HIV Infections
Conditions
Brief 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.
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.
Interventions
BEHAVIORALTreatment 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.
BEHAVIORALStandard of Care
Standard of care ART adherence support includes adherence counseling during visits scheduled at least twice annually and appointment reminders.
Sponsors
Amy K. Johnson, PhD, MSW
University of Illinois at Chicago
KC Care Health Center
Eskenazi Health
Corktown Health Center
Howard Brown Health Center
University of Cincinnati
Indiana University
Duke University
Amity Medical Group
Valley AIDS Council
Baylor College of Medicine
AIDS Healthcare Foundation
Comprehensive Care Center of Southwest Louisiana
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The proposed research uses a cluster randomized controlled trial design to evaluate the effectiveness of TXTXT intervention on adherence and viral load suppression at 3- and 6- months post intervention initiation.
Eligibility
Sex/Gender
ALL
Age
16 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV-1 RNA Viral Load | 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. |
| HIV Medication Adherence | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmy Johnson, PhD
Ann & Robert H Lurie Children's Hospital of Chicago
Outcome results
None listed