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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA022067 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Gilead Sciences | INDUSTRY |
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This study identifies social and behavioral factors likely to influence PrEP acceptability and adherence among men who have sex with men (MSM), and collaborates with a community health center to evaluate a two-stage intervention to improve PrEP decision-making, as well as persistence and adherence for those who chose to take PrEP.
Pre-exposure prophylaxis (PrEP) refers to daily or intermittent oral administration of antiretroviral drugs designed to protect high-risk HIV-negative individuals from infection. In order for PrEP to become an effective prevention tool, three critical factors must be addressed: a) acceptability, i.e., individuals who would benefit from PrEP must know about it and be willing to take it; b) adherence, i.e., individuals who choose to PrEP as a prevention strategy must take the pills as prescribed; and c) implementation, i.e., processes and protocols must be developed to allow for the integration of PrEP delivery and programs into real world settings in a way that is feasible, scalable, and realistic. This project has three specific aims: 1) Identifying social and behavioral factors that are likely to influence PrEP implementation, acceptance, and use/adherence by men who have sex with men (MSM) in NYC, including factors at individual-, community-, and organizational-levels; 2) Examining social and behavioral factors associated with disparities in access to prevention and care services among MSM in NYC that might directly impact PrEP implementation programs and policies; and 3) Evaluating an intervention in which PrEP is introduced, provided, and supported as part of a prevention package delivered in an community health center. The project has the potential to exert a sustained and powerful influence not only on the effectiveness of PrEP interventions for MSM, but also on dissemination and scalability of a targeted intervention within community-based settings and in a manner that reduces disparities in access and maximizes cultural competence and acceptability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counseling + SOC Adherence | Experimental | Sexual Health Counseling followed by Standard of Care Adherence Support |
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| Counseling + Enhanced Adherence | Experimental | Sexual Health Counseling followed by Enhanced Adherence Intervention |
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| Information + SOC Adherence | Experimental | PrEP Information followed by Standard of Care Adherence Support |
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| Information + Enhanced Adherence | Experimental | PrEP Information followed by Enhanced Adherence Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sexual Health Counseling | Behavioral | This brief intervention presents PrEP within the context of a patient's comprehensive sexual health plan and is designed to enhance decision-making around PrEP use and decrease sexual risk taking. |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Uptake | Whether or not the patient decides to take PrEP | BL through 3-months |
| PrEP Persistence | Whether or not patients who decide to take PrEP persist with the medication for the duration of the study. | BL through 12-months |
| PrEP Adherence | Biological measure of medication adherence using dried blood spots, and self-report measure of adherence using VAS. | BL through 12 months |
| Sexual Risk Behavior | Measured through STI testing and self-report. | BL through 12-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarit A Golub, PhD, MPH | Hunter College, CUNY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Callen-Lorde Community Health Center | New York | New York | 10011 | United States |
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| Label | URL |
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| Study Website | View source |
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| Enhanced Adherence Intervention | Behavioral | This brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support. |
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| PrEP Information (Active Control) | Behavioral | Standard of Care Information about PrEP |
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| Standard of Care Adherence Support (Active Control) | Behavioral | Standard of care information and instruction about PrEP adherence. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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