Evaluation of a Text Messaging-Based Human Papillomavirus Vaccination Intervention for Young Sexual Minority Men: Results from a Pilot Randomized Controlled Trial.

BACKGROUND: Men who have sex with men (MSM) are at high risk for human papillomavirus (HPV) infection and HPV-related anal cancer. Although a safe and effective vaccine is available to prevent HPV infection, HPV vaccine uptake among young MSM remains low. PURPOSE: This pilot randomized controlled trial tested the acceptability, feasibility, and preliminary efficacy of a text messaging-based HPV vaccination intervention for young sexual minority men. METHODS: In 2018, unvaccinated sexual minority men aged 18-25 years were recruited from Chicago to participate in a 9 month sexual health program called txt2protect. Participants (N = 150) were randomized to the intervention or control condition. Intervention condition messages focused primarily on HPV vaccination, with only a brief mention of other sexual health practices (e.g., condom use and HIV testing), while control condition messages focused on a variety of sexual health practices with only a brief mention of HPV vaccination. Participants received daily text messages for the first 3 weeks and monthly text messages for the remaining ~8 months of the trial. Participants completed surveys at baseline and 3 week and 9 month follow-ups. RESULTS: Participants reported high satisfaction with the intervention. Although trial retention was high (with over 88% completing the 9 month survey), the study fell short of meeting its recruitment goal. HPV vaccine series initiation was significantly higher among intervention participants (19.4%) compared to control participants (6.6%), odds ratio = 3.43, 95% confidence interval: 1.17, 10.08. CONCLUSIONS: Findings suggest that txt2protect is an acceptable and potentially promising intervention for increasing HPV vaccine initiation among young sexual minority men. CLINICAL TRIAL REGISTRATION: NCT02994108.

The CAN-DO-IT Model: a Process for Developing and Refining Online Recruitment in HIV/AIDS and Sexual Health Research.

PURPOSE OF REVIEW: HIV/AIDS and sexual health research has increasingly relied on online recruitment in recent years. However, as potential online recruitment avenues (e.g., dating and sexual networking applications, websites, social media) have proliferated, navigating this process has become increasingly complex. This paper presents a practical model to guide researchers through online recruitment irrespective of platform. RECENT FINDINGS: The CAN-DO-IT model reflects 7 iterative steps based on work by the authors and other investigators: conceptualize scope of recruitment campaign, acquire necessary expertise, navigate online platforms, develop advertisements, optimize recruitment-to-enrollment workflow, implement advertising campaign, and track performance of campaigns and respond accordingly. Online recruitment can accelerate HIV/AIDS research, yet relatively limited guidance exists to facilitate this process across platforms. The CAN-DO-IT model presents one approach to demystify online recruitment and reduce enrollment barriers.

Attrition and HIV Risk Behaviors: A Comparison of Young Men Who Have Sex with Men Recruited from Online and Offline Venues for an Online HIV Prevention Program.

In addition to offline venue-based and time-space sampling, recruitment of young men who have sex with men (YMSM) into HIV surveillance and prevention studies has expanded over time to include Internet-based approaches. Despite broadening recruitment strategies, enrolling racially and ethnically diverse YMSM who are disproportionately impacted by HIV continues to be challenging. Additionally, there is little literature on the impact of recruitment venue on participant characteristics and likelihood to enroll YMSM into online randomized control trials (RCT). This study used data from the multisite RCT, Keep It Up! 2.0, to examine the impact of recruitment venue on participant demographics, behavioral HIV risks, and enrollment. A total of 2984 participants were screened for eligibility from community-based organizations, Facebook, dating apps, and outreach events. There were significant differences by venue in age (χ2[3] = 54.38, p < .001), race/ethnicity (χ2[9] = 110.78, p < .001), sexual orientation (χ2[3] = 7.85, p < .05), relationship status (χ2[6] = 27.71, p < .001), and region of recruitment (χ2[6] = 1480.51, p < .001). There were no significant differences by venue in attrition during the enrollment process. The only difference in attrition was by race/ethnicity. Compared to White participants, eligible Black (OR: 0.35, p < .01) and Latino (OR: 0.46, p < .05) participants were significantly less likely to enroll in the intervention. There were also no significant differences by recruitment venue in sexual risk behaviors among enrolled participants. These findings suggest that recruitment into online HIV interventions from a variety of venues is feasible for diverse YMSM who are at similar risk for HIV infection.

Prevalence and Risk Factors for Rectal and Urethral Sexually Transmitted Infections From Self-Collected Samples Among Young Men Who Have Sex With Men Participating in the Keep It Up! 2.0 Randomized Controlled Trial.

BACKGROUND: Despite recommendations that sexually active men who have sex with men be regularly tested for sexually transmitted infections (STIs) and that testing reflect anatomical sites of potential exposure, regular testing is not widely performed, especially for rectal STIs. As such, little is known about the prevalence of rectal and urethral STIs among young men who have sex with men (YMSM). METHODS: The current study examined the prevalence and risk factors for rectal and urethral chlamydia and gonorrhea in a sample of 1113 YMSM ages 18 to 29 years (mean, 24.07 years). Before participating in a randomized controlled trial for an online human immunodeficiency virus prevention program (Keep It Up! 2.0), participants completed self-report measures and self-collected urine and rectal samples. Participants mailed samples to a laboratory for nucleic acid amplification testing. Viability of self-collected samples was examined as a potential method to increase STI screening for MSM without access to STI testing clinics. RESULTS: Results indicated that 15.1% of participants tested positive for an STI, 13.0% for a rectal STI, 3.4% for a urethral STI, and 1.2% for both rectal and urethral STIs. Rectal chlamydia was significantly more common (8.8%) than rectal gonorrhea (5.0%). Rectal STIs were higher among black YMSM compared with white YMSM. Additionally, rectal STIs were positively associated with condomless receptive anal sex with casual partners. CONCLUSIONS: Findings call attention to the need for health care providers to test YMSM for rectal STIs. This study also demonstrates the viability of including self-collected samples for STI testing in an eHealth program.

Exploring Patterns of Awareness and Use of HIV Pre-Exposure Prophylaxis Among Young Men Who Have Sex with Men.

Pre-exposure prophylaxis (PrEP) has shown promise as a safe and effective HIV prevention strategy, but there is limited research on awareness and use among young men who have sex with men (YMSM). Using baseline data from the "Keep It Up! 2.0" randomized control trial, we examined differences in PrEP awareness and use among racially diverse YMSM (N = 759; mean age = 24.2 years). Participants were recruited from study sites in Atlanta, Chicago, and New York City, as well as through national advertising on social media applications. While 67.5 % of participants reported awareness of PrEP, 8.7 % indicated using the medication. Awareness, but not use, varied by demographic variables. PrEP-users had twice as many condomless anal sex partners (ERR = 2.05) and more condomless anal sex acts (ERR = 1.60) than non-users. Future research should aim to improve PrEP awareness and uptake among YMSM and address condom use.

Predictors of Human Papillomavirus Vaccination Among Young Men Who Have Sex With Men.

BACKGROUND: Human papillomavirus (HPV) is a common sexually transmitted infection that causes anal, penile, and oropharyngeal cancers in men. Men who have sex with men (MSM) are at particularly high risk for HPV infection and HPV-related disease. Human papillomavirus vaccination is currently recommended for all MSM in the United States through age 26 years, yet little is known about HPV vaccine uptake in this population. The purpose of this study was to identify predictors of HPV vaccine uptake and barriers and facilitators to HPV vaccination that may be unique to young MSM. METHODS: Men aged 18 to 26 years (n = 336) were recruited via advertisements placed on a geospatial smartphone dating application designed for MSM. Participants completed an online survey. Correlates of vaccine uptake and provider recommendation for HPV vaccine were identified using logistic regression. RESULTS: In total, 21% of participants had received at least 1 dose of HPV vaccine. Provider recommendation was the strongest predictor of uptake such that MSM with a recommendation were more than 40 times more likely to have been vaccinated. Additional predictors of uptake included age and HPV vaccine attitudes. Predictors of provider recommendation included sexual identity, race/ethnicity, condomless anal sex, and HIV status. Psychosocial correlates and barriers and facilitators to HPV vaccination among unvaccinated men were also identified. CONCLUSIONS: Findings highlight potential disparities in HPV vaccine uptake, as well as disparities in provider recommendation practices for HPV vaccination. Future interventions should aim to clarify misconceptions, modify psychosocial beliefs, and address barriers and facilitators to HPV vaccine uptake specific to young MSM.

Keep It Up! 3.0: Study protocol for a type III hybrid implementation-effectiveness cluster-randomized trial.

BACKGROUND: Despite evidence that eHealth approaches can be effective in reducing HIV risk, their implementation requirements for public health scale up are not well established, and effective strategies to bring these programs into practice are still unknown. Keep It Up! (KIU!) is an online program proven to reduce HIV risk among young men who have sex with men (YMSM) and ideal candidate to develop and evaluate novel strategies for implementing eHealth HIV prevention programs. KIU! 3.0 is a Type III Hybrid Effectiveness-Implementation cluster randomized trial designed to 1) compare two strategies for implementing KIU!: community-based organizations (CBO) versus centralized direct-to-consumer (DTC) recruitment; 2) examine the effect of strategies and determinants on variability in implementation success; and 3) develop materials for sustainment of KIU! after the trial concludes. In this article, we describe the approaches used to achieve these aims. METHODS: Using county-level population estimates of YMSM, 66 counties were selected and randomized 2:1 to the CBO and DTC approaches. The RE-AIM model was used to drive outcome measurements, which were collected from CBO staff, YMSM, and technology providers. Mixed-methods research mapped onto the domains of the Consolidated Framework for Implementation Research will examine determinants and their relationship with implementation outcomes. DISCUSSION: In comparing our implementation recruitment models, we are examining two strategies which have shown effectiveness in delivering health technology interventions in the past, yet little is known about their comparative advantages and disadvantages in implementation. The results of the trial will further the understanding of eHealth prevention intervention implementation.

Geographic disparities in COVID-19 case rates are not reflected in seropositivity rates using a neighborhood survey in Chicago.

To date, COVID-19 case rates are disproportionately higher in Black and Latinx communities across the US, leading to more hospitalizations, and deaths in those communities. These differences in case rates are evident in comparisons of Chicago neighborhoods with differing race and/or ethnicities of their residents. Disparities could be due to neighborhoods with more adverse health outcomes associated with poverty and other social determinants of health experiencing higher prevalence of SARS-CoV-2 infection or due to greater morbidity and mortality resulting from equivalent SARS-CoV-2 infection prevalence. We surveyed five pairs of adjacent ZIP codes in Chicago with disparate COVID-19 case rates for highly specific and quantitative serologic evidence of any prior infection by SARS-CoV-2 to compare with their disparate COVID-19 case rates. Dried blood spot samples were self-collected at home by internet-recruited participants in summer 2020, shortly after Chicago's first wave of the COVID-19 pandemic. Pairs of neighboring ZIP codes with very different COVID-19 case rates had similar seropositivity rates for anti-SARS-CoV-2 receptor binding domain IgG antibodies. Overall, these findings of comparable exposure to SARS-CoV-2 across neighborhoods with very disparate COVID-19 case rates are consistent with social determinants of health, and the co-morbidities related to them, driving differences in COVID-19 rates across neighborhoods.

Development and feasibility of a Configurable Assessment Messaging Platform for Interventions (CAMPI).

INTRODUCTION: Short message service (SMS) is a widely accepted telecommunications approach used to support health informatics, including behavioral interventions, data collection, and patient-provider communication. However, SMS delivery platforms are not standardized and platforms are typically commercial "off-the-shelf" or developed "in-house." As a consequence of platform variability, implementing SMS-based interventions may be challenging for both providers and patients. Off-the-shelf SMS delivery platforms may require minimal development or technical resources from providers, but users are often limited in their functionality. Conversely, platforms that are developed in-house are often specified for individual projects, requiring specialized development and technical expertise. Patients are on the receiving end of programming and technical specification challenges; message delays or lagged data affect quality of SMS communications. To date, little work has been done to develop a generalizable SMS platform that can be scaled across health initiatives. OBJECTIVE: We propose the Configurable Assessment Messaging Platform for Interventions (CAMPI) to mitigate challenges associated with SMS intervention implementation (e.g., programming, data collection, message delivery). METHOD: CAMPI aims to optimize health data captured from a multitude of sources and enhance patient-provider communication through a technology that is simple and familiar to patients. Using representative examples from three behavioral intervention case studies implemented among diverse populations (pregnant women, young sexual minority men, and parents with young children), we describe CAMPI capabilities and feasibility. CONCLUSION: As a generalizable SMS platform, CAMPI can be scaled to meet the priorities of various health initiatives, while reducing unnecessary resource utilization and burden on providers and patients. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Measuring Acceptability and Engagement of The Keep It Up! Internet-Based HIV Prevention Randomized Controlled Trial for Young Men Who Have Sex With Men.

HIV disproportionately impacts young men of color who have sex with men. Keep It Up! (KIU!) is an online intervention that addresses the needs of this population. The study objective was to examine intervention acceptability and engagement. Outcomes of interests were qualitative and quantitative acceptability and engagement measures, content ratings, and paradata. On average, participants rated content (4 out of 5 stars) and acceptability (3.5 out of 4) highly. Compared to White participants, Black participants found KIU! more useful, engaging, and acceptable; Latino participants found KIU! more engaging; and other non-White participants found KIU! more engaging and acceptable. Participants with high school or less education found KIU! more useful, engaging, acceptable, and deserving of five stars than college graduates (p values = .047, <.001, .002, .01) and graduate degree holders (p values = .04, .001, <.001, .004). KIU! is a promising prevention tool for highest risk populations.

A Qualitative Analysis of Young Sexual Minority Men's Perspectives on Human Papillomavirus Vaccination.

Purpose: Men who have sex with men (MSM) are affected disproportionately by cancers caused by human papillomavirus (HPV). A safe and effective vaccine is available to prevent HPV infection, yet rates of HPV vaccination among young MSM are low. Guided by the Information, Motivation, and Behavioral Skills model, the purpose of this study was to identify young sexual minority men's perspectives on HPV vaccination. Methods: Men (N = 29) 18-26 years of age, who identified as gay, bisexual, or queer, completed a semistructured interview. Vaccinated (n = 9) and unvaccinated men (n = 20) were interviewed. The interview assessed knowledge, motivation, and behavioral skills related to HPV vaccination as well as relevant contextual factors (e.g., provider recommendation). Interviews were coded for recurring themes. Results: Most participants were aware of HPV and the HPV vaccine; however, misconceptions and knowledge gaps were common with many believing that HPV vaccination was only for women. Motivational factors included perceived advantages (e.g., reducing risk of HPV-related disease) and disadvantages (e.g., stigma) of HPV vaccination, perceived threat of HPV-related disease, and subjective norms for HPV vaccination. Relevant behavioral skills included disclosure of sexual orientation and comfort discussing HPV vaccination. Concerns about vaccine cost, access, and convenience were salient barriers to initiating and completing the series. Encouragement from a health care provider was cited as the primary reason for receiving the HPV vaccine. Conclusion: When developing interventions to increase HPV vaccination among young sexual minority men, it is important to address facilitators and barriers that reflect the unique needs of this population.

Biomedical and Behavioral Outcomes of Keep It Up!: An eHealth HIV Prevention Program RCT.

INTRODUCTION: HIV diagnoses among young men who have sex with men are increasing, but few effective HIV prevention interventions exist for this population. An RCT was conducted of the online Keep It Up! intervention to determine if it significantly reduced condomless anal sex and sexually transmitted infections compared with an HIV knowledge condition. STUDY DESIGN: From May 2013 to March 2017, a total of 901 participants were enrolled in a double-blinded RCT of Keep It Up! with 1-year follow-up. After completing baseline surveys and sexually transmitted infection testing, participants were randomized by an eHealth platform to the intervention or control condition. SETTING/PARTICIPANTS: HIV-negative men who have sex with men reporting condomless anal sex, aged 18-29 years, were recruited through advertising and from HIV testing sites and outreach in Atlanta, Georgia; Chicago, Illinois; and New York, New York. INTERVENTION: Multimedia was used to address HIV knowledge and motivate safer behaviors. The control condition reflected existing online HIV information. MAIN OUTCOME MEASURES: Primary outcomes were incident gonorrhea or chlamydia at 12-month follow-up and self-reported condomless anal sex with casual partners at 3-, 6-, and 12-month follow-up. RESULTS: In 2017, data were analyzed from 445 (49%) participants randomized to the intervention and 456 (51%) to the control. Participants were primarily racial/ethnic minorities (63%). Sexually transmitted infections at Month 12 was 40% lower for intervention participants (risk ratio=0.60, 95% CI=0.38, 0.95, p=0.01). For the primary behavioral outcome, both arms showed reductions over time with 44% of control and 37% of intervention participants reporting condomless anal sex at Month 12 (prevalence ratio=0.83, 95% CI=0.70, 0.99, p=0.04). CONCLUSIONS: The Keep It Up! intervention resulted in significantly lower sexually transmitted infection incidence and a small but significant decrease in condomless anal sex 12 months post-intervention relative to an online HIV knowledge condition. In addition, this study demonstrated the feasibility and acceptability of at-home sexually transmitted infection testing as part of an eHealth intervention. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01836445.

Internet-Based HIV Prevention With At-Home Sexually Transmitted Infection Testing for Young Men Having Sex With Men: Study Protocol of a Randomized Controlled Trial of Keep It Up! 2.0.

BACKGROUND: Human immunodeficiency virus (HIV) infections are increasing among young men who have sex with men (YMSM), yet few HIV prevention programs have studied this population. Keep It Up! (KIU!), an online HIV prevention program tailored to diverse YMSM, was developed to fill this gap. The KIU! 2.0 randomized controlled trial (RCT) was launched to establish intervention efficacy. OBJECTIVE: The objective of the KIU! study is to advance scientific knowledge of technology-based behavioral HIV prevention, as well as improve public health by establishing the efficacy of an innovative electronic health (eHealth) prevention program for ethnically and racially diverse YMSM. The intervention is initiated upon receipt of a negative HIV test result, based on the theory that testing negative is a teachable moment for future prevention behaviors. METHODS: This is a two-group, active-control RCT of the online KIU! intervention. The intervention condition includes modules that use videos, animation, games, and interactive exercises to address HIV knowledge, motivation for safer behaviors, self-efficacy, and behavioral skills. The control condition reflects HIV information that is readily available on many websites, with the aim to understand how the KIU! intervention improves upon information that is currently available online. Follow-up assessments are administered at 3, 6, and 12 months for each arm. Testing for urethral and rectal sexually transmitted infections (STIs) is completed at baseline and at 12-month follow-up for all participants, and at 3- and 6-month follow-ups for participants who test positive at baseline. The primary behavioral outcome is unprotected anal sex at all follow-up points, and the primary biomedical outcome is incident STIs at 12-month follow-up. RESULTS: Consistent with study aims, the KIU! technology has been successfully integrated into a widely-used health technology platform. Baseline enrollment for the RCT was completed on December 30, 2015 (N=901), and assessment of intervention outcomes is ongoing at 3-, 6-, and 12-month time points. Upon collection of all data, and after the efficacy of the intervention has been evaluated, we will explore whether the KIU! intervention has differential efficacy across subgroups of YMSM based on ethnicity/race and relationship status. CONCLUSIONS: Our approach is innovative in linking an eHealth solution to HIV and STI home testing, as well as serving as a model for integrating scalable behavioral prevention into other biomedical prevention strategies. TRIAL REGISTRATION: Clinicaltrials.gov NCT01836445; https://clinicaltrials.gov/ct2/show/NCT01836445 (Archived by WebCite at http://www.webcitation.org/6myMFlxnC).

Implementation and Evaluation of the Keep It Up! Online HIV Prevention Intervention in a Community-Based Setting.

Once HIV prevention programs have proven efficacy in research settings, it is important that ongoing data are collected to demonstrate effects in public health applications, yet such evaluations are rare in the published literature. This project describes the adaptation, implementation, and outcome evaluation of the Keep It Up! (KIU!) online HIV prevention intervention as a prevention service delivered in a community-based organization. Compared to pilot research examining KIU! feasibility and efficacy, intervention outcomes were robust to service delivery and client characteristics. In a sample of ethnically and racially diverse young men who have sex with men (N = 343), the intervention produced significant decreases in condomless anal sex acts with casual male partners at the 3-month follow-up compared to baseline (p < .05). In both qualitative and quantitative measures, participants reported that the intervention was highly acceptable and valuable to their sexual health needs.

Intimate Strangers? Social Networks in HIV Prevention Groups for Drug Users.

Group substance abuse treatment relies for its effectiveness on relationships formed within group sessions, but few studies have explored the importance of these relationships for group HIV prevention interventions for drug users. We survey the literature on group HIV prevention interventions, particularly for men of color, and analyze qualitative data from a pilot intervention for out-of-treatment, drug using men who have sex with men. We find that many participants were acquainted prior to the intervention, and formed relationships which they attempted (often unsuccessfully) to maintain after the intervention was over.