- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07625917
Feasibility of Internet-based HIV Prevention Research
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Guillermo Sanchez-Fat, MD
- 전화번호: 347-514-1513
- 이메일: guillermo.sanchezfat@einsteinmed.edu
연구 장소
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New York
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The Bronx, New York, 미국, 10467
- 모병
- Montefiore Medical Center
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수석 연구원:
- Aaron Fox, MD
-
연락하다:
- Guillermo Sanchez-Fat, MD
- 전화번호: 347-514-1513
- 이메일: guillermo.sanchezfat@einsteinmed.edu
-
연락하다:
- Aaron Fox, MD
- 전화번호: 718-920-7173
- 이메일: adfox@montefiore.org
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
HIV test completion
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Screening feasibility
기간: 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.
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Baseline
|
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Feasibility of study procedures
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Aaron Fox, Montefiore Medical Center/Albert Einstein College of Medicine
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 2022-14407
- K24DA057873 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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