Comparative- and Cost-effectiveness Research Determining the Optimal Intervention for Advancing Transgender Women Living With HIV to Full Viral Suppression

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Friends Community Center
RECRUITING
Los Angeles
Contact Information
Primary
Cathy J Reback, PhD
reback@friendsresearch.org
323-463-1601
Backup
Sean M Murphy, PhD
smm2010@med.cornell.edu
646-962-9710
Time Frame
Start Date: 2024-04-11
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 71
Treatments
Experimental: Peer Health Navigation (PHN)
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.
Experimental: Simple Message System (SMS [text messaging])
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.
Experimental: PHN and SMS
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.
Related Therapeutic Areas
Sponsors
Collaborators: Weill Medical College of Cornell University
Leads: Friends Research Institute, Inc.

This content was sourced from clinicaltrials.gov