ClinicalTrials.gg
RecruitingNCT07834853El CaminoUpdated Sep 22, 2026

El Camino HIV Prevention and Care Study

An interventional study of Camino Intervention in HIV Infections, sponsored by American University. Recruiting at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by American University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 2,802 studies in HIV Infections with a site in United States — 83 open to participants now, 140 under way, 11 of them phase 3. HIV Infections · United States.

Planned enrollment
1,223rd of 2,150
50 · median 60
Started
2026
with 25 others
No phase
718 of 2,802
42 open now
Primary completion
2029-02
later than 123 of 137 live
Registered
2,799th of 2,802
by date

Among the 2,802 studies in HIV Infections with a site in United States, this one is the 1,223rd largest by planned enrollment of the 2,150 interventional ones that give a count, is one of 26 that started in 2026, is one of 718 with no phase, reaches primary completion later than 123 of the 137 other live ones, and was the 2,799th registered.

HIV Infections

4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.

This study's planned enrollment of 50 is below the median of 80 across 3,489 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Open to participants now

83 of the 2,802 studies in HIV Infections with a site in United States are open now.

All 83 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 158 HIV Infections studies recruiting now, 104 (66%) set no upper age limit and 41 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.

This study: 18 Years and older · male · no healthy volunteers.

The full table on the hub →
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02

Study summary

The Camino Study evaluates a status-neutral, multi-level pilot intervention designed to improve HIV prevention and care engagement among Latin Americans with unmet HIV prevention and care needs. The intervention combines legal services with peer navigation to reduce fear of healthcare engagement, reduce stress, and improve access to HIV prevention and care services.

The study will enroll 50 Latin American participants in the Washington, DC, and Oakland, California areas. Using a quasi-experimental wait-list control design, the study will compare HIV outcomes among participants who receive the Camino intervention with those on a rolling waitlist over 18 months. Primary outcomes include HIV testing within the past six months and uptake of pre-exposure prophylaxis (PrEP), as well as HIV care visit attendance, antiretroviral therapy (ART) adherence, and viral load among people living with HIV. The study will also examine legal, social, and mental health factors associated with HIV prevention and care engagement and assess the feasibility of testing the intervention at a larger scale.

03

Conditions studied

  • HIV Infections

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Keywords

  • HIV prevention
  • HIV care
  • Pre-exposure prophylaxis (PrEP)
  • Peer navigation
  • Legal services
  • Latin Americans
  • Medical-legal partnership
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older
  • Assigned male sex at birth
  • Identifies as a Latin American man who has sex with men, transgender woman, or nonbinary person on the feminine spectrum
  • Not a U.S. citizen
  • Speaks Spanish or English
  • Resides in the Washington, DC metropolitan area or San Francisco Bay Area
  • Willing to receive health and/or supportive services through participating study partners
  • Willing to allow the study to obtain relevant medical record information
  • Meets one of the following prevention or care criteria:
  • Living with HIV and either not linked to HIV care, has missed an HIV care appointment within the past year, is not taking antiretroviral therapy (ART), or has a detectable viral load; or Not living with HIV, is sexually active, and is either not taking pre-exposure prophylaxis (PrEP) or has not received an HIV test within the past 6 months

Exclusion criteria

Exclusion Criteria:

  • Younger than 18 years
  • Does not meet the inclusion criteria above
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Camino Intervention

    Participants receive the Camino intervention, which includes peer navigation to support engagement in HIV prevention and care and legal services. Peer navigation begins immediately after enrollment. Participants receive the individual legal consultation when an attorney becomes available; therefore, the timing of receipt of the legal consultation varies across participants. Participants are followed for 18 months.

    Behavioral: Camino Intervention

Interventions

  • BehavioralCamino Intervention

    Camino is a multicomponent intervention designed to improve engagement in HIV prevention and care. Participants receive culturally and linguistically appropriate peer navigation beginning after enrollment to help identify and address barriers to HIV prevention and care and connect participants with relevant health and social services. The intervention also includes individualized consultation with an attorney and legal services and navigation. Because attorney availability varies, participants receive the individual legal consultation at different times during follow-up.

06

What researchers measure

Primary outcomes

  1. HIV testing within the past 6 months

    Survey data and medical records will be used to assess HIV testing within the past 6 months among participants not living with HIV.

    Time frame: 18 months

  2. PrEP Uptake

    Survey data and medical records will be used to assess initiation of pre-exposure prophylaxis (PrEP) among participants who are HIV-negative and eligible for PrEP.

    Time frame: 18 months

  3. HIV Care Visit Attendance

    Medical records will be used to assess HIV care visit attendance among participants living with HIV.

    Time frame: 18 months

  4. Antiretroviral Therapy Adherence

    Medical records and survey data will be used to assess adherence to antiretroviral therapy (ART) among participants living with HIV who are prescribed ART.

    Time frame: 18 months

  5. HIV Viral Load

    Medical records will be used to assess HIV viral load among participants living with HIV.

    Time frame: 18 months

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data collected during the study will be shared through the NIMH Data Archive (NDA) for secondary research use in accordance with NIH and NIMH data-sharing requirements.

Supporting information: Study protocol

Time frame: Data and supporting documentation will be submitted and made available in accordance with NIMH Data Archive submission and sharing timelines and will remain available according to NDA policies.

Access criteria: Data will be available through the NIMH Data Archive to authorized researchers who meet NDA access requirements. Researchers must submit a formal data access request and agree to NDA data use and confidentiality requirements.

Data sharing details ↗ · nda.nih.gov

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Feb 2029, 31 months after the start.

Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 31 months is above that.

Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2026
First posted
Sep 22, 2026
StartActual
Jul 16, 2026
Primary completionEst.
Feb 2029
CompletionEst.
Feb 2029
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07834853
Lead sponsor
American University
Responsible party
Sponsor
First posted
Sep 22, 2026
Start date
Jul 16, 2026
Primary completion
Feb 2029 (estimated)
Completion
Feb 2029 (estimated)
Last update
Sep 22, 2026

Study contacts

Thespina J Yamanis, Ph.D., MPH
principal investigator · American University
Erin Wilson, DrPH
principal investigator · San Francisco Department of Public Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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