Susanne Doblecki-Lewis

Self-efficacy (SE) is central to sexual health behavior change and may be important for pre-exposure prophylaxis (PrEP) adherence among men who have sex with men (MSM). This study examines factors associated with three PrEP self-efficacy domains: routine adherence (RA), medication management (MM), and overcoming psychosocial challenges (OPC). Three hundred U.S. MSM, who either initiated daily oral PrEP or reported anticipated adherence difficulties, and who all experienced at least one psychosocial syndemic condition, were recruited as part of a randomized controlled trial. Baseline assessments included PrEP SE and psychosocial, structural, and sociodemographic variables. Bayesian variable selection and multiple linear regression identified several predictors. Younger age (RA: b = 0.048, 95% CI [0.025, 0.072]; MM: b = 0.033, 95% CI [0.012, 0.054]; OPC: b = 0.060, 95% CI [0.023, 0.087]) and greater structural barriers (RA: b = − 0.090, 95% CI [-0.151, − 0.029]; MM: b = − 0.192, 95% CI [-0.246, − 0.138]; OPC: b = − 0.145, 95% CI [-0.229, − 0.055]) were associated with decreased SE across all factors ( p < .01). Social anxiety was associated with lower routine adherence SE ( b = − 0.039, 95% CI [-0.063, -0.016], p < .01); lifetime polysubstance use was associated with lower medication management SE ( b = − 0.192, 95% CI [-0.325, -0.058], p < .01); and overseas-born status ( b = − 0.932, 95% CI [-1.759, -0.106], p < .05) and greater sexual compulsivity ( b = − 0.157, 95% CI [-0.269, -0.046], p < .01) were both associated with lower SE in overcoming psychosocial challenges. Findings underscore the need for multilevel, culturally responsive PrEP interventions that promote SE across all three domains.

Background: Timely and accurate estimates of HIV incidence are essential for program monitoring and planning clinical studies. Real-world evidence from electronic medical records (EMRs) in sexual health clinics may provide a pragmatic alternative to resource-intensive surveys and surveillance. Setting: We conducted a retrospective cohort study across 5 health centers in the United States, South Africa, and Thailand to assess the feasibility of estimating HIV incidence using EMR data. Methods: Clients aged 16–64 years assigned male at birth who reported ever having sex with someone assigned male at birth and had at least 1 HIV test between July 1, 2022, and December 31, 2023, were included. Deidentified data were extracted and subcohorts created considering 1 versus more than 1 HIV test during the study period. Incidence rates were calculated within the multiple-test (MT) cohort using person-time at risk; diagnosis proportions were calculated for all cohorts. Results: All sites met data quality thresholds for essential demographic and clinical variables. A total of 25,801 clients were included. Diagnosis proportions in single-test cohorts were higher (2.9%–12.6%) than in MT cohorts (0%–0.53%). Incidence rates among MT cohorts ranged from 0.22 to 0.72 per 100 person-years, substantially lower than expected, likely due to PrEP use and selection bias toward health-engaged clients. Conclusion: EMR-based HIV incidence estimation is feasible but limited by data variability and selection bias thus incidence estimates from MT cohorts may not reflect true community incidence. Diagnoses data may be used for incidence modeling where there is sufficient sample size.

This study assesses expansion of the "Test-to-PrEP" (T2P) social network strategy to include people with HIV (PWH) as distributors of HIV self-test kits (HIVST) and PrEP/HIV treatment resources, in Miami and a newly introduced site in San Juan. PWH showed strong interest despite perceived barriers such as stigma. Stakeholders found the strategy acceptable and compatible. Findings highlight the potential of PWH-led T2P implementation to advance HIV prevention and treatment, underscoring the need to support scale-up and address barriers. (Am J Public Health. 2026;116(S1):S32-S35. https://doi.org/10.2105/AJPH.2025.308320).

In Miami-Dade County, high HIV incidence rates and suboptimal uptake of HIV prevention strategies, such as pre-exposure prophylaxis (PrEP), underscore significant gaps in community HIV awareness and service accessibility. Novel interventions leveraging community-based participatory research (CBPR) and peer-driven distribution mechanisms offer potential solutions for increasing engagement with HIV testing and preventive services, yet few existing interventions are culturally tailored or systematically integrated into local contexts. This study aimed to develop and refine a culturally sensitive, peer-distributed at-home HIV self-test (HIVST) and prevention information intervention called Test-to-PrEP, to address specific needs within Miami-Dade's diverse populations. A CBPR approach was employed, incorporating iterative community stakeholder engagement through a purposely selected, diverse 10-member advisory panel. Members included representatives from local HIV prevention organizations, academic experts, and community advocates reflecting key populations affected by HIV, notably Hispanic/Latino men who have sex with men (MSM), Black women, and immigrants. Development activities included structured weekly meetings, thematic analysis of qualitative panel discussions, and literature reviews to identify intervention gaps and opportunities for optimization. Materials were pretested among PrEP clients, incorporating feedback into intervention revisions. Training for intervention distributors utilized a standardized "Train-the-Trainer" module to promote fidelity and scalability. Key outputs included the development of gender- and sexual orientation-neutral educational materials (a six-page prevention booklet and discreetly packaged self-test kits), a culturally and linguistically adapted data collection survey available via QR code, and refined training procedures emphasizing distributor preparedness and self-efficacy. Thematic analysis revealed critical community preferences for neutral and inclusive messaging, privacy considerations in materials packaging, and systematic distributor-recipient linkage to enhance traceability and accountability. Pilot feedback affirmed the perceived quality, cultural acceptability, and broad accessibility of the developed materials. The CBPR-informed Test-to-PrEP intervention demonstrates an innovative, scalable model for improving accessibility and acceptability of HIV self-testing and prevention information in high-incidence communities. Results underscore the importance of inclusive, culturally sensitive intervention design, systematic training approaches, and rigorous community collaboration to optimize health services delivery. Future implementation studies are ongoing to quantitatively evaluate the intervention's effectiveness on HIV testing uptake, PrEP initiation, and subsequent clinical service utilization.

Background: Pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, but structural and logistical barriers, such as stigma, transportation, and time required for appointment, can limit PrEP continuation. Home-based (HB) PrEP systems may alleviate these barriers, promoting greater adherence and persistence in PrEP care. Methods: PrEP clients were recruited from a sexual health clinic program in South Florida. Participants received self-collection kits for urine, rectal, pharyngeal, and blood specimens by mail combined with remote assessments replacing 3 quarterly in-person visits. Data on demographic characteristics, PrEP follow-up preferences, and completion rates were collected. Bivariate and logistic regression analyses identified factors influencing HB PrEP adoption and completion. Results: Of 225 clients approached, 160 (71.1%) were screened with 60 (37.5%) opting for HB PrEP. In logistical regression analysis, Black Non-Hispanic/Latino race/ethnicity and any comfort level other than “very comfortable” for specimen collection were independent negative predictors of HB PrEP election (OR 0.11; 95% CI: 0.02 to 0.67; P = 0.02 and OR 0.12–0.25; 95% CI: 0.02 to 0.89; P = 0.01–0.04, respectively). HB PrEP completion rates were 48.3%, 16.7%, and 15% for the first, second, and third follow-up. Despite initial preference for HB PrEP, most participants returned to in-clinic care citing discomfort with self-collection, logistical challenges, convenience, and reliability concerns. Conclusions: HB PrEP shows potential for improving PrEP maintenance but faces challenges in equitable uptake and persistence. Addressing logistical issues, enhancing specimen collection ease, and providing robust support systems are crucial for broader adoption and sustained PrEP care. Integrating flexible follow-up options may better accommodate the diverse needs of priority populations.

Test-to-PrEP, a bundled HIV self-test (HIVST) and PrEP educational kit was distributed to the social networks (SN) of PrEP clients using social network strategies (SNS). PrEP clients (n = 100) distributed kits to their SN members (n = 415). Multilevel analysis assessed the relationship between demographic/network characteristics and likelihood of PrEP discussions. Higher network density (e.g., the level of linkage among network members) and daily contact were associated with having previously talked about PrEP. Networks that were denser (more ties/connections), more frequently in contact, and had a relationship type that assumes greater closeness (proximal relations) resulted in greater likelihood of having had PrEP conversations. This work demonstrates the feasibility of using SNS to increase routine HIV testing and PrEP knowledge. The Test-To-PrEP SNS strategy is a promising tool to increase HIV prevention and care access to all who may benefit.

Introduction: Barriers to pre‐exposure prophylaxis (PrEP) access have limited its reach to priority populations. Community‐based mobile clinics have potential to broaden PrEP engagement. We evaluated reach and persistence for fixed and mobile clinic cohorts in Miami‐Dade County, Florida.Methods: This observational cohort study analysed data from 1896 clients engaged through our fixed or mobile clinic from August 2018 to March 2023. Services were offered at no cost to clients. The same staff and package of barrier‐lowering strategies was deployed across fixed and mobile clinic sites. Chi‐square and Fisher's exact test or the Kruskal–Wallis test were used to test for differences in characteristics across sites as well as across services sought. Kaplan–Meier curves were generated to evaluate persistence on PrEP and in care, defined as completion of at least one clinic visit (including PrEP prescribing, for PrEP persistence, or for any reason, for persistence in care) within 24 weeks of the prior visit. Cox proportional hazards models were used to evaluate risk factors for discontinuation of PrEP or clinic care by 48 weeks by gender, race, ethnicity, insurance status and site.Results: The fixed and mobile clinics reached 781 and 1109 clients, respectively, during the study period. The median client age was 35 years; the majority (70.4%) of clients were cisgender men, identified as Hispanic/Latino (62.5%) and were men who have sex with men (54.5%). The mobile clinic extended reach to a higher proportion of cisgender women (32.1% mobile vs. 12.9% for fixed clinic), Black clients (34.5% vs. 13.1%) and older clients (median 37 vs. 33 years) compared with the fixed setting. Uninsured individuals, men and those who initiated services in the mobile clinic were more likely to continue PrEP to 48 weeks (HR: 1.20, p = 0.01; HR: 2.02, pp<0.01, respectively). Persistence did not differ by race or ethnicity.Conclusions: A mobile clinic strategy for PrEP engagement can increase reach to key populations underrepresented in HIV prevention care including cisgender women and Black clients. Persistence in PrEP was increased for the mobile clinic cohort, suggesting an additional benefit to this modality beyond other barrier‐lowering strategies employed in our fixed and mobile clinics.

Primary vaccination with mRNA-1273 (100-µg) was safe and efficacious at preventing coronavirus disease 2019 (COVID-19) in the previously reported, blinded Part A of the phase 3 Coronavirus Efficacy (COVE; NCT04470427) trial in adults (≥18 years) across 99 U.S. sites. The open-label (Parts B and C) primary objectives were evaluation of long-term safety and effectiveness of primary vaccination plus a 50-µg booster dose; immunogenicity was a secondary objective. Of 29,035 open-label participants, 19,609 received boosters (mRNA-1273 [n = 9647]; placebo-mRNA-1273 [n = 9952]; placebo [n = 10] groups). Booster safety was consistent with that reported for primary vaccination. Incidences of COVID-19 and severe COVID-19 were higher during the Omicron BA.1 than Delta variant waves and boosting versus non-boosting was associated with a significant, 47.0% (95% CI : 39.0-53.9%) reduction of Omicron BA.1 incidence (24.6 [23.4 − 25.8] vs 46.4 [40.6 − 52.7]/1000 person-months). In an exploratory Cox regression model adjusted for time-varying covariates, a longer median interval between primary vaccination and boosting (mRNA-1273 [13 months] vs placebo-mRNA-1273 [8 months]) was associated with significantly lower, COVID-19 risk (24.0% [16.0% − 32.0%]) during Omicron BA.1 predominance. Boosting elicited greater immune responses against SARS-CoV-2 than primary vaccination, irrespective of prior SARS-CoV-2 infection. Primary vaccination and boosting with mRNA-1273 demonstrated acceptable safety, effectiveness and immunogenicity against COVID-19, including emergent variants.

Introduction: Improving the delivery of existing evidence‐based interventions to prevent and diagnose HIV is key to Ending the HIV Epidemic in the United States. Structural barriers in the access and delivery of related health services require municipal or state‐level policy changes; however, suboptimal implementation can be addressed directly through interventions designed to improve the reach, effectiveness, adoption or maintenance of available interventions. Our objective was to estimate the cost‐effectiveness and potential epidemiological impact of six real‐world implementation interventions designed to address these barriers and increase the scale of delivery of interventions for HIV testing and pre‐exposure prophylaxis (PrEP) in three US metropolitan areas.Methods: We used a dynamic HIV transmission model calibrated to replicate HIV microepidemics in Atlanta, Los Angeles (LA) and Miami. We identified six implementation interventions designed to improve HIV testing uptake (“Academic detailing for HIV testing,” “CyBER/testing,” “All About Me”) and PrEP uptake/persistence (“Project SLIP,” “PrEPmate,” “PrEP patient navigation”). Our comparator scenario reflected a scale‐up of interventions with no additional efforts to mitigate implementation and structural barriers. We accounted for potential heterogeneity in population‐level effectiveness across jurisdictions. We sustained implementation interventions over a 10‐year period and evaluated HIV acquisitions averted, costs, quality‐adjusted life years and incremental cost‐effectiveness ratios over a 20‐year time horizon (2023–2042).Results: Across jurisdictions, implementation interventions to improve the scale of HIV testing were most cost‐effective in Atlanta and LA (CyBER/testing cost‐saving and All About Me cost‐effective), while interventions for PrEP were most cost‐effective in Miami (two of three were cost‐saving). We estimated that the most impactful HIV testing intervention, CyBER/testing, was projected to avert 111 (95% credible interval: 110–111), 230 (228–233) and 101 (101–103) acquisitions over 20 years in Atlanta, LA and Miami, respectively. The most impactful implementation intervention to improve PrEP engagement, PrEPmate, averted an estimated 936 (929–943), 860 (853–867) and 2152 (2127–2178) acquisitions over 20 years, in Atlanta, LA and Miami, respectively.Conclusions: Our results highlight the potential impact of interventions to enhance the implementation of existing evidence‐based interventions for the prevention and diagnosis of HIV.

Background: A growing number of mobile health (mHealth) technologies are being developed to support HIV preexposure prophylaxis (PrEP) adherence and persistence; however, most tools have focused on men who have sex with men (MSM), and few are available in Spanish. To maximize the potential impact of these tools in reducing gender and racial/ethnic disparities and promoting health equity, mHealth tools tailored to Spanish-speaking people and transgender women are critically needed. Objective: The aim of this study is to adapt and tailor 2 mHealth technologies, PrEPmate and DOT Diary, to support daily PrEP adherence and persistence among Spanish-speaking MSM and English- and Spanish-speaking transgender women and to evaluate the feasibility and acceptability of these tools. Methods: PrEPmate, an interactive, bidirectional, text messaging intervention that promotes personalized communication between PrEP users and providers, and DOT Diary, a mobile app that promotes self-management of PrEP use and sexual health through an integrated electronic pill-taking and sexual activity diary, were previously developed for English-speaking MSM. We conducted 3 focus groups with 15 English- and Spanish-speaking transgender women and MSM in San Francisco and Miami to culturally tailor these tools for these priority populations. We then conducted a 1-month technical pilot among 21 participants to assess the usability and acceptability of the adapted interventions and optimize the functionality of these tools. Results: Participants in focus groups liked the “human touch” of text messages in PrEPmate and thought it would be helpful for scheduling appointments and asking questions. They liked the daily reminder messages, especially the fun facts, gender affirmations, and transgender history topics. Participants recommended changes to tailor the language and messages for Spanish-speaking and transgender populations. For DOT Diary, participants liked the adherence tracking and protection level feedback and thought the calendar functions were easy to use. Based on participant recommendations, we tailored language within the app for Spanish-speaking MSM and transgender women, simplified the sexual diary, and added motivational badges. In the technical pilot of the refined tools, mean System Usability Scale scores were 81.2/100 for PrEPmate and 76.4/100 for DOT Diary (P=.48), falling in the “good” to “excellent” range, and mean Client Satisfaction Questionnaire scores were 28.6 and 28.3 for PrEPmate and DOT Diary, respectively (maximum possible score=32). Use of both tools was high over the 1-month pilot (average of 10.5 messages received from each participant for PrEPmate; average of 17.6 times accessing the DOT Diary app), indicating good feasibility for both tools. Conclusions: Using a user-centered design approach, we culturally tailored PrEPmate and DOT Diary to support daily PrEP use among Spanish-speaking MSM and English- and Spanish-speaking transgender women. Our positive findings in a technical pilot support further testing of these mHealth interventions in an upcoming comparative effectiveness trial.