Midwest TXTXT Scale up of an Evidence-Based Intervention to Promote HIV Medication Adherence
NCT05783297 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2024-08-28
Summary
This research study uses a cluster randomized controlled trial design to evaluate the effectiveness of Treatment Text (TXTXT) intervention on adherence and viral load suppression at 3- and 6- months post intervention initiation for youth and young adults with HIV. A total of 12 clinics will be randomized into one of the following two conditions:
1. Comparison Arm (n=6 clinics)- Clinics randomized to the comparison arm will have participants receive the standard of care for 3 months, followed by a 3-month intervention period.
2. Intervention Arm (n=6 clinics)- Clinics randomized to the intervention arm will have participants receive the TXTXT intervention for 6 months.
Conditions
- HIV Infections
Interventions
- BEHAVIORAL
-
Treatment Text (TXTXT)
This study will test a tailored, personalized SMS text message reminder intervention to improve adherence to ART among non-adherent youth and young adults with HIV. Participants will use their own cell phones for receipt of the intervention. Participants will have the option to choose a tailored personalized message that may be changed as requested throughout the 6-month intervention period. Participants will be asked to send a text message response indicating that that have successfully (or not) taken their meds per schedule. No identifying patient information will be included in the SMS text to protect patient confidentiality.
- BEHAVIORAL
-
Standard of Care
Standard of care ART adherence support includes adherence counseling during visits scheduled at least twice annually and appointment reminders.
Sponsors & Collaborators
-
University of Illinois at Chicago
collaborator OTHER -
KC Care Health Center
collaborator UNKNOWN -
Eskenazi Health
collaborator OTHER -
Corktown Health Center
collaborator UNKNOWN -
Howard Brown Health Center
collaborator OTHER -
University of Cincinnati
collaborator OTHER -
Indiana University
collaborator OTHER - collaborator OTHER
-
Amity Medical Group
collaborator UNKNOWN -
Valley AIDS Council
collaborator OTHER -
Baylor College of Medicine
collaborator OTHER -
AIDS Healthcare Foundation
collaborator OTHER -
Comprehensive Care Center of Southwest Louisiana
collaborator UNKNOWN -
Ann & Robert H Lurie Children's Hospital of Chicago
lead OTHER
Principal Investigators
-
Amy Johnson, PhD · Ann & Robert H Lurie Children's Hospital of Chicago
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-17
- Primary Completion
- 2025-08-31
- Completion
- 2025-08-31
Countries
- United States
Study Locations
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