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COVID-19 caused substantial barriers to recruitment.
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| Name | Class |
|---|---|
| Planned Parenthood Great Plains | OTHER |
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The investigators will pilot-test an accelerated PrEP initiation approach among young high-risk Black/African American (B/AA) men who have sex with men (MSM) and transgender women (YMSM/TW) at the point of care in community contexts.
The study team will provide a free 30-day supply of HIV pre-exposure prophylaxis (PrEP) to young Black MSM and TW identified as PrEP-eligible and interested in taking PrEP to reduce their risk of HIV acquisition. This intervention is intended to assist youth at high risk for HIV acquisition in successfully initiating PrEP use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PrEP Received | Experimental | Participants will be provided with a free 30-day supply of PrEP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emtricitabine / Tenofovir Disoproxil Oral Tablet | Drug | 30 day supply of 200mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intention to Continue PrEP | Intention to continue use of PrEP will be assessed via survey questions related to a respondent having made a follow-up appointment to continue taking PrEP, attended an appointment to continue taking PrEP, having filled a prescription for PrEP, and reporting an interest in continuing PrEP after current supply is complete. | Post Intervention (1 month after receiving intervention) |
| Intention to Continue PrEP | Intention to continue use of PrEP will be assessed via survey questions related to a respondent having made a follow-up appointment to continue taking PrEP, attended an appointment to continue taking PrEP, having filled a prescription for PrEP, and reporting an interest in continuing PrEP after current supply is complete. | Post Intervention (4 months after receiving intervention) |
| PrEP Adherence | PrEP adherence will be assessed via self-report of how many pills from the initial intervention remain and a self-assessment of success at remembering to take PrEP daily. | Post Intervention (1 month after receiving intervention) |
| PrEP Adherence | PrEP adherence will be assessed via self-report of how many pills from the initial intervention remain and a self-assessment of success at remembering to take PrEP daily. | Post Intervention (4 months after receiving intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Adherence Self-Efficacy | PrEP adherence self-efficacy will be assessed via a 9-question scale focused on respondents' belief that they could continue to take PrEP when experiencing barriers to adherence. Each item is scored on a 0-10 scale, where 0 means "cannot do at all" and 10 means "completely certainly can do." This scale has been adapted from the Adherence Self-Efficacy Scale (Johnson et al., 2007). |
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Inclusion Criteria:
Exclusion Criteria:
The study is open to cisgender men who have sex with men and transgender women.
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| Name | Affiliation | Role |
|---|---|---|
| Darnell N Motley, PhD | University of Chicago | Study Director |
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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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A single-arm longitudinal pre/post study
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| Post Intervention (1 month after receiving intervention) |
| PrEP Adherence Self-Efficacy | PrEP adherence self-efficacy will be assessed via a 9-question scale focused on respondents' belief that they could continue to take PrEP when experiencing barriers to adherence. Each item is scored on a 0-10 scale, where 0 means "cannot do at all" and 10 means "completely certainly can do." This scale has been adapted from the Adherence Self-Efficacy Scale (Johnson et al., 2007). | Post Intervention (4 months after receiving intervention) |
| 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 |