HIVNCT05434390
A Latino MSM Focused Pre-Exposure Prophylaxis Uptake Intervention
A study testing Estoy PrEParado/ I am PrEPared intervention in people with HIV, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Estoy PrEParado/ I am PrEPared intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 31 Aug 2024
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- assigned male at birth
- Identifies as Latino/Hispanic origin
- HIV-negative or HIV status unknown
- Man who has had sex with other men in the past 24 months
- Not currently using PrEP for HIV prevention
Who cannot join
- Male under 18 years of age
- Not identifying as being of Latino/Hispanic origin
- Man who has not had sex with other men in the past 24 months
- Identifies as cisgender or transgender Female/woman
- Assigned female at birth
Trial locations and contacts
1 site in 1 country.
United States1 site
Bienestar Human Services
Los Angeles, California, 90022
About this study
Official title: Evaluating the Feasibility and Acceptability of a Latino MSM Focused PrEP Uptake Intervention
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.
Read the detailed description
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.
- Conditions
- HIV
- Being tested
- Estoy PrEParado/ I am PrEPared intervention, Usual Care
- Keywords
- HIV prevention, Pre-exposure prophylaxis, Latino men who have sex with men
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estoy PrEParado/ I am PrEPared interventionBehavioural
Participants will receive an Information, Motivation, and Behavioral skills model PrEP intervention tailored for mixed immigrant status Latino men who have sex with men
Usual CareBehavioural
Participants will be offered PrEP navigation services as part of usual care at the study site.
| Study group | Role | What they receive |
|---|---|---|
| Latino MSM PrEP intervention | Experimental | The Latino MSM PrEP intervention consists of 4 small group sessions with concurrent peer navigation and counseling. Receives: Behavioral: Estoy PrEParado/ I am PrEPared intervention |
| Control condition | Active comparator | The control condition consists of usual care at the study site (i.e., referrals to PrEP services). Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: assessed at 3-month follow-up
Secondary outcomes (2)
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).
Measured: assessed at 1-month follow-up
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).
Measured: assessed at 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start3 Oct 2022
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
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.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Model description
- Parallel model. Participants will be randomly assigned to either an intervention or control arm of the study.
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Bienestar Human Services, Inc.
- Responsible party
- Principal investigator, Ronald Andrew Brooks, University of California, Los Angeles
- Investigators
- Ronald A Brooks, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434390
- Sponsor's protocol ID
- IRB#21-002132
- Status last verified
- Apr 2026
- First submitted
- 9 Jun 2022
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Evaluating the Feasibility and Acceptability of a Latino MSM Focused PrEP Uptake Intervention
- ClinicalTrials.gov ID
- NCT05434390
- Acronym / sponsor ID
- IRB#21-002132
- Conditions
- HIV
- Keywords
- HIV prevention, Pre-exposure prophylaxis, Latino men who have sex with men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Bienestar Human Services, Inc.
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 28 Jun 2022 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel model. Participants will be randomly assigned to either an intervention or control arm of the study.
| Arm | Type | Receives |
|---|---|---|
| Latino MSM PrEP intervention | Experimental | Behavioral: Estoy PrEParado/ I am PrEPared interventionThe Latino MSM PrEP intervention consists of 4 small group sessions with concurrent peer navigation and counseling. |
| Control condition | Active comparator | Behavioral: Usual CareThe control condition consists of usual care at the study site (i.e., referrals to PrEP services). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- assigned male at birth
- Identifies as Latino/Hispanic origin
- HIV-negative or HIV status unknown
- Man who has had sex with other men in the past 24 months
Key exclusion criteria (5 listed)
- Male under 18 years of age
- Not identifying as being of Latino/Hispanic origin
- Man who has not had sex with other men in the past 24 months
- Identifies as cisgender or transgender Female/woman
- Assigned female at birth
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 |
|---|---|---|
| Estoy PrEParado/ I am PrEPared interventionParticipants will receive an Information, Motivation, and Behavioral skills model PrEP intervention tailored for mixed immigrant status Latino men who have sex with men | Behavioural | Latino MSM PrEP intervention |
| Usual CareParticipants will be offered PrEP navigation services as part of usual care at the study site. | Behavioural | Control condition |
Primary outcome
PrEP initiation
Time frame: assessed at 1-month follow-up
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).
PrEP initiation
Time frame: assessed at 3-month follow-up
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).
PrEP adherence single measure
Time frame: assessed at 1-month follow-up
We will assess adherence to the PrEP medication using a single-item self-rating adherence measure.
PrEP adherence single measure
Time frame: assessed at 3-month follow-up
We will assess adherence to the PrEP medication using a single-item self-rating adherence measure.
PrEP adherence urine sample
Time frame: assessed at 1-month follow-up
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.
PrEP adherence urine sample
Time frame: assessed at 3-month follow-up
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.
2 secondary outcomes
Changes in Readiness to Adopt PrEP
Time frame: assessed at 1-month follow-up
Changes in Readiness to Adopt PrEP
Time frame: assessed at 3-month follow-up
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 20 Apr 2026.
Related trials for HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
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.
Ronald A Brooks, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estoy PrEParado/ I am PrEPared intervention in people with HIV, run by University of California, Los Angeles 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 6 inclusion and 5 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 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?
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?
PrEP initiation (time frame: assessed at 1-month follow-up). The study lists 6 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.