성매매 생존자를 위한 HIV/STI/HCV 검사 및 과다복용 예방
뉴욕시에 거주하는 성매매 생존자들의 HIV/STI/HCV 검사 및 약물 사용 서비스 이용률 증진을 위한 시민 과학 접근법
This project will assess whether a digital survivor crowdsourced intervention can increase HIV/STI/HCV testing and overdose prevention kit utilization among survivors of sex trafficking living in New York City. Survivors of sex trafficking have among the highest rates of HIV/STIs/HCV and substance use disorder (SUD), yet they face substantial barriers to care, including lack of information about care and financial and logistical constraints. In addition, there is a lack of public health messaging tailored specifically for survivors of sex trafficking to meet their needs. Citizen science approaches, such as crowdsourcing (i.e., engaging groups of individuals to address public health challenges and share solutions), are scalable, cost-effective tools that can increase HIV/SUD prevention and treatment utilization. Crowdsourcing can be used to engage survivors in developing tailored messaging to promote HIV/STI/HCV testing, overdose prevention, and treatment utilization. Complementing crowdsourcing, specimen self-collection with remote HIV/STI/HCV testing and online delivery of overdose prevention kits to survivors may also increase use of needed healthcare services. Study aims are: 1) develop crowdsourced digital messages to promote HIV/STI/HCV testing uptake and utilization of overdose prevention services for substance use among sex trafficking survivors; 2) in a randomized controlled trial, to compare the survivor-crowdsourced HIV and substance use intervention to existing public health messaging among sex trafficking survivors (n=368) in New York City; and 3) assess the contribution of multi-level factors on reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) outcomes. This work will result in a digital crowdsourced intervention to increase HIV/STI/HCV testing uptake, overdose prevention kit utilization, and linkage to care among survivors of sex trafficking. This project will also result in a crowdsourcing and messaging toolkit that can be broadly distributed to public health and other agencies across the country for their use in designing messaging campaigns for survivors. Findings from this project will lay the groundwork for citizen science-developed HIV and SUD interventions for sex trafficking survivors across the US.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The investigators propose to develop and assess whether a digital survivor-crowdsourced (i.e., engaging individuals to address public health challenges and share solutions) intervention can increase testing for HIV, sexually transmitted infections (STIs), and hepatitis C virus (HCV) and the utilization of life-saving overdose prevention practices and services among survivors of sex trafficking (ST) in New York City (NYC). ST survivors have higher risk substance use (e.g., injection drug use, fentanyl) than women who are not trafficked -- >84% have used substances, with ~33% experiencing forced substance use, and ~70% a drug overdose. ST survivors have higher HIV/STI prevalence rates (up to 70%) than even non-trafficked women in sex work. Nearly 50% of survivors have branding tattoos, increasing their risk for HCV. Despite their elevated rates of HIV/STIs/HCV and substance use disorder (SUD), there is a lack of public health messaging tailored specifically for ST survivors, and much of the existing messaging is denigrating toward this population. Survivors also face substantial barriers to care, including lack of information about care access and logistical constraints. In the absence of innovative interventions tailored for this population, health problems among ST survivors will persist.
The Study's Specific Aims are:
Aim 1: Develop crowdsourced digital messages to promote HIV/STI/HCV testing uptake and utilization of overdose prevention services for substance use among female ST survivors. To achieve this aim, in partnership with our Citizen Collaborative Research Board (CCRB), the investigators will use in-depth interviews and conduct a series of designathons, launched via a national crowdsourcing open call, in which survivors ideate, prototype and present multimedia content to promote HIV/STI/HCV testing uptake and utilization of overdose prevention services among peers.
Aim 2: In a randomized controlled trial, to compare the survivor-crowdsourced HIV and substance use intervention to existing public health messaging among ST survivors (n=368) in New York City.
Hypothesis: The crowdsourced intervention will increase HIV/STI/HCV testing uptake and utilization of overdose prevention services among survivors compared to control content. The primary outcome will be online HIV/STI/HCV tests completed and online ordering of overdose prevention kits. Secondary outcomes will be linkage to HIV/STI/HCV care, PrEP, and substance use disorder (SUD) services.
Aim 3: Assess the contribution of multi-level factors on reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) outcomes. The investigators will use the PRISM framework and a mixed methods approach to assess RE-AIM outcomes via qualitative interviews, surveys, and HIV/STI/HCV testing and overdose prevention kit referral vouchers.
Hypothesis: HIV/STI/HCV testing and overdose prevention kit referral and uptake will be significantly greater among the crowdsourced intervention arm than among the control arm.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Alissa Davis, PhD
- 전화번호: 212-851-2224
- 이메일: ad3324@columbia.edu
연구 장소
-
-
New York
-
New York, New York, 미국, 10027
- Columbia University
-
연락하다:
- Alissa Davis, PhD
- 전화번호: 212-851-2224
- 이메일: ad3324@columbia.edu
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 years or older
- Born biologically female or identify as a woman
- Living in New York City
- Used illicit substances within the past 12 months or has a history of substance use dependency
- Would feel safe participating in the study
- Is a survivor of sex trafficking as defined by the following criteria: 1) Has the individual ever had sex for things of value? If 'Yes', then the individual must also answer 'Yes' to the following question, 2) Was the individual pressured or forced by another person to do this?
Exclusion Criteria:
- Not willing to provide consent or not able to understand study procedures
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Crowdsourced Messaging Intervention
The digital crowdsourced intervention will be presented to participants in the intervention arm. |
Survivors of sex trafficking will participate in crowdsourcing contests to create digital materials to promote HIV/STI/HCV testing and use of overdose prevention kits. Entries will be judged by community and expert judges. Top entries will be selected for the digital intervention and presented to participants in the intervention arm. |
|
간섭 없음: Standard of Care
Standard informational materials about HIV/STI/HCV testing and overdose prevention currently used by Departments of Health and other health organizations will be presented to participants in the control arm. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
HIV/STI/HCV testing uptake
기간: From baseline to the 6 month follow-up
|
The number of participants who ordered and returned a HIV/STI/HCV test kit from baseline to the 6-month follow-up. It is a dichotomous outcome (yes/no). |
From baseline to the 6 month follow-up
|
|
Overdose Prevention Kit Uptake
기간: From baseline to the 6 month follow-up
|
The number of participants who ordered an overdose prevention kit from baseline to the 6-month follow-up. It is a dichotomous outcome (yes/no). |
From baseline to the 6 month follow-up
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Linkage to HIV/STI/HCV care
기간: From baseline to the 6-month follow-up
|
The number of participants who test positive for HIV/STI/HCV and who access care. It is a dichotomous outcome (yes/no). |
From baseline to the 6-month follow-up
|
|
Linkage to substance use services
기간: From baseline to the 6 month follow-up
|
The number of participants who use substances who accessed substance use services from baseline to the 6-month follow-up. It is a dichotomous outcome (yes/no). |
From baseline to the 6 month follow-up
|
|
HIV/STI stigma
기간: Baseline, 3 months, and 6 months
|
Mean score change in stigma from baseline to 3 months follow-up and 6 months follow-up. Higher scores correspond to higher stigma levels. |
Baseline, 3 months, and 6 months
|
|
Substance use stigma
기간: Baseline, 3 months, and 6 months
|
Mean score change in stigma from baseline to 3 months follow-up and 6-months follow-up. Higher scores correspond to higher stigma levels. |
Baseline, 3 months, and 6 months
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Alissa Davis, PhD, Columbia University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- AAAV8351
- 1R34DA063049 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Survey data from baseline and follow-up assessments will be preserved and deposited in the National Addiction and HIV Data Archive Program (NAHDAP) repository.
IPD 공유 기간
Final submission and release of the study data will occur within 12 months following publication of the main outcomes paper and will be available through the National Addiction and HIV Data Archive Program (NAHDAP) repository in perpetuity.
IPD 공유 액세스 기준
Data will be deposited as a restricted use dataset in NAHDAP. Investigators interested in analyzing the data must submit a request to NAHDAP and receive approval before they will be able to access the data.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .