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Идёт набор NCT07625917

Feasibility of Internet-based HIV Prevention Research

Без фазы С лечением HIV Prevention Injection Drug Use

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mail delivery of at-home self-administered HIV tests.
Кому может быть актуально
Состояния в реестре: HIV Prevention, Injection Drug Use. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест 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).

Первичные конечные точки

  • HIV test completion [Срок оценки: 12 months]
Вторичные конечные точки (2)
  • Screening feasibility [Срок оценки: Baseline]
  • Feasibility of study procedures [Срок оценки: 12 months]

Критерии участия

Критерии включения

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

Критерии исключения

  • HIV status known to be positive

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

США · 1 центр
  • Montefiore Medical Center — The Bronx

Публикации

  • 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 33710493
  • 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 34619446
  • 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 32915328

Идентификаторы

NCT: NCT07625917 · 2022-14407 · K24DA057873

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗