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

scholarly journals Testing the Efficacy of a Social Networking Gamification App to Improve Pre-Exposure Prophylaxis Adherence (P3: Prepared, Protected, emPowered): Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Sara LeGrand ◽  
Kelly Knudtson ◽  
David Benkeser ◽  
Kathryn Muessig ◽  
Andrew Mcgee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Social Networking ◽  
Text Messaging ◽  
Controlled Trial ◽  
Formative Research ◽  
Mobile App ◽  
Ongoing Research ◽  
Randomized Controlled ◽  
Sex With Men ◽  
Exposure Prophylaxis

BACKGROUND HIV prevalence is high among young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM), particularly among minorities. Despite its proven efficacy and safety, the uptake of and adherence to pre-exposure prophylaxis (PrEP) among YMSM and YTWSM is currently limited. To date, evidence-based interventions to promote and sustain PrEP adherence have been limited and not shown to be highly efficacious. Given the widespread adoption of smartphones, mobile apps can be utilized to increase PrEP adherence for many YMSM and YTWSM. OBJECTIVE The study consists of a formative research phase to develop an app-based intervention, P3 (Prepared, Protected, emPowered), to increase PrEP adherence, and a randomized controlled trial (RCT) to test its efficacy. P3 is a mobile app built on an established health platform, which includes social networking and game-based components to encourage PrEP adherence among YMSM and YTWSM. P3+ includes all P3 features plus adherence counseling delivered via two-way text messaging (short message service, SMS) through the app. METHODS The formative research phase includes usability testing to assess users’ comprehension of P3’s educational content, understanding and use of intervention features, and overall impressions of app functionality, followed by app refinements. A subsequent field trial will identify and resolve any remaining technical challenges. A three-arm RCT (P3, P3+, and standard of care) will then be conducted at 6 iTech subject recruitment venues to assess intervention efficacy and to conduct a comparison of costs to deliver the 2 intervention arms. RESULTS This is an ongoing research project with initial results from the formative work expected in 2020 and those from the RCT in 2021. CONCLUSIONS P3 aims to provide an engaging, interactive experience that is highly appealing for the target population, leveraging technology already heavily integrated into the lives of young people, and thus meeting users’ needs in a familiar, stimulating way. If efficacious, P3 could be a sustainable, easily disseminated, lower-cost PrEP intervention for YMSM and YTWSM. Further, the research aims to determine the processes that are essential to developing and implementing future health-related gamification interventions. CLINICALTRIAL ClinicalTrials.gov NCT03320512; https://clinicaltrials.gov/ct2/show/NCT03320512 (Archived by WebCite at http://www.webcitation.org/74OVZkICl) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/10448

scholarly journals A Theory-Based mHealth Intervention (Getting Off) for Methamphetamine-Using Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial

10.2196/22572 ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. e22572
Author(s):  
Cathy J Reback ◽  
Jesse B Fletcher ◽  
Raymond P Mata
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
Mobile App ◽  
Care Continuum ◽  
Mhealth Intervention ◽  
Randomized Controlled ◽  
Brick And Mortar ◽  
Sex With Men ◽  
The Impact

Background Methamphetamine (meth) use among men who have sex with men (MSM) is associated with increased HIV prevalence and transmission and substandard advancement along the HIV prevention and care continuum. Given the growth of mobile health (mHealth) technologies, it is no longer necessary to limit meth treatment options to physical, brick-and-mortar sites, and administration using generic, nontailored content. Objective In a 2-arm randomized controlled trial (RCT; N=300), we aim to evaluate the use of an mHealth intervention (Getting Off) to assess the impact and noninferiority of a cross-platform app (developed from a manualized meth treatment intervention) to help MSM reduce meth use and HIV sexual risk behaviors and improve their advancement along the HIV prevention and care continuum (HIV testing, pre-exposure prophylaxis uptake and persistence, and antiretroviral therapy uptake and adherence). Methods Participants will be randomized into 2 arms: arm A, with immediate access to the app (immediate delivery: n=150), or arm B, with delayed access to the app after a 30-day period (delayed delivery: n=150). Participants in both arms will use the same Getting Off app and will have 30 days to complete the 24 sessions. Participants will be assessed at the 1-, 2- (delayed delivery arm only), 3-, 6-, and 9-month timepoints to determine observed treatment effects and will be compared with a historical matched sample of participants (n=~600) who received the brick-and-mortar group-based Getting Off intervention. Results Recruitment began in January 2019 for phase 1, the formative phase. In January and February 2019, 4 focus groups (N=36) were formed to provide input on the adaptation of the group-based manual intervention to a mobile app. Data collection for phase 2, the RCT, is expected to be completed in January 2023. The final results are anticipated in April 2023. Conclusions By creating a culturally responsive mobile app, Getting Off aims to reduce meth use and improve sexual health outcomes among meth-using MSM. The Getting Off app could have significant public health impact by greatly expanding access to effective, affordable, private, culturally competent, and highly scalable meth treatment for MSM. Trial Registration Clinicaltrials.gov NCT03884946; https://clinicaltrials.gov/ct2/show/NCT03884946 International Registered Report Identifier (IRRID) DERR1-10.2196/22572

Measuring Acceptability and Engagement of the Keep It Up! Internet-based HIV Prevention Randomized Controlled Trial for Young Men who have Sex with Men (Preprint)

2018 ◽  
Author(s):  
Krystal Madkins ◽  
David Moskowitz ◽  
Kevin Moran ◽  
Trey Dellucci ◽  
Brian Mustanski
Keyword(s):  
High School ◽  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
P Values ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Intervention Acceptability ◽  
Intervention Content ◽  
Sex With Men

BACKGROUND Since 2010, HIV diagnoses among men who have sex with men (MSM) have remained stably high while decreasing for heterosexual men and women. The burden of infection has disproportionately impacted younger MSM of color relative to other populations. Despite the increased risk, there are few HIV prevention programs targeted to diverse and young MSM. The Keep It Up! (KIU!) online intervention was created to address the HIV prevention needs of this population. OBJECTIVE The objective of this study was to examine the acceptability and engagement of KIU!, and explore any differences by demographics, within the context of a randomized controlled trial (RCT). METHODS Between May 2013 and December 2015, 445 participants were randomized into the intervention arm of the KIU! RCT. Data were taken from the baseline assessment, KIU! 2.0 intervention modules, and immediate post-test assessments of intervention acceptability and engagement. Outcomes of interests were qualitative and quantitative measures of intervention acceptability and engagement as well as process measures (i.e., star ratings of intervention content and paradata on time spent in intervention). RESULTS Participants were an average of 24 years old, 62.9% (280/445) identified as a racial or ethnic minority, 86.5% (385/445) identified as gay, and 84.3% (375/445) reported having at least some college education. Most participants rated the intervention content highly (4 out of 5 stars) and gave the intervention an average acceptability score of 3.5 out of 4. Compared to White participants, Black participants found the intervention more useful (p = .03), engaging (p < .001), and acceptable (p = .001); Latino participants found the intervention more engaging (p = .03); and “other” non-White participants found the intervention more engaging (p = .008) and acceptable (p = .02). Participants with high school or less education found the intervention more useful, engaging, and acceptable, and were more likely to give intervention content a five star rating than college educated participants (p-values = .047, <.001, .002, .01 respectively) or those with graduate degrees (p-values = .04, .001, < .001, .004 respectively). White participants showed the most variation between education levels and reporting positive attitudes towards the intervention. Among Black participants, graduate degree-earning participants spent significantly more time on the intervention than high-school or less educated participants (p = .02). CONCLUSIONS Overall, participants gave the intervention high acceptability and engagement ratings; but it was most acceptable and engaging to participants who were younger, identified as racial and ethnic minorities, had less education, and lived in the South. As these are all groups with greater burden of HIV infection, the KIU! intervention is promising as a primary HIV prevention tool. Future implementations of KIU! are needed to assess its acceptability outside of the highly controlled environment of an RCT. CLINICALTRIAL RCT# NCT01836445

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

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