Clinical trial NCT04998019: PositiveLinks: mHealth for DC Cohort
Official title: Pragmatic Efficacy Trial of mHealth to Improve HIV Outcomes in the DC Cohort
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
Keywords: mobile Health
HIV care continuum
implementation science
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Virginia
First posted: 2021-08-10
Enrollment: 753
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized trial
Primary purpose: OTHER

Brief summary: To achieve the end of the HIV epidemic, concerted efforts will be needed to address the HIV care continuum, including improving retention in care (RIC) and viral suppression (VS) among persons with HIV (PWH). In the U.S., less than 50% of PWH are RIC and even fewer are VS. Studies have shown that these PWH have poorer clinical outcomes and are at risk of transmitting HIV to others, hence the need for innovative solutions to improve retention in care and subsequent viral suppression. Theory-based mHealth interventions have been shown to be promising in reaching these at-risk groups and improving HIV-related outcomes. PositiveLinks is a clinic-deployed mHealth platform that includes patient and provider smartphone apps, a web portal for clinic staff and providers to manage patient cohorts, an online implementation guide, and a learning management system to train and certify clinic staff. It has theory-based features including daily queries of adherence, mood, and stress, graphical feedback for self-monitoring, secure messaging with staff, appointment reminders, anonymized peer support, information resources, and document upload capability to support insurance re-enrollment. A 12-month prospective study in poorly retained PWH found that PL increased RIC and VS, with app use related to benefit as well as improved social support and stigma. PL is a promising existing mHealth tool for PWH, yet its efficacy has not been tested in a randomized trial, nor in urban populations. The investigators will test the efficacy of PositiveLinks to improve RIC and VS among a cohort of PWH in a high HIV prevalence city of Washington, DC. Participants will be identified from the DC Cohort, a longitudinal prospective cohort of PWH receiving HIV care at 15 clinics in DC. First, the investigators will conduct formative research to assess the feasibility, acceptability and usability of PositiveLinks among this urban cohort and conduct subsequent adaptations based on these findings. The investigators will then conduct an efficacy study through a cluster randomized controlled trial at 12 DC Cohort sites among 482 PWH. Clinics will be randomized to PL or usual care. Primary outcomes will include VS, RIC, and visit constancy at 12 months. Finally, the investigators will conduct mixed methods implementation science research guided by the Consolidated Framework for Implementation Research and RE-AIM to identify site, patient, provider, and system factors that characterize best practices in program implementation. If successful, this research will lead to the development of a novel and efficacious approach to improving RIC and VS among PWH which could lead to dissemination research that will contribute to HIV epidemic control. This project is responsive to NIH priorities, National HIV/AIDS Strategy, and Ending the HIV Epidemic goals as it is cross-cutting, seeks to reduce health inequities, and to improve health outcomes to achieve sustained viral suppression in a geographic hotspot for HIV.

Detailed description: Aim 1: To determine the feasibility, acceptability, and usability of PL, the investigators will conduct mixed methods research among the DC Cohort Executive Committee members (one focus group with a maximum of 20 members), providers from each of the DC Cohort participating clinics (individual in-depth interviews with a maximum of 28 providers), members of the DC Regional Planning Commission on Health and HIV (COHAH; one focus group with a maximum of 50 members), and PLWH who receiving care at each of the DC Cohort participating clinics (four focus groups with a maximum of 8 clinic patients in each group for a total of 32; user testing sessions followed by a survey with a maximum of 14 clinic patients; and beta testing preceded by a short demographic survey and followed by a brief in-depth interview and survey with a maximum of 14 clinic patients). Following user testing, the research and developer teams will review formative results and finalize the optimal set of app features for this urban cohort of PLWH. Following beta testing, the research and developer team will review results and make final app modifications. The prototype will pass stringent testing showing the app to be 100% bug-free, with no data loss. The app has robust transmission retries and data caching on the phone during periods of internet signal loss. Once connection is restored, all cached events are automatically sent to the PL servers on AWS (Amazon Web Services) S3 and are synchronized. The investigators will proceed to beta testing when it passes data reliability testing (retry, cache, re-send) at a 0% failure rate.

For the focus group, interview, and user testing participants, consent will be obtained verbally and a waiver of documentation of consent is requested. For beta-testing participants, written informed consent will be obtained. For the EC focus group, COHAH focus group, and provider interviews, participants will be sent a link to a brief REDCap survey prior to the study activities. The surveys will not be linked to their identities. For the focus groups with PLWH, participants will also be sent a link to a brief REDCap survey prior to the focus groups. During the user testing sessions, participants will be asked to download the app onto their phones. Users will be shown various app features by the study team and asked to share their impressions. Following the sessions, testers will be provided a link to the REDCap user testing survey. Users will be assigned a unique survey ID that will be linked to their DC Cohort ID so that they can be compensated. During the beta testing, participants will be asked to attend a virtual training session where participants will download the PositiveLinks app onto their personal smartphone, a study team member will set up the participants' PositiveLinks app account, and a study team member will demonstrate how to access PositiveLinks and its features.

Throughout the beta testing period, the study team will continuously collect data paradata or data related to app usage. This includes the frequency with which each participant uses app features as well as in-app data such as content information from check-in entries and comments, reminders, and community message board comments. Data collection will also include a 15-minute virtual user interview to debrief usage, likes and dislikes, identify bugs, and provide recommendations after one month of PL use. Along with an interview, participants will also complete a quick survey that will question participants overall experience with the app.

Aim 2: Aim 2 will entail a Cluster Randomized Clinical Trial that randomizes DC Cohort clinic patients (n=482) to either PL (n=6 clinics), or to the usual care conditions for engaging and retaining people in HIV care (n=6 clinics). Participants will be persons living with HIV who are previously enrolled in the DC Cohort or are eligible to enroll in the DC Cohort and have factors that may put them at risk for poor retention in care or lack of viral suppression (e.g. not virally suppressed, not retained in care, gap in care \>=6 months, newly diagnosed, etc.). Participants from clinics randomized to PL will get the patient smartphone app; clinic staff will receive the provider portal and provider smartphone app, the provider online LMS (learning management system), and the RA (research associate) will use the administrative website to enroll participants. Patients randomized to PL will use it for 12 months or more; they can opt to use it as long as it is available during the study (access depending on enrollment date). Participants from clinics randomized to Usual Care: Participants from clinics randomized to Usual Care will receive usual clinic retention and medication adherence support services for 12 months . The usual care condition ranges from having no ancillary support to only case management, to Ryan White funding and comprehensive services (adherence support, patient navigation, mental health, substance abuse, dental services and food banks).Participants will be assessed at baseline, 6 months, and 12 months to measure the primary outcomes of a) viral suppression (i.e., VL\<200 copies/ml) at 12 months, b) Visit Constancy (i.e., proportion of 4-month time intervals in which 1 HIV care visit was completed in 1 year, and c) Retention in care (i.e., 2 appointments separated by 90 days within 12 months per HRSA-1)

Aim 3: The investigators will conduct mixed methods research (in-depth interviews and focus groups) guided by the Consolidated Framework for Implementation Research and RE-AIM to identify site, patient, provider, and system factors that are barriers and facilitators of processes and outcomes of implementation at the 6 sites randomized to PL.

Eligibility criteria: Inclusion Criteria:

* PLWH and eligible for/enrolled in DC Cohort study age 16 or older
* speaks and reads English or Spanish at 4th grade level or above
* can provide informed consent; if a minor, is in charge of own HIV care
* plans to reside in the DC metro area for the next 12M
* has at least one of the following indicators of poor retention (in order of priority):

  * detectable virus,
  * not retained in care,
  * returning to care after a gap of ≥6 months, d) no visit constancy
  * newly diagnosed or initiating HIV care
  * recently transferred from a different HIV care site
  * evidence of HIV care receipt at a DC Cohort site and a non-DC Cohort site based on the DOH (Department of Health) linkage(\~9%).

Exclusion Criteria:

* age below 16, or if patient is 16-17; parent is in charge of HIV care
* unable to provide legal, independent consent to participate
* PLWH receiving care at two DC Cohort sites (\~10%) will be excluded

Primary outcomes:
measure: Viral Suppression
timeFrame: Month 12 from baseline
measure: Retention in Care
timeFrame: Month 12 from baseline
measure: Retention in Care
timeFrame: Month 12 from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: MetroHealth
state: District of Columbia
city: Washington
country: United States
facility: Unity Medical Center
state: District of Columbia
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Washington
country: United States
facility: La Clinica Del Pueblo
state: District of Columbia
city: Washington
country: United States
facility: Children's National Medical Center Pediatric Clinic
state: District of Columbia
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: Washington Health Institute
state: District of Columbia
city: Washington
country: United States
facility: Family and Medical Counseling Service
state: District of Columbia
city: Washington
country: United States
facility: Whitman-Walker Health
state: District of Columbia
city: Washington
country: United States
facility: George Washington Medical Faculty Associates
state: District of Columbia
city: Washington
country: United States
facility: Howard University Hospital Adult Clinic
state: District of Columbia
city: Washington
country: United States
facility: Howard University Hospital Pediatric Clinic
state: District of Columbia
city: Washington
country: United States
facility: Veterans Affairs Medical Center
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Amanda D Castel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Karen Ingersoll, PhD
role: PRINCIPAL_INVESTIGATOR
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