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An Electronic Pre-Exposure Prophylaxis Initiation and Maintenance Home Care System for Nonurban Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.
JMIR Res Protoc. 2019 Jun 10; 8(6):e13982.JR

Abstract

BACKGROUND

Pre-exposure prophylaxis (PrEP) is highly efficacious for preventing HIV but has not yet been brought to scale among at-risk persons. In several clinical trials in urban areas, technology-based interventions have shown a positive impact on PrEP adherence. In rural and small-town areas in the United States, which often do not have geographically proximal access to PrEP providers, additional support may be needed. This may be particularly true for younger persons who are more likely to face multiple barriers to accessing PrEP services. Home-based care, accomplished through a tailored mobile phone app, specimen self-collection (SSC), and interactive video consultations, could increase both PrEP initiation and persistence in care.

OBJECTIVE

The goal of this study is to assess the initiation and persistence in PrEP care for those randomized to a home-care intervention (electronic PrEP, ePrEP) relative to those assigned to the standard of care (control) condition. We will conduct additional assessments, including quantitative and qualitative analyses, to contextualize trial results and facilitate scale-up.

METHODS

This 2-arm, randomized controlled trial will enroll young men who have sex with men (YMSM) aged between 18 and 24 years from rural areas of Georgia, Mississippi, and North Carolina. The trial will seek to recruit a diverse sample, targeting 50% participation among highly impacted groups of black or Latino men who have sex with men. Intervention participants will receive a study app that incorporates a messaging platform, a scheduling and milestone-based tracking system for PrEP care progress, electronic behavioral surveys, and interactive video consultations with a clinician. Complemented by SSC kits mailed to laboratories for standard PrEP-related monitoring, the ePrEP system will allow participants to access PrEP care without leaving their homes. YMSM randomized to the control condition will receive a listing of nearest local PrEP providers to receive standard PrEP care. Both groups will complete quarterly electronic surveys. The primary outcome, assessed at 6 and 12 months after randomization, will be the difference in the proportion of intervention versus control participants that achieve protective levels of the active metabolite of oral PrEP (tenofovir diphosphate in dried blood spots).

RESULTS

Enrollment will begin in May 2019, with study completion in 2022.

CONCLUSIONS

This trial will determine whether home PrEP care provided through an app-based platform is an efficacious means of expanding access to PrEP care for a diverse group of YMSM in rural and small-town areas of the United States.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03729570; https://clinicaltrials.gov/ct2/show/NCT03729570 (Archived by WebCite at http://www.webcitation.org/78RE2Qizf).

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)

PRR1-10.2196/13982.

Authors+Show Affiliations

Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, GA, United States.Division of Infectious Diseases, Department of Medicine, University of Mississippi Medical Center, Jackson, MS, United States.Institute for Global Health & Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, GA, United States.Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA, United States.Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, GA, United States.Department of Population Health Science, John D Bower School of Population Health, University of Mississippi Medical Center, Jackson, MS, United States.Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, GA, United States.Division of Infectious Diseases, Department of Medicine, University of Mississippi Medical Center, Jackson, MS, United States. Department of Population Health Science, John D Bower School of Population Health, University of Mississippi Medical Center, Jackson, MS, United States.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31199326

Citation

Siegler, Aaron J., et al. "An Electronic Pre-Exposure Prophylaxis Initiation and Maintenance Home Care System for Nonurban Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial." JMIR Research Protocols, vol. 8, no. 6, 2019, pp. e13982.
Siegler AJ, Brock JB, Hurt CB, et al. An Electronic Pre-Exposure Prophylaxis Initiation and Maintenance Home Care System for Nonurban Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019;8(6):e13982.
Siegler, A. J., Brock, J. B., Hurt, C. B., Ahlschlager, L., Dominguez, K., Kelley, C. F., Jenness, S. M., Wilde, G., Jameson, S. B., Bailey-Herring, G., & Mena, L. A. (2019). An Electronic Pre-Exposure Prophylaxis Initiation and Maintenance Home Care System for Nonurban Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Research Protocols, 8(6), e13982. https://doi.org/10.2196/13982
Siegler AJ, et al. An Electronic Pre-Exposure Prophylaxis Initiation and Maintenance Home Care System for Nonurban Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jun 10;8(6):e13982. PubMed PMID: 31199326.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An Electronic Pre-Exposure Prophylaxis Initiation and Maintenance Home Care System for Nonurban Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. AU - Siegler,Aaron J, AU - Brock,James B, AU - Hurt,Christopher B, AU - Ahlschlager,Lauren, AU - Dominguez,Karen, AU - Kelley,Colleen F, AU - Jenness,Samuel M, AU - Wilde,Gretchen, AU - Jameson,Samuel B, AU - Bailey-Herring,Gina, AU - Mena,Leandro A, Y1 - 2019/06/10/ PY - 2019/03/11/received PY - 2019/05/02/accepted PY - 2019/05/01/revised PY - 2019/6/15/entrez PY - 2019/6/15/pubmed PY - 2019/6/15/medline KW - mHealth KW - mobile apps KW - pre-exposure prophylaxis KW - prevention KW - sexual and gender minorities KW - smartphone KW - telehealth KW - telemedicine SP - e13982 EP - e13982 JF - JMIR research protocols JO - JMIR Res Protoc VL - 8 IS - 6 N2 - BACKGROUND: Pre-exposure prophylaxis (PrEP) is highly efficacious for preventing HIV but has not yet been brought to scale among at-risk persons. In several clinical trials in urban areas, technology-based interventions have shown a positive impact on PrEP adherence. In rural and small-town areas in the United States, which often do not have geographically proximal access to PrEP providers, additional support may be needed. This may be particularly true for younger persons who are more likely to face multiple barriers to accessing PrEP services. Home-based care, accomplished through a tailored mobile phone app, specimen self-collection (SSC), and interactive video consultations, could increase both PrEP initiation and persistence in care. OBJECTIVE: The goal of this study is to assess the initiation and persistence in PrEP care for those randomized to a home-care intervention (electronic PrEP, ePrEP) relative to those assigned to the standard of care (control) condition. We will conduct additional assessments, including quantitative and qualitative analyses, to contextualize trial results and facilitate scale-up. METHODS: This 2-arm, randomized controlled trial will enroll young men who have sex with men (YMSM) aged between 18 and 24 years from rural areas of Georgia, Mississippi, and North Carolina. The trial will seek to recruit a diverse sample, targeting 50% participation among highly impacted groups of black or Latino men who have sex with men. Intervention participants will receive a study app that incorporates a messaging platform, a scheduling and milestone-based tracking system for PrEP care progress, electronic behavioral surveys, and interactive video consultations with a clinician. Complemented by SSC kits mailed to laboratories for standard PrEP-related monitoring, the ePrEP system will allow participants to access PrEP care without leaving their homes. YMSM randomized to the control condition will receive a listing of nearest local PrEP providers to receive standard PrEP care. Both groups will complete quarterly electronic surveys. The primary outcome, assessed at 6 and 12 months after randomization, will be the difference in the proportion of intervention versus control participants that achieve protective levels of the active metabolite of oral PrEP (tenofovir diphosphate in dried blood spots). RESULTS: Enrollment will begin in May 2019, with study completion in 2022. CONCLUSIONS: This trial will determine whether home PrEP care provided through an app-based platform is an efficacious means of expanding access to PrEP care for a diverse group of YMSM in rural and small-town areas of the United States. TRIAL REGISTRATION: ClinicalTrials.gov NCT03729570; https://clinicaltrials.gov/ct2/show/NCT03729570 (Archived by WebCite at http://www.webcitation.org/78RE2Qizf). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/13982. SN - 1929-0748 UR - https://www.unboundmedicine.com/medline/citation/31199326/An_Electronic_Pre_Exposure_Prophylaxis_Initiation_and_Maintenance_Home_Care_System_for_Nonurban_Young_Men_Who_Have_Sex_With_Men:_Protocol_for_a_Randomized_Controlled_Trial_ L2 - https://www.researchprotocols.org/2019/6/e13982/ DB - PRIME DP - Unbound Medicine ER -
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