Midwest TXTXT Scale up of an Evidence-Based Intervention to Promote HIV Medication Adherence

June 29, 2023 updated by: Ann & Robert H Lurie Children's Hospital of Chicago

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study investigators propose to use implementation science (IS) to scale up and evaluate the TXTXT evidence-based intervention (EBI) as an effective strategy to increase ART adherence and retention in HIV care, ultimately leading to a suppression of viral load in youth and young adults with HIV (YYALH) participating in the intervention. Investigators hypothesize that participants who complete the TXTXT intervention will demonstrate a clinically meaningful increase in ART adherence, viral suppression, and sustained retention in care. Additionally, investigators hypothesize that the implementation of TXTXT will reach ≥80% of the intended participants, will be fully adopted by ≥80% of clinic partners, and will achieve ≥90% ratings of satisfaction and acceptability. Investigators will use mixed methods to complete the study aims: 1) determine the real-world efficacy of a regional scale up of an EBI - TXTXT - among poorly adherent YYALH, aged 16-35 years, on our primary outcomes: adherence and viral load suppression at 3-month post initiation of the intervention; and secondary outcome: retention in HIV care at 6- and 12-months post baseline, and 2) apply the Consolidated Framework for Implementation Research (CFIR) to describe the implementation process and identify barriers and facilitators needed to be addressed; and measure implementation outcomes of the TXTXT intervention using the RE-AIM framework (Reach, Efficacy, Adoption, Implementation, Maintenance). Investigators will conduct a cluster randomized controlled trial to evaluate the intervention effectiveness (i.e., ART adherence, viral load suppression) at 3- and 6-months post-initiation of the intervention. Twelve clinic sites with the ability to enroll up to 50 participants at each site (N=600 participants total) will be trained to administer the TXTXT intervention. Sites will be randomized to either start the intervention immediately (i.e., intervention arm) or waitlisted to start at 3 months post baseline (i.e., comparison arm). In the comparison arm, the study will compare pre-post differences in adherence at 3- and 6-months post baseline. Last, investigators will evaluate retention in HIV care, viral suppression, and sustained impact of the intervention at 6 months and 12 months post baseline for all study participants.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • AIDS Healthcare Foundation
        • Principal Investigator:
          • Zachary Henry, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Active, not recruiting
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60613
        • Recruiting
        • Howard Brown Health
        • Contact:
          • David Ernesto Munar
          • Phone Number: 773-388-1600
        • Principal Investigator:
          • Hale Thompson, PhD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
        • Principal Investigator:
          • Geeta Mantravadi, MD
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Eskenazi Health
        • Contact:
        • Principal Investigator:
          • Saira Butt, MD
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Recruiting
        • Comprehensive Care Center of Southwest Louisiana
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48216
        • Recruiting
        • Corktown Health Center
        • Contact:
        • Principal Investigator:
          • Mary MacKool, MSN
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • KC CARE Health Center
        • Contact:
          • Corinne Kritikos
          • Phone Number: 816-753-5144
        • Principal Investigator:
          • Melissa Smith
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Principal Investigator:
          • Mehri McKellar, MD
        • Contact:
          • Amy C Barbee
          • Phone Number: 919-684-5175
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
      • McAllen, Texas, United States, 78501
        • Recruiting
        • Valley AIDS Council
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosed with HIV-infection and on ART regimen for at least one month
  2. Between 16-35 years of age
  3. Have a viral load ≥200c/mL and/or report poor adherence (<90% of pills taken in the last 30 days)
  4. Able to receive text messages
  5. Can provide informed consent for research component
  6. Current patient patient of a participating clinic

Exclusion Criteria:

  1. Participant is unable to give informed consent
  2. Participant is participating in another study related to ART adherence

Participants outside of the age range (16-35) will be excluded from the study because this study specifically focuses on youth and young adults living with HIV as they are more likely to disengage from care, delay initiation of ART, and have lower rates of virologic suppression compared to adult populations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Comparison
Clinics randomized to the comparison arm will have participants receive standard of care ART adherence support for 3 months, and will receive the TXTXT intervention for 3 months. The standard of care for ART adherence across clinic sites consists of routine follow-up from assigned case managers for appointment reminders and adherence counseling at scheduled visits .
Behavioral: Standard of Care
Standard of care ART adherence support includes adherence counseling during visits scheduled at least twice annually and appointment reminders.
Experimental: Intervention
Clinics randomized to the intervention arm will have participants complete a 6-month intervention period. Clinics will sign up eligible participants to receive automated SMS messages from the Dimagi CommCare platform during the participant's baseline study visit. Participants will have the option to tailor the message content based on their own preferences and will be able to select to receive messages in English or in Spanish, the time the messages are delivered, and frequency of messages. Clinic staff will enter this information in the Dimagi CommCare platform, and then test receipt of text messages by the participant before they complete this baseline visit.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV-1 RNA Viral Load
Time Frame: Up to 12 months
A documented viral load measured by nucleic acid test (NAT) less than (<) 200 copies/mL will be considered virally suppressed. The minimum value is 20 copies/mL and the maximum is 10,000,000 copies/mL. A higher value indicates a worse outcome. Time frame: 6 months, 12 months.
Up to 12 months
HIV Medication Adherence
Time Frame: Up to 12 months
Medication adherence will be measured via self-reported visual analog scale. The minimum value is 0% and the maximum value is 100%. A higher value indicates a better outcome. Adherence will be considered reporting greater than or equal to 90% on self-reported visual analog scale and non- adherence categorized at less than 90%. Time frame: 3 months, 6 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborators

Baylor College of Medicine
University of Illinois at Chicago
Duke University
Indiana University
University of Cincinnati
Howard Brown Health Center
AIDS Healthcare Foundation
KC Care Health Center
Eskenazi Health
Valley AIDS Council
Corktown Health Center
Amity Medical Group
Comprehensive Care Center of Southwest Louisiana

Investigators

  • Principal Investigator: Amy Johnson, PhD, Ann & Robert H Lurie Children's Hospital of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01PS005214 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share restricted de-identified datasets with those who initiate a data request and data sharing agreement via the PI (Dr. Amy Johnson).

IPD Sharing Time Frame

The data will be available by request within 6-months of the trial end date.

IPD Sharing Access Criteria

Completion of a data request form and execution of a data sharing form with the study PI and PI's institution.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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