scholarly journals Evaluation of a Stepped-Care eHealth HIV Prevention Program for Diverse Adolescent Men Who Have Sex With Men: Protocol for a Hybrid Type 1 Effectiveness Implementation Trial of SMART

10.2196/19701 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e19701 ◽  
Author(s):  
Brian Mustanski ◽  
David A Moskowitz ◽  
Kevin O Moran ◽  
Michael E Newcomb ◽  
Kathryn Macapagal ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Randomized Trial ◽  
Race And Ethnicity ◽  
Stepped Care ◽  
Differential Effectiveness ◽  
Care Package ◽  
Care Approach ◽  
Condom Use Intentions ◽  
Sex With Men ◽  
The Impact

Background Adolescent men who have sex with men (AMSM), aged 13 to 18 years, account for more than 80% of teen HIV occurrences. Despite this disproportionate burden, there is a conspicuous lack of evidence-based HIV prevention programs. Implementation issues are critical as traditional HIV prevention delivery channels (eg, community-based organizations, schools) have significant access limitations for AMSM. As such, eHealth interventions, such as our proposed SMART program, represent an excellent modality for delivering AMSM-specific intervention material where youth are. Objective This randomized trial aimed to test the effectiveness of the SMART program in reducing condom-less anal sex and increasing condom self-efficacy, condom use intentions, and HIV testing for AMSM. We also plan to test whether SMART has differential effectiveness across important subgroups of AMSM based on race and ethnicity, urban versus rural residence, age, socioeconomic status, and participation in an English versus a Spanish version of SMART. Methods Using a sequential multiple assignment randomized trial design, we will evaluate the impact of a stepped-care package of increasingly intensive eHealth interventions (ie, the universal, information-based SMART Sex Ed; the more intensive, selective SMART Squad; and a higher cost, indicated SMART Sessions). All intervention content is available in English and Spanish. Participants are recruited primarily from social media sources using paid and unpaid advertisements. Results The trial has enrolled 1285 AMSM aged 13 to 18 years, with a target enrollment of 1878. Recruitment concluded in June 2020. Participants were recruited from 49 US states as well as Puerto Rico and the District of Columbia. Assessments of intervention outcomes at 3, 6, 9, and 12 months are ongoing. Conclusions SMART is the first web-based program for AMSM to take a stepped-care approach to sexual education and HIV prevention. This design indicates that SMART delivers resources to all adolescents, but more costly treatments (eg, video chat counseling in SMART Sessions) are conserved for individuals who need them the most. SMART has the potential to reach AMSM to provide them with a sex-positive curriculum that empowers them with the information, motivation, and skills to make better health choices. Trial Registration ClinicalTrials.gov Identifier NCT03511131; https://clinicaltrials.gov/ct2/show/NCT03511131 International Registered Report Identifier (IRRID) DERR1-10.2196/19701

Evaluation of a Stepped-Care eHealth HIV Prevention Program for Diverse Adolescent Men Who Have Sex With Men: Protocol for a Hybrid Type 1 Effectiveness Implementation Trial of SMART (Preprint)

2020 ◽  
Author(s):  
Brian Mustanski ◽  
David A Moskowitz ◽  
Kevin O Moran ◽  
Michael E Newcomb ◽  
Kathryn Macapagal ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Randomized Trial ◽  
Race And Ethnicity ◽  
Stepped Care ◽  
Differential Effectiveness ◽  
Care Package ◽  
Care Approach ◽  
Condom Use Intentions ◽  
Sex With Men ◽  
The Impact

BACKGROUND Adolescent men who have sex with men (AMSM), aged 13 to 18 years, account for more than 80% of teen HIV occurrences. Despite this disproportionate burden, there is a conspicuous lack of evidence-based HIV prevention programs. Implementation issues are critical as traditional HIV prevention delivery channels (eg, community-based organizations, schools) have significant access limitations for AMSM. As such, eHealth interventions, such as our proposed SMART program, represent an excellent modality for delivering AMSM-specific intervention material where youth <i>are</i>. OBJECTIVE This randomized trial aimed to test the effectiveness of the SMART program in reducing condom-less anal sex and increasing condom self-efficacy, condom use intentions, and HIV testing for AMSM. We also plan to test whether SMART has differential effectiveness across important subgroups of AMSM based on race and ethnicity, urban versus rural residence, age, socioeconomic status, and participation in an English versus a Spanish version of SMART. METHODS Using a sequential multiple assignment randomized trial design, we will evaluate the impact of a stepped-care package of increasingly intensive eHealth interventions (ie, the universal, information-based SMART Sex Ed; the more intensive, selective SMART Squad; and a higher cost, indicated SMART Sessions). All intervention content is available in English and Spanish. Participants are recruited primarily from social media sources using paid and unpaid advertisements. RESULTS The trial has enrolled 1285 AMSM aged 13 to 18 years, with a target enrollment of 1878. Recruitment concluded in June 2020. Participants were recruited from 49 US states as well as Puerto Rico and the District of Columbia. Assessments of intervention outcomes at 3, 6, 9, and 12 months are ongoing. CONCLUSIONS SMART is the first web-based program for AMSM to take a stepped-care approach to sexual education and HIV prevention. This design indicates that SMART delivers resources to all adolescents, but more costly treatments (eg, video chat counseling in SMART Sessions) are conserved for individuals who need them the most. SMART has the potential to reach AMSM to provide them with a sex-positive curriculum that empowers them with the information, motivation, and skills to make better health choices. CLINICALTRIAL ClinicalTrials.gov Identifier NCT03511131; https://clinicaltrials.gov/ct2/show/NCT03511131 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19701

scholarly journals Correction: The Impact of Implementing a Test, Treat and Retain HIV Prevention Strategy in Atlanta among Black Men Who Have Sex with Men with a History of Incarceration: A Mathematical Model

PLoS ONE ◽  
2015 ◽  
Vol 10 (5) ◽  
pp. e0128734 ◽  
Author(s):  
Viviane D. Lima ◽  
Isabell Graf ◽  
Curt G. Beckwith ◽  
Sandra Springer ◽  
Frederick L. Altice ◽  
...  
Keyword(s):  
Mathematical Model ◽  
Hiv Prevention ◽  
Black Men ◽  
Prevention Strategy ◽  
History Of ◽  
Sex With Men ◽  
The Impact

scholarly journals COVID-19 Misinformation Prophylaxis: Protocol for a Randomized Trial of a Brief Informational Intervention (Preprint)

2020 ◽  
Author(s):  
Jon Agley ◽  
Yunyu Xiao ◽  
Esi E Thompson ◽  
Lilian Golzarri-Arroyo
Keyword(s):  
United States ◽  
Randomized Trial ◽  
Race And Ethnicity ◽  
Face Mask ◽  
The United States ◽  
Placebo Control ◽  
Preventive Behaviors ◽  
Institutional Review ◽  
Superiority Trial ◽  
The Impact

BACKGROUND As the COVID-19 pandemic continues to affect life in the United States, the important role of nonpharmaceutical preventive behaviors (such as wearing a face mask) in reducing the risk of infection has become clear. During the pandemic, researchers have observed the rapid proliferation of misinformed or inconsistent narratives about COVID-19. There is growing evidence that such misinformed narratives are associated with various forms of undesirable behavior (eg, burning down cell towers). Furthermore, individuals’ adherence to recommended COVID-19 preventive guidelines has been inconsistent, and such mandates have engendered opposition and controversy. Recent research suggests the possibility that trust in science and scientists may be an important thread to weave throughout these seemingly disparate components of the modern public health landscape. Thus, this paper describes the protocol for a randomized trial of a brief, digital intervention designed to increase trust in science. OBJECTIVE The objective of this study is to examine whether exposure to a curated infographic can increase trust in science, reduce the believability of misinformed narratives, and increase the likelihood to engage in preventive behaviors. METHODS This is a randomized, placebo-controlled, superiority trial comprising 2 parallel groups. A sample of 1000 adults aged ≥18 years who are representative of the population of the United States by gender, race and ethnicity, and age will be randomly assigned (via a 1:1 allocation) to an intervention or a placebo-control arm. The intervention will be a digital infographic with content based on principles of trust in science, developed by a health communications expert. The intervention will then be both pretested and pilot-tested to determine its viability. Study outcomes will include trust in science, a COVID-19 narrative belief latent profile membership, and the likelihood to engage in preventive behaviors, which will be controlled by 8 theoretically selected covariates. RESULTS This study was funded in August 2020, approved by the Indiana University Institutional Review Board on September 15, 2020, and prospectively registered with ClinicalTrials.gov. CONCLUSIONS COVID-19 misinformation prophylaxis is crucial. This proposed experiment investigates the impact of a brief yet actionable intervention that can be easily disseminated to increase individuals’ trust in science, with the intention of affecting misinformation believability and, consequently, preventive behavioral intentions. CLINICALTRIAL ClinicalTrials.gov NCT04557241; https://clinicaltrials.gov/ct2/show/NCT04557241 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/24383

scholarly journals Title: Keep It Up! 3.0: Study Protocol for a Type III Hybrid Implementation-Effectiveness Cluster-Randomized Trial

2020 ◽  
Author(s):  
Brian Mustanski ◽  
Justin Patrick Jones ◽  
Kathryn Macapagal ◽  
Nanette Benbow ◽  
Dennis H. Li ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Randomized Trial ◽  
Young Men ◽  
Cluster Randomized Trial ◽  
The United States ◽  
Community Based ◽  
Direct To Consumer ◽  
Community Based Organization ◽  
Sex With Men ◽  
Cluster Randomized

Abstract BackgroundYoung men who have sex with men are disproportionately impacted by the HIV epidemic in the United States. Few rigorously tested HIV prevention interventions have been developed for young men who have sex with men; previous interventions have primarily focused on in-person programming, with high variability in fidelity. With nearly all young men who have sex with men going online daily, eHealth approaches to prevention may successfully bridge research and practice. Keep It Up! is an eHealth HIV Prevention program for young men who have sex with men. Previous research has demonstrated its effectiveness in reducing sexually transmitted infections and condomless anal sex and efficiency in delivering HIV prevention education. Aim 1 is to compare two strategies for implementing KIU—implementation in community-based organizations and a centralized direct-to-consumer recruitment arm. Aim 2 is to examine adoption characteristics which explain variability in implementation success. Our exploratory aim will develop recommendations and materials for sustainment of KIU after completion of the trial.MethodsThis is a Type III Hybrid Effectiveness-Implementation cluster randomized trial. Using estimates of young men who have sex with men per county in the United States, we identified 113 counties for our sample frame. Using an iterative process, we selected 66 counties to randomize 2:1 to our two strategies in Aim 1. The RE-AIM model for implementation science will be used to drive our outcome measurements in reach, effectiveness, implementation variability, and cost. Outcome measures will be collected from community-based organization staff participants, young men who have sex with men participants, and the technology provider. Our second aim will use mixed-methods research mapped onto the domains of the consolidated framework for implementation research. DiscussionThe trial has launched and is ongoing. This study is among the first to use a cluster randomized trial design in HIV implementation science. In comparing the community-based organization and direct to consumer models for recruitment and ongoing participant engagement, we are examining two strategies which have shown effectiveness in delivering health and technology interventions in the past, but with little base knowledge on their comparative advantages and disadvantages in implementation. The results of the trial will further understanding of the implementation of eHealth prevention interventions.Trial RegistrationNCT03896776, clinicaltrials.gov, 1 April 2019

scholarly journals Overly Optimistic Forecasts for the Impact of Treatment of HIV Prevention for Men Who Have Sex With Men

2011 ◽  
Vol 53 (6) ◽  
pp. 611-612 ◽  
Author(s):  
D. P. Wilson ◽  
A. E. Grulich ◽  
M. Boyd
Keyword(s):  
Hiv Prevention ◽  
Sex With Men ◽  
The Impact

scholarly journals COVID-19 Misinformation Prophylaxis: Protocol for a Randomized Trial of a Brief Informational Intervention

10.2196/24383 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e24383
Author(s):  
Jon Agley ◽  
Yunyu Xiao ◽  
Esi E Thompson ◽  
Lilian Golzarri-Arroyo
Keyword(s):  
United States ◽  
Randomized Trial ◽  
Race And Ethnicity ◽  
Face Mask ◽  
The United States ◽  
Placebo Control ◽  
Preventive Behaviors ◽  
Institutional Review ◽  
Superiority Trial ◽  
The Impact

Background As the COVID-19 pandemic continues to affect life in the United States, the important role of nonpharmaceutical preventive behaviors (such as wearing a face mask) in reducing the risk of infection has become clear. During the pandemic, researchers have observed the rapid proliferation of misinformed or inconsistent narratives about COVID-19. There is growing evidence that such misinformed narratives are associated with various forms of undesirable behavior (eg, burning down cell towers). Furthermore, individuals’ adherence to recommended COVID-19 preventive guidelines has been inconsistent, and such mandates have engendered opposition and controversy. Recent research suggests the possibility that trust in science and scientists may be an important thread to weave throughout these seemingly disparate components of the modern public health landscape. Thus, this paper describes the protocol for a randomized trial of a brief, digital intervention designed to increase trust in science. Objective The objective of this study is to examine whether exposure to a curated infographic can increase trust in science, reduce the believability of misinformed narratives, and increase the likelihood to engage in preventive behaviors. Methods This is a randomized, placebo-controlled, superiority trial comprising 2 parallel groups. A sample of 1000 adults aged ≥18 years who are representative of the population of the United States by gender, race and ethnicity, and age will be randomly assigned (via a 1:1 allocation) to an intervention or a placebo-control arm. The intervention will be a digital infographic with content based on principles of trust in science, developed by a health communications expert. The intervention will then be both pretested and pilot-tested to determine its viability. Study outcomes will include trust in science, a COVID-19 narrative belief latent profile membership, and the likelihood to engage in preventive behaviors, which will be controlled by 8 theoretically selected covariates. Results This study was funded in August 2020, approved by the Indiana University Institutional Review Board on September 15, 2020, and prospectively registered with ClinicalTrials.gov. Conclusions COVID-19 misinformation prophylaxis is crucial. This proposed experiment investigates the impact of a brief yet actionable intervention that can be easily disseminated to increase individuals’ trust in science, with the intention of affecting misinformation believability and, consequently, preventive behavioral intentions. Trial Registration ClinicalTrials.gov NCT04557241; https://clinicaltrials.gov/ct2/show/NCT04557241 International Registered Report Identifier (IRRID) PRR1-10.2196/24383

scholarly journals The Impact of Implementing a Test, Treat and Retain HIV Prevention Strategy in Atlanta among Black Men Who Have Sex with Men with a History of Incarceration: A Mathematical Model

PLoS ONE ◽  
2015 ◽  
Vol 10 (4) ◽  
pp. e0123482 ◽  
Author(s):  
Viviane D. Lima ◽  
Isabell Graf ◽  
Curt G. Beckwith ◽  
Sandra Springer ◽  
Frederick L. Altice ◽  
...  
Keyword(s):  
Mathematical Model ◽  
Hiv Prevention ◽  
Black Men ◽  
Prevention Strategy ◽  
History Of ◽  
Sex With Men ◽  
The Impact
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