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Published in: Trials 1/2024

Open Access 01-12-2024 | Human Immunodeficiency Virus | Study protocol

Peers plus mobile app for treatment in HIV (PATH): protocol for a randomized controlled trial to test a community-based integrated peer support and mHealth intervention to improve viral suppression among Hispanic and Black people living with HIV

Authors: Eileen V. Pitpitan, Keith J. Horvath, Jeannette Aldous, Jamila K. Stockman, Thomas L. Patterson, Megan Liang, Constantino Barrozo, Veronica Moore, Katherine Penninga, Laramie R. Smith

Published in: Trials | Issue 1/2024

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Abstract

Background

Significant disparities continue to exist in the HIV care continuum, whereby Hispanic and Black people living with HIV (PLWH) are less likely to achieve viral suppression compared to their White counterparts. Studies have shown that intervention approaches that involve peer navigation may play an important role in supporting patients to stay engaged in HIV care. However, implementation may be challenging in real-world settings where there are limited resources to support peer navigators. Combining a peer navigation approach with scalable mobile health (mHealth) technology may improve impact and implementation outcomes.

Methods

We combined a peer navigation intervention with a mHealth application and are conducting a randomized controlled trial (RCT) to test the efficacy of this integrated “Peers plus mobile App for Treatment in HIV” (PATH) intervention to improve HIV care engagement, and ultimately sustained viral suppression, among Hispanic and Black PLWH. We will enroll up to 375 PLWH into a two-arm prospective RCT, conducting follow-up assessments every 3 months up to 12 months post-baseline. Participants randomized to the control arm will continue to receive usual care Ryan White Program case management services. Individuals randomized to receive the PATH intervention will receive usual care plus access to two main intervention components: (1) a peer navigation program and (2) a mHealth web application. The primary outcome is sustained HIV viral suppression (undetectable viral load observed at 6- and 12-month follow-up). Secondary outcomes are retention in HIV care, gaps in HIV medical visits, and self-reported ART adherence. Recruitment for the RCT began in November 2021 and will continue until June 2024. Follow-up assessments and medical chart abstractions will be conducted to collect measurements of outcome variables.

Discussion

The efficacy trial of PATH will help to fill gaps in our scientific understanding of how a combined peer navigation and mHealth approach may produce effects on HIV care outcomes while addressing potential implementation challenges of peer navigation in Ryan White-funded clinics.

Trial registration

The PATH trial is registered at the United States National Institutes of Health National Library of Medicine (ClinicalTrials.gov) under ID # NCT05427318. Registered on 22 June 2022.
Literature
7.
go back to reference Crepaz N, Dong X, Wang X, Hernandez AL, Hall HI. Racial and Ethnic Disparities in Sustained Viral Suppression and Transmission Risk Potential Among Persons Receiving HIV Care — United States, 2014. Morb Mortal Wkly Rep. 2018;67(4):113–8. https://doi.org/10.15585/mmwr.mm6704a2. Crepaz N, Dong X, Wang X, Hernandez AL, Hall HI. Racial and Ethnic Disparities in Sustained Viral Suppression and Transmission Risk Potential Among Persons Receiving HIV Care — United States, 2014. Morb Mortal Wkly Rep. 2018;67(4):113–8. https://​doi.​org/​10.​15585/​mmwr.​mm6704a2.
8.
go back to reference Centers for Disease Control and Prevention. Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data United States and 6 Dependent Areas, 2017. HIV Surveillance Report 2019.; 2019. Centers for Disease Control and Prevention. Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data United States and 6 Dependent Areas, 2017. HIV Surveillance Report 2019.; 2019.
13.
go back to reference Pitpitan EV, Semple SJ, Zians J, Strathdee SA, Patterson TL. Cognitive Behavioral Therapy for HIV-Negative Heterosexual Meth Users: The FASTLANE II Intervention Cognitive and Behavioral Practice. Cogn Behav Pract. Published online in press. Pitpitan EV, Semple SJ, Zians J, Strathdee SA, Patterson TL. Cognitive Behavioral Therapy for HIV-Negative Heterosexual Meth Users: The FASTLANE II Intervention Cognitive and Behavioral Practice. Cogn Behav Pract. Published online in press.
15.
18.
go back to reference Cahill S, Taylor SW, Elsesser SA, Mena L, Hickson D, Mayer KH. Stigma, medical mistrust, and perceived racism may affect PrEP awareness and uptake in black compared to white gay and bisexual men in Jackson, Mississippi and Boston, Massachusetts. AIDS Care. 2017;29(11):1351–8. https://doi.org/10.1080/09540121.2017.1300633. Cahill S, Taylor SW, Elsesser SA, Mena L, Hickson D, Mayer KH. Stigma, medical mistrust, and perceived racism may affect PrEP awareness and uptake in black compared to white gay and bisexual men in Jackson, Mississippi and Boston, Massachusetts. AIDS Care. 2017;29(11):1351–8. https://​doi.​org/​10.​1080/​09540121.​2017.​1300633.
19.
go back to reference Galvan FH, Bogart LM, Klein DJ, Wagner GJ, Chen YT. Medical mistrust as a key mediator in the association between perceived discrimination and adherence to antiretroviral therapy among HIV-positive Latino men. J Behav Med. 2017;40(5):784–93. Galvan FH, Bogart LM, Klein DJ, Wagner GJ, Chen YT. Medical mistrust as a key mediator in the association between perceived discrimination and adherence to antiretroviral therapy among HIV-positive Latino men. J Behav Med. 2017;40(5):784–93.
20.
go back to reference López-Cevallos DF, Harvey SM, Warren JT. Medical mistrust, perceived discrimination, and satisfaction with health care among young-adult rural Latinos. J Rural Health. 2014;30(4):344–51. López-Cevallos DF, Harvey SM, Warren JT. Medical mistrust, perceived discrimination, and satisfaction with health care among young-adult rural Latinos. J Rural Health. 2014;30(4):344–51.
21.
23.
go back to reference Schnall R, Bakken S, Rojas M, Travers J, Carballo-Dieguez A. mHealth technology as a persuasive tool for treatment, care and management of persons living with HIV. AIDS Behav. 2015;19(2):81–9. Schnall R, Bakken S, Rojas M, Travers J, Carballo-Dieguez A. mHealth technology as a persuasive tool for treatment, care and management of persons living with HIV. AIDS Behav. 2015;19(2):81–9.
24.
go back to reference Catalani C, Philbrick W, Fraser H, Mechael P, Israelski DM. mHealth for HIV treatment & prevention: a systematic review of the literature. Open AIDS J. 2013;7:17. Catalani C, Philbrick W, Fraser H, Mechael P, Israelski DM. mHealth for HIV treatment & prevention: a systematic review of the literature. Open AIDS J. 2013;7:17.
25.
go back to reference Stowell E, Lyson MC, Saksono H, et al. Designing and Evaluating mHealth Interventions for Vulnerable Populations: A Systematic Review. In: Proceedings of the 2018 CHI Conference on Human Factors in Computing Systems. CHI ’18. Association for Computing Machinery; 2018. p. 1–17. https://doi.org/10.1145/3173574.3173589. Stowell E, Lyson MC, Saksono H, et al. Designing and Evaluating mHealth Interventions for Vulnerable Populations: A Systematic Review. In: Proceedings of the 2018 CHI Conference on Human Factors in Computing Systems. CHI ’18. Association for Computing Machinery; 2018. p. 1–17. https://​doi.​org/​10.​1145/​3173574.​3173589.
30.
go back to reference Smith LR, Pitpitan EV. Tranquilo, Seguro, y Motivado: Participant perceptions of a peer navigation intervention for substance-involved HIV-positive key populations in Tijuana, Mexico. Presented at: 13th International Conference on HIV Treatment and Prevention Adherence. Miami, FL. June 2018. Smith LR, Pitpitan EV. Tranquilo, Seguro, y Motivado: Participant perceptions of a peer navigation intervention for substance-involved HIV-positive key populations in Tijuana, Mexico. Presented at: 13th International Conference on HIV Treatment and Prevention Adherence. Miami, FL. June 2018.
32.
go back to reference Rivet AK. A situated-Information Motivation Behavioral Skills Model of Care Initiation and Maintenance (sIMB-CIM): an IMB model based approach to understanding and intervening in engagement in care for chronic medical conditions. J Health Psychol. 2011;16(7):1071–81. Rivet AK. A situated-Information Motivation Behavioral Skills Model of Care Initiation and Maintenance (sIMB-CIM): an IMB model based approach to understanding and intervening in engagement in care for chronic medical conditions. J Health Psychol. 2011;16(7):1071–81.
33.
go back to reference Smith LR, Fisher JD, Cunningham CO, Amico KR. Understanding the behavioral determinants of retention in HIV care: a qualitative evaluation of a situated information, motivation, behavioral skills model of care initiation and maintenance. AIDS Patient Care STDs. 2012;26(6):344–55. Smith LR, Fisher JD, Cunningham CO, Amico KR. Understanding the behavioral determinants of retention in HIV care: a qualitative evaluation of a situated information, motivation, behavioral skills model of care initiation and maintenance. AIDS Patient Care STDs. 2012;26(6):344–55.
35.
go back to reference Bandura A. Social cognitive theory: an agentic perspective. Annu Rev Psychol. 2001;52(1):1–26. Bandura A. Social cognitive theory: an agentic perspective. Annu Rev Psychol. 2001;52(1):1–26.
36.
go back to reference Eaton LA, Driffin DD, Kegler C, et al. The role of stigma and medical mistrust in the routine health care engagement of black men who have sex with men. Am J Public Health. 2015;105(2):e75–82. Eaton LA, Driffin DD, Kegler C, et al. The role of stigma and medical mistrust in the routine health care engagement of black men who have sex with men. Am J Public Health. 2015;105(2):e75–82.
37.
go back to reference LaVeist TA, Nickerson KJ, Bowie JV. Attitudes about racism, medical mistrust, and satisfaction with care among African American and white cardiac patients. Med Care Res Rev. 2000;57(1_suppl):146–61. LaVeist TA, Nickerson KJ, Bowie JV. Attitudes about racism, medical mistrust, and satisfaction with care among African American and white cardiac patients. Med Care Res Rev. 2000;57(1_suppl):146–61.
38.
go back to reference Bogart LM, Wagner GJ, Galvan FH, Klein DJ. Longitudinal relationships between antiretroviral treatment adherence and discrimination due to HIV-serostatus, race, and sexual orientation among African-American men with HIV. Ann Behav Med. 2010;40(2):184–90. https://doi.org/10.1007/s12160-010-9200-x. Bogart LM, Wagner GJ, Galvan FH, Klein DJ. Longitudinal relationships between antiretroviral treatment adherence and discrimination due to HIV-serostatus, race, and sexual orientation among African-American men with HIV. Ann Behav Med. 2010;40(2):184–90. https://​doi.​org/​10.​1007/​s12160-010-9200-x.
39.
go back to reference Valera P, Boyas JF, Bernal C, Chiongbian VB, Chang Y, Shelton RC. A validation of the group-based medical mistrust scale in formerly incarcerated Black and Latino men. Am J Mens Health. 2018;12(4):844–50. Valera P, Boyas JF, Bernal C, Chiongbian VB, Chang Y, Shelton RC. A validation of the group-based medical mistrust scale in formerly incarcerated Black and Latino men. Am J Mens Health. 2018;12(4):844–50.
40.
go back to reference Pitpitan EV, Smith LR. Results from a pilot study of a peer navigator intervention for out-of-HIV-care key populations in Tijuana, Mexico. Presented at: 13th International Conference on HIV Treatment and Prevention Adherence. Miami, FL; 2018. Pitpitan EV, Smith LR. Results from a pilot study of a peer navigator intervention for out-of-HIV-care key populations in Tijuana, Mexico. Presented at: 13th International Conference on HIV Treatment and Prevention Adherence. Miami, FL; 2018.
41.
go back to reference Stockman JK, Anderson KM, Tsuyuki K, Horvath KJ. LinkPositively: a trauma-informed peer navigation and social networking WebApp to improve HIV care among black women affected by interpersonal violence. J Health Care Poor Underserved. 2021;32(2 Suppl):166–88. https://doi.org/10.1353/hpu.2021.0056. Stockman JK, Anderson KM, Tsuyuki K, Horvath KJ. LinkPositively: a trauma-informed peer navigation and social networking WebApp to improve HIV care among black women affected by interpersonal violence. J Health Care Poor Underserved. 2021;32(2 Suppl):166–88. https://​doi.​org/​10.​1353/​hpu.​2021.​0056.
46.
50.
go back to reference Earnshaw VA, Smith LR, Chaudoir SR, Amico KR, Copenhaver MM. HIV stigma mechanisms and well-being among PLWH: a test of the HIV stigma framework. AIDS Behav. 2013;17(5):1785–95. Earnshaw VA, Smith LR, Chaudoir SR, Amico KR, Copenhaver MM. HIV stigma mechanisms and well-being among PLWH: a test of the HIV stigma framework. AIDS Behav. 2013;17(5):1785–95.
52.
go back to reference Thompson HS, Valdimarsdottir HB, Winkel G, Jandorf L, Redd W. The Group-Based Medical Mistrust Scale: psychometric properties and association with breast cancer screening. Prev Med. 2004;38(2):209–18. Thompson HS, Valdimarsdottir HB, Winkel G, Jandorf L, Redd W. The Group-Based Medical Mistrust Scale: psychometric properties and association with breast cancer screening. Prev Med. 2004;38(2):209–18.
54.
go back to reference Kimerling R, Ouimette P, Prins A, et al. BRIEF REPORT: Utility of a short screening scale for DSM-IV PTSD in primary care. J Gen Intern Med. 2006;21(1):65–7. Kimerling R, Ouimette P, Prins A, et al. BRIEF REPORT: Utility of a short screening scale for DSM-IV PTSD in primary care. J Gen Intern Med. 2006;21(1):65–7.
56.
go back to reference Straus MA, Hamby SL, Boney-McCoy S, Sugarman DB. The revised conflict tactics scales (CTS2). J Fam Issues. 1996;17(3):283. Straus MA, Hamby SL, Boney-McCoy S, Sugarman DB. The revised conflict tactics scales (CTS2). J Fam Issues. 1996;17(3):283.
60.
go back to reference Smith LR, Earnshaw VA, Copenhaver MM, Cunningham CO. Substance use stigma: reliability and validity of a theory-based scale for substance-using populations. Drug Alcohol Depend. 2016;162:34–43. Smith LR, Earnshaw VA, Copenhaver MM, Cunningham CO. Substance use stigma: reliability and validity of a theory-based scale for substance-using populations. Drug Alcohol Depend. 2016;162:34–43.
69.
go back to reference Valeri L, Vanderweele TJ. Mediation analysis allowing for exposure-mediator interactions and causal interpretation: theoretical assumptions and implementation with SAS and SPSS macros. Psychol Methods. 2013;18(2):137–50. https://doi.org/10.1037/a0031034. Valeri L, Vanderweele TJ. Mediation analysis allowing for exposure-mediator interactions and causal interpretation: theoretical assumptions and implementation with SAS and SPSS macros. Psychol Methods. 2013;18(2):137–50. https://​doi.​org/​10.​1037/​a0031034.
70.
go back to reference Magnani R, Sabin K, Saidel T, Heckathorn D. Review of sampling hard-to-reach and hidden populations for HIV surveillance. AIDS. 2005;19:S67–72. Magnani R, Sabin K, Saidel T, Heckathorn D. Review of sampling hard-to-reach and hidden populations for HIV surveillance. AIDS. 2005;19:S67–72.
74.
go back to reference Walters SJ, Henriques-Cadby IB dos A, Bortolami O, et al. Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme. BMJ Open. 2017;7(3):e015276. https://doi.org/10.1136/bmjopen-2016-015276. Walters SJ, Henriques-Cadby IB dos A, Bortolami O, et al. Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme. BMJ Open. 2017;7(3):e015276. https://​doi.​org/​10.​1136/​bmjopen-2016-015276.
76.
go back to reference Braunstein JB, Sherber NS, Schulman SP, Ding EL, Powe NR. Race, medical researcher distrust, perceived harm, and willingness to participate in cardiovascular prevention trials. Medicine (Baltimore). 2008;87(1):1–9. Braunstein JB, Sherber NS, Schulman SP, Ding EL, Powe NR. Race, medical researcher distrust, perceived harm, and willingness to participate in cardiovascular prevention trials. Medicine (Baltimore). 2008;87(1):1–9.
79.
80.
go back to reference Nachega JB, Adetokunboh O, Uthman OA, et al. Community-based interventions to improve and sustain antiretroviral therapy adherence, retention in HIV care and clinical outcomes in low- and middle-income countries for achieving the UNAIDS 90–90-90 targets. Curr HIV/AIDS Rep. 2016;13(5):241–55. https://doi.org/10.1007/s11904-016-0325-9. Nachega JB, Adetokunboh O, Uthman OA, et al. Community-based interventions to improve and sustain antiretroviral therapy adherence, retention in HIV care and clinical outcomes in low- and middle-income countries for achieving the UNAIDS 90–90-90 targets. Curr HIV/AIDS Rep. 2016;13(5):241–55. https://​doi.​org/​10.​1007/​s11904-016-0325-9.
85.
go back to reference Fixsen D. Assessing Drivers Best Practices. Published online 2018. Fixsen D. Assessing Drivers Best Practices. Published online 2018.
86.
go back to reference Moullin JC, Dickson KS, Stadnick NA, Rabin B, Aarons GA. Systematic review of the exploration, preparation, implementation, sustainment (EPIS) framework. Implement Sci. 2019;14(1):1–16. Moullin JC, Dickson KS, Stadnick NA, Rabin B, Aarons GA. Systematic review of the exploration, preparation, implementation, sustainment (EPIS) framework. Implement Sci. 2019;14(1):1–16.
87.
go back to reference Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health Ment Health Serv Res. 2011;38(2):65–76. Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health Ment Health Serv Res. 2011;38(2):65–76.
Metadata
Title
Peers plus mobile app for treatment in HIV (PATH): protocol for a randomized controlled trial to test a community-based integrated peer support and mHealth intervention to improve viral suppression among Hispanic and Black people living with HIV
Authors
Eileen V. Pitpitan
Keith J. Horvath
Jeannette Aldous
Jamila K. Stockman
Thomas L. Patterson
Megan Liang
Constantino Barrozo
Veronica Moore
Katherine Penninga
Laramie R. Smith
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-08042-8

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