Programme science in action: lessons from an observational study of HIV prevention programming for key populations in Lusaka, Zambia.

INTRODUCTION: Optimizing uptake of pre-exposure prophylaxis (PrEP) for individuals at risk of HIV acquisition has been challenging despite clear scientific evidence and normative guidelines, particularly for key populations (KPs) such as men who have sex with men (MSM), female sex workers (FSWs), transgender (TG) people and persons who inject drugs (PWID). Applying an iterative Programme Science cycle, building on the effective programme coverage framework, we describe the approach used by the Centre for Infectious Disease Research in Zambia (CIDRZ) to scale up PrEP delivery and address inequities in PrEP access for KP in Lusaka, Zambia. METHODS: In 2019, CIDRZ partnered with 10 local KP civil society organizations (CSOs) and the Ministry of Health (MOH) to offer HIV services within KP-designated community safe spaces. KP CSO partners led KP mobilization, managed safe spaces and delivered peer support; MOH organized clinicians and clinical commodities; and CIDRZ provided technical oversight. In December 2021, we introduced a community-based intervention focused on PrEP delivery in venues where KP socialize. We collected routine programme data from September 2019 to June 2023 using programme-specific tools and the national electronic health record. We estimated the before-after effects of our intervention on PrEP uptake, continuation and equity for KP using descriptive statistics and interrupted time series regression, and used mixed-effects regression to estimate marginal probabilities of PrEP continuity. RESULTS: Most (25,658) of the 38,307 (67.0%) Key Population Investment Fund beneficiaries were reached with HIV prevention services at community-based venues. In total, 23,527 (61.4%) received HIV testing services, with 15,508 (65.9%) testing HIV negative and found PrEP eligible, and 15,241 (98.3%) initiating PrEP. Across all programme quarters and KP types, PrEP uptake was >90%. After introducing venue-based PrEP delivery, PrEP uptake (98.7% after vs. 96.5% before, p < 0.001) and the number of initiations (p = 0.014) increased significantly. The proportion of KP with ≥1 PrEP continuation visit within 6 months of initiation was unchanged post-intervention (46.7%, 95% confidence interval [CI]: 45.7%, 47.6%) versus pre-intervention (47.2%, 95% CI: 45.4%, 49.1%). CONCLUSIONS: Applying Programme Science principles, we demonstrate how decentralizing HIV prevention services to KP venues and safe spaces in partnership with KP CSOs enabled successful community-based PrEP delivery beyond the reach of traditional facility-based services.

Evaluating a multifaceted implementation strategy and package of evidence-based interventions based on WHO PEN for people living with HIV and cardiometabolic conditions in Lusaka, Zambia: protocol for the TASKPEN hybrid effectiveness-implementation stepped wedge cluster randomized trial.

BACKGROUND: Despite increasing morbidity and mortality from non-communicable diseases (NCD) globally, health systems in low- and middle-income countries (LMICs) have limited capacity to address these chronic conditions, particularly in sub-Saharan Africa (SSA). There is an urgent need, therefore, to respond to NCDs in SSA, beginning by applying lessons learned from the first global response to any chronic disease-HIV-to tackle the leading cardiometabolic killers of people living with HIV (PLHIV). We have developed a feasible and acceptable package of evidence-based interventions and a multi-faceted implementation strategy, known as "TASKPEN," that has been adapted to the Zambian setting to address hypertension, diabetes, and dyslipidemia. The TASKPEN multifaceted implementation strategy focuses on reorganizing service delivery for integrated HIV-NCD care and features task-shifting, practice facilitation, and leveraging HIV platforms for NCD care. We propose a hybrid type II effectiveness-implementation stepped-wedge cluster randomized trial to evaluate the effects of TASKPEN on clinical and implementation outcomes, including dual control of HIV and cardiometabolic NCDs, as well as quality of life, intervention reach, and cost-effectiveness. METHODS: The trial will be conducted in 12 urban health facilities in Lusaka, Zambia over a 30-month period. Clinical outcomes will be assessed via surveys with PLHIV accessing routine HIV services, and a prospective cohort of PLHIV with cardiometabolic comorbidities nested within the larger trial. We will also collect data using mixed methods, including in-depth interviews, questionnaires, focus group discussions, and structured observations, and estimate cost-effectiveness through time-and-motion studies and other costing methods, to understand implementation outcomes according to Proctor's Outcomes for Implementation Research, the Consolidated Framework for Implementation Research, and selected dimensions of RE-AIM. DISCUSSION: Findings from this study will be used to make discrete, actionable, and context-specific recommendations in Zambia and the region for integrating cardiometabolic NCD care into national HIV treatment programs. While the TASKPEN study focuses on cardiometabolic NCDs in PLHIV, the multifaceted implementation strategy studied will be relevant to other NCDs and to people without HIV. It is expected that the trial will generate new insights that enable delivery of high-quality integrated HIV-NCD care, which may improve cardiovascular morbidity and viral suppression for PLHIV in SSA. This study was registered at ClinicalTrials.gov (NCT05950919).

The Social Construction of Aging Among a Clinic-Based Population and Their Healthcare Workers in Zambia.

Objectives: We sought to understand the social construction of aging in a clinic-based population, with and without HIV, to address gaps in care for older individuals living with HIV in Zambia. Methods: Our exploratory qualitative study included 36 in-depth interviews with clinic clients and four focus group discussions with 36 professional and lay healthcare workers providing services to the clients. We identified themes based on social construction theory. Results: At the individual level, aging was multidimensional, perceived both as an achievement in the HIV era and as a period of cognitive, physical, and economic decline. In social interactions, older individuals were often stereotyped and treated as helpless, poor, and "witches." Those living with HIV faced the additional stigma of being labeled as promiscuous. Some of the participants living without HIV refused to take daily medication for non-communicable diseases to avoid being mistaken for taking antiretroviral therapy for HIV. Older individuals wanted quality healthcare and family support to address the intersectional stigma of aging, poverty, and chronic illness. Conclusion: Multifaceted interventions are required to combat age-related prejudice, intersectional stigma, and discriminatory practices, particularly for people living with HIV.

An exploration of multi-level factors affecting routine linkage to HIV care in Zambia's PEPFAR-supported treatment program in the treat all era.

Multiple steps from HIV diagnosis to treatment initiation and confirmed engagement with the health system are required for people living with HIV to establish full linkage to care in the modern treat all era. We undertook a qualitative study to gain an in-depth understanding of the impeding and enabling factors at each step of this linkage pathway. In-depth interviews were conducted with fifty-eight people living with HIV recruited from ten routine HIV care settings supported by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) in Lusaka, Zambia. Using a semi-structured interview guide informed by an established conceptual framework for linkage to care, questions explored the reasons behind late, missed, and early linkage into HIV treatment, as well as factors influencing the decision to silently transfer to a different clinic after an HIV diagnosis. We identified previously established and intersecting barriers of internal and external HIV-related stigma, concerns about ART side effects, substance use, uncertainties for the future, and a perceived lack of partner and social support that impeded linkage to care at every step of the linkage pathway. However, we also uncovered newer themes specific to the current test and treat era related to the rapidity of ART initiation and insufficient patient-centered post-test counseling that appeared to exacerbate these well-known barriers, including callous health workers and limited time to process a new HIV diagnosis before treatment. Long travel distance to the clinic where they were diagnosed was the most common reason for silently transferring to another clinic for treatment. On the other hand, individual resilience, quality counseling, patient-centered health workers, and a supportive and empathetic social network mitigated these barriers. These findings highlight potential areas for strengthening linkage to care and addressing early treatment interruption and silent transfer in the test and treat era in Zambia.

Mixed methods approach to examining the implementation experience of a phone-based survey for a SARS-CoV-2 test-negative case-control study in California.

OBJECTIVE: To describe the implementation of a test-negative design case-control study in California during the Coronavirus Disease 2019 (COVID-19) pandemic. STUDY DESIGN: Test-negative case-control study. METHODS: Between February 24, 2021 - February 24, 2022, a team of 34 interviewers called 38,470 Californians, enrolling 1,885 that tested positive for SARS-CoV-2 (cases) and 1,871 testing negative for SARS-CoV-2 (controls) for 20-minute telephone survey. We estimated adjusted odds ratios for answering the phone and consenting to participate using mixed effects logistic regression. We used a web-based anonymous survey to compile interviewer experiences. RESULTS: Cases had 1.29-fold (95% CI: 1.24-1.35) higher adjusted odds of answering the phone and 1.69-fold (1.56-1.83) higher adjusted odds of consenting to participate compared to controls. Calls placed from 4pm to 6pm had the highest adjusted odds of being answered. Some interviewers experienced mental wellness challenges interacting with participants with physical (e.g., food, shelter, etc.) and emotional (e.g., grief counseling) needs, and enduring verbal harassment from individuals called. CONCLUSIONS: Calls placed during afternoon hours may optimize response rate when enrolling controls to a case-control study during a public health emergency response. Proactive check-ins and continual collection of interviewer experience(s) and may help maintain mental wellbeing of investigation workforce. Remaining adaptive to the dynamic needs of the investigation team is critical to a successful study, especially in emergent public health crises, like that represented by the COVID-19 pandemic.

Comparison of patient exit interviews with unannounced standardised patients for assessing HIV service delivery in Zambia: a study nested within a cluster randomised trial.

OBJECTIVES: To compare unannounced standardised patient approach (eg, mystery clients) with typical exit interviews for assessing patient experiences in HIV care (eg, unfriendly providers, long waiting times). We hypothesise standardised patients would report more negative experiences than typical exit interviews affected by social desirability bias. SETTING: Cross-sectional surveys in 16 government-operated HIV primary care clinics in Lusaka, Zambia providing antiretroviral therapy (ART). PARTICIPANTS: 3526 participants aged ≥18 years receiving ART participated in the exit surveys between August 2019 and November 2021. INTERVENTION: Systematic sample (every nth file) of patients in clinic waiting area willing to be trained received pre-visit training and post-visit interviews. Providers were unaware of trained patients. OUTCOME MEASURES: We compared patient experience among patients who received brief training prior to their care visit (explaining each patient experience construct in the exit survey, being anonymous, without manipulating behaviour) with those who did not undergo training on the survey prior to their visit. RESULTS: Among 3526 participants who participated in exit surveys, 2415 were untrained (56% female, median age 40 (IQR: 32-47)) and 1111 were trained (50% female, median age 37 (IQR: 31-45)). Compared with untrained, trained patients were more likely to report a negative care experience overall (adjusted prevalence ratio (aPR) for aggregate sum score: 1.64 (95% CI: 1.39 to 1.94)), with a greater proportion reporting feeling unwelcome by providers (aPR: 1.71 (95% CI: 1.20 to 2.44)) and witnessing providers behaving rude (aPR: 2.28 (95% CI: 1.63 to 3.19)). CONCLUSION: Trained patients were more likely to identify suboptimal care. They may have understood the items solicited better or felt empowered to be more critical. We trained existing patients, unlike studies that use 'standardised patients' drawn from outside the patient population. This low-cost strategy could improve patient-centred service delivery elsewhere. TRIAL REGISTRATION NUMBER: Assessment was nested within a parent study; www.pactr.org registered the parent study (PACTR202101847907585).

Patterns of person-centred communications in public HIV clinics: a latent class analysis using the Roter interaction analysis system.

INTRODUCTION: Poor client-provider communication is a critical barrier to long-term retention in care among people living with HIV. However, standardized assessments of this key metric are limited in Africa. We used the Roter Interaction Analysis System (RIAS) to quantitatively characterize patterns of person-centred communication (PCC) behaviours in Zambia. METHODS: We enrolled pairs of people living with HIV making routine HIV follow-up visit and their providers at 24 Ministry of Health-facilities supported by the Centre for Infectious Disease Research in Zambia in Lusaka province between August 2019 and November 2021. Client-provider encounters were audio-recorded and coded using RIAS by trained research staff. We performed latent class analysis to identify interactions with distinctive patterns of provider PCC behaviours (i.e. rapport building, person-centred counselling, PCC micropractices [e.g. brief empathy statements], assessing barriers to care, shared decision-making and leveraging discretionary power) and compared their distribution across client, provider, interaction and facility characteristics. RESULTS: We enrolled 478 people living with HIV and 139 providers (14% nurses, 73.6% clinical officers, 12.3% were medical officers). We identified four distinct profiles: (1) "Medically Oriented Interaction, Minimal PCC Behaviours" (47.6% of interactions) was characterized by medical discussion, minimal psychosocial/non-medical talk and low use of PCC behaviours; (2) "Balanced Medical/Non-medical Interaction, Low PCC Behaviours" (21.0%) was characterized by medical and non-medical discussion but limited use of other PCC behaviours; (3) "Medically Oriented Interaction, Good PCC Behaviours" (23.9%) was characterized by medically oriented discussion, more information-giving and increased use of PCC behaviours; and (4) "Highly person-centred Interaction" (7.5%) was characterized by both balanced medical/non-medical focus and the highest use of PCC behaviours. Nurse interactions were more likely to be characterized by more PCC behaviours (i.e. Class 3 or 4) (44.8%), followed by medical officers (33.9%) and clinical officers (27.3%) (p = 0.031). Longer interactions were also more likely to integrate more PCC behaviours (p < 0.001). CONCLUSIONS: PCC behaviours are relatively uncommon in HIV care in Zambia, and often limited to brief rapport-building statements and PCC micropractices. Strengthening PCC, such as shared decision-making and leveraging discretionary power to better accommodate client needs and preferences, may be an important strategy for improving the quality in HIV treatment programmes.

Provider perspectives on patient-centredness: participatory formative research and rapid analysis methods to inform the design and implementation of a facility-based HIV care improvement intervention in Zambia.

INTRODUCTION: Implementation of patient-centred care (PCC) practices in HIV treatment depends on healthcare workers' (HCWs) perceptions of the acceptability, appropriateness and feasibility of such practices (e.g. use of intentional, metric-driven activities to improve patient experiences). METHODS: We applied rapid, rigorous formative research methods to refine a PCC intervention for future trial. In 2018, we conducted focus group discussions (FGDs) with 46 HCWs purposefully selected from two pilot sites. We elicited HCW perceptions of HIV service delivery, HCW motivation and perceived value of patient experience measures intended to improve PCC. FGDs utilized participatory methods to understand HCW responses to patient-reported care engagement challenges and Scholl's PCC Framework principles (e.g. seeing a patient as a unique person), enablers (e.g. care coordination) and activities (e.g. patient involvement). Our rapid analysis used analytic memos, thematic analysis, research team debriefs and HCW feedback to inform time-sensitive trial implementation. RESULTS: While HCWs nearly universally identified with and supported principles of PCC in both facilities, they raised practical barriers given the practice environment. HCWs described motivation to help patients, attached value to seeing positive health outcomes and the importance of teamwork. However, HCWs reported challenges with enablers needed to deliver PCC. HCWs cited a work culture characterized by differential power dynamics between cadres and departments restricting HCW autonomy and resource access. Barriers included inflexibility in accommodating individual patient needs due to high patient volumes, limited human resources, laboratory capacity, infrastructure and skills translating patient perspectives into practice. HCW motivation was negatively influenced by encounters with "difficult patients," and feeling "unappreciated" by management, resulting in cognitive dissonance between HCW beliefs and behaviours. However, the enactment of PCC values also occurred. Results suggested that PCC interventions should reduce practice barriers, highlighting the value of mentors who could help HCWs dynamically engage with health system constraints, to facilitate PCC. CONCLUSIONS: While HCWs perceived PCC principles as acceptable, they did not think it universally appropriate or feasible given the practice environment. Participatory and rapid methods provided timely insight that PCC interventions must provide clear and effective systems enabling PCC activities by measuring and mitigating relational and organizational constraints amenable to change such as inter-cadre coordination.

A mixed methods study on men's and women's tuberculosis care journeys in Lusaka, Zambia-Implications for gender-tailored tuberculosis health promotion and case finding strategies.

Men and women with undiagnosed tuberculosis (TB) in high burden countries may have differential factors influencing their healthcare seeking behaviors and access to TB services, which can result in delayed diagnoses and increase TB-related morbidity and mortality. A convergent, parallel, mixed-methods study design was used to explore and evaluate TB care engagement among adults (≥18 years) with newly diagnosed, microbiologically-confirmed TB attending three public health facilities in Lusaka, Zambia. Quantitative structured surveys characterized the TB care pathway (time to initial care-seeking, diagnosis, and treatment initiation) and collected information on factors influencing care engagement. Multinomial multivariable logistic regression was used to determine predicted probabilities of TB health-seeking behaviors and determinants of care engagement. Qualitative in-depth interviews (IDIs; n = 20) were conducted and analyzed using a hybrid approach to identify barriers and facilitators to TB care engagement by gender. Overall, 400 TB patients completed a structured survey, of which 275 (68.8%) and 125 (31.3%) were men and women, respectively. Men were more likely to be unmarried (39.3% and 27.2%), have a higher median daily income (50 and 30 Zambian Kwacha [ZMW]), alcohol use disorder (70.9% [AUDIT-C score ≥4] and 31.2% [AUDIT-C score ≥3]), and a history of smoking (63.3% and 8.8%), while women were more likely to be religious (96.8% and 70.8%) and living with HIV (70.4% and 36.0%). After adjusting for potential confounders, the probability of delayed health-seeking ≥4 weeks after symptom onset did not differ significantly by gender (44.0% and 36.2%, p = 0.14). While the top reasons for delayed healthcare-seeking were largely similar by gender, men were more likely to report initially perceiving their symptoms as not being serious (94.8% and 78.7%, p = 0.032), while women were more likely to report not knowing the symptoms of TB before their diagnosis (89.5% and 74.4%; p = 0.007) and having a prior bad healthcare experience (26.4% and 9.9%; p = 0.036). Notably, women had a higher probability of receiving TB diagnosis ≥2 weeks after initial healthcare seeking (56.5% and 41.0%, p = 0.007). While men and women reported similar acceptability of health-information sources, they emphasized different trusted messengers. Also, men had a higher adjusted probability of stating that no one influenced their health-related decision making (37.9% and 28.3%, p = 0.001). In IDIs, men recommended TB testing sites at convenient community locations, while women endorsed an incentivized, peer-based, case-finding approach. Sensitization and TB testing strategies at bars and churches were highlighted as promising approaches to reach men and women, respectively. This mixed-methods study found important differences between men and women with TB in Zambia. These differences suggest the need for gender-tailored TB health promotion, including addressing harmful alcohol use and smoking among men, and sensitizing HCWs to prolonged delays in TB diagnosis among women, and also using gender-specific approaches as part of community-based, active case-finding strategies to improve TB diagnosis in high burden settings.

Estimating potential silent transfer using baseline viral load measures among people presenting as new to HIV care in Lusaka, Zambia: a cross-sectional study.

OBJECTIVES: To estimate potential silent transfer using baseline viral load measures among individuals presenting as new to HIV care in routine HIV clinical settings in Lusaka, Zambia. DESIGN: Cross-sectional study. SETTING: Two large, urban government-operated health facilities supported by the Centre for Infectious Disease Research in Zambia. PARTICIPANTS: A total of 248 participants with an incident positive HIV rapid test. OUTCOME MEASURES: The primary outcome measure was HIV viral suppression at baseline (i.e., potential silent transfer), defined as having a viral load ≤1000 RNA copies(c)/mL at the time of initiating HIV care. We also examined viral suppression at ≤60 c/mL. METHODS: We surveyed and measured baseline HIV viral load as part of the national recent infection testing algorithm among people living with HIV (PLWH) presenting as new to care. Using mixed effects Poisson regression, we identified characteristics among PLWH associated with potential silent transfer. RESULTS: Among the 248 PLWH included, 63% were women with median age of 30, and 66 (27% (66/248)) had viral suppression at ≤1000 c/mL and 53 (21% (53/248)) at ≤60 c/mL thresholds, respectively. Participants aged 40+ years had a significantly higher adjusted prevalence of potential silent transfer (adjusted prevalence ratio (aPR): 2.10; 95% CI: 2.08, 2.13) compared with participants aged 18-24 years. Participants reporting no formal education had a significantly higher adjusted prevalence of potential silent transfer (aPR: 1.63; 95% CI: 1.52, 1.75) compared with those completing primary education. Among 57 potential silent transfers who completed a survey, 44 (77%) indicated having tested positive previously at ≥1 of 38 clinics in Zambia. CONCLUSIONS: The high proportion of PLWH with potential silent transfer points to clinic shopping and/or co-enrolment at multiple care sites simultaneously, suggesting an opportunity to improve care continuity at the time of HIV care entry.

Correction: Evaluation of kidney function among people living with HIV initiating antiretroviral therapy in Zambia.

[This corrects the article DOI: 10.1371/journal.pgph.0000124.].

Cross-sectional study to assess depression among healthcare workers in Lusaka, Zambia during the COVID-19 pandemic.

OBJECTIVES: We sought to assess depression among healthcare workers (HCWs) in the context of COVID-19 in Lusaka Province, Zambia. DESIGN: This cross-sectional study is nested within a larger study, the Person-Centred Public Health for HIV Treatment in Zambia (PCPH), a cluster-randomised trial to assess HIV care and outcomes. SETTING: The research was conducted in 24 government-run health facilities from 11 August to 15 October 2020 during the first wave of the COVID-19 pandemic in Lusaka, Zambia. PARTICIPANTS: We used convenience sampling to recruit HCW participants who were previously enrolled in the PCPH study, had more than 6 months' experience working at the facility and were voluntarily willing to participate. PRIMARY OUTCOME MEASURES: We implemented the well-validated 9-question Patient Health Questionnaire (PHQ-9) to assess HCW depression. We used mixed-effects, adjusted Poisson regression to estimate the marginal probability of HCWs experiencing depression that may warrant intervention (PHQ-9 score ≥5) by healthcare facility. RESULTS: We collected PHQ-9 survey responses from 713 professional and lay HCWs. Overall, 334 (46.8%, 95% CI 43.1%, 50.6%) HCWs recorded a PHQ-9 score ≥5, indicating the need for further assessment and potential intervention for depression. We identified significant heterogeneity across facilities and observed a greater proportion of HCWs with symptoms of depression in facilities providing COVID-19 testing and treatment services. CONCLUSIONS: Depression may be a concern for a large proportion of HCWs in Zambia. Further work to understand the magnitude and aetiologies of depression among HCWs in the public sector is needed to design effective prevention and treatment interventions to meet the needs for mental health support and to minimise poor health outcomes.

Real-world uptake of COVID-19 vaccination among individuals expressing vaccine hesitancy: A registry-linkage study.

INTRODUCTION: Uptake of COVID-19 vaccination remains suboptimal in the United States and other settings. Though early reports indicated that a strong majority of people were interested in receiving the COVID-19 vaccine, the association between vaccine intention and uptake is not yet fully understood. Ourobjective was todescribe predictors of vaccine uptake, and estimate the sensitivity, specificity, and predictive values of self-reported COVID-19 vaccine status compared to a comprehensive statewide COVID-19 vaccine registry. METHODS: A cohort of California residents that received a molecular test for SARS-CoV-2 infection during 24 February-5 December 2021 were enrolled in a telephone-administered survey. Survey participants were matched with records in a statewide immunization registry. Cox proportional hazards model were used to compare time to vaccination among those unvaccinated at survey enrollment by self-reported COVID-19 vaccination intention. RESULTS: Among 864 participants who were unvaccinated at the time of interview, 272 (31%) had documentation of receipt of COVID-19 vaccination at a later date; including 194/423 (45.9%) who had initially reported being willing to receive vaccination, 41/185 (22.2%) who reported being unsure about vaccination, and 37/278 (13.3%) who reported unwillingness to receive vaccination.Adjusted hazard ratios (aHRs) for registry-confirmed COVID-19 vaccination were 0.49 (95% confidence interval: 0.32-0.76) and 0.21 (0.12-0.36) for participants expressing uncertainty and unwillingness to receive vaccination, respectively, as compared with participants who reported being willing to receive vaccination. Time to vaccination was shorter among participants from higher-income households (aHR = 3.30 [2.02-5.39]) and who reported co-morbidities or immunocompromising conditions (aHR = 1.54 [1.01-2.36]).Sensitivity of self-reported COVID-19 vaccination status was 82% (80-85%) overall, and 98% (97-99%) among those referencing vaccination records; specificity was 87% (86-89%). CONCLUSION: Willingness to receive COVID-19 vaccination was an imperfect predictor of real-world vaccine uptake. Improved messaging about COVID-19 vaccination regardless of previous SARS-CoV-2 infection status may help improve uptake.

Waning of 2-Dose BNT162b2 and mRNA-1273 Vaccine Effectiveness Against Symptomatic SARS-CoV-2 Infection Accounting for Depletion-of-Susceptibles Bias.

Concerns about the duration of protection conferred by coronavirus disease 2019 (COVID-19) vaccines have arisen in postlicensure evaluations. "Depletion of susceptibles," a bias driven by differential accrual of infection among vaccinated and unvaccinated individuals, may obscure vaccine effectiveness (VE) estimates, hindering interpretation. We enrolled California residents who received molecular SARS-CoV-2 tests in a matched, test-negative design, case-control study to estimate VE of mRNA-based COVID-19 vaccines between February 23 and December 5, 2021. We analyzed waning protection following 2 vaccine doses using conditional logistic regression models. Additionally, we used data from a population-based serological study to adjust for "depletion-of-susceptibles" bias and estimated VE for 3 doses, by time since second dose receipt. Pooled VE of BNT162b2 and mRNA-1273 against symptomatic SARS-CoV-2 infection was 91.3% (95% confidence interval (CI): 83.8, 95.4) at 14 days after second-dose receipt and declined to 50.8% (95% CI: 19.7, 69.8) at 7 months. Adjusting for depletion-of-susceptibles bias, we estimated VE of 53.2% (95% CI: 23.6, 71.2) at 7 months after primary mRNA vaccination series. A booster dose of BN162b2 or mRNA-1273 increased VE to 95.0% (95% CI: 82.8, 98.6). These findings confirm that observed waning of protection is not attributable to epidemiologic bias and support ongoing efforts to administer additional vaccine doses to mitigate burden of COVID-19.

Receipt of COVID-19 and seasonal influenza vaccines in California (USA) during the 2021-2022 influenza season.

BACKGROUND: Despite lower circulation of influenza virus throughout 2020-2022 during the COVID-19 pandemic, seasonal influenza vaccination has remained a primary tool to reduce influenza-associated illness and death. The relationship between the decision to receive a COVID-19 vaccine and/or an influenza vaccine is not well understood. METHODS: We assessed predictors of receipt of 2021-2022 influenza vaccine in a secondary analysis of data from a case-control study enrolling individuals who received SARS-CoV-2 testing. We used mixed effects logistic regression to estimate factors associated with receipt of seasonal influenza vaccine. We also constructed multinomial adjusted marginal probability models of being vaccinated for COVID-19 only, seasonal influenza only, or both as compared with receipt of neither vaccination. RESULTS: Among 1261 eligible participants recruited between 22 October 2021-22 June 2022, 43% (545) were vaccinated with both seasonal influenza vaccine and >1 dose of a COVID-19 vaccine, 34% (426) received >1 dose of a COVID-19 vaccine only, 4% (49) received seasonal influenza vaccine only, and 19% (241) received neither vaccine. Receipt of >1 COVID-19 vaccine dose was associated with seasonal influenza vaccination (adjusted odds ratio [aOR]: 3.72; 95% confidence interval [CI]: 2.15-6.43); this association was stronger among participants receiving >1 COVID-19 booster dose (aOR = 16.50 [10.10-26.97]). Compared with participants testing negative for SARS- CoV-2 infection, participants testing positive had lower odds of receipt of 2021-2022 seasonal influenza vaccine (aOR = 0.64 [0.50-0.82]). CONCLUSIONS: Recipients of a COVID-19 vaccine were more likely to receive seasonal influenza vaccine during the 2021-2022 season. Factors associated with individuals' likelihood of receiving COVID-19 and seasonal influenza vaccines will be important to account for in future studies of vaccine effectiveness against both conditions. Participants who tested positive for SARS-CoV-2 in our sample were less likely to have received seasonal influenza vaccine, suggesting an opportunity to offer influenza vaccination before or after a COVID-19 diagnosis.

Immediate and early engagement of same-day antiretroviral therapy initiation among newly diagnosed people living with HIV in urban Zambia: a retrospective cohort study

Introduction: as Zambia moves towards attaining human immunodeficiency virus (HIV) epidemic control, it is clear significant efforts are required to facilitate achievement of UNAIDS treatment targets by 2030. To accelerate progress towards global target of 95% of people living with HIV (PLHIV) knowing their status, country is promoting community-based HIV testing and same-day antiretroviral therapy (ART) initiation. However, there are uncertainties of how this strategy affects immediate and early engagement in program settings. To address this research gap, we analysed a programme data of PLHIV newly diagnosed and initiated on ART in community and health facility settings. Study objectives were to estimate the proportion of immediate engagement, to estimate early engagement among newly diagnosed PLHIV and, to examine factors independently associated with immediate and early engagement in care among newly diagnosed PLHIV offered same-day ART initiation. Methods: we included all newly diagnosed PLHIV aged 18 years or older and provided same-day ART initiation between October 2018 and January 2019 in Lusaka District. Immediate engagement was estimated as proportion of newly diagnosed PLHIV who visited the health facility at least once within 14 days after same-day ART initiation, whereas early engagement as proportion of newly diagnosed PLHIV active 6 months after same-day ART initiation. Pearson's chi-squared test was used to assess association of outcomes with key background characteristics. Results: of 12,777 newly diagnosed PLHIV who initiated same day ART 7,943 (62%) were tested and initiated in the community. Overall, 6,257 (49%) engaged within 14 days (median 15, IQR: 13-37). Older individuals (36-49 years) were more likely to be engaged at 14 days (aRR 1.29; 95%CI 1.06 - 1.18; p<0.001) and retained at 6 months (aRR1.27;95%CI 1.21-1.34P<0.001) whilst risk of attrition at 6 months was highest in younger ages (18-24 years) (aRR 0.79;95 %CI 0.76-0.82; p<0.001). Conclusion: to adequately address the HIV epidemic targeted engagement approaches are required particularly in the younger ages.

Sexual and reproductive health services during outbreaks, epidemics, and pandemics in sub-Saharan Africa: a literature scoping review.

BACKGROUND: The COVID-19 pandemic could worsen adolescent sexual and reproductive health (ASRH). We sought evidence on the indirect impacts of previous infectious disease epidemics and the current COVID-19 pandemic on the uptake of ASRH in sub-Saharan Africa (SSA) to design relevant digital solutions. METHODS: We undertook a literature scoping review to synthesize evidence on the indirect impacts of COVID-19 on ASRH in SSA per the Arksey and O'Malley framework and PRISMA reporting guidelines. We conducted the search on PubMed, Embase, Google Scholar, and ResearchGate in June and November 2020. We included all peer-reviewed, English-language primary studies on the indirect impacts of infectious disease epidemics on the uptake of sexual and reproductive health (SRH) in SSA. RESULTS: We included 21 of 42 identified studies. Sixteen studies (76.2%) quantitatively assessed utilization and access to SRH during epidemics. Five studies (2 [9.6%] qualitative and 3 [14.3%] mixed methods) explored factors affecting SRH services. All studies focused on adult populations, most often on labor and delivery (n = 13 [61.9%]) and family planning (n = 8 [38.1%]) outcomes. Although we sought out to assess all outbreaks, epidemics, and pandemics, the only relevant studies took place during the West African Ebola pandemic (n = 17 [80.9%]) and COVID-19 pandemic (n = 4 [19.0%]). One study (4.8%) highlighted adolescent-specific outcomes and condom use. Most studies found declined access to and utilization of facility delivery, antenatal care, family planning, and HIV care. One study noted an increase in adolescent pregnancies. However, other studies noted similar, or even increasing trends in access to and utilization of other SRH services (family planning visits; HIV diagnosis; ART initiation) during epidemics. Barriers to SRH uptake included factors such as a reduced ability to pay for care due to lost income, travel restrictions, and fear of infection. Supply-side barriers included lack of open facilities, workers, commodities, and services. Community-based peer delivery systems, telemedicine, and transport services improved SRH uptake. CONCLUSION: Access to SRH services during epidemics among adolescents and young people in SSA is understudied. We found that no studies focused on SRH outcomes of abortion, emergency contraception, sexually transmitted infections, or cervical cancer. To improve access to and utilization of SRH during pandemics, we recommend the following; in terms of research, key standardized SRH indicators should be included in routine data collection, routine data should be disaggregated by age, gender, and geography to understand gaps in ASRH service delivery, and additional rigorous epidemiological and social-behavioral studies should be conducted. On implementation, community-based peer delivery systems and telemedicine, internet-based, and other technological solutions may better reach adolescent and young people in SSA.

Pilot Implementation of a User-Driven, Web-Based Application Designed to Improve Sexual Health Knowledge and Communication Among Young Zambians: Mixed Methods Study.

BACKGROUND: Digital health interventions show promise in improving the uptake of HIV services among adolescents and young people aged 15 to 24 years in sub-Saharan Africa. OBJECTIVE: This study aimed to pilot-test a theory-based, empirically grounded web-based application designed to increase condom-related knowledge, sexual and reproductive health (SRH) communication, and healthier choices among young Zambians. METHODS: We conducted a pre-post quasi-experimental evaluation of the user-driven Be in the Know Zambia (BITKZ) web application using web-based surveys and in-depth interviews (IDIs) on the phone. We enrolled participants using social media advertisements. Our final analysis set comprised 46.04% (749/1627) of participants in the intervention group (which received the BITKZ link) and 53.96% (878/1627) of participants in the comparison group (no intervention). We collected survey data at study enrollment (baseline) and 5 weeks after the first enrollment in each group. Approximately 85% (637/749) of BITKZ users completed a user survey, of whom 9.3% (59/637) participated in IDIs. We calculated the time interfacing with BITKZ using the application log files. We conducted descriptive analyses to describe baseline characteristics and the user experience. At the endline, we assessed association using a t test and adjusted logistic regression for binary outcomes and ordinal regression for ordered outcomes, conditioning on age, sex, marital status, and employment status. We used adjusted average treatment effects (aATE) to assess the effects of BITKZ intervention. We conducted rapid matrix analyses of IDI transcripts in Microsoft Excel, sorting the data by theme, gender, and experience rating. RESULTS: Users rated BITKZ highly (excellent: 352/609, 57.8%; good: 218/609, 35.8%). At the endline, the intervention group had a higher level of knowledge related to condoms (adjusted odds ratio [aOR]: 1.35, 95% CI 1.06-1.69) and on wearing condoms correctly (aOR: 1.23, 95% CI 1.02-1.49). Those who had full-time employment had increased odds of knowing how to wear condoms correctly (aOR: 1.67, 95% CI 1.06-2.63) compared with those who reported being unemployed, as did men when compared with women (aOR: 1.92, 95% CI 1.59-2.31). Those in the intervention group were more likely to score higher for intention to test for sexually transmitted infections (STIs; aATE 0.21; P=.01) and HIV (aATE 0.32; P=.05), as well as for resisting peer pressure (aATE 2.64; P=.02). IDIs corroborated increased knowledge on correct condom use among men and female condoms among women, awareness of STIs and testing, and resistance to peer pressure. Interviewees provided examples of more open SRH communication with partners and peers and of considering, adopting, and influencing others to adopt healthier behaviors. CONCLUSIONS: Despite the high baseline awareness of SRH among Zambian adolescents and young people with internet access, BITKZ provided modest gains in condom-related knowledge, resistance to peer pressure, and intention to test for STIs and HIV.

Effectiveness of Face Mask or Respirator Use in Indoor Public Settings for Prevention of SARS-CoV-2 Infection - California, February-December 2021.

The use of face masks or respirators (N95/KN95) is recommended to reduce transmission of SARS-CoV-2, the virus that causes COVID-19 (1). Well-fitting face masks and respirators effectively filter virus-sized particles in laboratory conditions (2,3), though few studies have assessed their real-world effectiveness in preventing acquisition of SARS-CoV-2 infection (4). A test-negative design case-control study enrolled randomly selected California residents who had received a test result for SARS-CoV-2 during February 18-December 1, 2021. Face mask or respirator use was assessed among 652 case-participants (residents who had received positive test results for SARS-CoV-2) and 1,176 matched control-participants (residents who had received negative test results for SARS-CoV-2) who self-reported being in indoor public settings during the 2 weeks preceding testing and who reported no known contact with anyone with confirmed or suspected SARS-CoV-2 infection during this time. Always using a face mask or respirator in indoor public settings was associated with lower adjusted odds of a positive test result compared with never wearing a face mask or respirator in these settings (adjusted odds ratio [aOR] = 0.44; 95% CI = 0.24-0.82). Among 534 participants who specified the type of face covering they typically used, wearing N95/KN95 respirators (aOR = 0.17; 95% CI = 0.05-0.64) or surgical masks (aOR = 0.34; 95% CI = 0.13-0.90) was associated with significantly lower adjusted odds of a positive test result compared with not wearing any face mask or respirator. These findings reinforce that in addition to being up to date with recommended COVID-19 vaccinations, consistently wearing a face mask or respirator in indoor public settings reduces the risk of acquiring SARS-CoV-2 infection. Using a respirator offers the highest level of personal protection against acquiring infection, although it is most important to wear a mask or respirator that is comfortable and can be used consistently.

Mitigating the effects of COVID-19 on HIV treatment and care in Lusaka, Zambia: a before-after cohort study using mixed effects regression.

INTRODUCTION: The Zambian Ministry of Health (MoH) issued COVID-19 mitigation guidance for HIV care immediately after the first COVID-19 case was confirmed in Zambia on 18 March 2020. The Centre for Infectious Disease Research in Zambia implemented MoH guidance by: 1) extending antiretroviral therapy (ART) refill duration to 6 multi-month dispensation (6MMD) and 2) task-shifting communication and mobilisation of those in HIV care to collect their next ART refill early. We assessed the impact of COVID-19 mitigation guidance on HIV care 3 months before and after guidance implementation. METHODS: We reviewed all ART pharmacy visit data in the national HIV medical record for PLHIV in care having ≥1 visit between 1 January-30 June 2020 at 59 HIV care facilities in Lusaka Province, Zambia. We undertook a before-after evaluation using mixed-effects Poisson regression to examine predictors and marginal probability of early clinic return (pharmacy visit >7 days before next appointment), proportion of late visit (>7 days late for next appointment) and probability of receiving a 6MMD ART refill. RESULTS: A total of 101 371 individuals (64% female, median age 39) with 130 486 pharmacy visits were included in the analysis. We observed a significant increase in the adjusted prevalence ratio (4.63; 95% CI 4.45 to 4.82) of early return before compared with after guidance implementation. Receipt of 6MMD increased from a weekly mean of 47.9% (95% CI 46.6% to 49.2%) before to 73.4% (95% CI 72.0% to 74.9%) after guidance implementation. The proportion of late visits (8-89 days late) was significantly higher before (18.8%, 95% CI17.2%to20.2%) compared with after (15.1%, 95% CI13.8%to16.4%) guidance implementation . CONCLUSIONS: Timely issuance and implementation of COVID-19 mitigation guidance involving task-shifted patient communication and mobilisation alongside 6MMD significantly increased early return to ART clinic, potentially reducing interruptions in HIV care during a global public health emergency.