性的搾取の生存者におけるHIV/STI/HCV検査と過剰摂取防止
ニューヨーク市在住の性的人身売買生存者におけるHIV/STI/HCV検査と薬物使用サービスの利用促進に向けた市民科学アプローチ
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Alissa Davis, PhD
- 電話番号：212-851-2224
- メール：ad3324@columbia.edu
研究場所
-
-
New York
-
New York、New York、アメリカ、10027
- Columbia University
-
コンタクト：
- Alissa Davis, PhD
- 電話番号：212-851-2224
- メール：ad3324@columbia.edu
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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. |
|
介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
HIV/STI/HCV testing uptake
時間枠：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
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Linkage to HIV/STI/HCV care
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Alissa Davis, PhD、Columbia University
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- AAAV8351
- 1R34DA063049 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。