Ignite Creation Date:
2024-05-06 @ 5:43 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05404750
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2022-05-19
Brief Title:
Harm Reduction in HIV Primary Care for PLWH Who Use Drugs
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Impact of Harm Reduction Care in HIV Clinical Settings on Stigma and Health Outcomes
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People living with HIV PLWH who use drugs experience significant health disparities including lower rates of retention in HIV care and higher rates of unsuppressed viral load resulting in secondary infections and increased mortality The proposed study will used mixed methods to explore a the relationship between healthcare providers attitudes towards working with PLWH who use drugs and providers acceptance and practice of structural and relational harm reduction b the degree to which relational harm reduction moderates the effect of intersectional stigma experienced in healthcare settings on patients perceptions of their relationship with providers c the degree to which structural HR moderates the relationship between the patient-provider relationship and clinical outcomes and d whether patient-perceived HR approaches to care are directly associated with HIV clinical outcomes The study will also use these findings to inform the development and pre-testing of an intervention to operationalize harm reduction in HIV clinical settings using stakeholder-engaged and human-centered design approaches presenting a novel path to reducing HIV health inequities for PLWH who use drugs
Detailed Description:
This observational study takes place across three study sites and will explore the extent to which harm reduction care mitigates stigma experienced in healthcare settings and contributes to improved clinical outcomes This will be explored via the following aims
Aim 1 Explore the relationship between healthcare providers stigmatizing attitudes towards working with PLWH who use drugs and providers acceptance and practice of structural and relational HR to elucidate the context for intervention development Providers n125 working HIV clinics in Birmingham AL and Pittsburgh PA will be surveyed to understand subjective responses around preparedness for and delivery of HR care to PLWH who use drugs A sequential explanatory mixed-methods approach will be utilized surveys will be followed by semi-structured interviews n40 with multiple provider types in both regions to further explore HR perspectives and inform intervention development It is hypothesized that providers with less stigmatizing attitudes toward serving people who use drugs are more likely to be accepting of relational and structural HR practices
Aim 2 Explore the interplay between patient-perceived HR and stigma and clinical outcomes specifically the degree to which a relational HR moderates the effect of intersectional stigma experienced in healthcare settings HIV- and substance use-related stigma and racial discrimination on patients perceptions of their relationship with providers b structural HR moderates the relationship between the patient-provider relationship and clinical outcomes ART adherence retention in care HIV and HCV viral suppression and c patient-perceived HR care is directly associated with HIV clinical outcomes see Figure 1 After qualitatively evaluating PAPHRS with HIV clinical and HR providers n20 and PLWH who use drugs n36 PLWH who use drugs n500 who receive care in the study sites will be surveyed to assess their perceptions of providers relational HR care experiences of intersectional stigma and perceived quality of relationships with their providers Other potential stigmatized identities eg HCV will be explored via patient focus groups n36 It is hypothesized that the effect of intersectional stigma on the patient-provider relationship is attenuated in higher degrees of relational HR care structural HR attenuates the effect of poor patient-provider relationships on clinical outcomes and higher degrees of HR care are associated with better clinical outcomes
Aim 3 Using human-centered design approaches develop and pre-test an intervention to operationalize HR care for PLWH who use drugs in HIV clinical settings Results from Aims 1 and 2 will be shared with with stakeholders n20 PLWH who use drugs clinical and HR providers to develop an intervention Acceptability and feasibility of the intervention design will be assessed with providers n12 in both regions
Aim 1 Explore the relationship between healthcare providers stigmatizing attitudes towards working with PLWH who use drugs and providers acceptance and practice of structural and relational HR to elucidate the context for intervention development Providers n125 working HIV clinics in Birmingham AL and Pittsburgh PA will be surveyed to understand subjective responses around preparedness for and delivery of HR care to PLWH who use drugs A sequential explanatory mixed-methods approach will be utilized surveys will be followed by semi-structured interviews n40 with multiple provider types in both regions to further explore HR perspectives and inform intervention development It is hypothesized that providers with less stigmatizing attitudes toward serving people who use drugs are more likely to be accepting of relational and structural HR practices
Aim 2 Explore the interplay between patient-perceived HR and stigma and clinical outcomes specifically the degree to which a relational HR moderates the effect of intersectional stigma experienced in healthcare settings HIV- and substance use-related stigma and racial discrimination on patients perceptions of their relationship with providers b structural HR moderates the relationship between the patient-provider relationship and clinical outcomes ART adherence retention in care HIV and HCV viral suppression and c patient-perceived HR care is directly associated with HIV clinical outcomes see Figure 1 After qualitatively evaluating PAPHRS with HIV clinical and HR providers n20 and PLWH who use drugs n36 PLWH who use drugs n500 who receive care in the study sites will be surveyed to assess their perceptions of providers relational HR care experiences of intersectional stigma and perceived quality of relationships with their providers Other potential stigmatized identities eg HCV will be explored via patient focus groups n36 It is hypothesized that the effect of intersectional stigma on the patient-provider relationship is attenuated in higher degrees of relational HR care structural HR attenuates the effect of poor patient-provider relationships on clinical outcomes and higher degrees of HR care are associated with better clinical outcomes
Aim 3 Using human-centered design approaches develop and pre-test an intervention to operationalize HR care for PLWH who use drugs in HIV clinical settings Results from Aims 1 and 2 will be shared with with stakeholders n20 PLWH who use drugs clinical and HR providers to develop an intervention Acceptability and feasibility of the intervention design will be assessed with providers n12 in both regions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA054832 | NIH | None | httpsreporternihgovquickSearchR01DA054832 |