- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03167606
A Pragmatic Clinical Trial of MyPEEPS Mobile to Improve HIV Prevention Behaviors in Diverse Adolescent MSM
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- Birmingham AIDS Outreach
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Illinois
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Chicago, Illinois, United States, 60611
- Lurie Children's Hospital
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New York
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New York, New York, United States, 10032
- Columbia University School of Nursing
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Washington
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Seattle, Washington, United States, 98105
- University of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Self-identify as male, nonbinary, or genderqueer
- Male sex assigned at birth
- Understand and read English
- Live in the United States or its territories
- Own or have access to a mobile device (e.g., smartphone or tablet)
- Same-sex attraction and either kissed another guy or intending to engage in sexual activity with another guy in next year
- Self-report HIV-negative or unknown status
Exclusion Criteria:
- HIV+
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
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Experimental: 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.
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Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Condomless Anal Sex Acts
Time Frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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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.
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Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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Number of Anal Sex Partners
Time Frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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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.
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Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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Number of Condomless Anal Sex Partners
Time Frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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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.
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Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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Number of Anal Sex Acts Under the Influence of Drugs/Alcohol
Time Frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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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.
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Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use
Time Frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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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.
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Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use
Time Frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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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.
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Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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Number of Participants With Self-Reported HIV Testing
Time Frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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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.
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Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing
Time Frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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Participants were asked to report past 3-month testing for sexually transmitted infections (STIs) at each timepoint.
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Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intent to Have Anal Sex
Time Frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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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.
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Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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Intent to Always Use Condoms During Anal Sex With All Sex Partners
Time Frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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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.
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Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk
Time Frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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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.
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Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex
Time Frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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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
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Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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Condom Use Errors
Time Frame: Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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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.
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Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rebecca Schnall, PhD, Columbia University School of Nursing
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAQ6500
- U01MD011279 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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