Clinical trial NCT06408350: Optimal Intervention to Full Viral Suppression: Text Me, Alexis!
Official title: Comparative- and Cost-effectiveness Research Determining the Optimal Intervention for Advancing Transgender Women Living With HIV to Full Viral Suppression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HIV
Keywords: HIV
transgender women
peer health navigation
SMS, text messaging
economic evaluation
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2024-05-10
Enrollment: 71
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three randomly assigned arms.
Primary purpose: TREATMENT

Brief summary: Text Me, Alexis! is a three-arm randomized controlled trial (RCT) to determine the optimal and most cost-effective intervention for advancing trans women living with HIV to full viral suppression. Participants will be randomized (1:1:1) to Peer Health Navigation (PHN) alone, SMS (text messaging) alone, or PHN+SMS. Participants in the PHN alone and PHN+SMS arms will receive unlimited navigation sessions over 3 months. Participants in the SMS alone and PHN+SMS arms will receive 3 daily theory-based text messages for 90 days for a total of 270 unique scripted messages.

Detailed description: 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: 1) 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.

Eligibility criteria: Inclusion Criteria:

* Self-identified transgender woman;
* Age 18 or older;
* Verified HIV positive status;
* Not currently in HIV care, and/or had not had an HIV care visit in the previous 6 months, and/or had a viral load of ≥200 copies/ml on her last lab test result, and/or not currently prescribed ART, and/or prescribed ART but does not rate her ability to take all her medications as "excellent";
* Ability to receive daily text messages on either a personal cell phone or via an email account

Exclusion Criteria:

* Does not identify as a transgender woman;
* Under 18 years of age;
* HIV negative status;
* Currently in HIV care, and had a HIV care visit in the previous 6 months, and had a viral load of ≤200 copies/ml on her last lab test result, and currently prescribed ART, and rates her ability to take all her medications as "excellent";
* Does not have the ability to receive daily text messages on either a personal cell phone or via an email account.

Primary outcomes:
measure: Rate of HIV Viral Load Suppression
timeFrame: 18 months
measure: Relative Cost Effectiveness
timeFrame: 18 months
Secondary outcomes:
measure: Measurements of Heterogeneous Intervention Effects
timeFrame: 18 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Community Center
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Cathy J Reback, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Sean M Murphy, PhD
role: PRINCIPAL_INVESTIGATOR
References: