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

NIH Pandemic-Era Grants

Pandemic Era Grants

2024

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Principal Investigator: Alida M Bouris
Organization: NORTHWESTERN UNIVERSITY AT CHICAGO
Fiscal Year: 2024
Award: $603,857
Funding agency: National Institute of Mental Health

Project 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), we have shown significant beneficial effects of an intervention that aims to increase positive affect
on viral suppression and psychological well being. We 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), we 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. We 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.

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