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| ID | Type | Description | Link |
|---|---|---|---|
| UH3AI169658 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
| Northwestern University | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This study will use community-informed advertisements and messages through electronic methods to recruit and retain a large (N=3,200), diverse national sample of high-risk young men who have sex with men (YMSM) and non-binary individuals that are assigned male sex at birth, 16-29 years of age to determine the efficacy of the MyPEEPS Mobile intervention on reduced incident HIV infections in comparison to a standard of care condition and to examine the degree to which reduced incident HIV infections occurs in the context of potential multilevel moderators and conceptual mediators. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.
In direct response to RFA-AI-21-018, Limited Interaction Targeted Epidemiology (LITE-2): To Advance HIV Prevention (UG3/UH3 Clinical Trial Optional), we proposed to harness innovative electronic methods to conduct a large, rigorous national study collecting and contextualizing epidemiological HIV incidence data in Young Men who have Sex with Men (YMSM) and testing the efficacy of MyPEEPS Mobile, an evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence. We proposed to establish a large national cohort of 3,200 racially and ethnically diverse YMSM 16-29 years old, the age YMSM are most susceptible to HIV acquisition to identify theoretically-driven correlates of HIV seroconversion among a key population experiencing a disproportionate number of new HIV diagnoses.
Randomized controlled trials (RCTs) are considered the gold standard for estimating treatment efficacy because randomization mitigates risk of bias by balancing measured and unmeasured confounders across treatment groups. However, RCTs are costly, time-consuming, and can be challenging to conduct in certain context. We are therefore integrating the robust epidemiological data that we collected during the UG3 phase into the clinical trial design. That integration is a potentially appealing way to generate an external comparator cohort to increase the power of our RCT to estimate the effect of MyPEEPS Mobile on HIV incidence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants randomized to the control arm will receive standard of care. This consists of HIV home testing every 6 months, information regarding sexual and other behaviors that potentiate one's risk for HIV infection, receipt of a fact sheet about PrEP and PEP, referrals to the local PrEP clinic, and referrals for local sexually transmitted disease testing. | |
| Intervention | Experimental | Participants randomized to the intervention arm will have access to MyPEEPS Mobile for the next 6 months. MyPEEPS Mobile is a secure web app with content delivered through games, scenarios, and role-plays within 22 mobile activities (true/ false questions, multiple choice, matching, videos). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyPEEPS Mobile | Behavioral | An evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence. |
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| Measure | Description | Time Frame |
|---|---|---|
| HIV Incidence | OraQuick In-Home HIV Tests will be shipped to participants at baseline, 6 and 12 months. | Baseline, 6 month follow up, 12 month follow up. |
| Total Condomless Anal Sex Occurring in the Context of Insufficient PrEP Protection | Condomless anal sex acts not protected by PrEP, defined as condomless anal sex acts in the prior 6 months without protection via PrEP. We will measure sexual risk with the AIDS-Risk Behavior Assessment. | Baseline, 6 month follow up, 12 month follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported PrEP Initiation | Self reported PrEP initiation variables will be measured for the purposes of characterizing the uptake of PrEP over the course of the study. We will use a self-reported approach to capture the date of initiation of medication, current use, and most recent date the medication was taken. | Baseline, 6 month follow up, 12 month follow up. |
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Inclusion Criteria:
Exclusion Criteria:
Sex assigned at birth is male and identify gender as male or non-binary
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Schnall, PhD, MPH | Contact | 212-342-6886 | rb897@columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Schnall, PhD, MPH | Columbia University | Principal Investigator |
| Robert Garofalo, MD, MPH | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States | |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Dustin Duncan, ScD |
| Columbia University |
| Principal Investigator |
| Columbia University |
| Recruiting |
| New York |
| New York |
| 10032 |
| United States |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |