scholarly journals A community-engaged mHealth intervention to increase uptake of HIV Pre-Exposure Prophylaxis (PrEP) among gay, bisexual and other men who have sex with men in China: Study protocol for a pilot randomized controlled trial

2020 ◽  
Author(s):  
Chunyan Li ◽  
Yuan Xiong ◽  
Kathryn E. Muessig ◽  
Weiming Tang ◽  
Haojie Huang ◽  
...  
Keyword(s):  
Social Media ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
System Capacity ◽  
Study Phase ◽  
Randomized Controlled ◽  
Link Type ◽  
Study Results ◽  
Sex With Men ◽  
Exposure Prophylaxis

ABSTRACTIntroductionEmtricitabine-Tenofovir was officially approved as the first medicine for HIV pre-exposure prophylaxis (PrEP) in China on August 11, 2020. The large number of key populations who would benefit from PrEP in the context of limited health system capacity and public awareness will pose challenges for timely PrEP scale-up. This suggests an urgent need for innovative and accessible intervention tools for promoting PrEP. Our overall goal is to develop and pilot test a theory-informed, tailored mobile phone intervention to increase engagement in PrEP education and initiation among Chinese gay, bisexual, and other men who have sex with men (GBMSM). We also aim to generate hypotheses of potential behavioral pathways to PrEP uptake among Chinese GBMSM.Methods and analysisThis two-phase study includes a formative assessment (Phase 1) using in-depth interviews (N=30) and a 12-week experimental pilot study (Phase 2) using a two-arm randomized controlled trial design (N=60). The primary intervention is delivered through a WeChat-based mini-app (a program built into a Chinese multipurpose social media application) developed by young GBMSM from a 2019 crowdsourcing hackathon. This participatory event brought together GBMSM, tech experts, health professionals, and other key stakeholders. This study will further investigate the specific needs and concerns among GBMSM in terms of using PrEP as an HIV prevention strategy, how their concerns and PrEP use behaviors may change with exposure to the mini-app intervention at 8-week and 12-week follow-up, and how we can further refine this intervention tool to better meet GBMSM ‘s needs for broader implementation.Ethics and disseminationThis study and its protocols have been reviewed and approved by the Institutional Review Boards of the University of North Carolina at Chapel Hill, USA (IRB#19-3481), the Guangdong Provincial Dermatology Hospital, China (IRB#2020031), and the Guangzhou Eighth People ‘s Hospital, China (IRB#202022155). Study staff will work with local GBMSM community-based organizations to disseminate the study results to participants and the community via social media, offline workshops, and journal publication. This research addresses a critical need as GBMSM bear a disproportionate burden of HIV infections in China and remain underserved in the healthcare system.Trial RegistrationThe study was registered on clinicaltrials.gov (Trial#: NCT04426656) on June 11, 2020. https://clinicaltrials.gov/ct2/show/NCT04426656. Prospectively registered.

scholarly journals Using eHealth to Reach Black and Hispanic Men Who Have Sex With Men Regarding Treatment as Prevention and Preexposure Prophylaxis: Protocol for a Small Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Jacob J van den Berg ◽  
Taylor Silverman ◽  
M Isabel Fernandez ◽  
Kirk D Henny ◽  
Zaneta J Gaul ◽  
...  
Keyword(s):  
Social Media ◽  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
Treatment As Prevention ◽  
Randomized Controlled ◽  
Preexposure Prophylaxis ◽  
Hispanic Men ◽  
Sex With Men ◽  
Ehealth Intervention

BACKGROUND Black and Hispanic men who have sex with men in the United States continue to be disproportionately affected by HIV and AIDS. Uptake of and knowledge about biobehavioral HIV prevention approaches, such as treatment as prevention and preexposure prophylaxis, are especially low in these populations. eHealth campaigns and social media messaging about treatment as prevention and preexposure prophylaxis may help to fill this gap in knowledge and lead to increased uptake of such strategies; however, no evidence exists of the effects of these targeted forms of communication on treatment as prevention and preexposure prophylaxis uptake in these populations. OBJECTIVE We describe the protocol for a 3-part study aiming to develop and evaluate an eHealth intervention with information about treatment as prevention and preexposure prophylaxis for HIV-positive and HIV-negative black and Hispanic men who have sex with men. METHODS Phases 1 and 2 will involve focus groups and cognitive interviews with members of the target populations, which we will use to create a culturally tailored, interactive website and applicable social media messaging for these men. Phase 3 will be a small randomized controlled trial of the eHealth intervention, in which participants will receive guided social media messages plus the newly developed website (active arm) or the website alone (control arm), with assessments at baseline and 6 months. RESULTS Participant recruitment began in August 2017 and will end in August 2020. CONCLUSIONS Public health interventions are greatly needed to increase knowledge about and uptake of biobehavioral HIV prevention strategies such as treatment as prevention and preexposure prophylaxis among black and Hispanic men who have sex with men. eHealth communication campaigns offer a strategy for engaging these populations in health communication about biobehavioral HIV prevention. CLINICALTRIAL ClinicalTrials.gov NCT03404531; https://www.clinicaltrials.gov/ct2/show/NCT03404531 (Archived by WebCite at http://www.webcitation.org/70myofp0R). REGISTERED REPORT IDENTIFIER RR1-10.2196/11047

scholarly journals A Mobile-Based App (MyChoices) to Increase Uptake of HIV Testing and Pre-Exposure Prophylaxis by Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Katie B Biello ◽  
Elliot Marrow ◽  
Matthew J Mimiaga ◽  
Patrick Sullivan ◽  
Lisa Hightow-Weidman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Testing ◽  
Controlled Trial ◽  
The United States ◽  
Randomized Controlled ◽  
Pilot Rct ◽  
Sex With Men ◽  
Exposure Prophylaxis ◽  
Beta Testing ◽  
Pilot Randomized Controlled Trial

BACKGROUND HIV incidence is growing most rapidly in the United States among young men who have sex with men (YMSM). Overwhelming evidence demonstrates that routine testing and expanded use of pre-exposure prophylaxis (PrEP) would dramatically reduce the population burden of HIV; however, uptake of both interventions is suboptimal among young adults. The use of mobile phone apps by YMSM is ubiquitous and may offer unique opportunities for public health interventions. MyChoices is a theory-driven app to increase HIV testing and PrEP uptake. It was developed by an interdisciplinary team based on feedback from a diverse sample of YMSM. OBJECTIVE The aim of this paper is to describe the protocol for the refinement, beta testing, and pilot randomized controlled trial (RCT) to examine the acceptability and feasibility of the MyChoices app. METHODS This 3-phase study includes 4 theater testing groups for app refinement with a total of approximately 30 YMSM; for beta testing, including quantitative assessments and exit interviews, with approximately 15 YMSM over a 2-month period; and for a pilot RCT with 60 YMSM. The pilot will assess feasibility, acceptability, and preliminary efficacy of the MyChoices app, compared with referrals only, in increasing HIV testing and PrEP uptake. All participants will be recruited at iTech clinical research sites in Boston, MA, and Bronx, NY. RESULTS App refinement is underway. Enrollment for the pilot RCT began in October 2018. CONCLUSIONS MyChoices is one of the first comprehensive, theory-driven HIV prevention apps designed specifically for YMSM. If MyChoices demonstrates acceptability and feasibility in this pilot RCT, a multicity, 3-arm randomized controlled efficacy trial of this app and another youth-optimized app (LYNX) versus standard of care is planned within iTech. If shown to be efficacious, the app will be scalable, with the ability to reach YMSM across the United States as well as be geographically individualized, with app content integrated with local prevention and testing activities. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/10694

scholarly journals Effects of a large-scale social media advertising campaign on holiday travel and COVID-19 infections: a cluster randomized controlled trial

2021 ◽  
Vol 27 (9) ◽  
pp. 1622-1628
Author(s):  
Emily Breza ◽  
Fatima Cody Stanford ◽  
Marcella Alsan ◽  
Burak Alsan ◽  
Abhijit Banerjee ◽  
...  
Keyword(s):  
Social Media ◽  
Randomized Controlled Trial ◽  
Health Professionals ◽  
High Intensity ◽  
Controlled Trial ◽  
The United States ◽  
Advertising Campaign ◽  
Low Intensity ◽  
Randomized Controlled ◽  
Link Type

AbstractDuring the Coronavirus Disease 2019 (COVID-19) epidemic, many health professionals used social media to promote preventative health behaviors. We conducted a randomized controlled trial of the effect of a Facebook advertising campaign consisting of short videos recorded by doctors and nurses to encourage users to stay at home for the Thanksgiving and Christmas holidays (NCT04644328 and AEARCTR-0006821). We randomly assigned counties to high intensity (n = 410 (386) at Thanksgiving (Christmas)) or low intensity (n = 410 (381)). The intervention was delivered to a large fraction of Facebook subscribers in 75% and 25% of randomly assigned zip codes in high- and low-intensity counties, respectively. In total, 6,998 (6,716) zip codes were included, and 11,954,109 (23,302,290) users were reached at Thanksgiving (Christmas). The first two primary outcomes were holiday travel and fraction leaving home, both measured using mobile phone location data of Facebook users. Average distance traveled in high-intensity counties decreased by −0.993 percentage points (95% confidence interval (CI): –1.616, −0.371; P = 0.002) for the 3 days before each holiday compared to low-intensity counties. The fraction of people who left home on the holiday was not significantly affected (adjusted difference: 0.030; 95% CI: −0.361, 0.420; P = 0.881). The third primary outcome was COVID-19 infections recorded at the zip code level in the 2-week period starting 5 days after the holiday. Infections declined by 3.5% (adjusted 95% CI: −6.2%, −0.7%; P = 0.013) in intervention compared to control zip codes. Social media messages recorded by health professionals before the winter holidays in the United States led to a significant reduction in holiday travel and subsequent COVID-19 infections.

scholarly journals A Pre-Exposure Prophylaxis Adherence Intervention (LifeSteps) for Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Katie B Biello ◽  
Christina Psaros ◽  
Douglas S Krakower ◽  
Elliot Marrow ◽  
Steven A Safren ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Young Men ◽  
The United States ◽  
Hiv Incidence ◽  
Randomized Controlled ◽  
Adherence Intervention ◽  
Sex With Men ◽  
Exposure Prophylaxis ◽  
Pilot Randomized Controlled Trial

BACKGROUND New HIV infections occur at a disproportionately high rate among young men who have sex with men (YMSM). It is, therefore, essential that comprehensive HIV prevention strategies, specifically tailored to their needs and perceptions, are developed, tested, and disseminated. Antiretroviral pre-exposure prophylaxis (PrEP) is effective in decreasing HIV transmission among men who have sex with men; however, adherence is critical to its efficacy. In open-label studies among YMSM, adherence was suboptimal. Hence, behavioral approaches that address the unique challenges to YMSM PrEP adherence are needed. OBJECTIVE This study aims to describe the protocol for intervention refinement and a pilot randomized controlled trial (RCT) of a PrEP adherence intervention, LifeSteps for pre-exposure prophylaxis for young men who have sex with men (LSPY). METHODS This study includes the following 2 phases: formative qualitative interviews with approximately 20 YMSM and 10 key informants for intervention adaptation and refinement and a pilot RCT of up to 50 YMSM to assess the feasibility, acceptability, and preliminary efficacy of the LSPY, compared with the PrEP standard of care, to improve PrEP adherence. Participants will be recruited at 3 iTech subject recruitment venues in the United States. RESULTS Phase 1 is expected to begin in June 2018, and enrollment of phase 2 is anticipated to begin in early 2019. CONCLUSIONS Few rigorously developed and tested interventions have been designed to increase PrEP adherence among YMSM in community settings, despite this population’s high HIV incidence. The long-term goal of this intervention is to develop scalable protocols to optimize at-risk YMSM’s PrEP uptake and adherence to decrease the HIV incidence. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/10661

scholarly journals 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

10.2196/13982 ◽  
2019 ◽  
Vol 8 (6) ◽  
pp. e13982 ◽  
Author(s):  
Aaron J Siegler ◽  
James B Brock ◽  
Christopher B Hurt ◽  
Lauren Ahlschlager ◽  
Karen Dominguez ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Home Care ◽  
Controlled Trial ◽  
Young Men ◽  
Randomized Controlled ◽  
Sex With Men ◽  
Exposure Prophylaxis ◽  
Care System

scholarly journals A Theoretically-Based Mobile App to Increase Pre-exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial

10.2196/16231 ◽  
2020 ◽  
Vol 9 (2) ◽  
pp. e16231 ◽  
Author(s):  
Jeb Jones ◽  
Karen Dominguez ◽  
Rob Stephenson ◽  
Joanne D Stekler ◽  
Amanda D Castel ◽  
...  
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
Mobile App ◽  
Southern United States ◽  
Randomized Controlled ◽  
Southern Us ◽  
Sex With Men ◽  
Exposure Prophylaxis

Background HealthMindr is a mobile phone HIV prevention app for men who have sex with men (MSM). In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM. PrEP is a highly effective HIV prevention intervention; however, uptake remains low. Objective To assess the efficacy of a mobile app for increasing PrEP uptake among MSM in the southern United States. Methods In this randomized controlled trial, we will assess the efficacy of HealthMindr for increasing PrEP uptake among MSM in the following three southern US cities: Atlanta, Georgia; Jackson, Mississippi; and Washington, DC. In total, 657 men will be recruited and randomized to intervention and control arms in a 2:1 ratio. Participants in the intervention arm will receive access to the full HealthMindr app, with information and resources about PrEP (eg, frequently asked questions, risk assessment tool, and PrEP provider locator), other HIV prevention information, ability to order free HIV/sexually transmitted infection test kits, and additional resources related to substance use and mental health. Participants in the control arm will use the HealthMindr app but will only have access to the study timeline and a message center to communicate with study staff. Participants will complete quarterly surveys to assess self-reported PrEP uptake over 12 months of follow-up. Self-reported PrEP uptake will be verified by dried blood spot testing and/or uploading a photograph of a PrEP prescription. Results Participant recruitment is expected to begin in January 2020. Conclusions This trial will determine whether the HealthMindr app can increase PrEP uptake among MSM in the southern United States. Trial Registration ClinicalTrials.gov NCT03763942; https://clinicaltrials.gov/ct2/show/NCT03763942 International Registered Report Identifier (IRRID) PRR1-10.2196/16231

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