Exploring Effects of Race and Differential Item Functioning on PrEP Stigma Experiences: Implications for Latent Stigma Measurement in Racially and Sexually Diverse Populations.

PrEP stigma measurement remains a challenge to the validity of studies and interventions addressing HIV prevention. It may lead to inaccurate assessment of the relationship between PrEP stigma and health outcomes such as PrEP persistence and care retention in groups experiencing HIV-related inequities. The present research explored the psychometric properties of a novel IV pre-exposure prophylaxis (PrEP) stigma scale in a cohort of racially diverse men who have sex with men (MSM). Using item response theory, analyses explored presence of differential item functioning (DIF) among Black and White respondents. Participants completed baseline surveys measuring psychosocial factors, sociodemographic factors, and PrEP stigma items. The primary analysis used a machine learning approach to assess (a) the presence of DIF; and (b) compare latent stigma between Black and White respondents, after correcting for any DIF. The model identified four out of 13 scale items as having a high probability of DIF for Black respondents, which is relatively good given that the original PrEP stigma scale was neither designed nor tested for validation comparing Black and White respondents. The DIF-adjusted latent PrEP stigma measure reveals statistically and substantially significantly higher levels of stigma for Black compared to White respondents (Diff.: 1.05 +/- 0.19). While most items performed well, findings demonstrate the importance of assessing measurement error in populations where stigma is rampant and being studied or intervened upon (and in this case, where multilevel and intersectional stigma may be present).

Development of a home-based pre-exposure prophylaxis care delivery system for long-acting injectable cabotegravir: a formative exploration of patient preferences.

Cabotegravir (CAB-LA), the only Food and Drug Administration-approved injectable pre-exposure prophylaxis (PrEP), is effective and may address PrEP uptake disparities among Black and Latino sexual and gender minority (SGM) men. Uptake of CAB-LA may require developing innovative non-clinic-based care delivery strategies in home-based settings. We explored SGM men's opinions on a future home-based CAB-LA PrEP care service to guide the adaptation of PrEP@Home, an existing home-based PrEP system for oral PrEP. Through 14 in-depth interviews with current or former SGM male participants in the PrEP@Home study, we explored the acceptability of a home-based injectable PrEP system and examined visit and communication-related preferences. All participants considered home-based CAB-LA care to be acceptable and 8/14 would utilize the system if available. Convenience and comfort with using a home-based system impacted the overall acceptance of the approach. Factors influencing acceptability included clinical teams' affiliation with healthcare systems, a credentialed two-person team, and staff identity verification methods. Logistical preferences included communicating pre-visit patient instructions, allowing flexible scheduling hours, and the use of text, phone calls, or mobile app communication methods based on urgency. Conclusively, a home-based CAB-LA PrEP delivery system was acceptable among the interviewed SGM men, guiding its development and future implementation.Trial registration: ClinicalTrials.gov identifier: NCT03569813.

Acceptability of an automated directly observed therapy (DOT) application for PrEP adherence support among young men who have sex with men: a qualitative exploration.

Pre-exposure prophylaxis (PrEP) adherence remains a challenge among young men who have sex with men (MSM). We developed and tested a smartphone application ("app"), "DOT Diary", which combines automated directly observed therapy (DOT) with information about PrEP protection levels, pill-taking reminders, a sexual behavior diary, and a PrEP dosing calendar. To contextualize trial results, we qualitatively explored participants' app experiences. The trial enrolled 100 young MSM in San Francisco and Atlanta. Participants were randomized 2:1 to DOT Diary versus standard-of-care and followed for 24 weeks. Interviews were conducted with 24 intervention participants. Data were analyzed using a memo-writing approach. Most expressed overall satisfaction with the app ("it was good for its purpose"), despite concerns about technical glitches. The most popular app features were the monthly calendar showing days PrEP was taken and information about level of protection based on pills taken. The DOT component helped participants establish PrEP routines. The reminders were "annoying but effective" at motivating dosing. Opinions about the sexual behavior diary varied. Overall, DOT Diary was acceptable; participants were willing to use it daily to record pill-taking. Critical components included the information about PrEP protection levels and calendar, while others may be modified to improve future success.Trial registration: ClinicalTrials.gov identifier: NCT03771638.

Use of COVIDTests.gov At-Home Test Kits Among Adults in a National Household Probability Sample - United States, 2022.

At-home rapid antigen COVID-19 tests were first authorized by the Food and Drug Administration in late 2020 (1-3). In January 2022, the White House launched COVIDTests.gov, which made all U.S. households eligible to receive free-to-the-user at-home test kits distributed by the U.S. Postal Service (2). By May 2022, more than 70 million test kit packages had been shipped to households across the United States (2); however, how these kits were used, and which groups were using them, has not been reported. Data from a national probability survey of U.S. households (COVIDVu), collected during April-May 2022, were used to evaluate awareness about and use of these test kits (4). Most respondent households (93.8%) were aware of the program, and more than one half (59.9%) had ordered kits. Among persons who received testing for COVID-19 during the preceding 6 months, 38.3% used a COVIDTests.gov kit. Among kit users, 95.5% rated the experience as acceptable, and 23.6% reported being unlikely to have tested without the COVIDTests.gov program. Use of COVIDTests.gov kits was similar among racial and ethnic groups (42.1% non-Hispanic Black or African American [Black]; 41.5% Hispanic or Latino [Hispanic]; 34.8% non-Hispanic White [White]; and 53.7% non-Hispanic other races [other races]). Use of other home COVID-19 tests differed by race and ethnicity (11.8% Black, 44.4% Hispanic, 45.8% White, 43.8% other races). Compared with White persons, Black persons were 72% less likely to use other home test kits (adjusted relative risk [aRR] = 0.28; 95% CI = 0.16-0.50). Provision of tests through this well-publicized program likely improved use of COVID-19 home testing and health equity in the United States, particularly among Black persons. National programs to address availability and accessibility of critical health services in a pandemic response have substantial health value.

Randomized Controlled Trial of Automated Directly Observed Therapy for Measurement and Support of PrEP Adherence Among Young Men Who have Sex with Men.

Measurement of adherence to oral pre-exposure prophylaxis (PrEP) in real-time has been challenging. We developed DOT Diary, a smartphone application that combines automated directly observed therapy with a PrEP adherence visualization toolkit, and tested its ability to measure PrEP adherence and to increase adherence among a diverse cohort of young men who have sex with men (MSM). We enrolled 100 MSM in San Francisco and Atlanta and randomly assigned them 2:1 to DOT Diary versus standard of care. Concordance between DOT Diary measurement and drug levels in dried blood spots was substantial, with 91.0% and 85.3% concordance between DOT Diary and emtricitabine-triphosphate and tenofovir-diphosphate, respectively. There was no significant difference in the proportion of participants with detectable PrEP drug levels at 24 weeks between study arms. These results suggest DOT Diary is substantially better than self-reported measures of adherence, but additional interventions are needed to improve PrEP adherence over time.

RESUMEN: La medición de la adherencia a la profilaxis oral previa a la exposición (PrEP) en tiempo real ha constituido un desafío. Hemos desarrollado DOT Diary, una aplicación para teléfonos inteligentes que combina la terapia automatizada observada de forma directa con un kit de herramientas para visualizar la adherencia a la PrEP, y testeamos su capacidad para medir la adherencia a la PrEP, así como para aumentar la adherencia entre una cohorte variada de hombres jóvenes que tienen sexo con hombres (HSH). Reclutamos a 100 HSH en San Francisco y Atlanta y los asignamos aleatoriamente 2:1 a DOT Diary con respecto a la asistencia estándar. La concordancia entre la medición del DOT Diary y los niveles de fármacos en gotas de sangre seca fue sustancial, con un 91,0% y un 85,3% de concordancia entre el uso del DOT Diary y el de emtricitabina-trifosfato y tenofovir-difosfato, respectivamente. No hubo diferencias significativas en la proporción de participantes con niveles detectables del fármaco de la PrEP a las 24 semanas entre los brazos del estudio. Estos resultados sugieren que DOT Diary es sustancialmente superior a las medidas de adherencia que se notifican de forma personal, aunque hacen falta intervenciones adicionales para mejorar la adherencia a la PrEP a largo plazo.

Effects of mode of transportation on PrEP persistence among urban men who have sex with men.

Little is known about the effect of travel-related factors, such as mode of transportation, on retention in PrEP care, or PrEP persistence. We used data from the 2020 American Men's Internet Survey and conducted multilevel logistic regression to estimate the association between mode of transportation used for healthcare access and PrEP persistence among urban gay, bisexual, and other men who have sex with men (MSM) in the U.S. MSM using public transportation were less likely to report PrEP persistence (aOR: 0.51; 95% CI: 0.28-0.95) than MSM using private transportation. There were no significant associations between PrEP persistence and using active transportation (aOR: 0.67; 95% CI: 0.35-1.29) or multimodal transportation (aOR: 0.85; 95% CI: 0.51-1.43) compared to using private transportation. Transportation-related interventions and policies are needed to address structural barriers to accessing PrEP services and to improve PrEP persistence in urban areas.

Assessing the association of stigma and HIV service and prevention uptake among men who have sex with men and transgender women in South Africa.

HIV prevention for gay, bisexual, and other men who have sex with men (GBMSM) and transgender women (TGW) is critical to reducing health disparities and population HIV prevalence. To understand if different types of stigma impact engagement with HIV prevention services, we assessed associations between stigmas and use of HIV prevention services offered through an HIV prevention intervention. This analysis included 201 GBMSM and TGW enrolled in a prospective cohort offering a package of HIV prevention interventions. Participants completed a baseline survey that included four domains of sexual identity/behavior stigma, HIV-related stigma, and healthcare stigma. Impact of stigma on PrEP uptake and the number of drop-in visits was assessed. No domain of stigma was associated with PrEP uptake. In bivariate analysis, increased enacted sexual identity stigma increased number of drop-in visits. In a logistic regression analysis constrained to sexual identity stigma, enacted stigma was associated with increased drop-in visits (aIRR = 1.30, [95% CI: 1.02, 1.65]). Participants reporting higher enacted stigma were modestly more likely to attend additional services and have contact with the study clinics and staff. GBMSM and TGW with higher levels of enacted stigma may seek out sensitized care after negative experiences in their communities or other healthcare settings.

Comparing open-ended question methods to vignette methods to explore willingness to obtain pre-exposure prophylaxis access in pharmacies among black men who have sex with men.

Black men who have sex with men (BMSM) are at higher risk of HIV transmission than any other group; however, their uptake of the highly effective HIV prevention medication, pre-exposure prophylaxis (PrEP), is low. In collaboration with a communitybased organization in Atlanta, Georgia, we explored ten HIV-negative BMSM's willingness to obtain PrEP in pharmacies using standard open-ended and vignette qualitative methods. Three overarching themes were identified: privacy, patient-pharmacist interactions, and HIV/STI screening. While open-ended questions allowed participants to provide broad answers on their willingness to receive prevention services at a pharmacy, the vignette drew out specific responses to facilitate in-pharmacy PrEP delivery. Using both openended questions and vignette data collection strategies, BMSM reported high willingness to screen for and uptake PrEP in pharmacies. However, the vignette method allowed for greater depth. Open-ended questions elicited responses that highlighted general barriers and facilitators of PrEP dispensing in pharmacies. However, the vignette allowed participants to customize a plan of action that would best fit their needs. Vignette methods are underutilized in HIV research and may be helpful in supplementing standard open-ended interview questions to uncovering unknown challenges about health behaviors and obtain more robust data on highly sensitive research topics in HIV research.

COVID-19 vaccine attitudes among a majority black sample in the Southern US: public health implications from a qualitative study.

BACKGROUND: The COVID-19 pandemic continues to have high caseloads in the US, with vaccines a critical component of the response. Disparities in COVID-19 morbidity and mortality have been identified across states and racial/ethnic groups, which are likely in part due to disparities in COVID-19 vaccine uptake. This study aims to better understand and contextualize COVID-19 vaccine hesitancy among persons from under-represented racial/ethnic populations in the Southern US. METHODS: We conducted 29 in-depth interviews with a sample of households in Atlanta, GA that were selected from an address-based sampling frame. We purposively approached households, from February 6 to June 27, 2021, that declined participation in a national COVID-19 serosurvey to gain perspectives of people who are often under-represented in research. Interviews were conducted in-person or over phone calls for participants with that preference. Thematic analysis was used to identify barriers and facilitators of COVID-19 vaccination, and to contextualize drivers of vaccine hesitancy. RESULTS: Decision-making about vaccination was described as dynamic, and was compared to the feeling of being on a roller coaster. The predominant reported sources of information were mass media and social media. Facilitators of vaccination included altruism, positive communication from trusted community members and workplace colleagues, and local vaccine provision sites. Driving reasons for vaccine hesitancy included limited trust in the government and concerns about COVID-19 vaccine safety, which one participant compared to jumping off a cliff without a tested rope. Among a subset of participants, beliefs regarding perceived intent to harm the Black community were prevalent. Opportunities to optimally address vaccine hesitancy included countering negative social media messages with positive messaging that matches the community's vivid ways of discussing vaccines, collaborating with community stakeholders on vaccine promotion efforts, and offering workplace-based vaccine promotion efforts. CONCLUSIONS: This study presents data that indicate it may be optimal to more broadly define 'community' in COVID-19 vaccine promotion efforts to include social media and workplace venues. To optimize vaccine and vaccine booster uptake and equity, public health must address historic racism and other concerns by using outreach that is grounded in communities.

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.

Alignment of PrEP use and sexual behavior over four months among men who have sex with men in the southern United States.

Unlike antiretrovirals for HIV treatment, pre-exposure prophylaxis (PrEP) does not require continual adherence to be fully effective; rather, PrEP adherence is important only in the context of episodes of sexual risk. Therefore, studies of PrEP adherence and persistence must incorporate contemporaneous measurement of sexual behavior. Short, frequent surveys of PrEP use and sexual behavior allow for the measurement of the alignment between PrEP use and sexual behavior. We assessed the feasibility of using biweekly PrEP use and sexual behavior questionnaires to measure adherence and persistence on PrEP over a period of four months. We also measured the alignment of PrEP use and condomless anal sex. PrEP-using MSM in the southern US were recruited using online advertisements. Participants completed a baseline survey followed by brief surveys every two weeks for 16 weeks to report their PrEP use and sexual behavior over the preceding two-week period. Study retention was high: 91% of participants completed the baseline and final survey and, overall, 86% of study surveys were completed. Self-reported PrEP adherence and persistence were high, but instances of PrEP non-adherence were observed to frequently overlap with episodes of condomless anal sex. The most prominent reasons cited for missing PrEP doses were being too busy, not having PrEP on hand, and not being sexually active. Completing short, biweekly surveys of PrEP use and sexual behavior is feasible and acceptable to MSM in the southern US. Future studies should investigate incorporating biomarker measurements to validate self-reported adherence.

Demographic and behavioral characteristics of urban and non-urban PrEP-using MSM in the South.

Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention intervention; however, most studies of PrEP adherence and persistence among men who have sex with men (MSM) have been conducted with MSM who live in urban areas. The experiences of PrEP-using MSM in non-urban areas might differ due to increased barriers to culturally competent care. We examined similarities and differences among urban and non-urban PrEP-using MSM in the southern United States, the region with the highest number of annual HIV diagnoses. We surveyed a total of 78 (n = 25 non-urban, n = 53 urban) PrEP-using MSM. Self-reported adherence was high across all participants. No differences were observed with respect to PrEP persistence, source of PrEP, or reasons for PrEP initiation. Fewer non-urban than urban men reported STI testing in the past 12 months. Overall, we observed few differences comparing urban and non-urban PrEP-using MSM. Additional studies are needed to describe differences in PrEP initiation comparing urban and non-urban MSM.

From declining PrEP to PrEP initiation as "first nature" - what changes PrEP initiation decisions among young, Black MSM.

Young Black men who have sex with men (YBMSM) bear a disproportionate burden of HIV, and HIV pre-exposure prophylaxis (PrEP) uptake has been slow. Decisions regarding PrEP initiation change in different life contexts over time. Our YBMSM cohort study found about 1/3 of those who initially declined PrEP subsequently changed and initiated PrEP care. This study explores the process of their PrEP decision changes. The study interviewed participants who initially voiced strong and clear reservations about PrEP, but subsequently started PrEP 1-14 months later. In "review/renew" follow-up interviews, participants reviewed their past statements from a time they declined PrEP, and renew their understanding regarding perspective and behavioral change. Analyzing the data with a positive deviance framework, we found that shifting the decisional balance in favor of PrEP initiation only required change in some areas. There were not consistent factors that prevented or facilitated PrEP uptake. Instead, YBMSM initiated PrEP while maintaining an array of substantial reservations. PrEP initiation discussions should be viewed by health practitioners as a longitudinal process, and routine PrEP offers should be made over time. To optimally facilitate PrEP use among YBMSM, the diverse benefits of PrEP should be emphasized rather than focusing on allaying all concerns.

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.

Estimating the Cumulative Incidence of SARS-CoV-2 Infection and the Infection Fatality Ratio in Light of Waning Antibodies.

BACKGROUND: Serology tests can identify previous infections and facilitate estimation of the number of total infections. However, immunoglobulins targeting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been reported to wane below the detectable level of serologic assays (which is not necessarily equivalent to the duration of protective immunity). We estimate the cumulative incidence of SARS-CoV-2 infection from serology studies, accounting for expected levels of antibody acquisition (seroconversion) and waning (seroreversion), and apply this framework using data from New York City and Connecticut. METHODS: We estimated time from seroconversion to seroreversion and infection fatality ratio (IFR) using mortality data from March to October 2020 and population-level cross-sectional seroprevalence data from April to August 2020 in New York City and Connecticut. We then estimated the daily seroprevalence and cumulative incidence of SARS-CoV-2 infection. RESULTS: The estimated average time from seroconversion to seroreversion was 3-4 months. The estimated IFR was 1.1% (95% credible interval, 1.0%, 1.2%) in New York City and 1.4% (1.1, 1.7%) in Connecticut. The estimated daily seroprevalence declined after a peak in the spring. The estimated cumulative incidence reached 26.8% (24.2%, 29.7%) at the end of September in New York City and 8.8% (7.1%, 11.3%) in Connecticut, higher than maximum seroprevalence measures (22.1% and 6.1%), respectively. CONCLUSIONS: The cumulative incidence of SARS-CoV-2 infection is underestimated using cross-sectional serology data without adjustment for waning antibodies. Our approach can help quantify the magnitude of underestimation and adjust estimates for waning antibodies.

Mixed-Methods Evaluation of the Incorporation of Home Specimen Self-Collection Kits for Laboratory Testing in a Telehealth Program for HIV Pre-exposure Prophylaxis.

Home specimen self-collection kits with central laboratory testing may improve persistence with PrEP and enhance telehealth programs. We offered Iowa TelePrEP clients the choice of using a home kit or visiting a laboratory site for routine monitoring. Mixed-methods evaluation determined the proportion of clients who chose a kit, factors influencing choice, associations between kit use and completion of indicated laboratory monitoring, and user experience. About 46% (35/77) chose to use a kit. Compared to laboratory site use, kit use was associated with higher completion of extra-genital swabs (OR 6.33, 95% CI 1.20-33.51, for anorectal swabs), but lower completion of blood tests (OR 0.21, 95% CI 0.06-0.73 for creatinine). Factors influencing choice included self-efficacy to use kits, time/convenience, and privacy/confidentiality. Clients reported kit use was straight-forward but described challenges with finger prick blood collection. Telehealth PrEP programs should offer clients home kits and support clients with blood collection and kit completion.

RESUMEN: Los kits de pruebas caseras de auto-recolección junto con los ensayos de laboratorio central puedan mejorar la persistencia de PrEP y aumentar los programas de telesalud. Ofrecimos a los clientes de Iowa TelePrEP la opción de o utilizar un kit de pruebas caseras o visitar un sitio de laboratorio para seguimiento rutinario.La evaluación de métodos mixtos determinó la proporción de los clientes que eligieron un kit, los factores que influyen en la elección, las asociaciones entre el uso del kit y la realización del monitoreo de laboratorio indicado y la experiencia de los usuarios. Casi 46 % (35 de 77) eligió utilizar un kit. Comparado con el uso del sitio de laboratorio, el kit fue asociado con mayores tasas de terminación para los hisopos extragenitales (OR 6.33, 95% CI 1.20-33.51, para hisopos anorectales), pero menores tasas de terminación para los análisis de sangre (OR 0.21, 95% CI 0.06-0.73 para creatinina). Los factores que influyeron en la elección incluyeron la autoeficacia para usar los kits, el tiempo / la comodidad y la privacidad/ confidencialidad. Los clientes informaron que el uso del kit fue sencillo pero describieron desafíos con la recolección de sangre por un pinchazo. Los programas de PrEP de telesalud deben ofrecer a los clientes kits para el hogar y apoyarlos con la recolección de sangre y la terminación del kit.

DOT Diary: Developing a Novel Mobile App Using Artificial Intelligence and an Electronic Sexual Diary to Measure and Support PrEP Adherence Among Young Men Who Have Sex with Men.

Young men who have sex with men (YMSM) are highly vulnerable to HIV. While pre-exposure prophylaxis (PrEP) has demonstrated effectiveness, adherence has been low among YMSM and difficult to measure accurately. In collaboration with a healthcare company, we configured an automated directly-observed therapy (aDOT) platform for monitoring and supporting PrEP use. Based on interest expressed in focus groups among 54 YMSM, we combined aDOT with an electronic sexual diary to provide feedback on level of protection during sex and to motivate app use. In an 8-week optimization pilot with 20 YMSM in San Francisco and Atlanta, the app was found to be highly acceptable, with median System Usability Scale scores in the "excellent" range (80/100). App use was high, with median PrEP adherence of 91% based on aDOT-confirmed dosing. Most (84%) participants reported the app helped with taking PrEP. These promising findings support further evaluation of DOT Diary in future effectiveness studies.

PrEParing for long-acting injectable PrEP in the South: perspectives from healthcare providers in Georgia.

New modalities of Pre-exposure Prophylaxis (PrEP) such as long-acting injectable PrEP (LAI-PrEP) promise increased prevention of HIV transmission; however, similar biomedical interventions have not been met with universal adoption by healthcare providers or populations most affected by HIV. This qualitative study explores healthcare provider considerations for the rollout of LAI-PrEP. Eleven key-informant in-depth interviews were conducted with clinicians who prescribe daily oral PrEP. Participants reviewed a currently proposed LAI regimen and were asked to reflect on its implications for their clinical practice. Interviews were transcribed verbatim and thematically coded, with results organized using the Consolidated Framework for Implementation Research (CFIR). All participants expressed interest in prescribing LAI-PrEP and anticipated that at least some patients would be interested. Participants identified characteristics of the intervention, inner intervention setting, and outer intervention setting that will be influential in bringing LAI-PrEP to scale. Clinicians in the South have unique insights into the challenges of and opportunities for successful rollout of future PrEP regimens. Bringing these insights into a CFIR framework highlights the nuances surrounding LAI-PrEP, including structural concerns such as cost barriers and access to in-person healthcare services. It is critical to address these challenges to ensure successful implementation of new PrEP formulations.

Pre-exposure Prophylaxis Uptake and Discontinuation Among Young Black Men Who Have Sex With Men in Atlanta, Georgia: A Prospective Cohort Study.

BACKGROUND: Human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) has great potential to reduce HIV incidence among young black men who have sex with men (YBMSM); however, initiation and persistence for this group remain low. We sought to understand the patterns and predictors of PrEP uptake and discontinuation among YBMSM in Atlanta, Georgia. METHODS: PrEP was offered to all participants in a prospective cohort of YBMSM aged 18-29 years not living with HIV. Time to PrEP uptake, first discontinuation, and final discontinuation were assessed using the Kaplan-Meier method. Cox proportional hazard models were used to identify predictors of uptake and discontinuation. RESULTS: After 440 person-years of follow-up, 44% of YBMSM initiated PrEP through the study after a median of 122 days. Of PrEP initiators, 69% had a first discontinuation and 40% had a final discontinuation during the study period. The median time to first PrEP discontinuation was 159 days. Factors associated with PrEP uptake included higher self-efficacy, sexually transmitted infection (STI), and condomless anal intercourse. Factors associated with discontinuation included younger age, cannabis use, STI, and fewer sex partners. HIV incidence was 5.23/100 person-years (95% confidence interval [CI], 3.40-7.23), with a lower rate among those who started PrEP (incidence rate ratio, 0.39; 95% CI, .16-.92). CONCLUSIONS: Persistent PrEP coverage in this cohort of YBMSM was suboptimal, and discontinuations were common despite additional support services available through the study. Interventions to support PrEP uptake and persistence, especially for younger and substance-using YBMSM, are necessary to achieve full PrEP effectiveness. CLINICAL TRIALS REGISTRATION: NCT02503618.