Work2Prevent Plus：黒人の性的マイノリティの男性のHIVケアを促進するための構造的介入
The goal of this observational study is to learn about the pilot test of the employment program among young men living with HIV or part of a community highly impacted by HIV.
The main question it aims to answer is: What is the feasibility and acceptability of the employment program?
Young male participants will attend the two day employment program and will complete four study surveys over the course of 6 months.
Employment program facilitators will complete a study survey and participate in a focus group over the course of 1 day.
調査の概要
詳細な説明
For this trial, we will recruit, screen, and enroll a sample of 120 young men from our networks of community-based organizations and LGBT-serving partners. Eligible participants will be pre-screened for enrollment by a University of Chicago study research staff/project manager. Next, the research staff will explain the scope of employment program and expectations of enrollees. Those interested in enrolling in the employment program and study will then be invited to an initial session of the employment program.
The overall employment program will consist of 2 days of workshop content focused on employment skills and the relationship between work and health.
Day One. Upon arrival, the program implementers and researchers will explain the employment program and purpose of the research study. University of Chiago research staff will complete informed consent procedures with participants prior to beginning the study baseline questionnaire and ensure that all participants are capable of consenting to participate. Participants will be asked to complete a release of information to access electronic medical records for the purposes of collecting measures of viral load and clinical care visit attendance at each time point.
Baseline (T1). Prior to the start of the first session, participants will be given an iPad tablet and headphones containing a 30-35 minute audio-computer assisted self-interview (ACASI) survey. Self-assessment measures, including: sociodemographic characteristics: age, race/ethnicity, income, incarceration history, and employment history; employment and housing: job seeking self-efficacy, average hours worked in a week (last 30 days), work motivation, job-seeking behavior, and homelessness (last 3 months); and clinical care: receipt of ART/PrEP prescription (past 4 months), visits for HIV/PrEP care (past 6 months), HIV/STI testing visits (past 6 months).
Day Two. Immediate-post program (T2). At the completion of the employment program on the second day, participants will complete a 25-30 minute ACASI survey assessing the feasibility, acceptability, and satisfaction with the employment program.
3-months (T3) and 6-months (T4) post-program. Participants will be contacted by study research staff to complete additional follow-up surveys via private phone conversation or independent completion online through the REDCap data collection platform. Follow-up surveys at 3 months and 6 months post-program will assess all variables addressed at T1.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Jordan Victorian
- 電話番号：773-702-5915
- メール：jordan.victorian@bsd.uchicago.edu
研究連絡先のバックアップ
- 名前：Darnell Motley
- 電話番号：773-834-5910
- メール：dmotley22@bsd.uchicago.edu
研究場所
-
-
Illinois
-
Chicago、Illinois、アメリカ、60637
- 募集
- University of Chicago
-
コンタクト：
- Jordan Victorian
- 電話番号：773-702-5915
- メール：jordan.victorian@bsd.uchicago.edu
-
コンタクト：
- Darnell Motley
- 電話番号：773-834-5910
- メール：dmotley22@bsd.uchicago.edu
-
主任研究者：
- Darnell Motley, PhD
-
-
参加基準
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
サンプリング方法
調査対象母集団
Young male cohort will be selected from primary care clinics serving young males; local gathering places and events for young sexual minority males, such as night clubs, House & Ball events, and other public places that serve the LGBTQ community (e.g., LGBTQ centers).
説明
Inclusion Criteria:
- Identifying as male
- Being ages 18-29 years old; AND
- EITHER living with HIV currently OR identifying with a population highly impacted by HIV (based on race/ethnicity or having ever had sex with another man) OR
- Being ages 18 or older
- Participated in facilitation or administrative support for the program, "The Work Shop," at a partnering community-based organization
Exclusion Criteria:
- Participated in the preceding employment intervention, "Work2Prevent"
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Young Black sexual male
Participate in two day employment program |
Employment intervention consists of 2 days (about 5 hours each) of interactive educational content focused on a variety of topics. |
|
Employment program facilitators
Lead or support the two day employment program |
Employment intervention consists of 2 days (about 5 hours each) of interactive educational content focused on a variety of topics. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acceptability of intervention
時間枠：Post-Intervention, week 2
|
Average score among participants of the Information Systems Success Model. The 16-item scale measures information quality, perceived usefulness, and overall satisfaction. Every item is scored on a 1-7 scale, with 1 being "Strongly Disagree" and 7 being "Strongly Agree". Responses are averaged to produce an overall ISSM score (1-7; higher scores indicate higher acceptability/satisfaction). |
Post-Intervention, week 2
|
|
Satisfaction with intervention
時間枠：Post-Intervention, week 2
|
Average score among participants of the Information Systems Success Model. The 16-item scale measures information quality, perceived usefulness, and overall satisfaction. Every item is scored on a 1-7 scale, with 1 being "Strongly Disagree" and 7 being "Strongly Agree". Responses are averaged to produce an overall ISSM score (1-7; higher scores indicate higher acceptability/satisfaction). |
Post-Intervention, week 2
|
|
Workshop feasibility
時間枠：Immediately after the intervention
|
Number of participants that complete at least two workshops |
Immediately after the intervention
|
|
Missed sexual healthcare visits
時間枠：Baseline, 3 months and 6 months
|
Ratio of scheduled sexual healthcare visits to missed sexual healthcare visits in the past 6 months |
Baseline, 3 months and 6 months
|
|
Change in participants perceived ability and confident to perform job seeking activities
時間枠：Baseline through 6 months
|
Average change in score between baseline and 6 months on Job-Seeking Self-Efficacy scale on participants perceived ability and confidence to perform job seeking activities. The 12-item Job Seeking Self-Efficacy scale uses response values on a 1-10 score, with 1 being "Not at All Confident" and 10 being "Very Confident". Responses are averaged to yield a total score, with higher scores indicating higher self-efficacy. Change in JSS will be calculated by subtracting the JSS score at baseline (T1) from the JSS score at the 3- (T3) and 6-month follow-ups (T4) (-9 to +9; negative change indicates decreased self-efficacy, while positive change indicates increased self-efficacy). |
Baseline through 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in hours worked per week
時間枠：Baseline through 6 months
|
Average change in number of reported hours worked each week between baseline and 6 months |
Baseline through 6 months
|
|
Change in self-reported sexual risk behaviors
時間枠：Baseline through 6 months
|
Average change in self-reported sexual risk behaviors from baseline through 6 months. Sexual risk behaviors will be measured using 7 (8 for trans male participants) yes/no items assessing for engagement in the following behaviors during the past 6 months:
|
Baseline through 6 months
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Darnell Motley, PhD、University of Chicago
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB22-0783
- K08MH130253 (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
A dataset that has been deidentified will be uploaded to a research data repository at the end of the study. All collected IPD from participants in the trial will be included.
IPD 共有時間枠
Data will be made available 6 months after the primary paper from the study is published.
IPD 共有アクセス基準
Sharing criteria to be determined
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
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
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。