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Background: Evidence-based HIV interventions often fail to reach anticipated impact due to insufficient utilization in realworld health systems. Human-centered design (HCD) represents a novel approach in tailoring innovations to fit end-users, narrowing the gap between efficacious interventions and impact at scale. Methods:We combined a narrative literature review of HCD in HIV programs with our experience using HCD to redesign an intervention promoting patient-centered care (PCC) practices among health care workers (HCW) in Zambia. We summarize the use and results of HCD in the global HIV response and share case study insights to advance conceptualization of HCD applications. Results:The literature review identified 13 articles (representing 7 studies) on the use of HCD in HIV. All studies featured HCD hallmarks including empathy development, user-driven inquiry, ideation, and iterative refinement. HCD was applied to mHealth design, a management intervention and pre-exposure prophylaxis delivery. Our HCD application addressed a behavioral service delivery target: changing HCW patient-centered beliefs, attitudes, and practices. Through in-depth developer-user interaction, our HCD approach revealed specific HCW support for and resistance to PCC, suggesting intervention revisions to improve feasibility and acceptability and PCC considerations that could inform implementation in transferable settings. Conclusions:As both a research and implementation tool, HCD has potential to improve effective implementation of the HIV response, particularly for product development; new intervention introduction; and complex system interventions. Further research on HCD application strengths and limitations is needed. Those promoting PCC may improve implementation success by seeking out resonance and anticipating the challenges our HCD process identified.

Importance: Evidence is needed to determine COVID-19 vaccine effectiveness under real world conditions of use. Objective: To determine the effectiveness of authorized vaccines against COVID-19 in the context of substantial circulation of SARS-CoV-2 variants of concern, and identify vaccine uptake barriers. Design: We recruited cases (testing positive) and controls (testing negative) based on SARS-CoV-2 molecular diagnostic test results from 24 February-7 April 2021. Controls were individually matched to cases by age, sex, and geographic region. We identified cases and controls via random sampling within predetermined demographic strata. We conducted enrollment and administered study questionnaires via telephone-based facilitated interviews. Setting: Population-based surveillance of all SARS-CoV-2 molecular diagnostic testing reported to the California Department of Public Health. During the study period, 69% of sequenced SARS-CoV-2 isolates in California belonged to variants of concern B.1.1.7, B.1.427, or B.1.429. Participants: We enrolled 645 adults aged ≥18y, including 325 cases and 320 controls Exposures: We assessed participants' self-reported history of COVID-19 vaccine receipt (BNT162b2 and mRNA-1273). Individuals were considered fully vaccinated two weeks after second dose receipt. Main Outcomes and Measures: The primary endpoint was a positive SARS-CoV-2 molecular test result. For unvaccinated participants, we assessed willingness to receive vaccination, when eligible. We measured vaccine effectiveness via the matched odds ratio of prior vaccination, comparing cases with controls. Results: Among 325 cases, 23 (7%) and 13 (4%) received BNT162b2 and mRNA-1273, respectively; 8 (2%) were fully vaccinated with either product. Among 260 controls, 49 (19%) and 49 (19%) received BNT162b2 and mRNA-1273, respectively; 42 (16%) were fully vaccinated with either product. Among fully vaccinated individuals, vaccine effectiveness was 86% (95% confidence interval: 67-94%). Vaccine effectiveness was 66% (-69% to 93%) and 78% (23% to 94%) one week following a first and second dose, respectively. Among unvaccinated participants, 39% of those residing in rural regions and 23% of those residing in urban regions reported hesitancy to receive COVID-19 vaccines, when eligible. In contrast, vaccine hesitancy did not significantly differ by age, sex, household income, or race/ethnicity. Conclusions and Relevance: Ongoing vaccination efforts are preventing SARS-CoV-2 infection in the general population in California. Vaccine hesitancy presents a barrier to reaching coverage levels needed for herd immunity.

Background Estimates of COVID-19 vaccine effectiveness under real-world conditions, and understanding of barriers to uptake, are necessary to inform vaccine rollout. Methods We enrolled cases (testing positive) and controls (testing negative) from among the population whose SARS-CoV-2 molecular diagnostic test results from 24 February-29 April 2021 were reported to the California Department of Public Health. Participants were matched on age, sex, and geographic region. We assessed participants’ self-reported history of mRNA-based COVID-19 vaccine receipt (BNT162b2 and mRNA-1273). Participants were considered fully vaccinated two weeks after second dose receipt. Among unvaccinated participants, we assessed willingness to receive vaccination. We measured vaccine effectiveness (VE) via the matched odds ratio of prior vaccination, comparing cases with controls. Results We enrolled 1023 eligible participants aged ≥18 years. Among 525 cases, 71 (13.5%) received BNT162b2 or mRNA-1273; 20 (3.8%) were fully vaccinated with either product. Among 498 controls, 185 (37.1%) received BNT162b2 or mRNA-1273; 86 (16.3%) were fully vaccinated with either product. Two weeks after second dose receipt, VE was 87.0% (95% confidence interval: 68.6-94.6%) and 86.2% (68.4-93.9%) for BNT162b2 and mRNA-1273, respectively. Fully vaccinated participants receiving either product experienced 91.3% (79.3-96.3%) and 68.3% (27.9-85.7%) VE against symptomatic and asymptomatic infection, respectively. Among unvaccinated participants, 42.4% (159/375) residing in rural regions and 23.8% (67/281) residing in urban regions reported hesitancy to receive COVID-19 vaccination. Conclusions Authorized mRNA-based vaccines are effective at reducing documented SARS-CoV-2 infections within the general population of California. Vaccine hesitancy presents a barrier to reaching coverage levels needed for herd immunity.

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