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Thrive With Me: Protocol for a Randomized Controlled Trial to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence Among Men Who Have Sex With Men.
JMIR Res Protoc. 2018 May 31; 7(5):e10182.JR

Abstract

BACKGROUND

The suboptimal rate of viral suppression among persons aged 13 years and older and residing in 37 states and the District of Columbia leaves considerable opportunities for onward transmission and contributes to poor health outcomes. Men who have sex with men (MSM) represent one of the most at-risk groups in the United States. There is a clear and continued need for innovative adherence support programs to optimize viral suppression. To address this gap, we designed and are implementing a randomized controlled trial (RCT) to test the efficacy of the Thrive with Me intervention for MSM living with HIV. Critical components of the protocol are presented.

OBJECTIVE

The aim of this study is to describe the protocol for rigorously testing the efficacy of Thrive with Me to improve antiretroviral therapy (ART) adherence among HIV-positive MSM residing in New York City.

METHODS

A community advisory board and beta testing were used to obtain feedback from HIV-positive MSM on the overall look and feel of Thrive with Me and problems with navigation to finalize intervention components and content. We will enroll 400 HIV-positive MSM residing in the New York City area into a two-arm prospective RCT and follow them for 17 months. Men in the Thrive with Me experimental intervention arm will have access to Thrive with Me for 5 months. Thrive with Me has three primary components: (1) a private social networking feature; (2) tailored HIV and ART adherence information; and (3) medication reminders, self-monitoring, and reflection. Gamification components include badges and leveling up to increase intrinsic motivation to engage with the intervention. Men randomized to the control condition will view a weekly newsletter for 5 months. The newsletter will be delivered via email and contains information on topics related to HIV with the exception of ART adherence. Study assessments will occur at enrollment and 5, 11, and 17 months post enrollment. The primary study outcome is HIV viral load, which is considered an objective indicator of ART adherence.

RESULTS

Participant recruitment for the RCT began in October 2016, and the data collection period is anticipated to end in the Fall of 2019.

CONCLUSIONS

The efficacy trial of Thrive with Me will help to fill gaps in understanding about the utility of multicomponent, technology-based interventions to improve ART adherence among HIV-positive MSM. Of importance is the ability for the results of the Thrive with Me trial to inform best practices for conducting technology-based interventions that incorporate social media features.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02704208; https://clinicaltrials.gov/ct2/show/NCT02704208 (Archived by WebCite at http://www.webcitation.org/6zQ8WPra6).

REGISTERED REPORT IDENTIFIER

RR1-10.2196/10182.

Authors+Show Affiliations

Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, United States.Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, MI, United States.Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, United States.Division of Health Policy and Management, School of Public Health, University of Minnesota, Minneapolis, MN, United States.Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, United States.Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, United States.Radiant Creative Group, Houston, TX, United States.Center for HIV/AIDS Educational Studies and Training (CHEST), Hunter College, Graduate Center of the City University of New York (CUNY), New York City, NY, United States.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29853437

Citation

Horvath, Keith J., et al. "Thrive With Me: Protocol for a Randomized Controlled Trial to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence Among Men Who Have Sex With Men." JMIR Research Protocols, vol. 7, no. 5, 2018, pp. e10182.
Horvath KJ, Amico KR, Erickson D, et al. Thrive With Me: Protocol for a Randomized Controlled Trial to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence Among Men Who Have Sex With Men. JMIR Res Protoc. 2018;7(5):e10182.
Horvath, K. J., Amico, K. R., Erickson, D., Ecklund, A. M., Martinka, A., DeWitt, J., McLaughlin, J., & Parsons, J. T. (2018). Thrive With Me: Protocol for a Randomized Controlled Trial to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence Among Men Who Have Sex With Men. JMIR Research Protocols, 7(5), e10182. https://doi.org/10.2196/10182
Horvath KJ, et al. Thrive With Me: Protocol for a Randomized Controlled Trial to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence Among Men Who Have Sex With Men. JMIR Res Protoc. 2018 May 31;7(5):e10182. PubMed PMID: 29853437.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Thrive With Me: Protocol for a Randomized Controlled Trial to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence Among Men Who Have Sex With Men. AU - Horvath,Keith J, AU - Amico,K Rivet, AU - Erickson,Darin, AU - Ecklund,Alexandra M, AU - Martinka,Aldona, AU - DeWitt,James, AU - McLaughlin,Jeffery, AU - Parsons,Jeffrey T, Y1 - 2018/05/31/ PY - 2018/02/20/received PY - 2018/04/12/accepted PY - 2018/04/11/revised PY - 2018/6/2/entrez PY - 2018/6/2/pubmed PY - 2018/6/2/medline KW - ART adherence KW - HIV KW - MSM KW - mobile app SP - e10182 EP - e10182 JF - JMIR research protocols JO - JMIR Res Protoc VL - 7 IS - 5 N2 - BACKGROUND: The suboptimal rate of viral suppression among persons aged 13 years and older and residing in 37 states and the District of Columbia leaves considerable opportunities for onward transmission and contributes to poor health outcomes. Men who have sex with men (MSM) represent one of the most at-risk groups in the United States. There is a clear and continued need for innovative adherence support programs to optimize viral suppression. To address this gap, we designed and are implementing a randomized controlled trial (RCT) to test the efficacy of the Thrive with Me intervention for MSM living with HIV. Critical components of the protocol are presented. OBJECTIVE: The aim of this study is to describe the protocol for rigorously testing the efficacy of Thrive with Me to improve antiretroviral therapy (ART) adherence among HIV-positive MSM residing in New York City. METHODS: A community advisory board and beta testing were used to obtain feedback from HIV-positive MSM on the overall look and feel of Thrive with Me and problems with navigation to finalize intervention components and content. We will enroll 400 HIV-positive MSM residing in the New York City area into a two-arm prospective RCT and follow them for 17 months. Men in the Thrive with Me experimental intervention arm will have access to Thrive with Me for 5 months. Thrive with Me has three primary components: (1) a private social networking feature; (2) tailored HIV and ART adherence information; and (3) medication reminders, self-monitoring, and reflection. Gamification components include badges and leveling up to increase intrinsic motivation to engage with the intervention. Men randomized to the control condition will view a weekly newsletter for 5 months. The newsletter will be delivered via email and contains information on topics related to HIV with the exception of ART adherence. Study assessments will occur at enrollment and 5, 11, and 17 months post enrollment. The primary study outcome is HIV viral load, which is considered an objective indicator of ART adherence. RESULTS: Participant recruitment for the RCT began in October 2016, and the data collection period is anticipated to end in the Fall of 2019. CONCLUSIONS: The efficacy trial of Thrive with Me will help to fill gaps in understanding about the utility of multicomponent, technology-based interventions to improve ART adherence among HIV-positive MSM. Of importance is the ability for the results of the Thrive with Me trial to inform best practices for conducting technology-based interventions that incorporate social media features. TRIAL REGISTRATION: ClinicalTrials.gov NCT02704208; https://clinicaltrials.gov/ct2/show/NCT02704208 (Archived by WebCite at http://www.webcitation.org/6zQ8WPra6). REGISTERED REPORT IDENTIFIER: RR1-10.2196/10182. SN - 1929-0748 UR - https://www.unboundmedicine.com/medline/citation/29853437/Thrive_With_Me:_Protocol_for_a_Randomized_Controlled_Trial_to_Test_a_Peer_Support_Intervention_to_Improve_Antiretroviral_Therapy_Adherence_Among_Men_Who_Have_Sex_With_Men_ L2 - https://www.researchprotocols.org/2018/5/e10182/ DB - PRIME DP - Unbound Medicine ER -
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