Lessons learnt from daily oral PrEP delivery to inform national planning for PrEP ring introduction for women in low-income and middle-income countries: a qualitative inquiry of international stakeholders.

INTRODUCTION: Some African countries plan to introduce and scale-up new long-acting pre-exposure prophylaxis methods (LA-PrEP), like the monthly dapivirine vaginal ring (PrEP ring) and injectable cabotegravir. National costed implementation plans, roadmaps for successful product implementation, are often overlooked. International stakeholders engaged in oral PrEP planning, introduction and scale-up are an information resource of lessons learned to advise LA-PrEP planning. We consulted such international stakeholders and synthesised oral PrEP lessons to inform the development of a costed rollout plan template for LA-PrEP. METHODS: From selected global health organisations (five international nongovernmental, four donor, four university/research and two multilateral), we interviewed 27 representatives based in America, Europe, Asia and Africa about strategic content and approaches for LA-PrEP policy, programming and implementation. We conducted a thematic analysis of the interview data for implementation considerations. RESULTS: From the consultations, we identified six implementation themes for LA-PrEP introduction and scale-up: (1) ethically increasing choice and avoiding coercion; (2) de-stigmatising PrEP by focusing on preference rather than risk-based eligibility; (3) integrating LA-PrEP into services that are more woman-oriented, couple-oriented and family-oriented, and providing private spaces for LA-PrEP delivery; (4) de-medicalising delivery of relatively safe products (eg, PrEP ring); (5) constructing multilevel, nuanced communication strategies to address measured and perceived product efficacy and effectiveness; and (6) devising product-agnostic, modular approaches to service delivery. Despite the widespread emphasis on integration, few stakeholders offered empirical examples of successful integration approaches and frameworks. CONCLUSIONS: Lessons learnt from stakeholder participants suggest standardised and modular processes can improve efficiencies in LA-PrEP planning and implementation. Tiered communication strategies addressing product efficacy and effectiveness will improve clients' and providers' efficacy in making informed decisions. Integration is important for LA-PrEP delivery, but data on empirical integration approaches and frameworks is minimal: further research in this discipline is needed.

Evaluating Dual Process Decision-Making Along the PrEP Consumer Journey: New Insights for Supporting PrEP Use.

With the rise of new and emerging Pre-Exposure Prophylaxis (PrEP) modalities, greater attention is needed to better understand how people who could benefit from PrEP make decisions to initiate, stop, pause, or switch PrEP regimens. In this study we borrow from the field of consumer research to create a consumer-derived PrEP Consumer Journey Model that describes key decision-making touchpoints a PrEP consumer moves through within and outside of a clinical context. Using in-depth interviews (n = 29) with gay and bisexual men who have sex with men, we evaluate which system 1 (emotional) and system 2 (cognitive) attributes are used for decision-making at different touchpoints along the PrEP Consumer Journey. Our results suggest system 1 attributes, such as feeling protected, reducing anxiety, enhancing pleasure, social norms, and taking ownership over health were more salient when consumers moved from pre-contemplation to information gathering, as well as evaluating post-uptake experience. System 2 attributes, including cost, side effects, dosing schedule, and sexual frequency, were present throughout the PrEP Consumer Journey, but particularly influential in the information gathering stage and when pausing, switching, or opting out of PrEP. We contend the PrEP Consumer Journey, and our findings related to decision-making, can help orient medical providers to anticipated patient concerns around PrEP use and ultimately provide more supportive and engaging PrEP counseling and services.

The Index of Engagement in PrEP Care: Evaluation of Psychometric Properties and Predictive Potential.

BACKGROUND: The Index of Engagement in HIV Care is a psychometrically valid 10-item self-report measure with predictive power to classify individuals to higher and lower odds of disengaging from HIV care. Given high rates of disengagement from preexposure prophylaxis (PrEP) care, we adapted the HIV Index to PrEP. METHODS: We evaluated the psychometric properties of the PrEP-Index in a cross-sectional validation among PrEP-eligible persons seen in an HIV Prevention Program and conducted exploratory analysis to assess its potential utility as a prognostic tool. The PrEP Index contains 10 items with answers ranging from (1) not at all to (5) extremely. Possible PrEP-Index scores ranged from 10 to 50, with higher sum scores representing higher levels of engagement. RESULTS: Study participants were cisgender men who have sex with men, and racially and ethnically diverse (non-Hispanic White = 39.2%). Factor analyses supported the 1-factor structure. Among 347 respondents, 118 individuals (34.0%) were available for predictive validity analysis. The PrEP Index score was positively associated with visit constancy at 6 months ( = 0.2261; 95% confidence interval: 0.0363 to 0.4051). Finally, a patient scoring 45 on the PrEP-Index will be classified as not returning within 6 months (sensitivity = 0.73, specificity = 0.65). CONCLUSIONS: The PrEP-Index is a psychometrically valid and reliable scale that demonstrates potential utility in identifying individuals at elevated risk of falling out of PrEP care by 6 months, the time point by which the majority of PrEP discontinuations occur. The PrEP-Index could be a useful clinical prognostic tool to allow for efficient resource targeting by clinics to improve engagement in PrEP care.

Implementation and resource needs for long-acting PrEP in low- and middle-income countries: a scoping review.

INTRODUCTION: Several low- and middle-income countries (LMICs) are preparing to introduce long-acting pre-exposure prophylaxis (LAP). Amid multiple pre-exposure prophylaxis (PrEP) options and constrained funding, decision-makers could benefit from systematic implementation planning and aligned costs. We reviewed national costed implementation plans (CIPs) to describe relevant implementation inputs and activities (domains) for informing the costed rollout of LAP. We assessed how primary costing evidence aligned with those domains. METHODS: We conducted a rapid review of CIPs for oral PrEP and family planning (FP) to develop a consensus of implementation domains, and a scoping review across nine electronic databases for publications on PrEP costing in LMICs between January 2010 and June 2022. We extracted cost data and assessed alignment with the implementation domains and the Global Health Costing Consortium principles. RESULTS: We identified 15 implementation domains from four national PrEP plans and FP-CIP template; only six were in all sources. We included 66 full-text manuscripts, 10 reported LAP, 13 (20%) were primary cost studies-representing seven countries, and none of the 13 included LAP. The 13 primary cost studies included PrEP commodities (n = 12), human resources (n = 11), indirect costs (n = 11), other commodities (n = 10), demand creation (n = 9) and counselling (n = 9). Few studies costed integration into non-HIV services (n = 5), above site costs (n = 3), supply chains and logistics (n = 3) or policy and planning (n = 2), and none included the costs of target setting, health information system adaptations or implementation research. Cost units and outcomes were variable (e.g. average per person-year). DISCUSSION: LAP planning will require updating HIV prevention policies, technical assistance for logistical and clinical support, expanding beyond HIV platforms, setting PrEP achievement targets overall and disaggregated by method, extensive supply chain and logistics planning and support, as well as updating health information systems to monitor multiple PrEP methods with different visit schedules. The 15 implementation domains were variable in reviewed studies. PrEP primary cost and budget data are necessary for new product introduction and should match implementation plans with financing. CONCLUSIONS: As PrEP services expand to include LAP, decision-makers need a framework, tools and a process to support countries in planning the systematic rollout and costing for LAP.

Determinants of Willingness to Use PrEP Among Gay and Bisexual Men in China Before Implementation: A Structural Equation Modeling Assessment.

With the recent endorsement of PrEP by the Chinese government, research is urgently needed to better understand factors impacting PrEP uptake among gay, bisexual, and other men who have sex with men (GBMSM) in China. This study examined willingness to use PrEP for HIV prevention among GBMSM in China through structural equation modeling. We examined the relationship among PrEP-related attitudes, subjective norms, PrEP-related knowledge and beliefs about medicines and willingness to use PrEP. The analysis showed a good fit between the data and both the measurement model (RMSEA = 0.060) and structural model (RMSEA = 0.054). Knowledge, attitudes, and subjective norms were significantly related to intention to use PrEP, whereas the effect of general beliefs about medicines was insignificant. These effect mechanisms point to the importance of designing interventions to support PrEP uptake that target knowledge, enhance positive attitudes about PrEP within social networks, and build positive social norms around PrEP among sexually active GBMSM.

The Long-Acting Cabotegravir Tail as an Implementation Challenge: Planning for Safe Discontinuation.

The long-acting feature of cabotegravir, an integrase-inhibitor highly effective in preventing acquisition of HIV in adolescents and adults, is both its greatest strength and a challenge to its implementation. Cab-LA is administered at 8-week intervals (after an initial loading dose) but has a long, variable drug "tail" that may leave users vulnerable to future drug resistance if they contract HIV during this critical period. The potential for cab-LA to meaningfully contribute to ending the HIV Epidemic is hindered by, among other factors, limited resources to guide patients and providers on how to safely discontinue injections. We suggest three key strategies to overcome this specific challenge: (1) Comprehensive patient education and counseling about the drug tail; (2) Training and coaching PrEP care teams, including clinical and non-clinical staff, on communication around the tail; (3) Adherence support strategies, including monitoring of cabotegravir drug levels after discontinuation, for a personalized medicine approach to safe discontinuation.

Get2PrEP: An Electronic Medical Record Laboratory Comment Increased Safe Sex Counseling But Not Preexposure Prophylaxis Services at a Large Urban Academic Medical Center in Northern Manhattan.

BACKGROUND: HIV preexposure prophylaxis (PrEP) remains underutilized despite its efficacy and potential population impact. Achieving PrEP's full potential depends on providers who are knowledgeable and comfortable prescribing it to individuals at risk of acquiring HIV. Previous educational interventions targeting provider-related uptake barriers have had limited success. We designed and tested an electronic medical record (EMR) interpretative comment to improve the delivery of PrEP. METHODS: An EMR comment provided information on PrEP eligibility and referral resources to providers delivering positive chlamydia and gonorrhea results. Positive test results for bacterial sexually transmitted infections before intervention (January 1, 2019-August 23, 2019) and after intervention (August 24, 2019-December 31, 2019) were identified. A retrospective chart review was conducted to ascertain provider documentation of PrEP discussions or provision, HIV prevention discussions, and HIV screening. Pretest-posttest analysis was performed to compare the provision of PrEP and HIV prevention services. RESULTS: We reviewed 856 preintervention encounters spanning 8 months and 461 postencounters spanning 4 months. Patient demographics were comparable. We observed an increase in provider documentation of safe sex and condom counseling (odds ratios [ORs], 1.2 [95% confidence interval {CI}, 1.07-1.18] and 1.11 [95% CI, 1.05-1.17], respectively), and the absence of any HIV prevention discussion decreased (OR, 0.85; 95% CI, 0.80-0.90), but not HIV screening or PrEP documentation. CONCLUSIONS: We demonstrated that an EMR laboratory comment had a modest effect on increasing risk reduction counseling, although not HIV screening or PrEP prescriptions. Future strategies to encourage provider delivery of sexual health services may benefit from more targeted strategies that combine behavioral and information technology approaches.

A mixed methods study evaluating acceptability of a daily COVID-19 testing regimen with a mobile-app connected, at-home, rapid antigen test: Implications for current and future pandemics.

BACKGROUND: Widespread use of at-home rapid COVID-19 antigen tests has been proposed as an important public health intervention to interrupt chains of transmission. Antigen tests may be preferred over PCR because they provide on-demand results for relatively low cost and can identify people when they are most likely to be infectious, particularly when used daily. Yet the extent to which a frequent antigen testing intervention will result in a positive public health impact for COVID-19 will depend on high acceptability and high adherence to such regimens. METHODS: We conducted a mixed-methods study assessing acceptability of and adherence to a daily at-home mobile-app connected rapid antigen testing regimen among employees of a US-based media company. Acceptability was assessed across seven domains of the Theoretical Framework of Acceptability. RESULTS: Among 31 study participants, acceptability of the daily testing intervention was generally high, with participants reporting high perceived effectiveness, intervention coherence, and self-efficacy; positive affective attitude; acceptable degree of burden and opportunity cost; and assessing the intervention as ethical. 71% reported a preference to test daily using an at-home antigen test than weekly employment-based PCR. Mean adherence to the 21-day testing regimen was 88% with 43% of participants achieving 100% adherence, 48% testing at least every other day, and 10% testing less than every other day. CONCLUSIONS: Despite overall high acceptability and adherence, we identified three implementation challenges that must be addressed for frequent serial testing for COVID-19 to be implemented at scale and have a positive public health impact. First, users need guidance on how and when to adapt testing frequencies to different epidemiological conditions. Second, users and institutions need guidelines for how to safely store and share test results. Third, implementation of serial testing strategies must prioritize health equity and protect those most vulnerable to COVID-19.

Antibody evasion by SARS-CoV-2 Omicron subvariants BA.2.12.1, BA.4 and BA.5.

SARS-CoV-2 Omicron subvariants BA.2.12.1 and BA.4/5 have surged notably to become dominant in the United States and South Africa, respectively1,2. These new subvariants carrying further mutations in their spike proteins raise concerns that they may further evade neutralizing antibodies, thereby further compromising the efficacy of COVID-19 vaccines and therapeutic monoclonals. We now report findings from a systematic antigenic analysis of these surging Omicron subvariants. BA.2.12.1 is only modestly (1.8-fold) more resistant to sera from vaccinated and boosted individuals than BA.2. However, BA.4/5 is substantially (4.2-fold) more resistant and thus more likely to lead to vaccine breakthrough infections. Mutation at spike residue L452 found in both BA.2.12.1 and BA.4/5 facilitates escape from some antibodies directed to the so-called class 2 and 3 regions of the receptor-binding domain3. The F486V mutation found in BA.4/5 facilitates escape from certain class 1 and 2 antibodies but compromises the spike affinity for the viral receptor. The R493Q reversion mutation, however, restores receptor affinity and consequently the fitness of BA.4/5. Among therapeutic antibodies authorized for clinical use, only bebtelovimab retains full potency against both BA.2.12.1 and BA.4/5. The Omicron lineage of SARS-CoV-2 continues to evolve, successively yielding subvariants that are not only more transmissible but also more evasive to antibodies.

Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variants.

Background: SARS-CoV-2 antigen-based tests are well-calibrated to infectiousness and have a critical role to play in the COVID-19 public health response. We report the development and performance of a unique lateral flow immunoassay (LFA). Methods: Combinations of several monoclonal antibodies targeting multiple antigenic sites on the SARS-CoV-2 nucleocapsid protein (NP) were isolated, evaluated, and chosen for the development of a LFA termed CoV-SCAN (BioMedomics, Inc.). Clinical point-of-care studies in symptomatic and asymptomatic individuals were conducted to evaluate positive predictive agreement (PPA) and negative predictive agreement (NPA) with RT-PCR as comparator. Results: In laboratory testing, CoV-SCAN detected 14 recombinant N-proteins of SARS-CoV-2 variants with sensitivity in the range of 0.2-3.2 ng/mL, and 10 authentic SARS-CoV-2 variants with sensitivity in the range of 1.6-12.5 TCID50/swab. No cross reactivity was observed with other human coronaviruses or other respiratory pathogens. In clinical point-of-care testing on 148 individuals over age 2 with symptoms of ≤5 days, PPA was 87.2% (CI 95: 78.3-94.8%) and NPA was 100% (CI 95: 94.2-100%). In another 884 asymptomatic individuals, PPA was 85.7% (CI 95: 42.1-99.6%) and 99.7% (99.0-99.9%). Overall, CoV-SCAN detected over 97.2% of specimens with CT values <30 and 93.8% of nasal swab specimens with the Omicron variant, even within the first 2 days after symptom onset. Conclusions: The unique construction of CoV-SCAN using two pairs of monoclonal antibodies has resulted in a test with high performance that remains durable across multiple variants in both laboratory and clinical evaluations. CoV-SCAN should identify almost all individuals harboring infectious SARS-CoV-2. Summary: Unique construction of a point-of-care rapid antigen test using two pairs of monoclonal antibodies has led to good performance that remained durable across multiple variants in laboratory and clinical evaluations. Test should identify almost all individuals harboring infectious SARS-CoV-2.

Clinic-Level Strategies for Mitigating Structural and Interpersonal HIV Pre-Exposure Prophylaxis Stigma.

Uptake of and persistence on pre-exposure prophylaxis (PrEP) in the United States have been limited. The potential of new PrEP modalities to increase access will be hindered if underlying structural and interpersonal barriers-including, insurance coverage, initiation and maintenance clinical protocols, provider bias, stigma, and lack of trust in health care-are not adequately addressed. We conducted in-person and telephone-based recorded interviews with 32 US-based clinical and nonclinical PrEP providers spanning the PrEP implementation continuum (clinicians, counselors, and support staff). Providers were recruited at biomedical HIV prevention conferences and networks to explore barriers to and strategies for PrEP implementation. Providers provided care to clients spanning adolescents to adulthood and a variety of genders across all geographic regions of the United States. To directly mitigate stigma, providers called for clinic-level interventions to normalize and universalize PrEP education and services, counseling and other services that center patients' lived experiences and circumstance, staffing and community engagement models that value patients, and implementation of specific programs and processes that facilitate access to services. To address disparities in access, PrEP implementation should acknowledge the interconnectedness of stigma and structural barriers to care.

HIV risk management among sexual minority men in China: context, lived experience, and implications for pre-exposure prophylaxis implementation.

This study examined the social context and lived experience of HIV risk management among sexual minority men in China. An interpretative phenomenological analysis of 25 in-depth interviews with participants in five Chinese cities was undertaken. Findings show how men managed HIV risk in the context of high risk perception and anxiety, and strong perceived social discrimination and marginalisation. Men's choice of risk management strategies was influenced by their often-negative perceptions of gay community, social norms around condom use, and prior lived experience. Results underscore the importance of considering these contexts when planning pre-exposure prophylaxis (PrEP) implementation in China and highlight the need for strategies to address potential PrEP-related stigma among sexual minority men.

Supervised Machine Learning Approach to Identify Early Predictors of Poor Outcome in Patients with COVID-19 Presenting to a Large Quaternary Care Hospital in New York City.

BACKGROUND: The progression of clinical manifestations in patients with coronavirus disease 2019 (COVID-19) highlights the need to account for symptom duration at the time of hospital presentation in decision-making algorithms. METHODS: We performed a nested case-control analysis of 4103 adult patients with COVID-19 and at least 28 days of follow-up who presented to a New York City medical center. Multivariable logistic regression and classification and regression tree (CART) analysis were used to identify predictors of poor outcome. RESULTS: Patients presenting to the hospital earlier in their disease course were older, had more comorbidities, and a greater proportion decompensated (<4 days, 41%; 4-8 days, 31%; >8 days, 26%). The first recorded oxygen delivery method was the most important predictor of decompensation overall in CART analysis. In patients with symptoms for <4, 4-8, and >8 days, requiring at least non-rebreather, age ≥ 63 years, and neutrophil/lymphocyte ratio ≥ 5.1; requiring at least non-rebreather, IL-6 ≥ 24.7 pg/mL, and D-dimer ≥ 2.4 µg/mL; and IL-6 ≥ 64.3 pg/mL, requiring non-rebreather, and CRP ≥ 152.5 mg/mL in predictive models were independently associated with poor outcome, respectively. CONCLUSION: Symptom duration in tandem with initial clinical and laboratory markers can be used to identify patients with COVID-19 at increased risk for poor outcomes.

Attitudes and Perceived Barriers to Sexually Transmitted Infection Screening Among Graduate Medical Trainees.

ABSTRACT: Graduate medical training is an opportune time to improve provider delivery of sexually transmitted infection (STI) screening. A survey of trainees found that the majority feel STI screening is their job but identified barriers to successful screening. Training that intentionally address service-specific barriers will be valuable in ending the STI epidemic.

Salient Constructs for the Development of Shared Decision-Making Tools for HIV Pre-Exposure Prophylaxis Uptake and Regimen Choice: Behaviors, Behavioral Skills, and Beliefs.

The availability of multiple pre-exposure prophylaxis (PrEP) regimens creates a preference-sensitive choice for individuals weighing alternative HIV prevention strategies. Investigating factors that are associated with PrEP uptake and regimen choice are key to developing tools to support that decision. A cross-sectional survey was offered to 536 participants in a PrEP demonstration project for gay, bisexual, and other men who have sex with men across 3 cities in China, of which 412 completed surveys and were included in the analysis. We conducted bivariable analyses followed by multi-variable logistic regressions to examine factors associated with overall PrEP uptake and PrEP regimen choice. Among the 412 participants, 36.9% were daily PrEP users, 28.4% were event-driven users, and 34.7% were non-PrEP users. Higher levels of education, lower PrEP use stigma, and higher perceived benefits of PrEP were associated with greater PrEP uptake. More frequent sex, higher PrEP adherence self-efficacy, higher endorsement of the belief in elevated efficacy of daily over on-demand PrEP, and lower endorsement of a desire for a PrEP method that is only taken when needed led to greater odds of choosing the daily PrEP regimen. As multiple HIV prevention modalities become available, there is a greater need for a shared decision-making approach to support this preference-sensitive choice of HIV prevention method. Our findings suggest salient constructs to inform the development of shared decision-making tools to support regimen choice.

Acceptability, Appropriateness, and Preliminary Effects of the PrEP Diffusion Training for Lay HIV Workers: Increased PrEP Knowledge, Decreased Stigma, and Diffusion of Innovation.

Training lay health workers is a critical intervention strategy to support HIV pre-exposure prophylaxis (PrEP) implementation. However, few evaluations of such trainings have been published. We conducted multi-time-point surveys to evaluate the effect of a training intervention on knowledge, PrEP stigma, and implementation behavior among lay HIV workers in China. Results indicated high acceptability and appropriateness of the training. PrEP knowledge score increased by 65% from pre- to post-training, and remained high one-month post-training. We observed a significant decrease in PrEP stigma and a positive influence on determinants of implementation behaviors. All lay HIV workers surveyed one-month after the training reported having disseminated PrEP information in social networks; 43% reported integrating PrEP education into routine work. The training is an effective strategy to build lay HIV workers' capacity in PrEP implementation. Longer-term post-training follow up would be ideal to further assess actual PrEP uptake and sustained effects on PrEP implementation.

Attitudes and Perceived Barriers to Routine HIV Screening and Provision and Linkage of Postexposure Prophylaxis and Pre-Exposure Prophylaxis Among Graduate Medical Trainees.

New York City is the metropolitan area in the United States with the highest number of new HIV diagnoses nationwide. The End-The-Epidemic (EtE) initiative calls for identifying persons with HIV who remain undiagnosed, linking and retaining persons living with HIV to maximize viral suppression, and facilitate access to pre-exposure prophylaxis (PrEP) for patients at increased risk of HIV. HIV screening represents the first step to both the primary and secondary HIV prevention cascades. We conducted an online, anonymous, cross-sectional survey of residents at all stages of training within four residency programs at one institution in Northern Manhattan between August 2017 and August 2018. All internal medicine, emergency medicine, obstetrics and gynecology trainees, and pediatrics were invited to complete the survey via email. Of 298 eligible trainees, 142 (48%) completed the survey. Most trainees were aware of the HIV testing law and agreed that HIV testing was their responsibility, but few successfully screened most of their patients. Most trainees were not knowledgeable about non-occupational post-exposure prophylaxis (nPEP) or PrEP, but felt that it was important to provide these services across settings. Barriers to HIV, nPEP, and PrEP varied across specialties. Ending the HIV epidemic will require efforts across clinical specialties. In this survey from an EtE jurisdiction, most trainees felt that it is important to provide HIV prevention services in most settings; however, their knowledge and comfort with HIV prevention services other than testing were low. Barriers varied across specialties, and developing specialty-specific materials for trainees may be beneficial.

Exploration of the Complex Relationships Among Multilevel Predictors of PrEP Use Among Men Who Have Sex with Men in the United States.

To explore the relationships among individual-, social-, and contextual- (state-level characteristics, including LBGTQ + and racial inequality) level factors and PrEP use. A cross-sectional survey was conducted in 2015-2016 among a geographically diverse group of men who have sex with men (MSM). Survey data was linked to publicly available state-level data based on participant zip code. Multivariable multilevel logistic regression was used to explore the association between multilevel variables and PrEP use. Of 4165 HIV-negative MSM, 13.4% were taking PrEP. In the regression analysis, several demographic and behavioral factors were associated with higher odds of PrEP use. Importantly, after adjusting for individual- and social-level factors, residents of states with high LGBTQ + equality had significantly higher odds of taking PrEP (OR 1.57; 95% CI 1.119, 2.023) compared to low equality states. LGBTQ + inequality between states may hinder PrEP use. States may need to take proactive measures to reduce LGBTQ + inequality as this may negatively impact the ability to reach the federal administration's stated goal to end the HIV epidemic in the US.

Behavioral and social science research to support development of educational materials for clinical trials of broadly neutralizing antibodies for HIV treatment and prevention.

BACKGROUND/AIMS: Early integration of behavioral and social sciences research into clinical trials can improve trial conduct and facilitate future implementation of biomedical interventions. We sought to examine participants' experiences in clinical trials with broadly neutralizing antibodies and describe the development of educational materials for use in future broadly neutralizing antibody research. METHODS: We conducted semi-structured interviews with trial participants in phase 1 trials evaluating safety and efficacy of broadly neutralizing antibodies for HIV prevention and treatment and key informants (i.e. trial staff involved in broadly neutralizing antibody research). Semi-structured interviews were transcribed and analyzed thematically. Based on findings from the interviews, we developed educational materials addressing concerns and misconceptions identified among trial participants with input from community and research stakeholders. Educational materials were used in subsequent clinical trials with broadly neutralizing antibodies. We evaluated trial staff's experiences with newly developed educational materials in follow-up key informant interviews. RESULTS: Although most participants were concerned about long-term harms related to the investigational product upon enrollment, absence of severe side effects in the trial led to an underestimation of risks related to the study during trial participation. Participants showed a poor understanding of what broadly neutralizing antibodies are and the differences between broadly neutralizing antibodies and other HIV prevention and treatment products, such as antiretrovirals. Many trial participants overestimated the possible public health impact of the broadly neutralizing antibody trials in which they were enrolled, associating broadly neutralizing antibody research with the development of vaccine or cure for HIV in the near future. Based on these concerns and misconceptions among trial participants, we developed a frequently asked questions document and adapted an existing educational video about broadly neutralizing antibodies. In follow-up interviews, key informants reported that materials helped address trial participants' concerns and questions related to the trial. Key informants reported using the educational materials not only during informed consent but also throughout trial participation, which contributed to making informed consent an "ongoing" process. CONCLUSION: Integration of behavioral research into clinical trials with broadly neutralizing antibodies is key to identify and address key concerns among trial participants. Behavioral and social sciences research promotes communication between trial participants and biomedical researchers, facilitates engagement of participants and trial staff, and strengthens trial conduct. Development of educational materials collaboratively by behavioral and clinical scientists, trial staff, and community stakeholders is feasible and may help to address trial participants' concerns and misconceptions. Future research should evaluate the impact of educational materials in recruitment and retention of trial participants.

Post-exposure prophylaxis: an underutilized biomedical HIV prevention method among gay, bisexual and other men who have sex with men in China.

Despite abundant evidence on its safety, tolerability and cost-effectiveness, post-exposure prophylaxis (PEP) has not been officially approved for non-occupational use in China. This study aims to assess awareness of, willingness to use, and actual experience with PEP in gay, bisexual and other men who have sex with men (GBM) in China and to explore potential associations between demographic, behavioral, and psychosocial factors and PEP-related outcomes. We recruited a convenience sample through community venue-based strategies, peer referrals, and online advertisement in four cities of China in 2018. We used bivariable and multivariable logistic regression to test associations between potential predictors and PEP outcomes. Over 60% of men reported having heard of PEP prior to the survey, 70% would be willing to use it if exposed to HIV, and 6% reported having used PEP. Awareness of PEP was associated with higher education, more frequent HIV testing, knowing someone who seroconverted in the past two years, having sex with only men in the past six months, and lower perceived risk of HIV infection. PEP willingness was associated with more frequent HIV testing, being worried about becoming HIV infected, prior awareness and favorable attitudes towards PEP among friends. Findings suggest PEP is an underutilized diomedical HIV prevention intervention among GBM in China. Clinical guidance on non-occupational PEP use, as well as communication campaigns targeting social networks of GBM are needed to address barriers to PEP awareness and uptake.