- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07625917
Feasibility of Internet-based HIV Prevention Research
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Guillermo Sanchez-Fat, MD
- Numero di telefono: 347-514-1513
- Email: guillermo.sanchezfat@einsteinmed.edu
Luoghi di studio
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New York
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The Bronx, New York, Stati Uniti, 10467
- Reclutamento
- Montefiore Medical Center
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Investigatore principale:
- Aaron Fox, MD
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Contatto:
- Guillermo Sanchez-Fat, MD
- Numero di telefono: 347-514-1513
- Email: guillermo.sanchezfat@einsteinmed.edu
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Contatto:
- Aaron Fox, MD
- Numero di telefono: 718-920-7173
- Email: adfox@montefiore.org
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Selezione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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).
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
HIV test completion
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Screening feasibility
Lasso di tempo: 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
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Feasibility of study procedures
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Aaron Fox, Montefiore Medical Center/Albert Einstein College of Medicine
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2022-14407
- K24DA057873 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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