Text Me, Alexis! is a three-arm randomized controlled trial (RCT) to determine the
optimal (considering effectiveness and cost-effectiveness) intervention, or intervention
combination for advancement along the HIV Care Continuum among trans women living with
HIV (N=195). After screening, informed consent, and baseline assessment, participants
will be randomized (1:1:1) into one of three arms: Peer Health Navigation (PHN) alone
(n=65), SMS (text messaging) alone (n=65), or PHN+SMS (n=65). The study uses repeated
assessments at baseline and at 3-, 6-, 12-, and 18-months post-enrollment, via an
"intent-to-treat" design, where all assessments are administered to participants
regardless of their engagement or retention. All intervention content is tailored and
culturally responsive to trans women living with HIV.
Peer Health Navigation (PHN) alone. PHN is based on the theoretical foundation of Social
Cognitive Theory. Participant-centered PHN helps to: (1) identify barriers to HIV care;
(2) identify and link participants into needed auxiliary services; and (3) increase
participants' self-efficacy in working with HIV care providers and other social service
and treatment facilities. PHNs do not provide counseling or psychotherapy; rather, they
work with each participant to successfully navigate complicated healthcare and social
service systems. The PHN intervention utilizes an individualized, Participant-centered
Treatment Plan with the specific goal of removing multiple and complex barriers that can
impede linkage-to and retention-in HIV care, as well as the sustainment of medication
adherence to achieve and maintain virological suppression. Each participant will work
with a PHN to develop a Participant-centered Treatment Plan and get linked to HIV care or
other needed auxiliary physical, mental health, and psychosocial services (e.g., hormone
therapy, dental care, hepatitis testing/care, tuberculosis testing/care, substance use
disorder treatment, mental health treatment, legal services, job training/development).
If necessary, the PHN transports and accompanies the participant to and from her HIV care
appointments (provision of transportation falls under the purview of PHN activities). The
Participant-centered Treatment Plan identifies actions for the participant and PHN that
must be taken by the next scheduled meeting, to help achieve short- and long-term goals,
including participant access to needed behavioral health services, and advancement across
the HIV Care Continuum. A priority of the first session is to schedule an HIV care
appointment for the participant, if needed. The PHN also works with each participant to
establish HIV self-efficacy regarding her treatment plan. Participants are introduced to
a PHN immediately following randomization. PHN sessions are unlimited for 90 days.
Simple Message System (SMS [text messaging]) alone. Text messages are based on, and
equally distributed across, three theories: Social Support Theory (SST), Social Cognitive
Theory (SCT), and Health Belief Model (HBM). Participants receive three daily,
theory-based text messages for 90 days (270 unique scripted messages), evenly arrayed
across the three theories and the HIV Care Continuum. Text messages are scripted across:
- HIV Care Continuum (HIV Positivity/Physical and Emotional Health, Linkage/Retention in
HIV Care, and Antiretroviral Therapy (ART) Adherence/Viral Load Suppression); and, 2)
theoretical foundation (SST, SCT, or HBM). Thus, each day participants receive one HIV
Positivity/Physical and Emotional Health, one Linkage/Retention in HIV Care, and one ART
Adherence/Viral Load Suppression message; each of which will be based on a theoretical
foundation (SST, SCT, or HBM). Text messages are transmitted through gradual automation
administration daily, including weekends, in real-time, within a 10-hour period, every
five hours (e.g., at 12:00 PM, 5:00 PM, and 10:00 PM). Optimum hours were determined to
be daily from 12:00 PM to 10:00 PM, though participants may personalize the schedule to
any 10-hour period, and can choose to have the text messages delivered through their cell
phone or email inbox. The automated text message delivery system was developed by Dimagi
(dimagi.com). Dimagi designs clinical interfaces, health information systems, and mobile
technologies to perform patient-level disease management, clinical decision support, and
health system monitoring. To maintain interest and enthusiasm for the intervention,
messages are systematically varied by theory and content, and participants never receive
the same message twice. At the completion of the enrollment visit, a Research Assistant
(RA) orients the participant to the SMS intervention.
PHN+SMS combined. Participants in the PHN+SMS arm will receive the same PHN and SMS
interventions described above, but in concert to determine the effectiveness of the
combined intervention when compared to PHN or SMS alone.