HIV Infections Clinical Trial
Official title:
Promoting HIV PrEP Among MSM: a Randomized Control Trial - Aim 3
NCT number | NCT05805306 |
Other study ID # | 1995640-1 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 15, 2023 |
Est. completion date | July 31, 2024 |
This is a randomized controlled trial with an attention placebo control group. The goal of this study is to decrease HIV incidence in Latino men who have sex with men by engaging their siblings in PrEP-use promotion. In the intervention arm, siblings will be trained to engage their gay brother in PrEP conversations. In the control arm, siblings will be trained to engage their gay brother in conversations about vaccines to prevent COVID, Hepatitis A/B, or MPOX.
Status | Recruiting |
Enrollment | 248 |
Est. completion date | July 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 39 Years |
Eligibility | Inclusion Criteria: Latino Men Who Have Sex with Men 1. self-identify as Latino 2. identify as male 3. be <40 years old 4. report HIV-negative status 5. be willing to talk about MSM healthcare issues with a sibling 6. either (a) have never used PrEP or (b) stopped using PrEP at least 90 days ago 7. missing most recent COVID vaccine 8. missing Hepatitis (A or B) vaccines 9. missing Mpox vaccine 10. meet CDC's PrEP eligibility criteria (be HIV-negative; any male sex partner in the past six months; not in a monogamous partnership with a recently tested, HIV-negative man; and at least one of the following: any anal sex without condoms in past 6 months, any sexually-transmitted infection (STI) diagnosed or reported in past 6 months, or is in an ongoing sexual relationship with an HIV-positive male partner). Exclusion Criteria: Latino Men Who Have Sex with Men 1. are unable to provide consent or 2. they do not meet any of the criteria above Inclusion Criteria: Siblings 1. at least 18 years old 2. report a close relationship his/her LMSM brother <40 years old 3. be willing to talk about MSM healthcare issues with his/her LMSM brother Exclusion Criteria: Siblings 1. are unable to provide consent or 2. they do not meet any of the criteria above |
Country | Name | City | State |
---|---|---|---|
United States | Charles R. Drew University of Medicine and Science | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Charles Drew University of Medicine and Science | St. John's Community Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants that start using PrEP | This measures how many participants in the experiment group started taking PrEP (baseline = 0 participants).
Tool: Pictures. Participants will submit a picture of their pill bottle to report PrEP use. |
90 days | |
Primary | Number of participants that get vaccinated | This measures whether participants in the control group decided to get vaccinated for COVID, Hep A/B, or MPOX.
Tool: Pictures. Participants will submit a picture of their proof-of-vaccination card to report vaccination status. |
90 days | |
Secondary | Number of participants who increase their willingness to use PrEP | This measures whether participants progress along the stages of change (e.g., pre-contemplation, contemplation, action) in their willingness to try PrEP if it were available to them.
Tool: Stages of Change questionnaire administered at baseline and 90 days. |
90 days | |
Secondary | Number of participants who increase their willingness to get vaccinated | This measures whether participants progress along the stages of change (e.g., pre-contemplation, contemplation, action) in their willingness to get vaccinated against COVID, Hep A/B, or MPOX if it were available to them.
Tool: Stages of Change questionnaire administered at baseline and 90 days. |
90 days |
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