Cumulative Incidence of SARS-CoV-2 Infections Among Adults in Georgia, United States, August to December 2020.

BACKGROUND: Reported coronavirus disease 2019 (COVID-19) cases underestimate true severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. Data on all infections, including asymptomatic infections, are needed. To minimize biases in estimates from reported cases and seroprevalence surveys, we conducted a household-based probability survey and estimated cumulative incidence of SARS-CoV-2 infections adjusted for antibody waning. METHODS: From August to December 2020, we mailed specimen collection kits (nasal swabs and blood spots) to a random sample of Georgia addresses. One household adult completed a survey and returned specimens for virus and antibody testing. We estimated cumulative incidence of SARS-CoV-2 infections adjusted for waning antibodies, reported fraction, and infection fatality ratio (IFR). Differences in seropositivity among demographic, geographic, and clinical subgroups were explored with weighted prevalence ratios (PR). RESULTS: Among 1370 participants, adjusted cumulative incidence of SARS-CoV-2 was 16.1% (95% credible interval [CrI], 13.5%-19.2%) as of 16 November 2020. The reported fraction was 26.6% and IFR was 0.78%. Non-Hispanic black (PR, 2.03; 95% confidence interval [CI], 1.0-4.1) and Hispanic adults (PR, 1.98; 95% CI, .74-5.31) were more likely than non-Hispanic white adults to be seropositive. CONCLUSIONS: As of mid-November 2020, 1 in 6 adults in Georgia had been infected with SARS-CoV-2. The COVID-19 epidemic in Georgia is likely substantially underestimated by reported cases.

Severe Acute Respiratory Syndrome Coronavirus 2 Cumulative Incidence, United States, August 2020-December 2020.

BACKGROUND: Reported coronavirus disease 2019 (COVID-19) cases underestimate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. We conducted a national probability survey of US households to estimate cumulative incidence adjusted for antibody waning. METHODS: From August-December 2020 a random sample of US addresses were mailed a survey and self-collected nasal swabs and dried blood spot cards. One adult household member completed the survey and mail specimens for viral detection and total (immunoglobulin [Ig] A, IgM, IgG) nucleocapsid antibody by a commercial, emergency use authorization-approved antigen capture assay. We estimated cumulative incidence of SARS-CoV-2 adjusted for waning antibodies and calculated reported fraction (RF) and infection fatality ratio (IFR). Differences in seropositivity among demographic, geographic, and clinical subgroups were explored. RESULTS: Among 39 500 sampled households, 4654 respondents provided responses. Cumulative incidence adjusted for waning was 11.9% (95% credible interval [CrI], 10.5%-13.5%) as of 30 October 2020. We estimated 30 332 842 (CrI, 26 703 753-34 335 338) total infections in the US adult population by 30 October 2020. RF was 22.3% and IFR was 0.85% among adults. Black non-Hispanics (Prevalence ratio (PR) 2.2) and Hispanics (PR, 3.1) were more likely than White non-Hispanics to be seropositive. CONCLUSIONS: One in 8 US adults had been infected with SARS-CoV-2 by October 2020; however, few had been accounted for in public health reporting. The COVID-19 pandemic is likely substantially underestimated by reported cases. Disparities in COVID-19 by race observed among reported cases cannot be attributed to differential diagnosis or reporting of infections in population subgroups.

What will it take to meet UNAIDS targets for preexposure prophylaxis users?

PURPOSE OF REVIEW: Preexposure prophylaxis (PrEP) is a critical strategy to curb new HIV infections globally. National and global targets have been set for people starting PrEP. However, global PrEP initiations fell short of UNAIDS 2020 targets, and reflection is needed on how we set and meet targets for PrEP use. RECENT FINDINGS: Recent literature documents challenges to meeting ambitious goals for PrEP coverage in multiple phases of PrEP: PrEP initiations are limited by gaps in the identification of those who might benefit from PrEP. Conversely, getting PrEP to those who need it most is threatened by inaccurate risk perception and HIV and PrEP stigma. Once people are on PrEP, a substantial number discontinue PrEP in the first year (the 'PrEP Cliff'), a finding that is robust across groups of PrEP users (e.g., women, men who have sex with men, transwomen) and across global prevention settings. Further, PrEP inequities - by which we refer to utilization of PrEP in a specific group that is not commensurate with their epidemic risk - threaten the overall population benefit of PrEP because those at highest risk of acquiring HIV are not adequately protected. SUMMARY: To realize global goals for PrEP utilization and impact, we must address multiple points of PrEP delivery programs that address not just PrEP starts, but also retention in PrEP and measurement and accountability to PrEP equity. We call for new approaches to better identify PrEP candidates, suggest additional research to address the known and consistent reasons for PrEP discontinuations, and advocate for metrics to measure and be accountable to PrEP equity.

Cross-sectional assessment of determinants of STIs among men who have sex with men and transgender women in Kigali, Rwanda.

BACKGROUND: STIs among men who have sex with men (MSM) and transgender women (TGW) continue to increase. In Rwanda, STI management relies on syndromic management with limited empirical data characterising the burden of specific STIs among MSM/TGW. This study evaluated the prevalence of syphilis, Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) and associated factors among MSM/TGW in Kigali. METHODS: From March to August 2018, 737 MSM/TGW >18 years were enrolled using respondent-driven sampling (RDS). Structured interviews and HIV/STI screening were conducted. Syphilis was screened with rapid plasma reagin confirmed by Treponema pallidum hemagglutination assay. CT/NG were tested by Cepheid GeneXpert. RDS-adjusted multivariable Poisson regression models with robust variance estimation were used to evaluate factors associated with any STI, and determinants of urethral and rectal STIs separately. RESULTS: Prevalence of any STI was 20% (RDS adjusted: 16.7% (95% CI: 13.2% to 20.2%)). Syphilis was 5.7% (RDS adjusted: 6.8% (95% CI: 4.3% to 9.4%)). CT was 9.1% (RDS adjusted: 6.1% (95% CI: 3.9% to 8.4%)) and NG was 8.8% (RDS adjusted: 7.1% (95% CI: 4.9% to 9.2%)). STIs were more common among older MSM and those with HIV (p<0.05). Of CT infections, 67% were urethral, 27% rectal and 6% were dual site. For NG infections, 52% were rectal, 29% urethral and 19% were dual site. Overall, 25.8% (23 of 89) of those with confirmed STI and returned for their results were symptomatic at time of testing.STI symptoms in the previous year (adjusted prevalence ratio (aPR): 1.94 (95% CI: 1.26 to 2.98)) were positively associated with any STI. Being circumcised was negatively associated with any STI (aPR: 0.47 (95% CI: 0.31 to 0.73)). HIV was positively associated with rectal STIs (aPR: 3.50 (95% CI: 1.09 to 11.21)) but negatively associated with urethral STIs. CONCLUSION: MSM/TGW, especially those living with HIV, are at high risk of STIs in Rwanda with the vast majority being asymptomatic. These data suggest the potential utility of active STI surveillance strategies using highly sensitive laboratory methods among those at high risk given the anatomical distribution and limited symptomatology of STIs observed among Rwandan MSM/TGW.

Behavioral Efficacy of a Sexual Health Mobile App for Men Who Have Sex With Men: Randomized Controlled Trial of Mobile Messaging for Men.

BACKGROUND: Gay, bisexual, and other men who have sex with men (GBMSM) face the highest burden of HIV in the United States, and there is a paucity of efficacious mobile health (mHealth) HIV prevention and care interventions tailored specifically for GBMSM. We tested a mobile app combining prevention messages and access to core prevention services for GBMSM. OBJECTIVE: This study aims to measure the efficacy of the Mobile Messaging for Men (M-cubed) app and related services to increase HIV prevention and care behaviors in diverse US GBMSM. METHODS: We conducted a randomized open-label study with a waitlist control group among GBMSM in 3 groups (low-risk HIV-negative group, high-risk HIV-negative group, and living-with-HIV [LWH] group) recruited online and in venues in Atlanta, Detroit, and New York City. Participants were randomly assigned to receive access to the app immediately or at 9 months after randomization. The app provided prevention messages in 6 domains of sexual health and offered ordering of at-home HIV and sexually transmitted infection test kits, receiving preexposure prophylaxis (PrEP) evaluations and navigation, and service locators. Serostatus- and risk-specific prevention outcomes were evaluated at baseline, at the end of the intervention period, and at 3, 6, and 9 months after the intervention period. RESULTS: In total, 1226 GBMSM were enrolled and randomized; of these 611 (49.84%) were assigned to the intervention group and 608 (99.51%) were analyzed, while 615 (50.16%) were assigned to the control group and 612 (99.51%) were analyzed. For high-risk GBMSM, allocation to the intervention arm was associated with higher odds of HIV testing during the intervention period (adjusted odds ratio [aOR] 2.02, 95% CI 1.11-3.66) and with higher odds of using PrEP in the 3 months after the intervention period (aOR 2.41, 95% CI 1.00-5.76, P<.05). No changes in HIV prevention or care were associated with allocation to the intervention arm for the low-risk HIV-negative and LWH groups. CONCLUSIONS: Access to the M-cubed app was associated with increased HIV testing and PrEP use among high-risk HIV-negative GBMSM in 3 US cities. The app could be made available through funded HIV prevention providers; additional efforts are needed to understand optimal strategies to implement the app outside of the research setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT03666247; https://clinicaltrials.gov/ct2/show/NCT03666247. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/16439.

A Data Visualization and Dissemination Resource to Support HIV Prevention and Care at the Local Level: Analysis and Uses of the AIDSVu Public Data Resource.

BACKGROUND: AIDSVu is a public resource for visualizing HIV surveillance data and other population-based information relevant to HIV prevention, care, policy, and impact assessment. OBJECTIVE: The site, AIDSVu.org, aims to make data about the US HIV epidemic widely available, easily accessible, and locally relevant to inform public health decision making. METHODS: AIDSVu develops visualizations, maps, and downloadable datasets using results from HIV surveillance systems, other population-based sources of information (eg, US Census and national probability surveys), and other data developed specifically for display and dissemination through the website (eg, pre-exposure prophylaxis [PrEP] prescriptions). Other types of content are developed to translate surveillance data into summarized content for diverse audiences using infographic panels, interactive maps, local and state fact sheets, and narrative blog posts. RESULTS: Over 10 years, AIDSVu.org has used an expanded number of data sources and has progressively provided HIV surveillance and related data at finer geographic levels, with current data resources providing HIV prevalence data down to the census tract level in many of the largest US cities. Data are available at the county level in 48 US states and at the ZIP Code level in more than 50 US cities. In 2019, over 500,000 unique users consumed AIDSVu data and resources, and HIV-related data and insights were disseminated through nearly 4,000,000 social media posts. Since AIDSVu's inception, at least 249 peer-reviewed publications have used AIDSVu data for analyses or referenced AIDSVu resources. Data uses have included targeting of HIV testing programs, identifying areas with inequitable PrEP uptake, including maps and data in academic and community grant applications, and strategically selecting locations for new HIV treatment and care facilities to serve high-need areas. CONCLUSIONS: Surveillance data should be actively used to guide and evaluate public health programs; AIDSVu translates high-quality, population-based data about the US HIV epidemic and makes that information available in formats that are not consistently available in surveillance reports. Bringing public health surveillance data to an online resource is a democratization of data, and presenting information about the HIV epidemic in more visual formats allows diverse stakeholders to engage with, understand, and use these important public health data to inform public health decision making.

Estimated Number of Injection-Involved Overdose Deaths in US States From 2000 to 2020: Secondary Analysis of Surveillance Data.

BACKGROUND: In the United States, both drug overdose mortality and injection-involved drug overdose mortality have increased nationally over the past 25 years. Despite documented geographic differences in overdose mortality and substances implicated in overdose mortality trends, injection-involved overdose mortality has not been summarized at a subnational level. OBJECTIVE: We aimed to estimate the annual number of injection-involved overdose deaths in each US state from 2000 to 2020. METHODS: We conducted a stratified analysis that used data from drug treatment admissions (Treatment Episodes Data Set-Admissions; TEDS-A) and the National Vital Statistics System (NVSS) to estimate state-specific percentages of reported drug overdose deaths that were injection-involved from 2000 to 2020. TEDS-A collects data on the route of administration and the type of substance used upon treatment admission. We used these data to calculate the percentage of reported injections for each drug type by demographic group (race or ethnicity, sex, and age group), year, and state. Additionally, using NVSS mortality data, the annual number of overdose deaths involving selected drug types was identified by the following specific multiple-cause-of-death codes: heroin or synthetic opioids other than methadone (T40.1, T40.4), natural or semisynthetic opioids and methadone (T40.2, T40.3), cocaine (T40.5), psychostimulants with abuse potential (T43.6), sedatives (T42.3, T42.4), and others (T36-T59.0). We used the probabilities of injection with the annual number of overdose deaths, by year, primary substance, and demographic groups to estimate the number of overdose deaths that were injection-involved. RESULTS: In 2020, there were 91,071 overdose deaths among adults recorded in the United States, and 93.1% (84,753/91,071) occurred in the 46 jurisdictions that reported data to TEDS-A. Slightly less than half (38,253/84,753, 45.1%; 95% CI 41.1%-49.8%) of those overdose deaths were estimated to be injection-involved, translating to 38,253 (95% CI 34,839-42,181) injection-involved overdose deaths in 2020. There was large variation among states in the estimated injection-involved overdose death rate (median 14.72, range 5.45-31.77 per 100,000 people). The national injection-involved overdose death rate increased by 323% (95% CI 255%-391%) from 2010 (3.78, 95% CI 3.33-4.31) to 2020 (15.97, 95% CI 14.55-17.61). States in which the estimated injection-involved overdose death rate increased faster than the national average were disproportionately concentrated in the Northeast region. CONCLUSIONS: Although overdose mortality and injection-involved overdose mortality have increased dramatically across the country, these trends have been more pronounced in some regions. A better understanding of state-level trends in injection-involved mortality can inform the prioritization of public health strategies that aim to reduce overdose mortality and prevent downstream consequences of injection drug use.

AIDSVu Cities' Progress Toward HIV Care Continuum Goals: Cross-Sectional Study.

BACKGROUND: Public health surveillance data are critical to understanding the current state of the HIV and AIDS epidemics. Surveillance data provide significant insight into patterns within and progress toward achieving targets for each of the steps in the HIV care continuum. Such targets include those outlined in the National HIV/AIDS Strategy (NHAS) goals. If these data are disseminated, they can be used to prioritize certain steps in the continuum, geographic locations, and groups of people. OBJECTIVE: We sought to develop and report indicators of progress toward the NHAS goals for US cities and to characterize progress toward those goals with categorical metrics. METHODS: Health departments used standardized SAS code to calculate care continuum indicators from their HIV surveillance data to ensure comparability across jurisdictions. We report 2018 descriptive statistics for continuum steps (timely diagnosis, linkage to medical care, receipt of medical care, and HIV viral load suppression) for 36 US cities and their progress toward 2020 NHAS goals as of 2018. Indicators are reported categorically as met or surpassed the goal, within 25% of attaining the goal, or further than 25% from achieving the goal. RESULTS: Cities were closest to meeting NHAS goals for timely diagnosis compared to the goals for linkage to care, receipt of care, and viral load suppression, with all cities (n=36, 100%) within 25% of meeting the goal for timely diagnosis. Only 8% (n=3) of cities were >25% from achieving the goal for receipt of care, but 69% (n=25) of cities were >25% from achieving the goal for viral suppression. CONCLUSIONS: Display of progress with graphical indicators enables communication of progress to stakeholders. AIDSVu analyses of HIV surveillance data facilitate cities' ability to benchmark their progress against that of other cities with similar characteristics. By identifying peer cities (eg, cities with analogous populations or similar NHAS goal concerns), the public display of indicators can promote dialogue between cities with comparable challenges and opportunities.

Claims-Based Algorithm to Identify Pre-Exposure Prophylaxis Indications for Tenofovir Disoproxil Fumarate and Emtricitabine Prescriptions (2012-2014): Validation Study.

BACKGROUND: To monitor the use of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) and related medicines for pre-exposure prophylaxis (PrEP) as HIV prevention using commercial pharmacy data, it is necessary to determine whether TDF/FTC prescriptions are used for PrEP or for some other clinical indication. OBJECTIVE: This study aimed to validate an algorithm to distinguish the use of TDF/FTC for HIV prevention or infectious disease treatment. METHODS: An algorithm was developed to identify whether TDF/FTC prescriptions were for PrEP or for other indications from large-scale administrative databases. The algorithm identifies TDF/FTC prescriptions and then excludes patients with International Classification of Diseases (ICD)-9 diagnostic codes, medications, or procedures that suggest indications other than for PrEP (eg, documentation of HIV infection, chronic hepatitis B, or use of TDF/FTC for postexposure prophylaxis). For evaluation, we collected data by clinician assessment of medical records for patients with TDF/FTC prescriptions and compared the assessed indication identified by the clinician review with the assessed indication identified by the algorithm. The algorithm was then applied and evaluated in a large, urban, community-based sexual health clinic. RESULTS: The PrEP algorithm demonstrated high sensitivity and moderate specificity (99.6% and 49.6%) in the electronic medical record database and high sensitivity and specificity (99% and 87%) in data from the urban community health clinic. CONCLUSIONS: The PrEP algorithm classified the indication for PrEP in most patients treated with TDF/FTC with sufficient accuracy to be useful for surveillance purposes. The methods described can serve as a basis for developing a robust and evolving case definition for antiretroviral prescriptions for HIV prevention purposes.

Estimating HIV Incident Diagnoses Among Men Who Have Sex With Men Eligible for Pre-exposure Prophylaxis but Not Taking It: Protocol and Feasibility Assessment of Data Sources and Methods.

BACKGROUND: HIV incidence estimates are published each year for all Ending the HIV Epidemic (EHE) counties, but they are not stratified by the demographic variables highly associated with risk of infection. Regularly updated estimates of HIV incident diagnoses available at local levels are required to monitor the epidemic in the United States over time and could contribute to background incidence rate estimates for alternative clinical trial designs for new HIV prevention products. OBJECTIVE: We describe methods using existing, robust data sources within areas in the United States to reliably estimate longitudinal HIV incident diagnoses stratified by race and age categories among men who have sex with other men (MSM) eligible for pre-exposure prophylaxis (PrEP) but not taking it. METHODS: This is a secondary analysis of existing data sources to develop new estimates of incident HIV diagnoses in MSM. We reviewed past methods used to estimate incident diagnoses and explored opportunities to improve these estimates. We will use existing surveillance data sources and population sizes of HIV PrEP-eligible MSM estimated from population-based data sources (eg, US Census data and pharmaceutical prescription databases) to develop metropolitan statistical area-level estimates of new HIV diagnoses among PrEP-eligible MSM. Required parameters are number of new diagnoses among MSM, estimates of MSM with an indication for PrEP, and prevalent PrEP use including median duration of use; these parameters will be stratified by jurisdiction and age group or race or ethnicity. Preliminary outputs will be available in 2023, and updated estimates will be produced annually thereafter. RESULTS: Data to parameterize new HIV diagnoses among PrEP-eligible MSM are available with varying levels of public availability and timeliness. In early 2023, the most recent available data on new HIV diagnoses were from the 2020 HIV surveillance report, which reports 30,689 new HIV infections in 2020, and 24,724 of them occurred in an MSA with a population of ≥500,000. Updated estimates for PrEP coverage based on commercial pharmacy claims data through February 2023 will be generated. The rate of new HIV diagnoses among MSM can be estimated from new diagnoses within each demographic group (numerator) and the total person-time at risk of diagnosis for each group (denominator) by metropolitan statistical area and year. To estimate time at risk, the person-time of individuals on PrEP or person-time after incident HIV infection but before diagnosis should be removed from stratified population size estimates of the total number of person-years with indications for PrEP. CONCLUSIONS: Reliable, serial, cross-sectional estimates for rates of new HIV diagnoses for MSM with PrEP indications can serve as benchmark community estimates of failures of HIV prevention and opportunities to improve services and will support public health epidemic monitoring and alternative clinical trial designs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42267.

Health Information on Pre-Exposure Prophylaxis From Search Engines and Twitter: Readability Analysis.

BACKGROUND: Pre-exposure prophylaxis (PrEP) is proven to prevent HIV infection. However, PrEP uptake to date has been limited and inequitable. Analyzing the readability of existing PrEP-related information is important to understand the potential impact of available PrEP information on PrEP uptake and identify opportunities to improve PrEP-related education and communication. OBJECTIVE: We examined the readability of web-based PrEP information identified using search engines and on Twitter. We investigated the readability of web-based PrEP documents, stratified by how the PrEP document was obtained on the web, information source, document format and communication method, PrEP modality, and intended audience. METHODS: Web-based PrEP information in English was systematically identified using search engines and the Twitter API. We manually verified and categorized results and described the method used to obtain information, information source, document format and communication method, PrEP modality, and intended audience. Documents were converted to plain text for the analysis and readability of the collected documents was assessed using 4 readability indices. We conducted pairwise comparisons of readability based on how the PrEP document was obtained on the web, information source, document format, communication method, PrEP modality, and intended audience, then adjusted for multiple comparisons. RESULTS: A total of 463 documents were identified. Overall, the readability of web-based PrEP information was at a higher level (10.2-grade reading level) than what is recommended for health information provided to the general public (ninth-grade reading level, as suggested by the Department of Health and Human Services). Brochures (n=33, 7% of all identified resources) were the only type of PrEP materials that achieved the target of ninth-grade reading level. CONCLUSIONS: Web-based PrEP information is often written at a complex level for potential and current PrEP users to understand. This may hinder PrEP uptake for some people who would benefit from it. The readability of PrEP-related information found on the web should be improved to align more closely with health communication guidelines for reading level to improve access to this important health information, facilitate informed decisions by those with a need for PrEP, and realize national prevention goals for PrEP uptake and reducing new HIV infections in the United States.

Clinic-Integrated Smartphone App (JomPrEP) to Improve Uptake of HIV Testing and Pre-exposure Prophylaxis Among Men Who Have Sex With Men in Malaysia: Mixed Methods Evaluation of Usability and Acceptability.

BACKGROUND: HIV disproportionately affects men who have sex with men (MSM). In Malaysia, where stigma and discrimination toward MSM are high, including in health care settings, mobile health (mHealth) platforms have the potential to open new frontiers in HIV prevention. OBJECTIVE: We developed an innovative, clinic-integrated smartphone app called JomPrEP, which provides a virtual platform for Malaysian MSM to engage in HIV prevention services. In collaboration with the local clinics in Malaysia, JomPrEP offers a range of HIV prevention (ie, HIV testing and pre-exposure prophylaxis [PrEP]) and other support services (eg, referral to mental health support) without having to interface face to face with clinicians. This study evaluated the usability and acceptability of JomPrEP to deliver HIV prevention services for MSM in Malaysia. METHODS: In total, 50 PrEP-naive MSM without HIV in Greater Kuala Lumpur, Malaysia, were recruited between March and April 2022. Participants used JomPrEP for a month and completed a postuse survey. The usability of the app and its features were assessed using self-report and objective measures (eg, app analytics, clinic dashboard). Acceptability was evaluated using the System Usability Scale (SUS). RESULTS: The participants' mean age was 27.9 (SD 5.3) years. Participants used JomPrEP for an average of 8 (SD 5.0) times during 30 days of testing, with each session lasting an average of 28 (SD 38.9) minutes. Of the 50 participants, 42 (84%) ordered an HIV self-testing (HIVST) kit using the app, of whom 18 (42%) ordered an HIVST more than once. Almost all participants (46/50, 92%) initiated PrEP using the app (same-day PrEP initiation: 30/46, 65%); of these, 16/46 (35%) participants chose PrEP e-consultation via the app (vs in-person consultation). Regarding PrEP dispensing, 18/46 (39%) participants chose to receive their PrEP via mail delivery (vs pharmacy pickup). The app was rated as having high acceptability with a mean score of 73.8 (SD 10.1) on the SUS. CONCLUSIONS: JomPrEP was found to be a highly feasible and acceptable tool for MSM in Malaysia to access HIV prevention services quickly and conveniently. A broader, randomized controlled trial is warranted to evaluate its efficacy on HIV prevention outcomes among MSM in Malaysia. TRIAL REGISTRATION: ClinicalTrials.gov NCT05052411; https://clinicaltrials.gov/ct2/show/NCT05052411. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/43318.

Engaging Black or African American and Hispanic or Latino Men Who Have Sex With Men for HIV Testing and Prevention Services Through Technology: Protocol for the iSTAMP Comparative Effectiveness Trial.

BACKGROUND: Gay, bisexual, and other men who have sex with men (MSM), particularly Black or African American MSM (BMSM) and Hispanic or Latino MSM (HLMSM), continue to be disproportionately affected by the HIV epidemic in the United States. Previous HIV self-testing programs have yielded high testing rates, although these studies predominantly enrolled White, non-Hispanic MSM. Mobile health tools can support HIV prevention, testing, and treatment. This protocol details an implementation study of mailing free HIV self-tests (HIVSTs) nested within a randomized controlled trial designed to assess the benefit of a mobile phone app for increasing the uptake of HIV prevention and other social services. OBJECTIVE: This study was a comparative effectiveness trial of innovative recruitment and testing promotion strategies intended to effectively reach cisgender BMSM and HLMSM. We evaluated the use of a mobile app for increasing access to care. METHODS: Study development began with individual and group consultations that elicited feedback from 3 core groups: HIV care practitioners and researchers, HIV service organization leaders from study states, and BMSM and HLMSM living in the study states. Upon completion of the formative qualitative work, participants from 11 states, based on the observed areas of highest rate of new HIV diagnoses among Black and Hispanic MSM, were recruited through social networking websites and smartphone apps. After eligibility was verified, participants consented and were randomized to the intervention arm (access to the Know@Home mobile app) or the control arm (referral to web resources). We provided all participants with HIVSTs. The evaluation of the efficacy of a mobile phone app to support linkage to posttest prevention services that included sexually transmitted infection testing, pre-exposure prophylaxis initiation, antiretroviral treatment, and acquisition of condoms and compatible lubricants has been planned. Data on these outcomes were obtained from several sources, including HIVST-reporting surveys, the 4-month follow-up survey, laboratory analyses of dried blood spot cards returned by the participant, and data obtained from the state health department surveillance systems. Where possible, relevant subgroup analyses were performed. RESULTS: During the formative development phase, 9 consultations were conducted: 6 in-depth individual discussions and 3 group consultations. From February 2020 through February 2021, we enrolled 2093 MSM in the randomized controlled trial from 11 states, 1149 BMSM and 944 HLMSM. CONCLUSIONS: This study was designed and implemented to evaluate the effectiveness of recruitment strategies to reach BMSM and HMSM and of a mobile app with regard to linkage to HIV prevention or treatment services. Data were also obtained to allow for the analyses of cost and cost-effectiveness related to study enrollment, HIV testing uptake, identification of previously undiagnosed HIV, sexually transmitted infection testing and treatment, and linkage to HIV prevention or treatment services. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04219878); https://clinicaltrials.gov/ct2/show/NCT04219878. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43414.

Public Health Implications of Adapting HIV Pre-exposure Prophylaxis Programs for Virtual Service Delivery in the Context of the COVID-19 Pandemic: Systematic Review.

BACKGROUND: The novel coronavirus disease COVID-19 caused by SARS-CoV-2 threatens to disrupt global progress toward HIV epidemic control. Opportunities exist to leverage ongoing public health responses to mitigate the impacts of COVID-19 on HIV services, and novel approaches to care provision might help address both epidemics. OBJECTIVE: As the COVID-19 pandemic continues, novel approaches to maintain comprehensive HIV prevention service delivery are needed. The aim of this study was to summarize the related literature to highlight adaptations that could address potential COVID-19-related service interruptions. METHODS: We performed a systematic review and searched six databases, OVID/Medline, Scopus, Cochrane Library, CINAHL, PsycINFO, and Embase, for studies published between January 1, 2010, and October 26, 2021, related to recent technology-based interventions for virtual service delivery. Search terms included "telemedicine," "telehealth," "mobile health," "eHealth," "mHealth," "telecommunication," "social media," "mobile device," and "internet," among others. Of the 6685 abstracts identified, 1259 focused on HIV virtual service delivery, 120 of which were relevant for HIV prevention efforts; 48 pertained to pre-exposure prophylaxis (PrEP) and 19 of these focused on evaluations of interventions for the virtual service delivery of PrEP. Of the 16 systematic reviews identified, three were specific to PrEP. All 35 papers were reviewed for outcomes of efficacy, feasibility, and/or acceptability. Limitations included heterogeneity of the studies' methodological approaches and outcomes; thus, a meta-analysis was not performed. We considered the evidence-based interventions found in our review and developed a virtual service delivery model for HIV prevention interventions. We also considered how this platform could be leveraged for COVID-19 prevention and care. RESULTS: We summarize 19 studies of virtual service delivery of PrEP and 16 relevant reviews. Examples of technology-based interventions that were effective, feasible, and/or acceptable for PrEP service delivery include: use of SMS, internet, and smartphone apps such as iText (50% [95% CI 16%-71%] reduction in discontinuation of PrEP) and PrEPmate (OR 2.62, 95% CI 1.24-5.5.4); telehealth and eHealth platforms for virtual visits such as PrEPTECH and IowaTelePrEP; and platforms for training of health care workers such as Extension for Community Healthcare Outcomes (ECHO). We suggest a virtual service delivery model for PrEP that can be leveraged for COVID-19 using the internet and social media for demand creation, community-based self-testing, telehealth platforms for risk assessment and follow-up, applications for support groups and adherence/appointment reminders, and applications for monitoring. CONCLUSIONS: Innovations in the virtual service provision of PrEP occurred before COVID-19 but have new relevance during the COVID-19 pandemic. The innovations we describe might strengthen HIV prevention service delivery during the COVID-19 pandemic and in the long run by engaging traditionally hard-to-reach populations, reducing stigma, and creating a more accessible health care platform. These virtual service delivery platforms can mitigate the impacts of the COVID-19 pandemic on HIV services, which can be leveraged to facilitate COVID-19 pandemic control now and for future responses.

America's HIV Epidemic Analysis Dashboard: Protocol for a Data Resource to Support Ending the HIV Epidemic in the United States.

BACKGROUND: The Ending the HIV Epidemic (EHE) plan aims to end the HIV epidemic in the United States by 2030. Having timely and accessible data to assess progress toward EHE goals at the local level is a critical resource to achieve this goal. OBJECTIVE: The aim of this paper was to introduce America's HIV Epidemic Analysis Dashboard (AHEAD), a data visualization tool that displays relevant data on the 6 HIV indicators provided by the Centers for Disease Control and Prevention. AHEAD can be used to monitor progress toward ending the HIV epidemic in local communities across the United States. Its objective is to make data available to stakeholders, which can be used to measure national and local progress toward 2025 and 2030 EHE goals and to help jurisdictions make local decisions that are grounded in high-quality data. METHODS: AHEAD displays data from public health data systems (eg, surveillance systems and census data), organized around the 6 EHE indicators (HIV incidence, knowledge of HIV status, HIV diagnoses, linkage to HIV medical care, viral HIV suppression, and preexposure prophylaxis coverage). Data are displayed for each of the EHE priority areas (48 counties in Washington, District of Columbia, and San Juan, Puerto Rico) which accounted for more than 50% of all US HIV diagnoses in 2016 and 2017 and 7 primarily southern states with high rates of HIV in rural communities. AHEAD also displays data for the 43 remaining states for which data are available. Data features prioritize interactive data visualization tools that allow users to compare indicator data stratified by sex at birth, race or ethnicity, age, and transmission category within a jurisdiction (when available) or compare data on EHE indicators between jurisdictions. RESULTS: AHEAD was launched on August 14, 2020. In the 11 months since its launch, the Dashboard has been visited 26,591 times by 17,600 unique users. About one-quarter of all users returned to the Dashboard at least once. On average, users engaged with 2.4 pages during their visit to the Dashboard, indicating that the average user goes beyond the informational landing page to engage with 1 or more pages of data and content. The most frequently visited content pages are the jurisdiction webpages. CONCLUSIONS: The Ending the HIV Epidemic plan is described as a "whole of society" effort. Societal public health initiatives require objective indicators and require that all societal stakeholders have transparent access to indicator data at the level of the health jurisdictions responsible for meeting the goals of the plan. Data transparency empowers local stakeholders to track movement toward EHE goals, identify areas with needs for improvement, and make data-informed adjustments to deploy the expertise and resources required to locally tailor and implement strategies to end the HIV epidemic in their jurisdiction.

Clinic-Integrated Mobile Health Intervention ("JomPrEP" App) to Improve Uptake of HIV Testing and Pre-exposure Prophylaxis Among Men Who Have Sex With Men in Malaysia: Protocol for an Intervention Development and Multiphase Trial.

BACKGROUND: Men who have sex with men (MSM) are disproportionately affected by the HIV epidemic in Malaysia and globally. Cross-cutting prevention strategies such as mobile health (mHealth), particularly smartphone apps, hold great promise for HIV prevention efforts among Malaysian MSM, especially when linked to HIV testing and pre-exposure prophylaxis (PrEP). OBJECTIVE: This study aims to adapt an existing app to create and test a clinic-integrated app (JomPrEP), a virtual platform to deliver HIV testing and PrEP services for MSM in Malaysia. METHODS: The JomPrEP project involves developing and testing an app-based platform for HIV prevention among Malaysian MSM and will be conducted in 2 phases. In phase I (development phase), we will adapt an existing mHealth app (HealthMindr) to create a new clinic-integrated app called "JomPrEP" to deliver holistic HIV prevention services (eg, HIV testing, PrEP, support services for mental health and substance use) among MSM in Malaysia. During phase II (testing phase), we will use a type I hybrid implementation science trial design to test the efficacy of JomPrEP while gathering information on implementation factors to guide future scale-up in real-world settings. RESULTS: As of September 2022, we have completed phase I of the proposed study. Based on a series of formative work completed during phase I, we developed a fully functional, clinic-integrated JomPrEP app, which provides a virtual platform for MSM in Malaysia to facilitate their engagement in HIV prevention in a fast and convenient manner. Based on participant feedback provided during phase I, we are currently optimizing JomPrEP and the research protocols for a large-scale efficacy trial (phase II), which will commence in January 2023. CONCLUSIONS: Scant HIV prevention resources coupled with entrenched stigma, discrimination, and criminalization of same-sex sexual behavior and substance use hamper access to HIV prevention services in Malaysia. If found efficacious, JomPrEP can be easily adapted for a range of health outcomes and health care delivery services for MSM, including adaptation to other low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT05325476; https://clinicaltrials.gov/ct2/show/NCT05325476. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43318.

Factors affecting wound leakage in 23-gauge sutureless pars plana vitrectomy.

PURPOSE: To evaluate risk factors for sclerotomy leakage in 23-gauge sutureless pars plana vitrectomy in 219 patients. METHODS: Nested case-control study involving 48 patients with wound leaks (visible on-table sclerotomy leakage requiring sutures) and 171 control subjects without wound leaks. Patients received either a conventional sclerotomy incision at 45°, which was then changed to 90° midincision, or an extremely oblique sclerotomy incision (OSI) at 10°, which was then changed to 30° midincision. Risk factors studied included age, gender, laterality, surgical duration, sclerotomy incision (OSI vs. conventional sclerotomy incision), preoperative diagnosis (macular vs. nonmacular), history of vitrectomy, and primary surgeon (attending vs. supervised resident). RESULTS: Multivariate logistic regression analysis found significant (P ≤ 0.05) protective factors for wound leakage including OSI, macular preoperative diagnosis, no previous vitrectomy, and female gender. Surgical duration at least 45 minutes was considered a borderline risk factor. CONCLUSION: Using an extremely OSI versus a conventional sclerotomy incision reduces the incidence of wound leakage postoperatively because of its self-sealing effect. Other factors that contribute to wound leakage, such as increased surgical duration and nonmacular diagnosis, may be indirect measurements of extensive trocar rotation, causing wound leakage despite the use of an OSI.

COVID-19 Vaccine Perceptions, Intentions, and Uptake Among Young Adults in the United States: Prospective College-Based Cohort Study.

BACKGROUND: Uptake of the COVID-19 vaccine among US young adults, particularly those that belong to racial and ethnic minorities, remains low compared to their older peers. Understanding vaccine perceptions and their influence on vaccination uptake among this population remains crucial to achieving population herd immunity. OBJECTIVE: We sought to study perceptions of COVID-19 vaccines as well as intended and actual vaccine uptake among one population of college students, faculty, and staff. METHODS: As part of a larger study aimed at investigating the dynamics of COVID-19 transmission, serology, and perception on a college campus, participants were asked about their views on the COVID-19 vaccine in February 2021. Vaccination status was assessed by self-report in April 2021. Logistic regression was used to calculate prevalence ratios with marginal standardization. RESULTS: We found that non-White participants were 25% less likely to report COVID-19 vaccination compared to White participants. Among those who were unvaccinated, Black and other non-White participants were significantly more likely to indicate they were unwilling to receive a COVID-19 vaccine compared to White participants. The most common reason for unwillingness to receive the vaccine was belief that the vaccine approval process was rushed. CONCLUSIONS: There are racial differences in perceptions of the COVID-19 vaccine among young adults, and these differences might differentially impact vaccine uptake among young racial and ethnic minorities. Efforts to increase vaccine uptake among college populations might require campaigns specifically tailored to these minority groups.

Correction: Disparities in Care Outcomes in Atlanta Between Black and White Men Who Have Sex With Men Living With HIV: Protocol for a Prospective Cohort Study (Engage[men]t).

[This corrects the article DOI: 10.2196/21985.].

Disparities in Care Outcomes in Atlanta Between Black and White Men Who Have Sex With Men Living With HIV: Protocol for a Prospective Cohort Study (Engage[men]t).

BACKGROUND: The US HIV epidemic is driven by infections in men who have sex with men and characterized by profound disparities in HIV prevalence and outcomes for Black Americans. Black men who have sex with men living with HIV are reported to have worse care outcomes than other men who have sex with men, but the reasons for these health inequities are not clear. We planned a prospective observational cohort study to help understand the reasons for worse HIV care outcomes for Black versus White men who have sex with men in Atlanta. OBJECTIVE: The aim of this study is to identify individual, dyadic, network, neighborhood, and structural factors that explain disparities in HIV viral suppression between Black and White men who have sex with men living with HIV in Atlanta. METHODS: Black and White men who have sex with men living with HIV were enrolled in a prospective cohort study with in-person visits and viral suppression assessments at baseline, 12 months, and 24 months; additional surveys of care and risk behaviors at 3, 6, and 18 months; analysis of care received outside the study through public health reporting; and qualitative interviews for participants who experienced sentinel health events (eg, loss of viral suppression) during the study. The study is based on the Bronfenbrenner socioecological theoretical model. RESULTS: Men who have sex with men (n=400) were enrolled between June 2016 and June 2017 in Atlanta. Follow-up was completed in June 2019; final study retention was 80% at 24 months. CONCLUSIONS: Health disparities for Black men who have sex with men are hypothesized to be driven by structural racism and barriers to care. Observational studies are important to document and quantify the specific factors within the socioecological framework that account for disparities in viral suppression. In the meantime, it is also critical to push for steps to improve access to care, including Medicaid expansion in Southern states, such as Georgia, which have not yet moved to expand Medicaid. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21985.