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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH104083-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fenway Community Health | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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This study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis (PrEP) for HIV prevention among men who have sex with men (MSM). The overall objective is to determine the feasibility of a clinic-based Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report occasional condomless sex and who anticipate a period of high-risk while away from home (e.g. vacation) during the study period.
This proposed study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis for HIV prevention among men who have sex with men (MSM). Long-term PrEP may be unnecessary for the many HIV-uninfected men who have episodic contextually defined high-risk periods, particularly when away from their home setting. Alternative dosing strategies, such as short-term fixed-interval episodic PrEP (Epi-PrEP), may be a more realistic, feasible, acceptable, and useful option with high public health impact for the majority of MSM. The overall objective is to determine the feasibility of a clinic-based Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report occasional condomless sex and who anticipate a period of high-risk while away from home (e.g. vacation) during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| emtricitabine/tenofovir | Drug | Short-term episodic use for 2-3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With PrEP Adherence | Biological measure of medication in the blood. Adherence will be measured using plasma analyses. We used the cut off of 4 doses/week to determine protective levels of adherence. The determination of this was drug levels equal to TFV 4.2 ng/mL FTC 4.6 ng/mL. | Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald D Stall, PhD, MPH | University of Pittsburgh | Principal Investigator |
| Kenneth Mayer, MD | Fenway Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fenway Institute | Boston | Massachusetts | 02215 | United States | ||
| Div of Infectious Diseases, University of Pittsburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32692109 | Derived | Egan JE, Ho K, Stall R, Drucker MT, Tappin R, Hendrix CW, Marzinke MA, Safren SA, Mimiaga MJ, Psaros C, Elsesser S, Mayer KH. Feasibility of Short-Term PrEP Uptake for Men Who Have Sex With Men With Episodic Periods of Increased HIV Risk. J Acquir Immune Defic Syndr. 2020 Aug 15;84(5):508-513. doi: 10.1097/QAI.0000000000002382. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence emtricitabine/tenofovir: Short-term episodic use for 2-3 weeks. CBT-based counseling: Brief CBT-based counseling to promote adherence |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence emtricitabine/tenofovir: Short-term episodic use for 2-3 weeks. CBT-based counseling: Brief CBT-based counseling to promote adherence |
| 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 Participants With PrEP Adherence | Biological measure of medication in the blood. Adherence will be measured using plasma analyses. We used the cut off of 4 doses/week to determine protective levels of adherence. The determination of this was drug levels equal to TFV 4.2 ng/mL FTC 4.6 ng/mL. | Posted | Count of Participants | Participants | Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP) |
|
4 months
Systematic Assessment of participant reported events at post-trip visit and 3-month follow up.
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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 | Intervention | Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence emtricitabine/tenofovir: Short-term episodic use for 2-3 weeks. CBT-based counseling: Brief CBT-based counseling to promote adherence |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HIV seroconverstion | Infections and infestations | Systematic Assessment | 1 participant became HIV-infected 2+ months after vacation due to a lapse in insurance to cover ongoing PrEP (move and job change); after 3 months of follow-up there were no other seroconversions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Egan | University of Pittsburgh, Graduate School of Public Health | 4126242255 | jee48@pitt.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 | Jun 2, 2016 | Mar 26, 2019 | Prot_SAP_000.pdf |
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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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| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| CBT-based counseling | Behavioral | Brief CBT-based counseling to promote adherence |
|
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 48 |
| 1 |
| 48 |
| 0 |
| 48 |
|
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| 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 |
| D000068679 |
| Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |