Feasibility of Internet-based HIV Prevention Research
May 29, 2026 updated by: Montefiore Medical Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
In the past decade, injection drug use (IDU) has been linked to rural and urban HIV outbreaks, increased hepatitis C virus (HCV) transmission, and skyrocketing overdose rates in the US. Internet-based mail delivery public health programs mail naloxone or other HIV prevention supplies where allowed by law. Recruiting people who inject drugs (PWID) for research has traditionally been done in person, and the feasibility of collecting data from those who are recruited via the internet is unknown. Thus, the study's objectives are to: (1) recruit a representative sample of people who inject drugs for internet-based HIV prevention research; and (2) test the feasibility of at-home HIV testing for people who inject drugs.
This study will use social media to recruit 500 PWID. Investigators will assess the feasibility of online assessments and PWID's ability to perform at-home self-administered HIV testing. Participants will complete online questionnaires at baseline and investigators will mail participants HIV testing kits that they will self-administer and mail to a central laboratory. No other supplies will be mailed to participants.
- Recruitment will occur through with study advertisements on social media platforms and websites (i.e., Reddit, Twitter, Facebook, Instagram).
- Participants who click on an advertisement or study link will be taken to a screening questionnaire and informed consent page programmed into Qualtrics.
- To help minimize potentially fraudulent participants, the program will use cookies to block multiple submissions from a given device. Study staff will also manually review all surveys flagged for suspicious responses using a pre- determined process, such as comparing responses from the same Internet Protocol (IP) addresses, and examining those from proxy-IP addresses.
- Participants who complete informed consent and the baseline questionnaire will provide an e-mail address (to receive compensation) and a physical address where an HIV testing kit could be mailed.
- The research team will mail participants an OraSure HIV-1 Oral Specimen Collection Device. A self-addressed and stamped envelope will be included with the collection kit. 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).
- Research staff will follow a defined protocol to deliver any positive HIV tests results.
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guillermo Sanchez-Fat, MD
- Phone Number: 347-514-1513
- Email: guillermo.sanchezfat@einsteinmed.edu
Study Locations
-
-
New York
-
The Bronx, New York, United States, 10467
- Recruiting
- Montefiore Medical Center
-
Principal Investigator:
- Aaron Fox, MD
-
Contact:
- Guillermo Sanchez-Fat, MD
- Phone Number: 347-514-1513
- Email: guillermo.sanchezfat@einsteinmed.edu
-
Contact:
- Aaron Fox, MD
- Phone Number: 718-920-7173
- Email: adfox@montefiore.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: At-home self-administered HIV testing
All participants will be mailed at-home self-administered HIV testing kits
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HIV test completion
Time Frame: 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Screening feasibility
Time Frame: Baseline
|
This outcome will measure the percentage of potential participants who complete enrollment.
The numerator will be the number of participants that complete screening questionnaires and provide informed consent.
The denominator will be the total number of potential participants that click on study advertisement or link to the study.
|
Baseline
|
|
Feasibility of study procedures
Time Frame: 12 months
|
This outcome will be the percentage of enrolled participants that complete baseline questionnaires and mail in HIV testing kits to the laboratory.
The numerator will be the number of HIV test kits received at the laboratory and the denominator will be the total number of enrolled participants.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Aaron Fox, Montefiore Medical Center/Albert Einstein College of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2025
Primary Completion (Estimated)
May 29, 2028
Study Completion (Estimated)
May 29, 2028
Study Registration Dates
First Submitted
May 29, 2026
First Submitted That Met QC Criteria
May 29, 2026
First Posted (Actual)
June 4, 2026
Study Record Updates
Last Update Posted (Actual)
June 4, 2026
Last Update Submitted That Met QC Criteria
May 29, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022-14407
- K24DA057873 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data collected on injection drug use could include self-disclosure of illegal activity.
Participant information will be kept confidential to protect privacy.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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