Recruiting

Observational Study

Sponsor:

Montefiore Medical Center

Code:

NCT07625917

Conditions

HIV Prevention

Injection Drug Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mail delivery of at-home self-administered HIV tests

Study Details

Brief summary:

The study will use social media to recruit a diverse sample of people who self-report injecting drugs, assessing the feasibility of online assessments and participants' ability to perform at-home self-administered HIV testing. Participants will complete online questionnaires at baseline and will be mailed HIV testing kits that they will self-administer and mail to a central laboratory. Investigators will track completion of questionnaires and whether at-home self-administered HIV tests were completed and sent to the laboratory.

Conditions

HIV Prevention

Injection Drug Use

Study ID

NCT07625917

Start date

Aug 1, 2025

Status verified date

May, 2026

Completion date

May 29, 2028

Anticipated

Primary completion date

May 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years or older
  • US residency
  • English or Spanish fluency
  • injection drug use (self-report, past 30 days)
  • basic reading comprehension

Exclusion Criteria:

  • HIV status known to be positive

Study Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: At-home self-administered HIV testing

All participants will be mailed at-home self-administered HIV testing kits

Interventions

Mail delivery of at-home self-administered HIV tests

Investigators will mail participants an OraSure HIV-1 Oral Specimen Collection Device. The kit will include a self-addressed and stamped envelope with the collection device. Participants will follow enclosed directions to collect oral-fluid samples and mail them to the study laboratory for analysis. Envelopes and samples will only be marked with a bar code and not with any other personal identifiers (e.g., name or address).

Primary outcome measure

  • HIV test completion [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Guillermo Sanchez-Fat, MD

347-514-1513guillermo.sanchezfat@einsteinmed.edu

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Guillermo Sanchez-Fat, MD

347-514-1513guillermo.sanchezfat@einsteinmed.edu

Aaron Fox, MD

718-920-7173adfox@montefiore.org

Principal Investigator:

Aaron Fox, MD

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jun 4, 2026

Last verified

May, 2026

Keywords

  • HIV testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-06-04.