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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD019181 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
| Callen-Lorde Community Health Center | OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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MyPEEPS Mobile Plus, a multi-level intervention for improving HIV prevention outcomes in YMSM, is a novel and evidence-driven approach using mobile technology to deliver HIV prevention information specifically developed for YMSM. Building on strong preliminary work, the proposed research is the next logical step in a body of work designed to assess whether refinement of this mobile intervention used in combination with virtual PrEP Peer Navigation will result in improvements in PrEP uptake and a reduction in HIV-related behavior. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.
This study expands MyPEEPS Mobile to develop MyPEEPS Mobile Plus, a multi-level intervention comprised of MyPEEPS Mobile with added PrEP content (based upon expert advisory and youth feedback) + PrEP E-Peer Navigation to overcome the challenges of PrEP initiation, adherence, and persistence among YMSM. Peer navigation is an evidence-based, widely recommended intervention for reaching youth and MSM for HIV-related care outcomes, with evidence of acceptability among racial/ethnic minority YMSM for PrEP. Peer navigation addresses common reasons for failing to begin or maintain PrEP use, including low perceived risk, structural or logistic barriers to care engagement, and anticipated side effects. Relative to in-person and group-based HIV prevention programs, behavioral interventions with digital and virtual components can have vast reach and present unique potential to rapidly scale delivery to very large and hidden groups. Therefore, the investigators propose to conduct a randomized controlled trial to test the efficacy of MyPEEPS Mobile Plus (a multi-level intervention comprised of MyPEEPS Mobile + PrEP E-Peer Navigation) for promoting initiation, adherence, and persistence of PrEP and decreased HIV risk behavior in YMSM. Building upon the team's demonstrated ability to enroll large numbers of young racially and ethnically diverse YMSM and extensive experience developing mobile health interventions, the proposed study will test the efficacy of this expanded, multi-level mobile HIV prevention intervention emphasizing PrEP. If efficacious, it will increase PrEP initiation, adherence, and persistence and decrease overall HIV risk in diverse YMSM in the US.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Participants randomized to the control arm will receive standard of care 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, and will have access to the MyPEEPS Mobile App during the study. |
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| Intervention | Experimental | Participants randomized to the intervention arm will have access to the MyPEEPS mobile application and Electronic peer PrEP navigation for the entire 12-month study period. |
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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 |
|---|---|---|
| PrEP Initiation: | Participants will self-report attending at least one PrEP-related care visit to asess medical eligibility for PrEP initiation. | Baseline, 6-month follow-up, 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Adherence | Daily oral PrEP users will report PrEP use in the past 7-days. | Baseline, 6-month follow-up, 12-month follow-up |
| PrEP Persistence | Questions will be measure visit constancy, i.e., self-report at least 1 PrEP related care visit in the past 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
male, nonbinary
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Schnall, PhD, MPH | Contact | 212-342-6886 | rb897@columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert Garofalo, MD, MPH | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Lisa Kuhns, PhD, MPH | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | Recruiting | New York | New York | 10032 | 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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| Electronic PrEP peer navigation | Behavioral | Electronic peer navigation to PreP services |
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| Baseline, 6-month follow-up, 12-month follow-up |
| 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 |