Who falls between the cracks? Identifying eligible PrEP users among people with Sub-Saharan African migration background living in Antwerp, Belgium.

INTRODUCTION: This study produces an estimate of the proportion of eligible PrEP users among people of Sub-Saharan African background based on the Belgian PrEP eligibility criteria and examines associations with socio-economic and demographic characteristics. METHODS: We performed logistic regression analysis on data of a representative community-based survey conducted among Sub-Saharan African communities (n = 685) living in Antwerp. RESULTS: Almost a third (30.3%) of the respondents were eligible to use PrEP. Those who were male, single, lower educated, undocumented, and had experienced forced sex were more likely to be eligible for PrEP use. The findings highlight the importance of taking intra-, interpersonal and structural HIV risk factors into account. CONCLUSIONS: The study shows high unmet PrEP needs in this population, especially among those with high vulnerability for HIV acquisition. A better understanding of barriers to PrEP use in this population group is needed to allow for equitable access.

Virtual CROI 2020: Highlights of Epidemiology, Public Health, and Prevention Research.

At the 2020 Conference on Retroviruses and Opportunistic Infections, held virtually as a result of the emerging COVID-19 pandemic, trends in the HIV epidemic were highlighted, with decreasing HIV incidence reported across several countries, although key regions remain heavily impacted, including the US South. Adolescent girls and young women, men who have sex with men (MSM), transgender persons, and people who inject drugs continue to experience a high burden of new infections. Sexually transmitted infections during pregnancy can lead to a number of adverse outcomes in infants; novel strategies to detect and treat these infections are needed. Innovative HIV testing strategies, including self-testing and assisted partner services, are expanding the reach of testing; however, linkage to care can be improved. Novel preexposure prophylaxis (PrEP) delivery strategies are increasing uptake of PrEP in different groups, although adherence and persistence remain a challenge. Use of on-demand PrEP is increasing among MSM in the US. Strategies are needed to address barriers to PrEP uptake and persistence among cis- and transgender women. Several novel regimens for postexposure prophylaxis show promise.

Cost-Effectiveness of a Statewide Pre-Exposure Prophylaxis Program for Gay, Bisexual, and Other Men Who Have Sex with Men.

Pre-exposure prophylaxis (PrEP) is an effective tool for preventing HIV infection among men who have sex with men (MSM), but its cost-effectiveness has varied across settings. Using an agent-based model, we projected the cost-effectiveness of a statewide PrEP program for MSM in Rhode Island over the next decade. In the absence of PrEP, the model predicted an average of 830 new HIV infections over ten years. Scaling up the existing PrEP program to cover 15% of MSM with ten or more partners each year could reduce the number of new HIV infections by 33.1% at a cost of $184,234 per quality-adjusted life-year (QALY) gained. Expanded PrEP use among MSM at high risk for HIV infection has the potential to prevent a large number of new HIV infections but the high drug-related costs may limit the cost-effectiveness of this intervention.

Brief Report: Integration of PrEP Services Into Routine Antenatal and Postnatal Care: Experiences From an Implementation Program in Western Kenya.

BACKGROUND: Programmatic approaches for delivering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women in settings with high HIV burden are undefined. The PrEP Implementation for Young Women and Adolescents (PrIYA) Program developed approaches for delivering PrEP in maternal child health (MCH) clinics. METHODS: Under the PrIYA Program, nurse-led teams worked with MCH staff at 16 public, faith-based, and private facilities in Kisumu, Kenya, to determine optimal clinic flow for PrEP integration into antenatal care (ANC) and postnatal care (PNC). A program-dedicated nurse facilitated integration. HIV-uninfected women were screened for behavioral risk factors; same-day PrEP was provided to interested and medically eligible women. PrEP and MCH services were evaluated using standardized flow mapping and time-and-motion surveys. RESULTS: Clinics developed 2 approaches for integrating PrEP delivery within ANC/PNC: (1) co-delivery: ANC/PNC and PrEP services delivered by same MCH nurse or (2) sequential services: PrEP services after ANC/PNC by a PrEP-specialized nurse. Three clinics selected co-delivery and 13 sequential services, based on patient volume and space availability. Overall, 86 ANC/PNC visits were observed. Clients who initiated PrEP took a median of 18 minutes (interquartile range 15-26) for PrEP-related activities (risk assessment, PrEP counseling, creatinine testing, dispensation, and documentation) in addition to other routine ANC/PNC activities. For clients who declined PrEP, an additional 13 minutes (interquartile range 7-15) was spent on PrEP-related risk assessment and counseling. CONCLUSIONS: PrEP delivery within MCH used co-delivery or sequential approaches. The moderate additional time burden for PrEP initiation in MCH would likely decline with community awareness and innovations such as group/peer counseling or expedited dispensing.

How to do it: setting up a PrEP service in an integrated sexual reproductive health service setting.

Pre-exposure prophylaxis for HIV (PrEP) has been shown to reduce transmission of HIV in a number of trials; however, there is limited evidence regarding the optimal way to deliver PrEP through pre-existing UK services, particularly through fully integrated drop-in sexual health service models. PrEP in the form of Truvada was launched in Wales in July 2017. We set up a PrEP service to be delivered via our drop-in integrated sexual reproductive health service. In the first 5 months of PrEP service provision, we found unforeseen levels of comorbidity, polypharmacy and renal impairment in our cohort of PrEP patients. As a result, we have altered our service model and all patients are now followed up in booked appointment PrEP clinics run by members of the HIV team. Those patients with estimated glomerular filtration rate (eGFR) of 60-70 mL/min or with eGFR of 60-80 mL/min and with comorbidities impacting on renal function are monitored every 4-6 weeks initially, and PrEP has been incorporated into our pre-existing virtual HIV renal clinic for discussion with a renal physician. The PrEP team clinicians report that monitoring and managing the PrEP cohort is now easier in its appointment-only format, although some patients have reported that they would prefer a drop-in system.

Evolving Models and Ongoing Challenges for HIV Preexposure Prophylaxis Implementation in the United States.

BACKGROUND: The use of preexposure prophylaxis (PrEP) for HIV prevention was approved by the Food and Drug Administration in 2012, but delivery to at-risk persons has lagged. This critical review analyzes the current state of PrEP implementation in the United States, by reviewing barriers and innovative solutions to enhance PrEP access and uptake. SETTING: Clinical care settings, public health programs, and community-based organizations (CBOs). METHODS: Critical review of recent peer-reviewed literature. RESULTS: More than 100 papers were reviewed. PrEP is currently provided in diverse settings. Care models include sexually transmitted disease clinics, community health centers, CBOs, pharmacies, and private primary care providers (PCPs). Sexually transmitted disease clinics have staff trained in sexual health counseling and are linked to public health programs (eg, partner notification services), whereas PCPs and community health centers may be less comfortable counseling and feel time-constrained in managing PrEP. However, PCPs may be ideal PrEP providers, given their long-term relationships with patients, integrating PrEP into routine care. Collaborations with CBOs can expand PrEP care through adherence support and insurance navigation. Pharmacies can deliver PrEP, given their experience with medication dispensing and counseling, and may be more accessible for some patients, but to address other health concerns, liaisons with PCPs may be needed. CONCLUSIONS: PrEP implementation in the United States is moving forward with the development of diverse models of delivery. Optimal scale-up will require learning about the best features of each model and providing choices to consumers that enhance engagement and uptake.

Transgender Women in Clinical Trials of Pre-Exposure Prophylaxis.

Lessons were learned with trans women who participated (as volunteers and investigators) in trials of HIV pre-exposure prophylaxis (PrEP). Trans women are not men. Compared with men who have sex with men, trans women trial participants were more likely to be involved with transactional sex, had more sexual partners, and were less likely to have PrEP medications detected in blood. Trans women define themselves differently in different cultures. One best practice is to ask at least 2 gender questions: sex assigned at birth and current gender. More information is needed to fully situate PrEP efficacy for trans women, including analysis of drug-drug interactions between PrEP medications and feminizing hormones and PrEP drug penetration into neovaginal tissues. Including trans women in studies is helpful only if their participation is specifically reported, as could occur in a table of baseline characteristics of the enrolled cohort. Gender-affirming care is important to foster appropriate uptake and use of PrEP. Such care includes use of preferred pronouns and names, safety to use the bathroom of choice, and access to gender-affirming hormone therapy and surgery. The consistent finding that PrEP works when taken across diverse populations having diverse practices related to gender, sexual intercourse, and hormone use provides a basis for offering PrEP to people at substantial risk of acquiring HIV although some subgroups may not have been fully represented in trials. Nonetheless, specific PrEP implementation science for trans women (and men) is essential to develop best practices for PrEP delivery and use.

Planning for HIV preexposure prophylaxis introduction: lessons learned from contraception.

PURPOSE OF REVIEW: We summarize key lessons learned from contraceptive development and introduction, and implications for preexposure prophylaxis (PrEP). RECENT FINDINGS: New approaches to HIV prevention are urgently needed. PrEP is a new technology for HIV prevention. Uncertainty remains about its acceptance, use and potential to have an impact on the HIV epidemic. Despite imperfect use and implementation of programs, the use of modern contraception has led to significant reproductive health and social gains, making it one of the public health's major achievements. Guided by the WHO strategic approach to contraception introduction, we identified the following lessons for PrEP introduction from contraception: (1) the importance of a broader focus on the method mix rather than promotion of a single technology, (2) new technologies alone do not increase choice--service delivery systems and providers are equally important to success, and (3) that failure to account for user preferences and social context can undermine the potential of new methods to provide benefit. SUMMARY: Taking a strategic approach to PrEP introduction that includes a broader focus on the technology/user interface, the method mix, delivery strategies, and the context in which methods are introduced will benefit HIV prevention programs, and will ensure greater success.

The preexposure prophylaxis revolution; from clinical trials to programmatic implementation.

PURPOSE OF REVIEW: An investment in preexposure prophylaxis (PrEP) delivery must have public health impact in reducing HIV infections. Sustainable delivery of PrEP requires policy, integration of services, and synergy with other existing HIV prevention programs. This review discusses key policy and programmatic considerations for implementation and scale up of PrEP in Africa. RECENT FINDINGS: PrEP delivery has been delayed by concerns about adherence and delivery in 'real world' settings. Demonstration projects and clinical service delivery models are providing evidence of PrEP effectiveness with an impact much higher than that found in randomized clinical trials. Data confirm that PrEP uptake, adherence, and retention has been high, more so by persons who perceive themselves at high risk for HIV infection, and PrEP is well tolerated. PrEP delivery is more than dispensation of a pill and programs should address other risk drivers, which differ by population. In Africa, barriers to PrEP uptake and adherence include stigma among MSM and low HIV risk perception among young women. Additional data have provided insight into optimal points of service delivery, provider training requirements and quality assurance needs. Of the 2 million new HIV infections in 2014, 70% were in Africa. PrEP use is not lifelong, and use limited to periods of risk may be both effective and cost-effective for the continent. SUMMARY: HIV prevention programs should determine strategies to identify those at substantial risk for HIV infection, formulate and deliver PrEP in combination with interventions that target social drivers of HIV vulnerability specific to each population. Policy guidance for optimal combination of interventions and service delivery avenues, clinical protocols, health infrastructure requirements are required. Cost-effectiveness and efficiency data are essential for policy guidance to navigate ethical questions over use of antiretroviral therapy for HIV-negative individuals when treatment coverage has not been attained in many parts of Africa. Countries need to invest in purposeful advocacy at both local and global forums. Failure to implement PrEP will be a failure to protect future generations.

The European preexposure prophylaxis revolution.

PURPOSE OF REVIEW: The review describes the European epidemic and the challenges in moving from clinical trials of preexposure prophylaxis (PrEP) to routine practice. RECENT FINDINGS: Two European trials conducted in gay and other MSM and transgender women reported a high and consistent reduction in HIV incidence using oral PrEP with tenofovir/emtricitabine (TDF/FTC). The incidence of HIV infection in the control group was much higher than anticipated, based on routine surveillance data in MSM, in spite of the highest standard of HIV prevention available. SUMMARY: Recent results have highlighted the urgent need to make PrEP available to key populations in Europe as an additional prevention tool. Gilead has not yet submitted an application to use TDF/FTC as PrEP in Europe. Although regulatory approval would accelerate implementation, countries are already dispensing TDF/FTC as postexposure prophylaxis without this. Services for prevention are diverse across countries ranging from free, walk-in services for the diagnosis and treatment of HIV and other sexually transmitted infections, to insurance-dependent reimbursement of private clinical services. Momentum is gathering in Europe with PrEP demonstration projects in MSM and a growing demand from community organizations. Each Member State urgently needs to identify their key populations and determine the service best placed to provide this new prevention strategy within a comprehensive prevention package.

The preexposure prophylaxis revolution: from clinical trials to routine practice: implementation view from the USA.

PURPOSE OF REVIEW: This article describes the use of tenofovir/emtricitabine (Truvada) as prevention for exposure to HIV [preexposure prophylaxis (PrEP)] infection in the USA. The use of PrEP and the challenges of implementation are very instructive as other countries adopt this intervention and it becomes a fundamental part of worldwide efforts for HIV prevention and much can be learned from the first 3 years in the USA. RECENT FINDINGS: Randomized trials and demonstration projects have shown the benefits of PrEP for men and women who are at risk for HIV. Numerous studies have showed that the level of prevention is excellent when the drug is taken at least four times weekly, once adequate levels are obtained. However, adherence remains a critical issue as well as tailoring delivery models for specific populations. Six recent studies are discussed, that support excellent efficacy and significantly support PrEP as a means of prevention. These projects have shown high acceptance of PrEP with excellent adherence by individuals demonstrated by those at risk remaining free of HIV over extended periods of time. SUMMARY: The USA faces three significant challenges in scaling up PrEP. The first challenge in implementation in the USA is to get individuals to recognize the actual risks that their behaviors represent and to engage with providers to address these issues. The second challenge is getting a population of providers to recognize the exact same issues and offer PrEP in a compassionate, nonjudgmental fashion. The third challenge is identifying the set of providers and locations to scale-up the response in a timely, cost-effective fashion.

Current concepts for PrEP adherence in the PrEP revolution: from clinical trials to routine practice.

PURPOSE OF REVIEW: The review describes the current understanding of adherence to oral preexposure prophylaxis (PrEP), methods for adherence measurement, approaches to supporting PrEP adherence, and guidance for defining PrEP adherence goals within the larger context of HIV prevention. RECENT FINDINGS: PrEP adherence has generally been higher in recent trials, open-label extensions, and demonstration projects compared with the initial clinical trials; potential explanations include known PrEP efficacy and different motivations to take PrEP. Recent studies have explored adherence monitoring through electronic pill containers, short message service (SMS), and drug concentrations in hair and dried blood spots. The few PrEP adherence interventions developed to date include combinations of enhanced counseling, feedback of objective adherence measurement, and SMS. Conceptualization of PrEP adherence is evolving. The goal is not 100% adherence indefinitely, as it was in clinical trials. PrEP adherence should be defined with respect to HIV exposure, which varies over time by sexual behavior and use of other prevention strategies. SUMMARY: PrEP adherence beyond clinical trials has generally been high enough to achieve reliable HIV prevention. Future efforts to measure and support PrEP adherence should focus on the context of risk for HIV acquisition, accounting for dynamic behaviors and choices among HIV prevention options.

Promise and pitfalls of pre-exposure prophylaxis for female sex workers.

PURPOSE OF REVIEW: We explore the potential benefits of integrating preexposure prophylaxis (PrEP) into combination HIV prevention for female sex workers (FSWs) and the likely challenges to implementation. RECENT FINDINGS: Evidence for the biological effectiveness of PrEP in women who can adhere to daily dosing is strong. FSWs in many countries bear the brunt of the HIV epidemic. Current combination prevention approaches enable many FSWs to remain HIV-free, but in some settings FSWs are unable to mitigate their risk. PrEP provides a new prevention tool for these women. To benefit, HIV-negative FSWs need to perceive that they are at risk, be motivated and able to take PrEP daily and to attend health services for prescription refill and clinical monitoring. FSWs face particular structural challenges to PrEP uptake and use, including stigmatizing health services; fear of disclosure to other FSWs and clients; fear of the authorities; lack of social support; substance use; unplanned travel and risk compensation many of which can be addressed through combination prevention approaches. SUMMARY: For those FSWs who are unable to mitigate their HIV risk, PrEP, if adequately supported and integrated with combination prevention, may empower them to remain HIV-free.

The role of healthcare providers in the roll out of preexposure prophylaxis.

PURPOSE OF REVIEW: To review the most recent studies assessing the preparedness of healthcare practitioners to provide anti-HIV preexposure prophylaxis (PrEP) and suggest areas for future implementation research. RECENT FINDINGS: As PrEP is a biobehavioral intervention, healthcare providers are likely to play a critical role in implementing PrEP in care settings. Studies suggest that many specialized providers are aware of PrEP and support its provision as a public health intervention, though knowledge and acceptance are less among generalists. Therefore, utilization of PrEP by clinicians has been limited to a few early adopters. Concerns about the efficacy and long-term safety of PrEP, and perceived barriers to prescribing PrEP, could limit prescribing behaviors and intentions. Resistance to performing routine HIV risk assessments by clinicians is an additional barrier to implementing PrEP, although innovative tools to help clinicians routinely perform risk assessments, are being developed. SUMMARY: Interventions are needed to engage a broader array of healthcare providers in PrEP provision. Utilizing a framework based on diffusion of innovation theory, this review proposes strategies that can be implemented and evaluated to increase PrEP prescribing by healthcare providers. If resources are invested in training clinicians to provide PrEP, then these stakeholders could enhance the use of PrEP as part of a prevention package by primary providers.