HivNCT06406049
Finishing HIV Project
A study testing Social network intervention in people with Hiv, run by University of Miami at 1 site in United States.
Trial summary
This study aims to learn how to help enable healthy behaviors and lower the risk of HIV among Latinx Men. Read more about this study
- Who is it for?
- Ages 18 to 54 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Social network intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 624 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2024to 31 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Being 18 to 54 years of age
- Being a cis-gender male
- 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)
Show all 11Show fewer
- 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
- Self-reported status as HIV negative
- Willing to be tested for HIV
Who cannot join
- 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
- <18 years old or >54 years old
- Self-reported living with HIV
- Reactive HIV test (for "Amigx" seeds or "Yo Quiero" control participants)
Show all 10Show fewer
- Refusal of HIV test
- Identifies as Non-Latinx
- Individuals enrolled in other PrEP initiation interventions
- Individuals with an active PrEP prescription in the last 6-months (oral or injectable)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Mariano Kanamori, PhD, 305-243-0595, mjk194@miami.edu
Mariano Kanamori, PhD
About this study
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
This study aims to learn how to help enable healthy behaviors and lower the risk of HIV among Latinx Men.
- Conditions
- Hiv
- Being tested
- Control group-Standard Health Promotion, Social network intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group-Standard Health PromotionOther
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.
Social network interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| I want "Yo Quiero" Control Group | Active comparator | Participants will receive the standard of care for up to 15-months Receives: Other: Control group-Standard Health Promotion |
| Friend "Amigx" Social network intervention | Experimental | Participant will receive a social network intervention for up to 15-months Receives: Behavioral: Social network intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 12-months
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
Measured: Up to 12-months
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
Measured: Up to 12-months
Secondary outcomes (2)
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.
Measured: Up to 12-months
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
Measured: Up to 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start8 Nov 2024
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 624 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariano Juan Kanamori Nishimura, University of Miami
- Investigators
- Mariano Kanamori, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406049
- Sponsor's protocol ID
- 20250806
- Other IDs
- R01AI169643, 20220377
- Status last verified
- Apr 2026
- First submitted
- 2 May 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06406049
- Acronym / sponsor ID
- 20250806
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 624 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to learn how to help enable healthy behaviors and lower the risk of HIV among Latinx Men.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I want "Yo Quiero" Control Group | Active comparator | Other: Control group-Standard Health PromotionParticipants will receive the standard of care for up to 15-months |
| Friend "Amigx" Social network intervention | Experimental | Behavioral: Social network interventionParticipant will receive a social network intervention for up to 15-months |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Being 18 to 54 years of age
- Being a cis-gender male
- 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
Key exclusion criteria (10 listed)
- Display diminished capacity to consent because of:
- <18 years old or >54 years old
- Self-reported living with HIV
- Reactive HIV test (for "Amigx" seeds or "Yo Quiero" control participants)
- Refusal of HIV test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control group-Standard Health PromotionParticipants 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. | Other | I want "Yo Quiero" Control Group |
| Social network interventionParticipants 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. | Behavioural | Friend "Amigx" Social network intervention |
Primary outcome
Number of participants that report using PrEP
Time frame: Up to 12-months
PrEP initiation will be measured by analyzing the number of participants that initiate PrEP divided by the total number of participants
Number of Dried Blood Spot (DBS) tests that report PrEP use
Time frame: Up to 12-months
PrEP initiation will be measured by analyzing the number of DBS tests that report PrEP use divided by the total number of participants
Number of participants that bring a proof of PrEP prescription
Time frame: Up to 12-months
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
2 secondary outcomes
PrEP knowledge measured by PrEP knowledge question
Time frame: Up to 12-months
Number of Dried Blood Spot (DBS) tests that report adequate PrEP adherence
Time frame: Up to 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariano Kanamori, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social network intervention in people with Hiv, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariano Kanamori, PhD ((305) 2430595, mjk194@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that report using PrEP (time frame: Up to 12-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.