平等に HIV の蔓延を終わらせる: 人種差別と差別の影響を軽減するための介入
HIV 流行の終結: 患者と医療に対する構造的人種差別と差別の影響を軽減するための全施設介入
The scope of this study is to engage Ryan White HIV/AIDS Program (RWHAP) funded organizations in the South/East US to co-develop context-responsive programs utilizing evidence-informed interventions to reduce stigma against living with HIV (PLH) who have difficulties accessing and remaining engaged in life-saving treatment. Five RWHAP clinics will be selected for this trial. Clinic members will participate in interactive trainings to raise awareness of and reduce stigma, from the clinic policy level to individual attitudes. Clinic members and select patients will complete self-administered surveys every 6 months over 24 months.
調査の概要
詳細な説明
The scope of this study is to engage HIV care clinics in the United States to co-develop context-responsive programs utilizing evidence-informed interventions to reduce processes and practices perceived as stigmatizing by people living with HIV who have difficulties accessing and remaining engaged in life-saving treatment. HIV-related stigma in a clinical setting directly impacts access to and uptake of healthcare, including engagement in HIV care services. The proposed intervention draws on the evidence-based Health Policy Plus (HP+) 'total' facility HIV stigma-reduction intervention that focuses on the clinics' organizational and interpersonal levels to strengthen patient care and engagement in services, and staff wellbeing. We will conduct an implementation trial of our HIV stigma-reduction intervention. Clinics will receive training to support them in 1) identifying/creating organizational-level policies and practices (e.g., clear understanding of what practices can be experienced as stigmatizing) to reduce HIV stigma, and 2) deliver participatory trainings to all staff (e.g., building awareness of the impact of patient perceptions and experiences of HIV-related stigma on health). In Aim 3, we will evaluate outcomes, including at the organization (primary outcome of Stigma Reduction Index - ratings of mission/vision statements, policies around HIV stigma, comfort level in clinics), interpersonal (secondary outcomes of provider/staff attitudes; behavior), and individual patient and/or staff (tertiary outcomes of clinic-level HIV indicators, reports of HIV care practices that can be experienced as stigmatizing, anxiety, depression, and stress) levels. Assessments will take place every 6 months.
The intervention will generate strategies to improve the wellbeing of the healthcare workforce. Ultimately, the study will produce implementation lessons on how to effectuate clinical practice changes to increase access to effective HIV treatment, as well as the wellbeing of the healthcare workforce.
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：Corina T Lelutiu-Weinberger, PhD
- 電話番号：212-305-5756
- メール：cl4265@cumc.columbia.edu
研究連絡先のバックアップ
- 名前：Felicia A Browne, ScD
- 電話番号：919-541-6596
- メール：fbrowne@rti.org
研究場所
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New York
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New York、New York、アメリカ、10032
- 募集
- Columbia University School of Nursing
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コンタクト：
- Corina Lelutiu-Weinberger, PhD
- メール：cl4265@cumc.columbia.edu
-
-
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:
- Selected Ryan White Clinics. Selection based on the following:
First, clinic leaders will complete a 15-min Site Characteristics Survey, assessing suitability for participation and clinic comparability. Staff and leadership at Ryan White clinics will next complete an anonymous 15-minute Eligibility Survey.
Within each clinic, both clinic staff and patients will be invited to participate.
Exclusion Criteria:
- Non-Ryan White Clinics
- Clinics not located in the geographical area of interest
- Clinics that are not interested in participating
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：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
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実験的：Intervention
The intervention will be implemented across six months with a total of five clinics. The intervention consists of a series of interactive trainings that cover stigma and health-related topics, such as roots, manifestations, and consequences of stigma in healthcare, history of HIV stigma, and stress and stigma. These will be split across several sessions, depending on clinics' schedules. At the end of the intervention, each clinic will create a Code of Practice that will be formalized into a manual for each clinic, to guide the implementation and sustainability of stigma reduction efforts. |
The HP+ curriculum includes total-site training and co-facilitation via participatory modules. To change clinic culture, a multi-level approach that includes the whole facility and reaches all parties is required. The intervention aims to modify top-down mechanisms of influence. The training is modeled on these principles and supports the development of multiple stigma-reduction strategies to improve patient and staff wellbeing.
他の名前：
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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 |
|---|---|---|
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Change in Stigma Index (SI)
時間枠：Baseline, 6, 12, 18, and 24 months
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The SI is a rating of clinic mission/vision statements, the anti-stigma policy, and the clinic context. A change in the mean score of SI post-intervention implementation will be measured. Scores range from 0-100, with a higher score indicating increased anti-stigma policies and procedures. |
Baseline, 6, 12, 18, and 24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Cultural Humility Score
時間枠：Baseline, 6, 12, 18, and 24 months
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Cultural humility as measured by the adapted Trauma-Informed, Resilience-Oriented Care (TI-ROC) Cultural Humility Scale, which assess staff's perceptions of colleagues and clinic context. Scores range from 12-60. The negative items are reverse coded such that higher scores indicate higher cultural humility indicating better outcomes. |
Baseline, 6, 12, 18, and 24 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Time to Linkage to Care
時間枠：Baseline, 6, 12, 18, and 24 months
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Change in time to linkage to care from diagnosis at the clinics. |
Baseline, 6, 12, 18, and 24 months
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Change in Patients Retained in Care
時間枠：Baseline, 6, 12, 18, and 24 months
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Change in the number of patients retained in care at the clinics. |
Baseline, 6, 12, 18, and 24 months
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Change in Number of Patients HIV Virally Suppressed
時間枠：Baseline, 6, 12, 18, and 24 months
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Change in the number of patients virally suppressed at the clinics. Viral suppression defined as less than 200 copies/mL. |
Baseline, 6, 12, 18, and 24 months
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Change in Frequency of Perceived HIV and Other Stigmas
時間枠：Baseline, 6, 12, 18, and 24 months
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Change in the frequency of perceived stigma-related events by staff and patients attending the clinic as collected by self-administered Experiences of Perceived Stigma survey. |
Baseline, 6, 12, 18, and 24 months
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Change in Depression and Anxiety
時間枠：Baseline, 6, 12, 18, and 24 months
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A 4-item scale that assesses depression and anxiety (PHQ-4) over the past week. Scores range from 0-63 with a lower score indicating a better outcome. |
Baseline, 6, 12, 18, and 24 months
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Corina Lelutiu-Weinberger, PhD、Columbia University
- 主任研究者：Felicia A Browne, ScD、RTI International
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
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。