Finishing HIV Project

Hiv Clinical Trial

Official title:

FINISHING HIV: An Ending the HIV Epidemic (EHE) Model for Latinx Integrating One-Stop-Shop Pre-Exposure Prophylaxis (PrEP) Services, a Social Network Support Program and a National Pharmacy Chain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06406049
• Other study ID #: 20220377
• Secondary ID: R01AI169643
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2024
• Est. completion date: November 15, 2029

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: Mariano Kanamori, PhD
• Phone: (305) 2430595
• Email: mjk194[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to learn how to help enable healthy behaviors and lower the risk of HIV among Latinx Men.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 624
• Est. completion date: November 15, 2029
• Est. primary completion date: November 15, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 54 Years

Eligibility

Inclusion Criteria

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Being 18 to 54 years of age

4. Being a cis-gender male

5. Self-report one or more of the following behaviors and health conditions in the last 6 months which meet the Centers for Disease Control and Prevention (CDC) clinical guidelines for PrEP eligibility

• Diagnosed with bacterial sexually transmitted infection (e.g., syphilis, gonorrhea, or chlamydia)

• Sex with a partner who is living with HIV

• Sex without a condom with two or more partners whose HIV status were unknown

• Injection drug use and sharing injection equipment

6. Self-reported status as HIV negative

7. Willing to be tested for HIV

Exclusion Criteria

1. Display diminished capacity to consent because of:

• An inability to provide informed consent (e.g., cognitive impairment)

• Severe psychiatric symptoms (e.g., mania, psychosis) that impair capacity to provide informed consent, as assessed by interviewers with Collaborative Institutional Training Initiative (CITI) Human Subjects Research and National Institutes of Health (NIH) Good Clinical Practice training

2. <18 years old or >54 years old

3. Self-reported living with HIV

4. Reactive HIV test (for "Amigx" seeds or "Yo Quiero" control participants)

5. Refusal of HIV test

6. Identifies as Non-Latinx

7. Individuals enrolled in other PrEP initiation interventions

8. Individuals with an active PrEP prescription in the last 6-months (oral or injectable)

Related Conditions & MeSH terms

• Hiv

Intervention

Other:
• Control group
Participants will receive the standard of care (beginning of the study) which includes sexual health information once in-person for up to 15 minutes for the duration of the study.

Behavioral:
• Social network intervention
Participants will come to the study location for up to 2 hours three times (beginning of the study, 6-month and 12-month follow-ups) during the duration of the study. During the study, participants will receive sexual health counseling for HIV prevention. Additionally participants will receive information and resources for PrEP usage. Participants will be encouraged to share sexual health information two times (three and nine months after the beginning of the study) during the duration of the study.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants that report using PrEP	PrEP initiation will be measured by analyzing the number of participants that initiate PrEP divided by the total number of participants	Up to 12-months
Primary	Number of Dried Blood Spot (DBS) tests that report PrEP use	PrEP initiation will be measured by analyzing the number of DBS tests that report PrEP use divided by the total number of participants	Up to 12-months
Primary	Number of participants that bring a proof of PrEP prescription	PrEP initiation will be measured by analyzing the number of participants that bring proof of a PrEP prescription divided by the total number of participants	Up to 12-months
Secondary	PrEP knowledge measured by PrEP knowledge question	Scores range from 1 (I don't know) to 5 (99% or more than 99% effective). Higher scores indicate adequate PrEP knowledge.	Up to 12-months
Secondary	Number of Dried Blood Spot (DBS) tests that report adequate PrEP adherence	PrEP adherence will be measured by analyzing the number of DBS tests that report PrEP adherence divided by the total number of participants that initiate PrEP during the study	Up to 12-months