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| Name | Class |
|---|---|
| Bienestar Human Services, Inc. | OTHER |
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The clinical study will evaluate the feasibility and acceptability of a culturally tailored behavioral intervention to improve uptake of pre-exposure prophylaxis for HIV prevention among at-risk Latino men who have sex with men.
The clinical study will evaluate the feasibility and acceptability of a brief small group and peer navigation behavioral intervention to improve uptake of pre-exposure prophylaxis (PrEP) for HIV prevention among at-risk Latino men who have sex with men. The brief intervention consists of 4 small group sessions with concurrent peer navigation and counseling. Study participants will be randomized to either an intervention or control condition. Participants in the control condition will receive usual care for PrEP promotion (i.e., referral to PrEP services). The study will determine the feasibility and acceptability of the intervention among Latino men who have sex with men and assess the preliminary impact of the intervention compared to control condition in facilitating PrEP uptake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Latino MSM PrEP intervention | Experimental | The Latino MSM PrEP intervention consists of 4 small group sessions with concurrent peer navigation and counseling. |
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| Control condition | Active Comparator | The control condition consists of usual care at the study site (i.e., referrals to PrEP services). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estoy PrEParado/ I am PrEPared intervention | Behavioral | Participants will receive an Information, Motivation, and Behavioral skills model PrEP intervention tailored for mixed immigrant status Latino men who have sex with men |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP initiation | We will assess PrEP uptake using evidence of a prescription for Truvada® or Descovy® (participant shows us their prescription bottle in person or via a text photo). | assessed at 1-month follow-up |
| PrEP initiation | We will assess PrEP uptake using evidence of a prescription for Truvada® or Descovy® (participant shows us their prescription bottle in person or via a text photo). | assessed at 3-month follow-up |
| PrEP adherence single measure | We will assess adherence to the PrEP medication using a single-item self-rating adherence measure. | assessed at 1-month follow-up |
| PrEP adherence single measure | We will assess adherence to the PrEP medication using a single-item self-rating adherence measure. | assessed at 3-month follow-up |
| PrEP adherence urine sample | We will assess adherence to the PrEP medication by analyzing participants' urine sample to determine the presence of the medication tenofovir, a key medication in the PrEP medication. | assessed at 1-month follow-up |
| PrEP adherence urine sample | We will assess adherence to the PrEP medication by analyzing participants' urine sample to determine the presence of the medication tenofovir, a key medication in the PrEP medication. | assessed at 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Readiness to Adopt PrEP | We will assess changes in readiness to adopt PrEP using the PrEP Transtheoretical Stages of Change Model measure (pre-contemplation, contemplation, preparation, action & initiation, and maintenance). | assessed at 1-month follow-up |
| Changes in Readiness to Adopt PrEP |
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Inclusion Criteria:
Exclusion Criteria:
cisgender male
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| Name | Affiliation | Role |
|---|---|---|
| Ronald A Brooks, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bienestar Human Services | Los Angeles | California | 90022 | United States |
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Parallel model. Participants will be randomly assigned to either an intervention or control arm of the study.
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| Usual Care | Behavioral | Participants will be offered PrEP navigation services as part of usual care at the study site. |
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We will assess changes in readiness to adopt PrEP using the PrEP Transtheoretical Stages of Change Model measure (pre-contemplation, contemplation, preparation, action & initiation, and maintenance). |
| assessed at 3-month follow-up |