Clinical trial NCT05123144: A Hybrid Type II Trial of the Optimizing Resilience and Coping With HIV Through Internet Delivery in Ryan White Clinics in Chicago
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: People Living With HIV
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: AIDS Foundation Chicago
First posted: 2021-11-17
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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 HIV/AIDS 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 load.23 As with many other cities, Chicago falls far below these targets: in 2018, only 41.1% 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 (i.e., \<200 copies/mL 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 (n=159) or are sexual minority men who use methamphetamines (n=110); 2) an online adaptation of the positive affect intervention for people with elevated depression demonstrates feasibility, acceptability and efficacy (n=539); 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.

Eligibility criteria: Inclusion Criteria:

Clinic-Level:

* Ryan White clinic in the Chicagoland area
* On-site medical services

Individual-Level:

* Age 18 and over
* Speaks and reads English
* Receives medical case management through one of the eligible Ryan White clinics
* Referral from medical case manager (on basis of screening positive for elevated depression through a clinic-based screener; PHQ-9 score \> 5)
* Daily access to a device connected to the internet
* Willingness to provide access to health and medical care from the Chicago Department of Health, primary care provider, and/or from the AIDS Foundation Chicago, confirmed by signature on two Release of Information forms.

Exclusion Criteria:

* None

Primary outcomes:
measure: Depression
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: AIDS Foundation of Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
References: