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

10.2196/10661 ◽  
2019 ◽  
Vol 8 (1) ◽  
pp. e10661 ◽  
Author(s):  
Katie B Biello ◽  
Christina Psaros ◽  
Douglas S Krakower ◽  
Elliot Marrow ◽  
Steven A Safren ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Young Men ◽  
Randomized Controlled ◽  
Adherence Intervention ◽  
Sex With Men ◽  
Exposure Prophylaxis ◽  
Pilot Randomized Controlled Trial

scholarly journals Assisted Partner Notification and Uptake of HIV Testing among Men Who Have Sex with Men: A Randomized Controlled Trial in China

2021 ◽  
Vol 12 ◽  
pp. 100171
Author(s):  
Qing-Hai Hu ◽  
Han-Zhu Qian ◽  
Jia-Ming Li ◽  
Sequoia I. Leuba ◽  
Zhen-Xing Chu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Testing ◽  
Controlled Trial ◽  
Partner Notification ◽  
Randomized Controlled ◽  
Sex With Men

scholarly journals Optimizing Pre-Exposure Antiretroviral Prophylaxis Adherence in Men Who Have Sex with Men: Results of a Pilot Randomized Controlled Trial of “Life-Steps for PrEP”

2016 ◽  
Vol 21 (5) ◽  
pp. 1350-1360 ◽  
Author(s):  
Kenneth H. Mayer ◽  
Steven A. Safren ◽  
Steven A. Elsesser ◽  
Christina Psaros ◽  
Jake P. Tinsley ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Antiretroviral Prophylaxis ◽  
Sex With Men ◽  
Pilot Randomized Controlled Trial

scholarly journals Feasibility and Acceptability of an Electronic Health HIV Prevention Toolkit Intervention With Concordant HIV-Negative, Same-Sex Male Couples on Sexual Agreement Outcomes: Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Jason William Mitchell ◽  
Ji-Young Lee ◽  
Yanyan Wu ◽  
Patrick S Sullivan ◽  
Rob Stephenson
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
The United States ◽  
Relationship Dynamics ◽  
Male Couples ◽  
Randomized Controlled ◽  
Electronic Health ◽  
Pilot Randomized Controlled Trial ◽  
Over Time

BACKGROUND There is a need to develop innovative and accessible dyadic interventions that provide male couples with the behavioral skills to manage the risk of HIV transmission within their relationship. OBJECTIVE We conducted a pilot randomized controlled trial (RCT) to assess the feasibility and acceptability of the electronic health (eHealth) HIV prevention toolkit intervention to encourage seroconcordant negative male couples in the United States to establish and adhere to a sexual agreement (SA). METHODS Eligible, consented couples were randomly assigned to the intervention or education control and followed up for 6 months, with assessments occurring every 3 months after baseline. Acceptability items were assessed at both follow-up assessments. Descriptive and comparative statistics summarized cohort characteristics, relationship dynamics, and SA outcomes for the entire cohort and by trial arm. To examine the association between couples’ relationship dynamics and their establishment of an SA over time and by trial arm, multilevel logistic regression analyses were performed with a random intercept to account for correlations of repeated measurements of relationship dynamics at months 3 and 6; the odds ratio (OR) of establishment of an SA and the corresponding 95% confidence interval were then reported. RESULTS Overall, 7959 individuals initiated screening. Reasons for individual ineligibility varied. An electronic algorithm was used to assess couple-level eligibility, which identified 1080 ineligible and 266 eligible dyads. Eligible couples (n=149) were enrolled in the pilot RCT: 68 received the intervention and 81 received the education control. Retention was 71.5% (213/298 partnered men) over the 6 months. Participants reported high acceptability of the intervention along with some areas for improvement. A significantly higher proportion of couples who received the intervention established an SA at 6 months compared with those who received the education control (32/43, 74% vs 27/50, 54%; <i>P</i>=.05). The OR of establishing an SA for couples in the intervention versus those in the control condition was greater than 2 when controlling for a number of different relationship dynamics. In addition, the odds of establishing an SA increased by 88% to 322% for each unit increase in a variety of averaged relationship dynamic scores; the opposite result was found for dynamics of stigma. Differences between trial arms for SA type and adherence were nonsignificant at each assessment. However, changes in these 2 SA aspects were noted over time. The average number of items couples included in their SA was 18, and about one-fourth to one-third of couples included HIV prevention items. CONCLUSIONS The findings demonstrate strong evidence for the acceptability and feasibility of the eHealth toolkit as a brief, stand-alone, couples-based HIV prevention intervention. These findings support the need to update the toolkit and evaluate it in a larger clinical trial powered for efficacy. CLINICALTRIAL ClinicalTrials.gov NCT02494817; http://clinicaltrials.gov/ct2/show/NCT02494817

scholarly journals A Mobile Gaming Intervention for Persons on Pre-Exposure Prophylaxis: Protocol for Intervention Development and Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Laura Whiteley ◽  
Elizabeth Olsen ◽  
Leandro Mena ◽  
Kayla Haubrick ◽  
Lacey Craker ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Positive Impact ◽  
Controlled Trial ◽  
The United States ◽  
Developmental Phase ◽  
Randomized Controlled ◽  
Research Activities ◽  
Young Msm ◽  
Exposure Prophylaxis ◽  
Gaming Intervention

BACKGROUND In the United States, young minority men who have sex with men (MSM) are the most likely to become infected with HIV. Pre-exposure prophylaxis (PrEP) is an efficacious and promising prevention strategy. However, PrEP’s safety and effectiveness can be greatly compromised by suboptimal adherence to treatment. To maximize the positive impact of PrEP, it is necessary to combine its prescription with cost-effective behavioral interventions that promote adherence and decrease HIV risk behaviors. In this project, we developed a theoretically informed app/gaming intervention to engage young MSM in learning information, practicing behaviors, and improving motivation for HIV preventative behaviors and PrEP adherence. OBJECTIVE The goal of this project was to develop and test a cutting-edge, engaging, and entertaining app/gaming intervention for improving adherence to PrEP and building HIV prevention knowledge, skills, and behavior. METHODS This study was conducted in two phases. In the developmental phase, we conducted qualitative interviews with young MSM (n=20) to guide the development of the gaming intervention. In the randomized controlled trial, we tested the preliminary efficacy of the gaming intervention compared to a comparison condition among young MSM. Subjects were recruited from the University of Mississippi Medical Center HIV/STI testing clinics (n=60). RESULTS Institutional review board approval was received in February 2015. Research activities began in June 2015 and are still ongoing. CONCLUSIONS This app/gaming intervention aimed to improve PrEP adherence and HIV preventative behaviors in young MSM. Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion. It is important to develop interventions that are enjoyable, engaging, and easily incorporated into clinical settings. CLINICALTRIAL ClinicalTrials.gov RCT02611362; https://tinyurl.com/y65gkuwr INTERNATIONAL REGISTERED REPORT DERR1-10.2196/18640

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