Concerns related to the interactions between COVID-19 vaccination and cancer/cancer treatment were barriers to complete primary vaccination series among Chinese cancer patients: A multicentre cross-sectional survey.

COVID-19 vaccination is effective for cancer patients without safety concerns. However, COVID-19 vaccination hesitancy is common among cancer patients. This study investigated factors affecting primary COVID-19 vaccination series completion rate among cancer patients in China. A multicentre cross-sectional study was conducted in four Chinese cities in different geographic regions between May and June 2022. A total of 893 cancer inpatients provided written informed consent and completed the study. Logistic regression models were fitted. Among the participants, 58.8% completed the primary COVID-19 vaccination series. After adjusting for background characteristics, concerns about interactions between COVID-19 vaccination and cancers/cancer treatment (adjusted odds ratios [AOR]: 0.97, 95%CI: 0.94, 0.99) were associated with lower completion of primary vaccination series. In addition, perceived higher risk of COVID-19 infection comparing to people without cancers (AOR: 0.46, 95%CI: 0.24, 0.88), perceived a high chance of having severe consequences of COVID-19 infection (AOR: 0.68, 95%CI: 0.51, 0.91) were also associated with lower completion rate. Being suggested by significant others (AOR: 1.32, 95%CI: 1.23, 1.41) and perceived higher self-efficacy to receive COVID-19 vaccination (AOR: 1.48, 95%CI: 1.31, 1.67) were positively associated with the dependent variable. Completion rate of primary COVID-19 vaccination series was low among Chinese cancer patients. Given the large population size and their vulnerability, this group urgently needs to increase COVID-19 vaccination coverage. Removing concerns about interactions between COVID-19 vaccination and cancers, using fear appeal approach, involving significant others, and facilitating patients to make a plan to receive COVID-19 vaccination might be useful strategies.

Precise modification of the surface charge of antigen enhances vaccine immunogenicity.

Aluminum (alum) adjuvant is the most extensively used protein subunit vaccine adjuvant, and its effectiveness and safety have been widely recognized. The surface charge of the antigen determines its electrostatic adsorption to alum adjuvant, which directly affects the immune efficacy of the protein vaccine. In our study, we precisely modified its surface charge by inserting charged amino acids into the flexible region of the SARS-CoV-2 receptor-binding domain (RBD), achieving electrostatic adsorption and a site-specific anchor between the immunogen and alum adjuvant. This innovative strategy extended the bioavailability of the RBD and directionally displayed the neutralizing epitopes, thereby significantly enhancing humoral and cellular immunity. Furthermore, the required dose of antigen and alum adjuvant was greatly reduced, which improved the safety and accessibility of the protein subunit vaccine. On this basis, the wide applicability of this novel strategy to a series of representative pathogen antigens such as SARS-RBD, MERS-RBD, Mpox-M1, MenB-fHbp, and Tularemia-Tul4 was further confirmed. Charge modification of antigens provides a straightforward approach for antigenicity optimization of alum-adjuvanted vaccines, which has great potential to be adopted as a global defense against infectious diseases.

Hesitancy to Receive the Booster Doses of COVID-19 Vaccine Among Cancer Patients in China: A Multicenter Cross-Sectional Survey - Four PLADs, China, 2022.

What is already known about this topic?: Cancer patients are more vulnerable and have higher mortality rates from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) than the general population; however, coverage for booster doses of the coronavirus disease 2019 (COVID-19) vaccine was low among cancer patients in China. What is added by this report?: Overall, 32.0% and 56.4% of cancer patients from four Provincial Level Administrative Divisions (PLADs) expressed hesitancy toward the first and second booster doses, respectively. Factors negatively associated with hesitancy to receive booster doses included positive attitudes, perceived support, and higher exposure to COVID-19 vaccination information. Conversely, postvaccination fatigue was positively associated with vaccine hesitancy. What are the implications for public health practice?: Improved COVID-19 vaccination coverage is needed to promote health for cancer patients.

The safety and immunogenicity of a two-dose schedule of CoronaVac, and the immune persistence of vaccination for six months, in people living with HIV: A multicenter prospective cohort study.

Background: People living with HIV (PLWH) are more vulnerable to SARS-CoV-2. However, evidence on the immunogenicity of coronavirus disease 2019 (COVID-19) vaccines in this population is insufficient. The objective of this study is to assess the immunogenicity and safety of the two-dose schedule of Sinovac CoronaVac for 6 months postvaccination in PLWH. Methods: We conducted a multicenter prospective cohort study among PLWH and HIV-negative adults in China. Participants who received two doses of CoronaVac prior to the recruitment were allocated into two groups and followed up for 6 months. The neutralizing antibodies (nAbs), immunoglobulin G against the receptor-binding domain of the spike protein (S-IgG), and gamma-interferon (IFN-γ) were measured to assess the associations among CoronaVac immunogenicity and related factors. Adverse reactions were collected to evaluate the safety profile of vaccination. Results: A total of 203 PLWH and 100 HIV-negative individuals were enrolled. A small portion of participants reported mild or moderate adverse reactions without serious adverse events. Median nAbs level in PLWH (31.96 IU/mL, IQR: 12.34-76.40) was lower than that in the control group (46.52 IU/mL, IQR: 29.08-77.30) at the 2-4 weeks postvaccination (P=0.002), and the same trend was presented for median S-IgG titer (37.09 vs. 60.02 IU/ml) (both P <0.05). The nAbs seroconversion rate in the PLWH group was also lower than in the control group (75.86% vs. 89.00%). After then, the immune responses reduced over time in term of only 23.04% of PLWH and 36.00% of HIV-negative individuals had a positive seroconversion for nAbs at 6-month. The multivariable generalized estimating equation analysis showed that PLWH with CD4+T count≥350 cells/µL presented higher immune response than PLWH with CD4+T count <350 cells/µL in terms of antibody seroconversion and titers. The immunogenicity did not differ in participants with low or high HIV viral load. The S-antigen specific IFN-γ immunity was generally stable and had a slow attenuation in both two groups for 6 months postvaccination. Conclusion: The Sinovac CoronaVac was generally safe and immunogenic in PLWH, but the immunity response was inferior and the antibodies vanished faster compared to HIV-negative individuals. This study suggested a shorter than 6-month interval of prime-boost vaccination for PLWH to ensure a better protection.

The impact of COVID-19 non-pharmaceutical interventions on HIV care continuum in China: An interrupted time series analysis.

Background: China implemented strict non-pharmaceutical interventions to contain COVID-19 at the early stage. We aimed to evaluate the impact of COVID-19 on HIV care continuum in China. Methods: Aggregated data on HIV care continuum between 1 January 2017 and 31 December 2020 were collected from centers for disease control and prevention at different levels and major infectious disease hospitals in various regions in China. We used interrupted time series analysis to characterize temporal trend in weekly numbers of HIV post-exposure prophylaxis (PEP) prescriptions, HIV tests, HIV diagnoses, median time intervals between HIV diagnosis and antiretroviral therapy (ART) initiation (time intervals, days), ART initiations, mean CD4+ T cell counts at ART initiation (CD4 counts, cells/µL), ART collections, and missed visits for ART collection, before and after the implementation of massive NPIs (23 January to 7 April 2020). We used Poisson segmented regression models to estimate the immediate and long-term impact of NPIs on these outcomes. Findings: A total of 16,780 PEP prescriptions, 1,101,686 HIV tests, 69,659 HIV diagnoses, 63,409 time intervals and ART initiations, 61,518 CD4 counts, 1,528,802 ART collections, and 6656 missed visits were recorded during the study period. The majority of outcomes occurred in males (55·3-87·4%), 21-50 year olds (51·7-90·5%), Southwestern China (38·2-82·0%) and heterosexual transmission (47·9-66·1%). NPIs was associated with 71·5% decrease in PEP prescriptions (IRR 0·285; 95% CI 0·192-0·423), 36·1% decrease in HIV tests (0·639, 0·497-0·822), 32·0% decrease in HIV diagnoses (0·680, 0·511-0·904), 59·3% increase in time intervals (1·593, 1·270-1·997) and 17·4% decrease in CD4 counts (0·826, 0·746-0·915) in the first week during NPIs. There was no marked change in the number of ART initiations, ART collections and missed visits during the NPIs. By the end of 2020, the number of HIV tests, HIV diagnoses, time intervals, ART initiations, and CD4 counts reached expected levels, but the number of PEP prescriptions (0·523, 0·394-0·696), ART collections (0·720, 0·595-0·872), and missed visits (0·137, 0·086-0·220) were still below expected levels. With the ease of restrictions, PEP prescriptions (slope change 1·024/week, 1·012-1·037), HIV tests (1·016/week, 1·008-1·026), and CD4 counts (1·005/week, 1·001-1·009) showed a significant increasing trend. Interpretation: HIV care continuum in China was affected by the COVID-19 NPIs at various levels. Preparedness and efforts to maintain the HIV care continuum during public health emergencies should leverage collaborations between stakeholders. Funding: Natural Science Foundation of China.

Uptake of Heterologous or Homologous COVID-19 Booster Dose and Related Adverse Events Among Diabetic Patients: A Multicenter Cross-Sectional Study - China, 2022.

What is already known about this topic?: Although a third coronavirus disease 2019 (COVID-19) vaccination (booster) dose is highly recommended for diabetic patients, the vaccination behaviors and related adverse events are unclear among diabetic patients with a COVID-19 booster dose. What is added by this report?: Diabetic patients with higher postprandial blood glucose, worrying about the safety of the booster dose were less likely to get the vaccine. While having positive attitudes towards COVID-19 booster vaccination, trusting the health professionals' advice on vaccination, diabetic patients were more likely to get the booster vaccine. Furthermore, the prevalence of adverse events was not significantly different between the homologous and heterologous boosting groups. What are the implications for public health practice?: Effective measures should be taken to promote the COVID-19 booster dose uptake among diabetic patients. Health professionals should educate Chinese diabetic patients about the safety and efficacy of booster doses and continue to increase the COVID-19 booster dose vaccination coverage.

Challenges and developments in universal vaccine design against SARS-CoV-2 variants.

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had become a global concern because of its unexpectedly high pathogenicity and transmissibility. SARS-CoV-2 variants that reduce the immune protection elicited from previous vaccination or natural infection raise challenges in controlling the spread of the pandemic. The development of universal vaccines against these variants seems to be a practical solution to alleviate the physical and economic effects caused by this disease, but it is hard to achieve. In this review, we describe the high mutation rate of RNA viruses and dynamic molecular structures of SARS-CoV-2 variants in several major neutralizing epitopes, trying to answer the question of why universal vaccines are difficult to design. Understanding the biological basis of immune evasion is crucial for combating these obstacles. We then summarize several advancements worthy of further study, including heterologous prime-boost regimens, construction of chimeric immunogens, design of protein nanoparticle antigens, and utilization of conserved neutralizing epitopes. The fact that some immunogens can induce cross-reactive immune responses against heterologous coronaviruses provides hints for universal vaccine development. We hope this review can provide inspiration to current universal vaccine studies.

Lung-Targeted Transgene Expression of Nanocomplexed Ad5 Enhances Immune Response in the Presence of Preexisting Immunity.

Recombinant adenovirus serotype 5 (Ad5) vector has been widely applied in vaccine development targeting infectious diseases, such as Ebola virus disease and coronavirus disease 2019 (COVID-19). However, the high prevalence of preexisting anti-vector immunity compromises the immunogenicity of Ad5-based vaccines. Thus, there is a substantial unmet need to minimize preexisting immunity while improving the insert-induced immunity of Ad5 vectors. Herein, we address this need by utilizing biocompatible nanoparticles to modulate Ad5-host interactions. We show that positively charged human serum albumin nanoparticles ((+)HSAnp), which are capable of forming a complex with Ad5, significantly increase the transgene expression of Ad5 in both coxsackievirus-adenovirus receptor-positive and -negative cells. Furthermore, in charge- and dose-dependent manners, Ad5/(+)HSAnp complexes achieve robust (up to 227-fold higher) and long-term (up to 60 days) transgene expression in the lungs of mice following intranasal instillation. Importantly, in the presence of preexisting anti-Ad5 immunity, complexed Ad5-based Ebola and COVID-19 vaccines significantly enhance antigen-specific humoral response and mucosal immunity. These findings suggest that viral aggregation and charge modification could be leveraged to engineer enhanced viral vectors for vaccines and gene therapies.

It is time to improve the acceptance of COVID-19 vaccines among people with chronic diseases: A systematic review and meta-analysis.

This study aims to investigated COVID-19 vaccine acceptance among people with chronic diseases and the factors correlating with their vaccination hesitancy. The articles were searched in PubMed, Ovid, EMBASE, and web of science databases between December 2019 and October 2022. Cross-sectional studies, including the acceptance of the COVID-19 vaccine by patients with chronic diseases (≥18 years old), were included in this study. The outcomes included the proportion and 95% confidence interval (95% CI) of chronic disease patients willing to be vaccinated and the odds ratio (OR) and 95% CI of correlating factors. The source of heterogeneity was analyzed through meta-regression and subgroup analysis. We included 31 studies involving 57 875 patients with chronic disease. The overall COVID-19 vaccine acceptance among patients with chronic disease was 0.65 (95% CI, 0.59-0.72). The acceptance among the elderly patients was 0.53 (95% CI, 0.26-0.80). South America had the highest COVID-19 vaccine acceptance rate and Asia the lowest, while on a country level, the United Kingdom had the highest acceptance rate among patients with chronic diseases. People with rheumatic immune diseases had the lowest rate of COVID-19 vaccine acceptance. Concerns about vaccine safety had a statistically different effect on acceptance. Overall, the health systems ought to focus on educating specific groups of individuals on the benefits of COVID-19 vaccination and addressing safety concerns.

COVID-19 Vaccination Uptake Among a Nationwide Sample of People Living With HIV During the Early Phase of Vaccine Rollout in China.

People living with HIV (PLWH), if infected with Coronavirus Disease 2019 (COVID-19), had an increased risk of mortality compared to people without HIV infection. They are considered as a priority group to receive COVID-19 vaccination. This cross-sectional online survey investigated the prevalence of and factors associated with COVID-19 vaccination uptake among 2740 PLWH aged 18-65 years in eight Chinese metropolitan cities between January and February 2021. As validated by requesting participants to send an image of receipt hiding personal identification, 6.2% of PLWH had taken up COVID-19 vaccination. Participants living in cities where individuals could make an appointment to receive COVID-19 vaccination reported significantly higher uptake than those living in cities without such allowance (11.0 vs. 2.9%, p < 0.001). Being a member of priority groups to receive vaccination, concerning about the side effects of COVID-19 vaccination and its interaction with HIV treatment, and exposing to information on the Internet/social media supporting PLWH to receive COVID-19 vaccination were significantly associated with COVID-19 vaccination uptake in both groups of participants. Receiving advice from the staff of community-based organizations supporting COVID-19 vaccination was associated with higher uptake among participants living in cities where individuals could make an appointment to receive such vaccination, while a shortage in COVID-19 vaccine supply was associated with a lower uptake among participants living in other cities. Our findings presented a snapshot of COVID-19 vaccination uptake among PLWH in the early phase of vaccine rollout in China. It provided a knowledge basis to formulate interventions promoting COVID-19 vaccination for PLWH.

Correction: Reasons for COVID-19 Vaccine Hesitancy Among Chinese People Living With HIV/AIDS: Structural Equation Modeling Analysis.

[This corrects the article DOI: 10.2196/33995.].

Reasons for COVID-19 Vaccine Hesitancy Among Chinese People Living With HIV/AIDS: Structural Equation Modeling Analysis.

BACKGROUND: Many countries and organizations recommended people living with HIV/AIDS (PLWHA) receive the COVID-19 vaccine. However, vaccine hesitancy still exists and becomes a barrier for promoting COVID-19 vaccination among PLWHA. OBJECTIVE: This study aims to investigate factors that contributed to COVID-19 vaccine hesitancy among PLWHA. METHODS: The study used a multicenter cross-sectional design and an online survey mode. We recruited PLWHA aged 18-65 years from 5 metropolitan cities in China between January 2021 and February 2021. Participants completed an online survey through Golden Data, a widely used encrypted web-based survey platform. Multiple linear regression models were used to assess the background characteristics in relation to COVID-19 vaccine hesitancy, and structural equation modeling was performed to assess the relationships among perceived benefits, perceived risks, self-efficacy, subjective norms, and COVID-19 vaccine hesitancy. RESULTS: Among 1735 participants, 41.61% (722/1735) reported COVID-19 vaccine hesitancy. Older age, no other vaccinations in the past 3 years, and having chronic disease history were positively associated with COVID-19 vaccine hesitancy. Structural equation modeling revealed a direct relationship of perceived benefits, perceived risks, and subjective norms with self-efficacy and vaccine hesitancy and an indirect relationship of perceived benefits, perceived risks, and subjective norms with vaccine hesitancy. Moreover, self-efficacy toward COVID-19 vaccination was low. PLWHA had concerns of HIV disclosure during COVID-19 vaccination. Family member support could have an impact on COVID-19 vaccination decision-making. CONCLUSIONS: COVID-19 vaccine hesitancy was high among PLWHA in China. To reduce COVID-19 vaccine hesitancy, programs and strategies should be adopted to eliminate the concerns for COVID-19 vaccination, disseminate accurate information on the safety and efficacy of the COVID-19 vaccine, encourage family member support for COVID-19 vaccination, and improve PLWHA's trust of medical professionals.

Prevalence and Determinants of COVID-19 Vaccination Uptake Were Different between Chinese Diabetic Inpatients with and without Chronic Complications: A Cross-Sectional Survey.

The health of people with chronic diabetes mellitus (DM) complications will worsen following coronavirus disease 2019 (COVID-19) infection. This cross-sectional study compared perceptions and factors related to COVID-19 vaccination uptake between subgroups of DM inpatients with and without chronic complications in China. A multivariate logistic regression model was used for data analysis. Of the 645 participants, those without any complications reported significantly higher uptake of at least one dose of COVID-19 vaccination (43.2% versus 11.2%, p < 0.001). For people with chronic DM complications, a perception of higher risk and severer consequences of COVID-19 infection, a belief that doctors would suggest they receive COVID-19 vaccination, and a belief that relatives' vaccination uptake would influence their own decision to receive a COVID-19 vaccination were all associated with higher COVID-19 vaccination uptake. For their counterparts without chronic complications, a perception of severer consequences of COVID-19 infection, a belief that receiving COVID-19 vaccination could reduce the risk of infection, and a belief that relatives' vaccination uptake would influence their own decision to receive a COVID-19 vaccination were all associated with higher COVID-19 vaccination uptake. Concerns about the safety and the side effects of vaccination were negatively associated with COVID-19 vaccination uptake in both groups of DM patients. Different strategies might be applied to promote COVID-19 vaccination uptake in DM patients with and without chronic complications.

COVID-19 Vaccination Uptake Among a Nationwide Sample of People Living With HIV During the Early Phase of Vaccine Rollout in China

People living with HIV (PLWH), if infected with Coronavirus Disease 2019 (COVID-19), had an increased risk of mortality compared to people without HIV infection. They are considered as a priority group to receive COVID-19 vaccination. This cross-sectional online survey investigated the prevalence of and factors associated with COVID-19 vaccination uptake among 2740 PLWH aged 18–65 years in eight Chinese metropolitan cities between January and February 2021. As validated by requesting participants to send an image of receipt hiding personal identification, 6.2% of PLWH had taken up COVID-19 vaccination. Participants living in cities where individuals could make an appointment to receive COVID-19 vaccination reported significantly higher uptake than those living in cities without such allowance (11.0 vs. 2.9%, p < 0.001). Being a member of priority groups to receive vaccination, concerning about the side effects of COVID-19 vaccination and its interaction with HIV treatment, and exposing to information on the Internet/social media supporting PLWH to receive COVID-19 vaccination were significantly associated with COVID-19 vaccination uptake in both groups of participants. Receiving advice from the staff of community-based organizations supporting COVID-19 vaccination was associated with higher uptake among participants living in cities where individuals could make an appointment to receive such vaccination, while a shortage in COVID-19 vaccine supply was associated with a lower uptake among participants living in other cities. Our findings presented a snapshot of COVID-19 vaccination uptake among PLWH in the early phase of vaccine rollout in China. It provided a knowledge basis to formulate interventions promoting COVID-19 vaccination for PLWH.

Immunogenicity and safety of heterologous versus homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine: a systematic review.

BACKGROUND: Heterologous prime-boost with ChAdOx1 nCoV-19 vector vaccine (ChAd) and a messenger RNA vaccine (BNT or mRNA-1273) has been widely facilitating mass coronavirus disease 2019 (COVID-19) immunisation. This review aimed to synthesize immunogenicity and reactogenicity of heterologous immunisations with ChAd and BNT (mRNA-1273) vaccine compared with homologous ChAd or BNT (mRNA-1273) immunisation. METHODS: PubMed, Web of Science, and Embase databases were searched from inception to March 7, 2022. Immunogenicity involving serum antibodies against different SAS-CoV-2 fragments, neutralizing antibody, or spike-specific T cells response were compared. Any, local and systemic reactions were pooled by meta-analysis for comparison. RESULTS: Of 14,571 records identified, 13 studies (3024 participants) were included for analysis. Compared with homologous BNT/BNT vaccination, heterologous ChAd/BNT schedule probably induced noninferior anti-spike protein while higher neutralizing antibody and better T cells response. Heterologous ChAd/BNT (mRNA-1273) immunisation induced superior anti-spike protein and higher neutralizing antibody and better T cells response compared with homologous ChAd/ChAd vaccination. Heterologous ChAd/BNT (mRNA-1273) had similar risk of any reaction (RR = 1.30, 95% CI: 0.86-1.96) while higher risk of local reactions (RR = 1.65, 95% CI: 1.27-2.15) and systemic reactions (RR = 1.49, 95% CI: 1.17-1.90) compared with homologous ChAd/ChAd vaccination. There was a higher risk of local reactions (RR = 1.16, 95% CI: 1.03-1.31) in heterologous ChAd/BNT (mRNA-1273) vaccination compare with homologous BNT/BNT but a similar risk of any reaction (RR = 1.03, 95% CI: 0.79-1.34) and systemic reactions (RR = 0.89, 95% CI: 0.60-1.30). CONCLUSIONS: Heterologous ChAd/BNT schedule induced at least comparable immunogenicity compared with homologous BNT/BNT and better immunogenicity compared with homologous ChAd/ChAd vaccination. The synthetical evidence supported the general application of heterologous prime-boost vaccination using ChAd and BNT COVID-19 vaccines.

The COVID-19 Vaccination Behavior and Correlates in Diabetic Patients: A Health Belief Model Theory-Based Cross-Sectional Study in China, 2021.

The population with diabetes is more susceptible to severe acute respiratory syndrome-associated coronavirus (SARS-CoV)-2, and have a significantly higher coronavirus disease-2019 (COVID-19) mortality rate. Previous studies have shown low willingness for the COVID-19 vaccination, and there are limited reports on the behavior and relevance of the COVID-19 vaccination. This study aimed to determine the uptake behavior and associated factors of the COVID-19 vaccine. In our cross-sectional questionnaire-based clinical study, 645 diabetes patients affiliated with two affiliated hospitals of Changzhi Medical College completed the questionnaire between June to October 2021. The health belief model (HBM) was used in examining factors influencing vaccination behavior. After adjusting for covariates with significant differences in social background characteristics, a multivariable logistic regression was used to determine predictors related to uptake in COVID-19 vaccination. A total of 162 vaccinated and 483 unvaccinated eligible diabetic patients were recruited. Patients who believed that the COVID-19 syndrome is severe (aOR3.67, 95%CI 1.88-7.17; p < 0.001), believe that vaccination can significantly reduce the risk of SARS-Cov-2 infection (aOR3.48, 95%CI 1.80-6.73; p < 0.001), believe that vaccination is beneficial to themselves and others (aOR 4.53, 95%CI 1.71-11.99; p = 0.002), think that relatives' vaccination status has a positive impact on their vaccination behavior (aOR 5.68, 95%CI 2.83-11.39; p < 0.001), and were more likely to be vaccinated; worrying about the adverse health effects of COVID-19 vaccination (aOR 0.18, 95%CI 0.09-0.35; p < 0.001) was negatively correlated with COVID-19 vaccination behavior. Health care workers should provide targeted informative interventions based on the safety and protective effects theory of HBM to improve vaccination behavior in patients with diabetes.

Medication Non-adherence and Condomless Anal Intercourse Increased Substantially During the COVID-19 Pandemic Among MSM PrEP Users: A Retrospective Cohort Study in Four Chinese Metropolises.

Background: The coronavirus disease (COVID-19) pandemic has impacted HIV prevention strategies globally. However, changes in pre-exposure prophylaxis (PrEP) adherence and HIV-related behaviors, and their associations with medication adherence among men who have sex with men (MSM) PrEP users remain unclear since the onset of the COVID-19 pandemic. Methods: A Retrospective Cohort Study of HIV-negative MSM PrEP users was conducted in four Chinese metropolises from December 2018 to March 2020, assessing the changes in PrEP adherence and HIV-related behaviors before and during the COVID-19. The primary outcome was poor PrEP adherence determined from self-reported missing at least one PrEP dose in the previous month. We used multivariable logistic regression to determine factors correlated with poor adherence during COVID-19. Results: We enrolled 791 eligible participants (418 [52.8%] in daily PrEP and 373 [47.2%] in event-driven PrEP). Compared with the data conducted before the COVID-19, the proportion of PrEP users decreased from 97.9 to 64.3%, and the proportion of poor PrEP adherence increased from 23.6 to 50.1% during the COVID-19 [odds ratio (OR) 3.24, 95% confidence interval (CI) 2.62-4.02]. While the percentage of condomless anal intercourse (CAI) with regular partners (11.8 vs. 25.7%) and with casual partners (4.4 vs. 9.0%) both significantly increased. The proportion of those who were tested for HIV decreased from 50.1 to 25.9%. Factors correlated with poor PrEP adherence during the COVID-19 included not being tested for HIV (adjusted odds ratio [aOR] = 1.38 [95% CI: 1.00, 1.91]), using condoms consistently with regular partners (vs. never, aOR = 2.19 [95% CI: 1.16, 4.13]), and being married or cohabitating with a woman (vs. not married, aOR = 3.08 [95% CI: 1.60, 5.95]). Conclusions: Increased poor PrEP adherence and CAI along with the decrease in HIV testing can lead to an increase in HIV acquisition and drug resistance to PrEP. Targeted interventions are needed to improve PrEP adherence and HIV prevention strategies.

Monetary incentives and peer referral in promoting secondary distribution of HIV self-testing among men who have sex with men in China: A randomized controlled trial.

BACKGROUND: Digital network-based methods may enhance peer distribution of HIV self-testing (HIVST) kits, but interventions that can optimize this approach are needed. We aimed to assess whether monetary incentives and peer referral could improve a secondary distribution program for HIVST among men who have sex with men (MSM) in China. METHODS AND FINDINGS: Between October 21, 2019 and September 14, 2020, a 3-arm randomized controlled, single-blinded trial was conducted online among 309 individuals (defined as index participants) who were assigned male at birth, aged 18 years or older, ever had male-to-male sex, willing to order HIVST kits online, and consented to take surveys online. We randomly assigned index participants into one of the 3 arms: (1) standard secondary distribution (control) group (n = 102); (2) secondary distribution with monetary incentives (SD-M) group (n = 103); and (3) secondary distribution with monetary incentives plus peer referral (SD-M-PR) group (n = 104). Index participants in 3 groups were encouraged to order HIVST kits online and distribute to members within their social networks. Members who received kits directly from index participants or through peer referral links from index MSM were defined as alters. Index participants in the 2 intervention groups could receive a fixed incentive ($3 USD) online for the verified test result uploaded to the digital platform by each unique alter. Index participants in the SD-M-PR group could additionally have a personalized peer referral link for alters to order kits online. Both index participants and alters needed to pay a refundable deposit ($15 USD) for ordering a kit. All index participants were assigned an online 3-month follow-up survey after ordering kits. The primary outcomes were the mean number of alters motivated by index participants in each arm and the mean number of newly tested alters motivated by index participants in each arm. These were assessed using zero-inflated negative binomial regression to determine the group differences in the mean number of alters and the mean number of newly tested alters motivated by index participants. Analyses were performed on an intention-to-treat basis. We also conducted an economic evaluation using microcosting from a health provider perspective with a 3-month time horizon. The mean number of unique tested alters motivated by index participants was 0.57 ± 0.96 (mean ± standard deviation [SD]) in the control group, compared with 0.98 ± 1.38 in the SD-M group (mean difference [MD] = 0.41),and 1.78 ± 2.05 in the SD-M-PR group (MD = 1.21). The mean number of newly tested alters motivated by index participants was 0.16 ± 0.39 (mean ± SD) in the control group, compared with 0.41 ± 0.73 in the SD-M group (MD = 0.25) and 0.57 ± 0.91 in the SD-M-PR group (MD = 0.41), respectively. Results indicated that index participants in intervention arms were more likely to motivate unique tested alters (control versus SD-M: incidence rate ratio [IRR = 2.98, 95% CI = 1.82 to 4.89, p-value < 0.001; control versus SD-M-PR: IRR = 3.26, 95% CI = 2.29 to 4.63, p-value < 0.001) and newly tested alters (control versus SD-M: IRR = 4.22, 95% CI = 1.93 to 9.23, p-value < 0.001; control versus SD-M-PR: IRR = 3.49, 95% CI = 1.92 to 6.37, p-value < 0.001) to conduct HIVST. The proportion of newly tested testers among alters was 28% in the control group, 42% in the SD-M group, and 32% in the SD-M-PR group. A total of 18 testers (3 index participants and 15 alters) tested as HIV positive, and the HIV reactive rates for alters were similar between the 3 groups. The total costs were $19,485.97 for 794 testers, including 450 index participants and 344 alter testers. Overall, the average cost per tester was $24.54, and the average cost per alter tester was $56.65. Monetary incentives alone (SD-M group) were more cost-effective than monetary incentives with peer referral (SD-M-PR group) on average in terms of alters tested and newly tested alters, despite SD-M-PR having larger effects. Compared to the control group, the cost for one more alter tester in the SD-M group was $14.90 and $16.61 in the SD-M-PR group. For newly tested alters, the cost of one more alter in the SD-M group was $24.65 and $49.07 in the SD-M-PR group. No study-related adverse events were reported during the study. Limitations include the digital network approach might neglect individuals who lack internet access. CONCLUSIONS: Monetary incentives alone and the combined intervention of monetary incentives and peer referral can promote the secondary distribution of HIVST among MSM. Monetary incentives can also expand HIV testing by encouraging first-time testing through secondary distribution by MSM. This social network-based digital approach can be expanded to other public health research, especially in the era of the Coronavirus Disease 2019 (COVID-19). TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR) ChiCTR1900025433.