- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05785169
Die HIV-Epidemie mit Gerechtigkeit beenden: eine Intervention zur Verringerung der Auswirkungen von Rassismus und Diskriminierung
Beendigung der HIV-Epidemie: Eine Intervention aller Einrichtungen zur Verringerung der Auswirkungen von strukturellem Rassismus und Diskriminierung auf Patienten und Gesundheitsversorgung
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Corina T Lelutiu-Weinberger, PhD
- Telefonnummer: 212-305-5756
- E-Mail: cl4265@cumc.columbia.edu
Studieren Sie die Kontaktsicherung
- Name: Felicia A Browne, ScD
- Telefonnummer: 919-541-6596
- E-Mail: fbrowne@rti.org
Studienorte
-
-
New York
-
New York, New York, Vereinigte Staaten, 10032
- Rekrutierung
- Columbia University School of Nursing
-
Kontakt:
- Corina Lelutiu-Weinberger, PhD
- E-Mail: cl4265@cumc.columbia.edu
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Stigma Index (SI)
Zeitfenster: Baseline, 6, 12, 18, and 24 months
|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Cultural Humility Score
Zeitfenster: Baseline, 6, 12, 18, and 24 months
|
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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Time to Linkage to Care
Zeitfenster: Baseline, 6, 12, 18, and 24 months
|
Change in time to linkage to care from diagnosis at the clinics. |
Baseline, 6, 12, 18, and 24 months
|
|
Change in Patients Retained in Care
Zeitfenster: Baseline, 6, 12, 18, and 24 months
|
Change in the number of patients retained in care at the clinics. |
Baseline, 6, 12, 18, and 24 months
|
|
Change in Number of Patients HIV Virally Suppressed
Zeitfenster: Baseline, 6, 12, 18, and 24 months
|
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
|
|
Change in Frequency of Perceived HIV and Other Stigmas
Zeitfenster: Baseline, 6, 12, 18, and 24 months
|
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
|
|
Change in Depression and Anxiety
Zeitfenster: Baseline, 6, 12, 18, and 24 months
|
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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Corina Lelutiu-Weinberger, PhD, Columbia University
- Hauptermittler: Felicia A Browne, ScD, RTI International
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- AAAU1559
- 1R01NR020583 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .