NCT07625917

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Aug 2025May 2028

Study Start

First participant enrolled

August 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2028

Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

May 29, 2026

Last Update Submit

May 29, 2026

Conditions

HIV PreventionInjection Drug Use

Keywords

HIV testing

Outcome Measures

Primary Outcomes (1)

  • HIV test completion

    This outcome will be the percentage of enrolled participants that have valid HIV testing results. The numerator will be the number of HIV test kits collected properly and sent to the laboratory for testing successfully. The denominator will be the total number of enrolled participants.

    12 months

Secondary Outcomes (2)

  • Screening feasibility

    Baseline

  • Feasibility of study procedures

    12 months

Study Arms (1)

At-home self-administered HIV testing

EXPERIMENTAL

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

Diagnostic Test: Mail delivery of at-home self-administered HIV tests

Interventions

Mail delivery of at-home self-administered HIV testsDIAGNOSTIC_TEST

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).

At-home self-administered HIV testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • HIV status known to be positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (3)

  • Hayes BT, Favaro J, Davis CS, Gonsalves GS, Beletsky L, Vlahov D, Heimer R, Fox AD. Harm Reduction, By Mail: the Next Step in Promoting the Health of People Who Use Drugs. J Urban Health. 2021 Aug;98(4):532-537. doi: 10.1007/s11524-021-00534-1. Epub 2021 Mar 12. No abstract available.

    PMID: 33710493BACKGROUND

  • Hayes BT, Favaro J, Coello D, Behrends CN, Jakubowski A, Fox AD. Participants of a mail delivery syringe services program are underserved by other safe sources for sterile injection supplies. Int J Drug Policy. 2022 Jan;99:103474. doi: 10.1016/j.drugpo.2021.103474. Epub 2021 Oct 5.

    PMID: 34619446BACKGROUND

  • D'Angelo AB, Morrison CA, Lopez-Rios J, MacCrate CJ, Pantalone DW, Stief M, Grov C. Experiences Receiving HIV-Positive Results by Phone: Acceptability and Implications for Clinical and Behavioral Research. AIDS Behav. 2021 Mar;25(3):709-720. doi: 10.1007/s10461-020-03027-5.

    PMID: 32915328BACKGROUND

Study Officials

  • Aaron Fox

    Montefiore Medical Center/Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillermo Sanchez-Fat, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2026

First Posted

June 4, 2026

Study Start

August 1, 2025

Primary Completion (Estimated)

May 29, 2028

Study Completion (Estimated)

May 29, 2028

Last Updated

June 4, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Data collected on injection drug use could include self-disclosure of illegal activity. Participant information will be kept confidential to protect privacy.

Locations

US(1)