正義を求める集団におけるHIV治療・予防のための共有意思決定（STOP）（R33）
STOP (司法関連集団におけるHIV治療または予防のための共有意思決定)
This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.
調査の概要
詳細な説明
This study will be done in two phases. Aim 1, the R61 portion of the project will be a Pilot Study, and Aim 2, the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot.
The focus of this registration is Aim 2, the randomized controlled trial. The Aim 1 (R61) portion is registered with NCT06439329. In Aim 2 (R33), investigators will evaluate standard PN compared to PN+PC on participant outcomes, implementation outcomes and costs associated with implementing the study.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Alysse Schultheis, MA
- 電話番号：203-231-2454
- メール：alysse.schultheis@yale.edu
研究連絡先のバックアップ
- 名前：Sandra Springer, MD
- 電話番号：203-231-2454
- メール：Sandra.springer@yale.edu
研究場所
-
-
Connecticut
-
New Haven、Connecticut、アメリカ、06510
- 募集
- Yale School of Medicine
-
主任研究者：
- Sandy Springer, MD
-
-
Kentucky
-
Lexington、Kentucky、アメリカ、40506
- 募集
- College of Medicine at the University of Kentucky
-
主任研究者：
- Michele Staton, PhD, MSW
-
-
Texas
-
Dallas、Texas、アメリカ、75390
- 募集
- University of Texas Southwestern Medical Center (UTSW)
-
主任研究者：
- Ank Nijhawan, MD, MPH
-
Fort Worth、Texas、アメリカ、76109
- 募集
- Texas Christian University's (TCU) School of Medicine
-
主任研究者：
- Kevin Knight,, 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
説明
Inclusion Criteria:
- able to provide written informed consent in English or Spanish;
- living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);
- Those with current justice involvement (with in the past 12 months) (e.g., prison, jail, community supervision);
- willing to have HIV testing to determine negative or positive status;
- persons with HIV who report not currently taking ART in past 6 months OR persons who test negative for HIV who report not taking PrEP that have a PrEP indication in past 12 months, including (i) condomless sexual intercourse; and/or (ii) sharing IDU equipment with HIV positive or unknown status partner; and/or (iii) bacterial STI and;
- Having a history of opioid and/or stimulant use in the last 12 months within the community.
Exclusion Criteria:
- severe medical or psychiatric disability making participation unsafe;
- unable to provide consent.
- persons self-reporting pregnancy
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Standard Patient Navigation (PN)
PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked to PrEP/ART and SUD services. This manualized PN approach provides a complete assessment of participant needs, goal setting, and help with appointment scheduling. |
Standard of care |
|
実験的：PN + Patient Choice (PC) (PN+PC)
PNs working in the PN + PC arm will be trained to engage participants in selecting from a menu of service options in their community. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our Community Advisory Boards (CAB). PNs will also be trained to discuss sexual and substance use history with participants in order to provide education and motivation towards starting PrEP/ART and SUD treatment. |
Standard of care Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services. |
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 |
|---|---|---|
|
Percentage of participants who initiate or re-initiate PrEP
時間枠：6 months
|
Percentage of participants not living with HIV who initiate or re-initiate PrEP within the 6-month intervention period by self report |
6 months
|
|
Percentage of participants who initiate or re-initiate ART
時間枠：6 months
|
Percentage of participants living with HIV who initiate or re-initiate ART within the 6-month intervention period by self report |
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of participants that adhere to PrEP
時間枠：6 and 12 months
|
Percentage of participants that adhere to PrEP |
6 and 12 months
|
|
Percentage of participants retaining on PrEP
時間枠：6 and 12 months
|
Percentage of participants retaining on PrEP |
6 and 12 months
|
|
HIV incidence
時間枠：6 and 12 months
|
HIV incidence [binary] for those testing negative using rapid point of care (POC) test over time |
6 and 12 months
|
|
Percentage of participants that adhere to ART
時間枠：6 and 12 months
|
Percentage of participants that adhere to ART |
6 and 12 months
|
|
ART retention
時間枠：6 and 12 months
|
For persons living with HIV (PLH), ART retention [binary] |
6 and 12 months
|
|
Substance use treatment
時間枠：6 and 12 months
|
Percentage of participants engaged in substance use disorder (SUD) treatment |
6 and 12 months
|
|
HIV viral suppression
時間枠：6 months
|
For PLH, HIV viral suppression, for those with HIV at time of randomization: the percent who maintain or achieve HIV viral load < 200 copies/mL at 6 months |
6 months
|
|
Retention in HIV PrEP/ART
時間枠：6 months
|
Retention in HIV PrEP/ART care [binary]: defined as attending 2 or more visits in 6-months |
6 months
|
|
Number of Participants Who Had Any Needle Sharing Activity to Assess HIV Risk Behavior
時間枠：6 and 12 months
|
Number of Participants Who Had Any Needle Sharing Activity |
6 and 12 months
|
|
Number of Participants Who Had Sex Without a Condom to assess HIV Risk Behavior
時間枠：6 and 12 months
|
Number of Participants Who Had Vaginal or Anal Sex Without a Condom |
6 and 12 months
|
|
Days of using opioids
時間枠：6 and 12 months
|
Measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use |
6 and 12 months
|
|
Number of participants with with overdose events
時間枠：6 and 12 months
|
Number of participants with non-fatal and fatal overdose events |
6 and 12 months
|
|
Percentage of participants with retention in SUD treatment
時間枠：6 and 12 months
|
Retention in SUD treatment including but not exclusive to Medication for Opioid Use Disorder (MOUD) for Opioid Use Disorder (OUD) |
6 and 12 months
|
|
Quality of Life assessed using PROMIS-PROPr
時間枠：6 and 12 months
|
PROMIS-PROPr assesses general societal health. Total summary score ranges from -0.022, worse than dead, to 1, perfect health. |
6 and 12 months
|
|
Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)
時間枠：6 and 12 months
|
Depression will be assessed using the PHQ-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety. |
6 and 12 months
|
|
Recidivism: Reasons
時間枠：6 and 12 months
|
Number of participants per reason for arrest/ incarceration/return-to-custody |
6 and 12 months
|
|
Recidivism: Mean days in custody/incarcerated
時間枠：6 and 12 months
|
Mean days in custody/incarcerated |
6 and 12 months
|
|
Recidivism: Mean days to return
時間枠：6 and 12 months
|
Mean days to return to custody/incarcerated |
6 and 12 months
|
|
HIV and SU Stigma assessed using Substance Use Stigma Mechanisms Scale (SU-SMS)
時間枠：6 and 12 months
|
Mean score for Enacted (6 items), Anticipated (6 items), and Internalized (6 items) scales. Each scale is scored 1-5, with higher scores indicating greater endorsement of substance use stigma |
6 and 12 months
|
|
Percentage of participants diagnosed with SUD
時間枠：Baseline and 12 months
|
Percentage of participants diagnosed with SUD using DSM-5 |
Baseline and 12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Sandra Springer, MD、Yale University
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
追加の関連 MeSH 用語
その他の研究ID番号
- 2000037052_a
- 4R33DA060625-02 (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?
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。