standard Error | units on a scale | Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group) |
|
|
|
| 0 |
| 382 |
| 0 |
| 382 |
| 0 |
| 382 |
| EG001 | Delayed Intervention | Study participants randomized to the delayed intervention arm will complete visits at baseline, 3 months, 6 months, 9 months, and 12 months. They will have access to the MyPEEPS Mobile from the 9-month follow-up visit until the 12-month follow-up visit. MyPEEPS Mobile: Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM. | 0 | 381 | 0 | 381 | 0 | 381 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| 3-Month Follow-up |
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| 12-Month Follow-up |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 9-Month Follow-up |
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| 12-Month Follow-up |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 9-Month Follow-up |
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| 12-Month Follow-up |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 9-Month Follow-up |
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| 12-Month Follow-up |
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| 3-Month Follow-up |
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| 12-Month Follow-up |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 9-Month Follow-up |
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| 12-Month Follow-up |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 9-Month Follow-up |
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| 12-Month Follow-up |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 9-Month Follow-up |
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| 12-Month Follow-up |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 9-Month Follow-up |
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| 12-Month Follow-up |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 9-Month Follow-up |
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| 12-Month Follow-up |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 9-Month Follow-up |
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| 12-Month Follow-up |
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