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

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 A Theory-based mHealth Intervention for Methamphetamine-using MSM: Study Protocol for a Randomized Controlled Trial (Getting Off) (Preprint)

2020 ◽  
Author(s):  
Cathy J Reback ◽  
Jesse B Fletcher ◽  
Raymond P Mata
Keyword(s):  
Public Health ◽  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
Mobile App ◽  
Repeated Measures Design ◽  
Historical Comparison ◽  
Randomized Controlled ◽  
Cross Platform ◽  
The Impact

BACKGROUND Methamphetamine (meth) use among men who have sex with men (MSM) is associated with increased rates of HIV prevalence and transmission, as well as substandard advancement along the HIV Prevention and Care Continua. Meth use among MSM is deeply integrated into socio-sexual networks including the use of smartphone applications (“app”) and websites to find sexual partners. Given the growth of mobile health (mHealth) technology, it is no longer necessary or reasonable to limit meth treatment options to physical sites, clustered in urban areas, and administered using generic, non-tailored content. OBJECTIVE In a two-arm randomized controlled trial (N=300), Getting Off will assess the impact and non-inferiority of a cross-platform app (developed from an established manualized Getting Off meth treatment intervention) to help MSM (18 to 65 years) reduce or eliminate meth use and HIV sexual risk behaviors, and increase advancement along the HIV Prevention or Care Continuum including uptake of HIV testing, pre-, and post-exposure prophylaxis [PEP/PrEP] and PrEP adherence and persistence for those who are HIV negative; ART uptake and adherence for those who are HIV positive. METHODS Participants will be randomized into one of two arms: Arm A: Immediate access to the Getting Off app (Immediate Delivery [ID]: n=150); or Arm B: Participants will have access to the Getting Off app after a delayed 30-day period (Delayed Delivery [DD]: n=150). Participants in both arms will receive the same Getting Off app and participants in both arms will be given 30-days to complete the 24 sessions. The randomized two-arm repeated measures design will assess participants at 1-, 2- (DD arm only), 3-, 6-, and 9-months post-randomization to determine longitudinal intervention effects, overserved treatment effects, and a historical comparison with a matched sample of participants (n=600) who have attended 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, four separate focus groups (N=36) were conducted to provide input on the adaptation of the Getting Off group-based manual to a cross-platform computerized mobile app. The data collection for Phase 2, the randomized controlled trial, is expected to be completed in January 2023. Final results are anticipated for April 2023. CONCLUSIONS By creating a culturally responsive, cross-platform computerized mobile app, Getting Off aims to reduce methamphetamine use and improve sexual health outcomes among meth-using MSM. Given the severe personal and public health consequences of meth use, 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 and other high-risk populations. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT03884946 https://clinicaltrials.gov/ct2/show/NCT03884946

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

scholarly journals The Development and Testing of a Relationship Skills Intervention to Improve HIV Prevention Uptake Among Young Gay, Bisexual, and Other Men Who Have Sex With Men and Their Primary Partners (We Prevent): Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Kristi E Gamarel ◽  
Lynae A Darbes ◽  
Lisa Hightow-Weidman ◽  
Patrick Sullivan ◽  
Rob Stephenson
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Hiv Testing ◽  
Communication Skills ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Relationship Skills ◽  
Randomized Controlled ◽  
Sex With Men ◽  
Prevention Plan

BACKGROUND Young gay, bisexual, and other men who have sex with men (YMSM) continue to be the group most heavily impacted by HIV in the United States. Substantial evidence indicates that up to two-thirds of new HIV infections occur in the context of a main partnership. Couples HIV testing and counseling (CHTC) has been shown to be a promising and effective strategy for increasing HIV prevention uptake among male couples; however, YMSM who are new to relationships may not have yet developed the efficacy, negotiation, and communication skills to navigate HIV testing in their relationship and communicate around developing a prevention plan. OBJECTIVE This study aims to develop and test a relationship skills–focused HIV prevention intervention for YMSM and their partners. The intervention consists of two telehealth-delivered sessions: the first focuses on relationship skills and the second consists of CHTC and prevention planning. Both sessions are attended by both members of the dyad. METHODS This protocol describes the development of the proposed intervention (We Prevent) and pilot test to examine its feasibility and preliminary efficacy. The intervention will include two motivational interviewing–based sessions: session one is a relationship skills–building session, focused on techniques to explore and build communication skills in a relationship, to help YMSM develop and enhance necessary skills for their current and future relationships; the second session is a CHTC session with YMSM and their partners, to help them develop an HIV prevention plan. Through qualitative data collection and a one-arm pilot with YMSM, we will develop and refine a developmentally appropriate relationship skills session as an addition to the current CHTC intervention. We will then conduct a pilot randomized controlled trial (RCT), comparing the acceptability, feasibility, and preliminary efficacy of the adapted two-session telehealth intervention for YMSM versus a control group receiving one session only—a CHTC session delivered via telehealth. RESULTS The We Prevent intervention is designed to increase uptake of HIV prevention, shown through self-reported reductions in condomless sex and increases in knowledge and uptake of pre-exposure prophylaxis. In addition, the intervention is designed to increase HIV and sexually transmitted infection (STI) testing. STI incidence is examined as a secondary outcome. A cost-input analysis will examine the costs associated with intervention delivery to inform future scale-up of the intervention. CONCLUSIONS Drawing on theory and existing CHTC protocols delivered with video-based counseling, this proposed intervention affords the opportunity to empower YMSM with the skills necessary to communicate with their partners and protect themselves from HIV in their current and future relationships. CLINICALTRIAL Clinicaltrials.gov NCT03551938; https://clinicaltrials.gov/ct2/show/NCT03551938 (Archived by WebCite at http://www.webcitation.org/73omJCz1a) INTERNATIONAL REGISTERED REPOR RR1-10.2196/10370

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