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Feasibility of Internet-based HIV Prevention Research

29. maj 2026 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

  1. Recruitment will occur through with study advertisements on social media platforms and websites (i.e., Reddit, Twitter, Facebook, Instagram).
  2. Participants who click on an advertisement or study link will be taken to a screening questionnaire and informed consent page programmed into Qualtrics.
  3. 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.
  4. 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.
  5. 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).
  6. Research staff will follow a defined protocol to deliver any positive HIV tests results.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

500

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HIV test completion
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Screening feasibility
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Aaron Fox, Montefiore Medical Center/Albert Einstein College of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2025

Primær færdiggørelse (Anslået)

29. maj 2028

Studieafslutning (Anslået)

29. maj 2028

Datoer for studieregistrering

Først indsendt

29. maj 2026

Først indsendt, der opfyldte QC-kriterier

29. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2022-14407
  • K24DA057873 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner