HIV InfectionsNCT05805306
Entre Herman@s: Promoting Health Among Latino MSM
A study testing Entre Herman@s and Vaccines for Health in people with HIV Infections, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Entre Herman@s and Vaccines for Health
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- self-identify as Latino
- identify as male
- be <40 years old
- report HIV-negative status
- be willing to talk about MSM healthcare issues with a sibling
- either (a) have never used PrEP or (b) stopped using PrEP at least 90 days ago
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- missing most recent COVID vaccine
- missing Hepatitis (A or B) vaccines
- missing Mpox vaccine
- 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).
- at least 18 years old
- report a close relationship his/her LMSM brother <40 years old
- be willing to talk about MSM healthcare issues with his/her LMSM brother
Who cannot join
- are unable to provide consent or
- they do not meet any of the criteria above
- are unable to provide consent or
- they do not meet any of the criteria above
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles R. Drew University of Medicine and Science
Los Angeles, California, 90059
About this study
Official title: Promoting HIV PrEP Among MSM: a Randomized Control Trial - Aim 3
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.
- Conditions
- HIV Infections
- Being tested
- Entre Herman@s, Vaccines for Health
- Keywords
- Men Who Have Sex with Men, Latino men, HIV PrEP, Siblings
- Medical subject headings
- HIV Infections, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entre Herman@sBehavioural
The intervention unfolds as follows: (Week 1) the research team, Latino MSM, \& sibling will all engage in a PrEP Conversation followed by an individual Sibling Training for siblings to learn communication strategies for promoting health behaviors; (Week 2) we will send siblings reminders and a link to motivational interviewing techniques; (Week 3) we will conduct brief Follow-ups with siblings to determine if their brother changed his behavior; (Week 4) we will send a reminder to Latino MSM that they will have a follow-up the following week; (Week 5) we will conduct 30-day Follow-up with Latino MSM to determine if there was uptake of the new behavior change; (Week 7) same as week 5 above; (Week 10) send siblings information on motivational interviewing; (Week 12) final follow-up for both Latino MSM and siblings.
Vaccines for HealthBehavioural
The intervention unfolds as follows: (Week 1) the research team, Latino MSM, \& sibling will all engage in a Health Conversation about vaccines for COVID, Hep A/B, or MPOX, followed by an individual Sibling Training for siblings to learn communication strategies for promoting health behaviors; (Week 2) we will send siblings reminders and a link to motivational interviewing techniques; (Week 3) we will conduct brief Follow-ups with siblings to determine if their brother changed his behavior; (Week 4) we will send a reminder to Latino MSM that they will have a follow-up the following week; (Week 5) we will conduct 30-day Follow-up with Latino MSM to determine if there was uptake of the new behavior change; (Week 7) same as week 5 above; (Week 10) send siblings information on motivational interviewing; (Week 12) final follow-up for both Latino MSM and siblings.
| Study group | Role | What they receive |
|---|---|---|
| PrEP Promotion | Experimental | Not described Receives: Behavioral: Entre Herman@s |
| Vaccine Promotion | Placebo comparator | Not described Receives: Behavioral: Vaccines for Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
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.
Measured: 90 days
Secondary outcomes (2)
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.
Measured: 90 days
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start29 Apr 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- St. Johns Community Health, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Homero del Pino, Charles Drew University of Medicine and Science
- Investigators
- Homero del Pino, PhD, MS, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805306
- Sponsor's protocol ID
- 1995640-1
- Other IDs
- U54MD007598
- Status last verified
- Apr 2026
- First submitted
- 1 Mar 2023
- Last updated
- 6 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting HIV PrEP Among MSM: a Randomized Control Trial - Aim 3
- ClinicalTrials.gov ID
- NCT05805306
- Acronym / sponsor ID
- 1995640-1
- Conditions
- HIV Infections
- Keywords
- Men Who Have Sex with Men, Latino men, HIV PrEP, Siblings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- St. Johns Community Health, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 29 Apr 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 10 Apr 2023 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrEP Promotion | Experimental | Behavioral: Entre Herman@s |
| Vaccine Promotion | Placebo comparator | Behavioral: Vaccines for Health |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- self-identify as Latino
- identify as male
- be <40 years old
- report HIV-negative status
- be willing to talk about MSM healthcare issues with a sibling
Key exclusion criteria (4 listed)
- are unable to provide consent or
- they do not meet any of the criteria above
- are unable to provide consent or
- they do not meet any of the criteria above
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 |
|---|---|---|
| Entre Herman@sThe intervention unfolds as follows: (Week 1) the research team, Latino MSM, \& sibling will all engage in a PrEP Conversation followed by an individual Sibling Training for siblings to learn communication strategies for promoting health behaviors; (Week 2) we will send siblings reminders and a link to motivational interviewing techniques; (Week 3) we will conduct brief Follow-ups with siblings to determine if their brother changed his behavior; (Week 4) we will send a reminder to Latino MSM that they will have a follow-up the following week; (Week 5) we will conduct 30-day Follow-up with Latino MSM to determine if there was uptake of the new behavior change; (Week 7) same as week 5 above; (Week 10) send siblings information on motivational interviewing; (Week 12) final follow-up for both Latino MSM and siblings. | Behavioural | PrEP Promotion |
| Vaccines for HealthThe intervention unfolds as follows: (Week 1) the research team, Latino MSM, \& sibling will all engage in a Health Conversation about vaccines for COVID, Hep A/B, or MPOX, followed by an individual Sibling Training for siblings to learn communication strategies for promoting health behaviors; (Week 2) we will send siblings reminders and a link to motivational interviewing techniques; (Week 3) we will conduct brief Follow-ups with siblings to determine if their brother changed his behavior; (Week 4) we will send a reminder to Latino MSM that they will have a follow-up the following week; (Week 5) we will conduct 30-day Follow-up with Latino MSM to determine if there was uptake of the new behavior change; (Week 7) same as week 5 above; (Week 10) send siblings information on motivational interviewing; (Week 12) final follow-up for both Latino MSM and siblings. | Behavioural | Vaccine Promotion |
Primary outcome
Number of participants that start using PrEP
Time frame: 90 days
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.
Number of participants that get vaccinated
Time frame: 90 days
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.
2 secondary outcomes
Number of participants who increase their willingness to use PrEP
Time frame: 90 days
Number of participants who increase their willingness to get vaccinated
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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. This study is not recruiting at the moment.
Homero del Pino, PhD, MS principal investigator
Charles Drew University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entre Herman@s and Vaccines for Health in people with HIV Infections, run by Charles Drew University of Medicine and Science 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 13 inclusion and 4 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: finished, as of the sponsor's last update on 6 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that start using PrEP (time frame: 90 days). The study lists 2 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 6 Apr 2026.