Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541028
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Reducing Stigma in People Who Inject Drugs PWID With HIV Using a Rapid Start Antiretroviral Therapy Intervention ART
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Reducing Stigma in People Who Inject Drugs With HIV Using a Rapid Start Antiretroviral Therapy Intervention RS-ART
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RS-ART
Brief Summary:
This study seeks to develop an RS-ART implementation strategy by utilizing the Delphi method and interviewing experts and PWID regarding their experiences with ART This strategy will then be pilot tested in a randomized controlled trial Aim 3 The research will not impact the type of medication and dose prescribed but rather how soon providers are able to prescribe ART after diagnosis The focus of this registration is Aim 3
Detailed Description:
Investigators will use a prospective longitudinal design to pilot test a newly developed RS-ART protocol for PWID with both participants and their HIV clinicians PWID with HIV will be initiated into the protocol as part of routine care Aim 3 will be further divided into into aims 3a general population and 3b prisoner population Aim 3a will not be opened until informed by data collected from Aim 1 and 2 Aim 3b Will not open until the project is certified by OHRP
Systematic reviews and cohort studies confirm rapid-start ART RS-ART significantly increases ART initiation and viral suppression VS central tenets for HIV treatment as prevention TasP It focuses on ART initiation within 7 days of diagnosis Despite recommendations by international agencies and Malaysias Ministry of Health MoH to widely implement RS-ART immediately after diagnosis it is rarely implemented in Malaysia in key-affected populations KAPs Because RS-ART redesigns HIV care by focusing on clinical indicators rather than exploring a patients worthiness ie stereotypes for treatment it has the potential to reduce stigma though it has not been tested empirically as a stigma reduction strategy in MSM
Stigma is a well-documented global barrier to health-seeking behavior engagement in care and adherence to treatment across a range of health conditionsStigma emerges when a label associated with a negative stereotype eg MSM etc causing such persons to be seen as separate from and lower in status than others and thus as legitimate targets of discrimination
RS-ART may potentially reduce stigma as a behavioral design intervention BDI which can be especially effective where stigma is deeply embedded and difficult to change BDIs unlike most extant stigma reduction interventions use choice architecture framing and nudging to guide individuals to make specific choices eg immediate ART or guide behaviors
Systematic reviews and cohort studies confirm rapid-start ART RS-ART significantly increases ART initiation and viral suppression VS central tenets for HIV treatment as prevention TasP It focuses on ART initiation within 7 days of diagnosis Despite recommendations by international agencies and Malaysias Ministry of Health MoH to widely implement RS-ART immediately after diagnosis it is rarely implemented in Malaysia in key-affected populations KAPs Because RS-ART redesigns HIV care by focusing on clinical indicators rather than exploring a patients worthiness ie stereotypes for treatment it has the potential to reduce stigma though it has not been tested empirically as a stigma reduction strategy in MSM
Stigma is a well-documented global barrier to health-seeking behavior engagement in care and adherence to treatment across a range of health conditionsStigma emerges when a label associated with a negative stereotype eg MSM etc causing such persons to be seen as separate from and lower in status than others and thus as legitimate targets of discrimination
RS-ART may potentially reduce stigma as a behavioral design intervention BDI which can be especially effective where stigma is deeply embedded and difficult to change BDIs unlike most extant stigma reduction interventions use choice architecture framing and nudging to guide individuals to make specific choices eg immediate ART or guide behaviors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None