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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
| KC Care Health Center | OTHER |
| Eskenazi Health | OTHER |
| Corktown Health Center |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 . |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Amy Johnson, PhD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIDS Healthcare Foundation | Fort Lauderdale | Florida | 33308 | United States | ||
| University of Illinois at Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 23620241 | 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. | |
| 16941380 |
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We will share restricted de-identified datasets with those who initiate a data request and data sharing agreement via the PI (Dr. Amy Johnson).
The data will be available by request within 6-months of the trial end date.
Completion of a data request form and execution of a data sharing form with the study PI and PI's institution.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 1, 2022 |
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| UNKNOWN |
| Howard Brown Health Center | OTHER |
| University of Cincinnati | OTHER |
| Indiana University | OTHER |
| Duke University | OTHER |
| Amity Medical Group | UNKNOWN |
| Valley AIDS Council | OTHER |
| Baylor College of Medicine | OTHER |
| AIDS Healthcare Foundation | OTHER |
| Comprehensive Care Center of Southwest Louisiana | UNKNOWN |
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.
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|
| Standard of Care | Behavioral | Standard of care ART adherence support includes adherence counseling during visits scheduled at least twice annually and appointment reminders. |
|
| Chicago |
| Illinois |
| 60612 |
| United States |
| Howard Brown Health | Chicago | Illinois | 60613 | United States |
| Eskenazi Health | Indianapolis | Indiana | 46202 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Comprehensive Care Center of Southwest Louisiana | Lake Charles | Louisiana | 70601 | United States |
| Corktown Health Center | Detroit | Michigan | 48216 | United States |
| KC Care Health Center | Kansas City | Missouri | 64111 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Valley AIDS Council | McAllen | Texas | 78501 | United States |
| 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. |
| 21767103 | 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. |
| 21367734 | 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. |
| 19270345 | 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. |
| 21637114 | 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. |
| 16036264 | 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. |
| 26983056 | 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. |
| 23033848 | 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. |
| 21826014 | 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. |
| 21284498 | 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. |
| 20024697 | 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. |
| 22820781 | 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. |
| 24601734 | 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. |
| 23142855 | 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. |
| 26362167 | 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. |
| 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). |
| 30730529 | 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. |
| 25705113 | 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. |
| 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). |
| 27402185 | 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. |
| 18369722 | 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. |
| 19664226 | 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. |
| 25986374 | 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. |
| 34152554 | 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. |
| 30125127 | 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. |
| 17150029 | 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. |
| 11148297 | Background | Bandura A. Social cognitive theory: an agentic perspective. Annu Rev Psychol. 2001;52:1-26. doi: 10.1146/annurev.psych.52.1.1. |
| 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). |
| 32738408 | 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. |
| 23011397 | 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. |
| 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). |
| 28187747 | 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. |
| Background | SocioCultural Research Consultants, L. (Los Angeles, CA, 2018) |
| 16204405 | Background | Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687. |
| Background | Tinsley, H. E. & Weiss, D. J. in Handbook of applied multivariate statistics and mathematical modeling 95-124 (Elsevier, 2000). |
| 26269693 | 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. |
| Feb 9, 2023 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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