Optimal Intervention to Full Viral Suppression: Text Me, Alexis!

NCT06408350 | Terminated DMC

• 1 other identifier: R01DA056287
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; transgender women; peer health navigation; SMS, text messaging; economic evaluation

Outcome Measures

Primary Outcomes (2)

• Rate of HIV Viral Load Suppression

  HIV virological suppression is defined as the undetectability threshold ˂200 copies/mL. Key indicators of HIV care will be regressed on treatment condition and a series of baseline and time-varying covariates. Responses at each timepoint will be considered nested within an individual, which is necessary to control for the violations of independence that can occur when repeated measurements are taken from the same individual.

  18 months

• Relative Cost Effectiveness

  The primary outcome of the cost-effectiveness analysis is the incremental cost-effectiveness ratio (ICER), which will be calculated as the incremental mean cost of a given intervention relative to an alternative, divided by the incremental mean effectiveness of the two interventions. Two types of ICERs will be calculated, one for each measure of effectiveness: a) The quality-adjusted life-year (QALY) is a measure that combines the health-related quality-of-life (HRQoL) associated with an individual's health state and their time spent in that state, and b) Advancement along the HIV Care Continuum. All measures of mean cost and effectiveness will be adjusted for important covariates. Relative cost-effectiveness will be assessed according to multiple decision-maker perspectives, and will be evaluated across a range of willingness-to-pay thresholds.

  18 months

Secondary Outcomes (1)

• Measurements of Heterogeneous Intervention Effects

  18 months

Study Arms (3)

Peer Health Navigation (PHN)

EXPERIMENTAL

PHN is a peer navigation intervention to advance trans women through the HIV Care Continuum by identifying their individual needs and barriers to HIV care, including: substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Participants receive unlimited navigation sessions over 3 months; PHN sessions are delivered in a private room similar to a one-on-one peer counseling session.

Behavioral: Text Me, Alexis!

Simple Message System (SMS [text messaging])

EXPERIMENTAL

Text messages are scripted across: 1) HIV Care Continuum (HIV Positivity/Physical and Emotional Health, Linkage/Retention in HIV Care, and ART Adherence/Viral Load Suppression); and, 2) theoretical foundation (Social Support Theory, Social Cognitive Theory, or Health Belief Model). Participants receive three daily, theory-based text messages for 90 days (270 unique scripted messages), evenly arrayed across the HIV Care Continuum. Text messages are delivered and transmitted to either a cell phone or an email inbox.

Behavioral: Text Me, Alexis!

PHN and SMS

EXPERIMENTAL

PHN + SMS is the combined intervention. PHN is a peer navigation intervention to advance trans women through the HIV Care Continuum by identifying their individual needs and barriers to HIV care, including: substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Participants receive unlimited navigation sessions over 3 months; PHN sessions are delivered in a private room similar to a one-on-one peer counseling session. Text messages are scripted across: 1) HIV Care Continuum (HIV Positivity/Physical and Emotional Health, Linkage/Retention in HIV Care, and ART Adherence/Viral Load Suppression); and, 2) theoretical foundation (Social Support Theory, Social Cognitive Theory, or Health Belief Model). Participants receive three daily, theory-based text messages for 90 days (270 unique scripted messages), evenly arrayed across the HIV Care Continuum. Text messages are delivered and transmitted to either a cell phone or an email inbox.

Behavioral: Text Me, Alexis!

Interventions

Text Me, Alexis! BEHAVIORAL

Determine the Optimal Intervention for Advancing Transgender Women Living with HIV to Full Viral Suppression

PHN and SMS; Peer Health Navigation (PHN); Simple Message System (SMS [text messaging])

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identified Transgender Woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Friends Community Center

Los Angeles, California, 90028, United States

Location

Study Officials

• Cathy J Reback, PhD

  Friends Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

• Sean M Murphy, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three randomly assigned arms.

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 10, 2024
• Study Start: April 11, 2024
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: February 11, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)