Ignite Creation Date:
2024-05-06 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05123144
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2021-06-24
Brief Title:
A Hybrid Type II Trial of the Optimizing Resilience and Coping With HIV Through Internet Delivery in Ryan White Clinics in Chicago
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Stepped Wedge Hybrid Type II Trial of an Online Positive Affect Intervention Blending Implementation and Effectiveness to Improve HIV Continuum Outcomes in Ryan White Clinics in Chicago
Status:
RECRUITING
Status Verified Date:
2024-03
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:
ORCHID
Brief Summary:
Among people living with HIV PLWH positive affect is uniquely associated with lower levels of depression slower disease progression better adherence to medication and higher likelihood of achieving suppressed viral load independent of negative affect In two randomized controlled trials with PLWH R01 MH084723 R01 DA033854 the investigators have shown significant beneficial effects of an intervention that aims to increase positive affect on viral suppression and psychological well being The investigators also have demonstrated feasibility acceptability and early efficacy of a self-guided online-delivered positive affect skills intervention for PLWH R34 MH101265 Now in collaboration with the AIDS Foundation of Chicago AFC the investigators propose to conduct a Hybrid Type II effectiveness-implementations study of a stepped wedge cluster randomized trial SW-CRT of mental health screening and referral to ORCHID Optimizing Resilience and Coping with HIV through Internet Delivery The proposed study was initiated by AFC which developed the mental health screening and selected the SW-CRT design as an ethical way to study implementation while ensuring that all clients with elevated depression receive the intervention Mental health screening ORCHID will be implemented through all medical case managers MCMs at 17 Ryan White-funded clinics in Chicago The investigators will use the RE-AIM framework to structure the effectiveness and implementation outcomes and the Consolidated Framework for Implementation Research CFIR to understand the implementation outcomes at the patient and clinic levels The specific aims are to 1 Operationalize an implementation facilitation strategy to link mental health screening with referral to ORCHID through MCMs at Ryan White-funded clinics in Chicago 2 Determine the effectiveness of screening ORCHID for improving depression retention in care and viral suppression among 300 PLWH receiving care at 17 Ryan White clinical sites using a stepped wedge cluster randomized design Depression is the primary outcome and retention in care and viral suppression at both the individual and clinic level are the secondary outcomes and 3 Evaluate the implementation of screening ORCHID and iteratively refine the strategy for subsequent steps The proposed research holds significant promise for advancing current knowledge on how best to integrate and respond to mental health screening in Ryan White clinics Data from the hybrid trial will result in a sustainable scalable program that can be disseminated in Ryan White clinics nationwide thus holding significant promise for advancing Chicago toward goals in the National Ending the HIV Epidemic Plan
Detailed Description:
Current HIV prevention strategies for PLWH emphasize engagement across the HIV Continuum of Care linkage to and retention in care adherence to antiretroviral therapy and maintenance of suppressed viral load The National HIVAIDS Strategy goals for engagement in each phase of the continuum include 85 of those diagnosed with HIV linked to care within 1 month 90 of those living with HIV retained in care and 80 achieving suppressed viral load23 As with many other cities Chicago falls far below these targets in 2018 only 411 of PLWH were retained in care as measured by having at least 2 visits during which CD4 or viral load count were obtained 3 months apart and 52 were virally suppressed ie 200 copiesmL at their last viral load test
Depression highly prevalent in PLWH predicts HIV progression and is associated with lack of engagement in Continuum of Care Screening for depression is a first step to addressing the significant barrier to engaging in care and improving the health and well-being of PLWH However even if clients are routinely screened there are few models of effective sustainable and cost-effective mental health care that are easily integrated into clinic workflow In many places there is a dearth of mental health providers and services able to address the needs of PLWH and depression The investigators propose to address this gap with ORCHID Optimizing Resilience and Coping with HIV through Internet Delivery a self-guided online-delivered intervention that specifically targets positive affect The theory and empirically-based program includes eight skills noticing and capitalizing on positive events gratitude mindfulness positive reappraisal personal strengths attainable goals and self-compassion delivered in a self-guided online format Across delivery modes and type of participant stress the intervention has shown good feasibility acceptability and efficacy
The intervention is based on revised Stress and Coping Theory and the Broaden-and-Build Theory of positive emotion The preliminary data for the proposed study consists of 1 two randomized trials of an in-person positive affect intervention for PLWH who are newly diagnosed n159 or are sexual minority men who use methamphetamines n110 2 an online adaptation of the positive affect intervention for people with elevated depression demonstrates feasibility acceptability and efficacy n539 and 3 a pilot RCT of the online version of this intervention conducted with 21 PLWH
The goal of the proposed study is to examine whether those who complete ORCHID as implemented through Ryan White clinics will experience improvements to depression and engagement in care At the clinic level we will examine whether clinics that are implementing the screening and referral to ORCHID have overall lower depression and higher engagement in care compared to those clinics not yet implementing the screening and ORCHID referral If effective the ORCHID program can be disseminated to other geographical locations facing a high burden of HIV
Depression highly prevalent in PLWH predicts HIV progression and is associated with lack of engagement in Continuum of Care Screening for depression is a first step to addressing the significant barrier to engaging in care and improving the health and well-being of PLWH However even if clients are routinely screened there are few models of effective sustainable and cost-effective mental health care that are easily integrated into clinic workflow In many places there is a dearth of mental health providers and services able to address the needs of PLWH and depression The investigators propose to address this gap with ORCHID Optimizing Resilience and Coping with HIV through Internet Delivery a self-guided online-delivered intervention that specifically targets positive affect The theory and empirically-based program includes eight skills noticing and capitalizing on positive events gratitude mindfulness positive reappraisal personal strengths attainable goals and self-compassion delivered in a self-guided online format Across delivery modes and type of participant stress the intervention has shown good feasibility acceptability and efficacy
The intervention is based on revised Stress and Coping Theory and the Broaden-and-Build Theory of positive emotion The preliminary data for the proposed study consists of 1 two randomized trials of an in-person positive affect intervention for PLWH who are newly diagnosed n159 or are sexual minority men who use methamphetamines n110 2 an online adaptation of the positive affect intervention for people with elevated depression demonstrates feasibility acceptability and efficacy n539 and 3 a pilot RCT of the online version of this intervention conducted with 21 PLWH
The goal of the proposed study is to examine whether those who complete ORCHID as implemented through Ryan White clinics will experience improvements to depression and engagement in care At the clinic level we will examine whether clinics that are implementing the screening and referral to ORCHID have overall lower depression and higher engagement in care compared to those clinics not yet implementing the screening and ORCHID referral If effective the ORCHID program can be disseminated to other geographical locations facing a high burden of HIV
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