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.