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

NCT05783297 | Active Not Recruiting

• 1 other identifier: U01PS005214
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 12

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. 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. 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

Outcome Measures

Primary Outcomes (2)

• HIV-1 RNA Viral Load

  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

  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

Study Arms (2)

Comparison

ACTIVE COMPARATOR

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

Intervention

EXPERIMENTAL

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)

Interventions

Treatment Text (TXTXT) BEHAVIORAL

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.

Intervention

Standard of Care BEHAVIORAL

Standard of care ART adherence support includes adherence counseling during visits scheduled at least twice annually and appointment reminders.

Comparison

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Participant is unable to give informed consent
• 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.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• University of Illinois at Chicago: collaborator
• KC Care Health Center: collaborator
• Eskenazi Health: collaborator
• Corktown Health Center: collaborator
• Howard Brown Health Center: collaborator
• University of Cincinnati: collaborator
• Indiana University: collaborator
• Duke University: collaborator
• Amity Medical Group: collaborator
• Valley AIDS Council: collaborator
• Baylor College of Medicine: collaborator
• AIDS Healthcare Foundation: collaborator
• Comprehensive Care Center of Southwest Louisiana: collaborator

Study Sites (12)

AIDS Healthcare Foundation

Fort Lauderdale, Florida, 33308, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Howard Brown Health

Chicago, Illinois, 60613, United States

Location

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Comprehensive Care Center of Southwest Louisiana

Lake Charles, Louisiana, 70601, United States

Location

Corktown Health Center

Detroit, Michigan, 48216, United States

Location

KC Care Health Center

Kansas City, Missouri, 64111, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Valley AIDS Council

McAllen, Texas, 78501, United States

Location

Related Publications (41)

• Centers for Disease Control and Prevention. Diagnoses of HIV infection in the United States and dependent areas, 2019. (2019).

  BACKGROUND

• Denning, P. & DiNenno, E. in XVIII international AIDS conference.

  BACKGROUND

• Maulsby C, Millett G, Lindsey K, Kelley R, Johnson K, Montoya D, Holtgrave D. HIV among Black men who have sex with men (MSM) in the United States: a review of the literature. AIDS Behav. 2014 Jan;18(1):10-25. doi: 10.1007/s10461-013-0476-2.

  PMID: 23620241 BACKGROUND

• Bangsberg DR. Less than 95% adherence to nonnucleoside reverse-transcriptase inhibitor therapy can lead to viral suppression. Clin Infect Dis. 2006 Oct 1;43(7):939-41. doi: 10.1086/507526. Epub 2006 Aug 23.

  PMID: 16941380 BACKGROUND

• Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18.

  PMID: 21767103 BACKGROUND

• Gardner EM, McLees MP, Steiner JF, Del Rio C, Burman WJ. The spectrum of engagement in HIV care and its relevance to test-and-treat strategies for prevention of HIV infection. Clin Infect Dis. 2011 Mar 15;52(6):793-800. doi: 10.1093/cid/ciq243.

  PMID: 21367734 BACKGROUND

• Reisner SL, Mimiaga MJ, Skeer M, Perkovich B, Johnson CV, Safren SA. A review of HIV antiretroviral adherence and intervention studies among HIV-infected youth. Top HIV Med. 2009 Feb-Mar;17(1):14-25.

  PMID: 19270345 BACKGROUND

• Agwu AL, Fleishman JA, Korthuis PT, Siberry GK, Ellen JM, Gaur AH, Rutstein R, Gebo KA; HIV Research Network. Disparities in antiretroviral treatment: a comparison of behaviorally HIV-infected youth and adults in the HIV Research Network. J Acquir Immune Defic Syndr. 2011 Sep 1;58(1):100-7. doi: 10.1097/QAI.0b013e31822327df.

  PMID: 21637114 BACKGROUND

• Giordano TP, Visnegarwala F, White AC Jr, Troisi CL, Frankowski RF, Hartman CM, Grimes RM. Patients referred to an urban HIV clinic frequently fail to establish care: factors predicting failure. AIDS Care. 2005 Aug;17(6):773-83. doi: 10.1080/09540120412331336652.

  PMID: 16036264 BACKGROUND

• Lee L, Yehia BR, Gaur AH, Rutstein R, Gebo K, Keruly JC, Moore RD, Nijhawan AE, Agwu AL; HIV Research Network. The Impact of Youth-Friendly Structures of Care on Retention Among HIV-Infected Youth. AIDS Patient Care STDS. 2016 Apr;30(4):170-7. doi: 10.1089/apc.2015.0263. Epub 2016 Mar 16.

  PMID: 26983056 BACKGROUND

• Minniear TD, Gaur AH, Thridandapani A, Sinnock C, Tolley EA, Flynn PM. Delayed entry into and failure to remain in HIV care among HIV-infected adolescents. AIDS Res Hum Retroviruses. 2013 Jan;29(1):99-104. doi: 10.1089/AID.2012.0267. Epub 2012 Nov 7.

  PMID: 23033848 BACKGROUND

• Ryscavage P, Anderson EJ, Sutton SH, Reddy S, Taiwo B. Clinical outcomes of adolescents and young adults in adult HIV care. J Acquir Immune Defic Syndr. 2011 Oct 1;58(2):193-7. doi: 10.1097/QAI.0b013e31822d7564.

  PMID: 21826014 BACKGROUND

• Torian LV, Wiewel EW. Continuity of HIV-related medical care, New York City, 2005-2009: Do patients who initiate care stay in care? AIDS Patient Care STDS. 2011 Feb;25(2):79-88. doi: 10.1089/apc.2010.0151.

  PMID: 21284498 BACKGROUND

• Vijayan T, Benin AL, Wagner K, Romano S, Andiman WA. We never thought this would happen: transitioning care of adolescents with perinatally acquired HIV infection from pediatrics to internal medicine. AIDS Care. 2009 Oct;21(10):1222-9. doi: 10.1080/09540120902730054.

  PMID: 20024697 BACKGROUND

• Yehia BR, Fleishman JA, Metlay JP, Moore RD, Gebo KA. Sustained viral suppression in HIV-infected patients receiving antiretroviral therapy. JAMA. 2012 Jul 25;308(4):339-42. doi: 10.1001/jama.2012.5927. No abstract available.

  PMID: 22820781 BACKGROUND

• Zanoni BC, Mayer KH. The adolescent and young adult HIV cascade of care in the United States: exaggerated health disparities. AIDS Patient Care STDS. 2014 Mar;28(3):128-35. doi: 10.1089/apc.2013.0345.

  PMID: 24601734 BACKGROUND

• MacDonell K, Naar-King S, Huszti H, Belzer M. Barriers to medication adherence in behaviorally and perinatally infected youth living with HIV. AIDS Behav. 2013 Jan;17(1):86-93. doi: 10.1007/s10461-012-0364-1.

  PMID: 23142855 BACKGROUND

• Garofalo R, Kuhns LM, Hotton A, Johnson A, Muldoon A, Rice D. A Randomized Controlled Trial of Personalized Text Message Reminders to Promote Medication Adherence Among HIV-Positive Adolescents and Young Adults. AIDS Behav. 2016 May;20(5):1049-59. doi: 10.1007/s10461-015-1192-x.

  PMID: 26362167 BACKGROUND

• Project, H. A. P. R. S. (ed Centers for Disease Control and Prevention) https://www.cdc.gov/hiv/research/interventionresearch/compendium/index.html (2020).

  BACKGROUND

• Fauci AS, Redfield RR, Sigounas G, Weahkee MD, Giroir BP. Ending the HIV Epidemic: A Plan for the United States. JAMA. 2019 Mar 5;321(9):844-845. doi: 10.1001/jama.2019.1343. No abstract available.

  PMID: 30730529 BACKGROUND

• Hosek SG, Harper GW, Domanico R. Predictors of medication adherence among HIV-infected youth. Psychol Health Med. 2005 May;10(2):166-179. doi: 10.1080/1354350042000326584.

  PMID: 25705113 BACKGROUND

• Centers for Disease Control and Prevention. Vol. 29 (ed Department of Health and Human Services) (Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, Atlanta, GA, 2018).

  BACKGROUND

• Collins CB Jr, Sapiano TN. Lessons Learned From Dissemination of Evidence-Based Interventions for HIV Prevention. Am J Prev Med. 2016 Oct;51(4 Suppl 2):S140-7. doi: 10.1016/j.amepre.2016.05.017. Epub 2016 Jul 9.

  PMID: 27402185 BACKGROUND

• Bauermeister JA, Tross S, Ehrhardt AA. A review of HIV/AIDS system-level interventions. AIDS Behav. 2009 Jun;13(3):430-48. doi: 10.1007/s10461-008-9379-z. Epub 2008 Mar 28.

  PMID: 18369722 BACKGROUND

• Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.

  PMID: 19664226 BACKGROUND

• Lambdin BH, Cheng B, Peter T, Mbwambo J, Apollo T, Dunbar M, Udoh IC, Cattamanchi A, Geng EH, Volberding P. Implementing Implementation Science: An Approach for HIV Prevention, Care and Treatment Programs. Curr HIV Res. 2015;13(3):244-9. doi: 10.2174/1570162x1303150506185423.

  PMID: 25986374 BACKGROUND

• Whiteley LB, Olsen EM, Haubrick KK, Odoom E, Tarantino N, Brown LK. A Review of Interventions to Enhance HIV Medication Adherence. Curr HIV/AIDS Rep. 2021 Oct;18(5):443-457. doi: 10.1007/s11904-021-00568-9. Epub 2021 Jun 21.

  PMID: 34152554 BACKGROUND

• Zullig LL, Deschodt M, Liska J, Bosworth HB, De Geest S. Moving from the Trial to the Real World: Improving Medication Adherence Using Insights of Implementation Science. Annu Rev Pharmacol Toxicol. 2019 Jan 6;59:423-445. doi: 10.1146/annurev-pharmtox-010818-021348. Epub 2018 Aug 20.

  PMID: 30125127 BACKGROUND

• Glasgow RE, Emmons KM. How can we increase translation of research into practice? Types of evidence needed. Annu Rev Public Health. 2007;28:413-33. doi: 10.1146/annurev.publhealth.28.021406.144145.

  PMID: 17150029 BACKGROUND

• Bandura A. Social cognitive theory: an agentic perspective. Annu Rev Psychol. 2001;52:1-26. doi: 10.1146/annurev.psych.52.1.1.

  PMID: 11148297 BACKGROUND

• Hedeker, D. in Encyclopedia of Statistics in Behavioral Science (eds B. Everitt & D. Howell) (Wiley, 2005).

  BACKGROUND

• Diggle, P., Liang, K.-Y. & Zeger, S. L. Longitudinal data analysis. New York: Oxford University Press 5, 13 (1994).

  BACKGROUND

• Lewis MA, Harshbarger C, Bann C, Burrus O, Peinado S, Garner BR, Khavjou O, Shrestha RK, Karns S, Borkowf CB, Zulkiewicz BA, Ortiz A, Galindo CA, DallaPiazza M, Holm P, Marconi VC, Somboonwit C, Swaminathan S; Positive Health Check Study Team. Positive Health Check evaluation: A type 1 hybrid design randomized trial to decrease HIV viral loads in patients seen in HIV primary care. Contemp Clin Trials. 2020 Sep;96:106097. doi: 10.1016/j.cct.2020.106097. Epub 2020 Jul 29.

  PMID: 32738408 BACKGROUND

• Mugavero MJ, Westfall AO, Zinski A, Davila J, Drainoni ML, Gardner LI, Keruly JC, Malitz F, Marks G, Metsch L, Wilson TE, Giordano TP; Retention in Care (RIC) Study Group. Measuring retention in HIV care: the elusive gold standard. J Acquir Immune Defic Syndr. 2012 Dec 15;61(5):574-80. doi: 10.1097/QAI.0b013e318273762f.

  PMID: 23011397 BACKGROUND

• Health Resources & Services Administration. HIV/AIDS Bureau Performance Measures. (2019).

  BACKGROUND

• Ahn, C., Heo, M. & Zhang, S. Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research. 1 edn, 223-225 (Chapman and Hall, 2015).

  BACKGROUND

• Keith RE, Crosson JC, O'Malley AS, Cromp D, Taylor EF. Using the Consolidated Framework for Implementation Research (CFIR) to produce actionable findings: a rapid-cycle evaluation approach to improving implementation. Implement Sci. 2017 Feb 10;12(1):15. doi: 10.1186/s13012-017-0550-7.

  PMID: 28187747 BACKGROUND

• SocioCultural Research Consultants, L. (Los Angeles, CA, 2018)

  BACKGROUND

• Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.

  PMID: 16204405 BACKGROUND

• Tinsley, H. E. & Weiss, D. J. in Handbook of applied multivariate statistics and mathematical modeling 95-124 (Elsevier, 2000).

  BACKGROUND

• Breimaier HE, Heckemann B, Halfens RJ, Lohrmann C. The Consolidated Framework for Implementation Research (CFIR): a useful theoretical framework for guiding and evaluating a guideline implementation process in a hospital-based nursing practice. BMC Nurs. 2015 Aug 12;14:43. doi: 10.1186/s12912-015-0088-4. eCollection 2015.

  PMID: 26269693 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Amy Johnson, PhD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: March 24, 2023
• Study Start: April 17, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will be available by request within 6-months of the trial end date.
• Access Criteria: Completion of a data request form and execution of a data sharing form with the study PI and PI's institution.

Locations

US (12)