Columbia University School of Nursing
New York, 10032, United States
Location status: Recruiting
NCT Number: NCT05785169
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10032, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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.
Other names: Health Policy+ infused with US HIV care clinic-relevant content and activities
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6, 12, 18, and 24 months
Change in time to linkage to care from diagnosis at the clinics.
Time frame: Baseline, 6, 12, 18, and 24 months
Change in the number of patients retained in care at the clinics.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Corina T Lelutiu-Weinberger, PhD
CONTACT
Felicia A Browne, ScD
CONTACT
Columbia University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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