Implementation of a national HIV pre-exposure prophylaxis service is associated with changes in characteristics of people with newly diagnosed HIV: a retrospective cohort study.

OBJECTIVES: To review characteristics of individuals newly diagnosed with HIV following implementation of a national pre-exposure prophylaxis (PrEP) programme (comprehensive PrEP services, delivered in sexual health clinics) to inform future delivery and broader HIV prevention strategies. METHODS: We extracted data from national HIV databases (July 2015-June 2018). We compared sociodemographic characteristics of individuals diagnosed in the period before and after PrEP implementation, and determined the proportion of 'potentially preventable' infections with the sexual health clinic-based PrEP delivery model used. RESULTS: Those diagnosed with HIV before PrEP implementation were more likely to be male (342/418, 81.8% vs 142/197, 72.1%, p=0.005), be white indigenous (327/418, 78.2% vs 126/197, 64.0%, p<0.001), report transmission route as sex between men (219/418, 52.4% vs 81/197, 41.1%, p=0.014), and have acquired HIV in the country of the programme (302/418, 72.2% vs 114/197, 57.9% p<0.001) and less likely to report transmission through heterosexual sex (114/418, 27.3% vs 77/197, 39.1%, p=0.002) than after implementation.Pre-implementation, 8.6% (36/418) diagnoses were 'potentially preventable' with the PrEP model used. Post-implementation, this was 6.6% (13/197), but higher among those with recently acquired HIV (49/170, 28.8%). Overall, individuals with 'potentially preventable' infections were more likely to be male (49/49, 100% vs 435/566, 76.9%, p<0.001), aged <40 years (37/49, 75.5% vs 307/566, 54.2%, p=0.004), report transmission route as sex between men (49/49, 100% vs 251/566, 44.3%, p<0.001), have previously received post-exposure prophylaxis (12/49, 24.5% vs 7/566, 1.2%, p<0.001) and less likely to be black African (0/49, 0% vs 67/566, 11.8%, p=0.010) than those not meeting this definition. CONCLUSIONS: The sexual health clinic-based national PrEP delivery model appeared to best suit men who have sex with men and white indigenous individuals but had limited reach into other key vulnerable groups. Enhanced models of delivery and HIV combination prevention are required to widen access to individuals not benefiting from PrEP at present.

Expansion of Preexposure Prophylaxis Capacity in Response to an HIV Outbreak Among People Who Inject Drugs-Cabell County, West Virginia, 2019.

From January 1, 2018, through October 9, 2019, 82 HIV diagnoses occurred among people who inject drugs (PWID) in Cabell County, West Virginia. Increasing the use of HIV preexposure prophylaxis (PrEP) among PWID was one of the goals of a joint federal, state, and local response to this HIV outbreak. Through partnerships with the local health department, a federally qualified health center, and an academic medical system, we integrated PrEP into medication-assisted treatment, syringe services program, and primary health care settings. During the initial PrEP implementation period (April 18-May 17, 2019), 110 health care providers and administrators received PrEP training, the number of clinics offering PrEP increased from 2 to 15, and PrEP referrals were integrated with partner services, outreach, and testing activities. The number of people on PrEP increased from 15 in the 6 months before PrEP expansion to 127 in the 6 months after PrEP implementation. Lessons learned included the importance of implementing PrEP within existing health care services, integrating PrEP with other HIV prevention response activities, adapting training and material to fit the local context, and customizing care to meet the needs of PWID. The delivery of PrEP to PWID is challenging but complements other HIV prevention interventions. The expansion of PrEP in response to this HIV outbreak in Cabell County provides a framework for expanding PrEP in other outbreak and non-outbreak settings.

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.

Decentralizing PrEP delivery: Implementation and dissemination strategies to increase PrEP uptake among MSM in Toronto, Canada.

Pre-exposure prophylaxis (PrEP) is traditionally prescribed by HIV specialist physicians. Given finite specialist resources, there is a need to scale up PrEP delivery by decentralizing services via other healthcare professionals. We aimed to assess the feasibility of delivering PrEP to men who have sex with men (MSM) through primary care physicians and sexual health clinic nurses. We piloted a multi-component, implementation and dissemination research program to increase provision of PrEP through primary care physicians and sexual health clinic nurses in Toronto, Canada. Community-based organizations (CBOs) provided prospective participants with information cards that contained links to an online module on engaging providers in a conversation about PrEP. In our patient-initiated continuing medical education (PICME) strategy, participants saw their family doctors and gave them the card, which also contained a link to a Continuing Medical Education module. In the nurse-led strategy, participants visited one of two participating clinics to obtain PrEP. We administered an optional online questionnaire to patients and providers at baseline and six months. CBOs distributed 3043 cards. At least 339 men accessed the online module and 196 completed baseline questionnaires. Most (55%) intended to visit nurses while 21% intended to consult their physicians. Among 45 men completing follow-up questionnaires at 6 months, 31% reported bringing cards to their physicians and obtaining PrEP through them; sexual health clinics delivered PrEP to 244 patients. Participants who went through the PICME approach reported no changes in relationships with their providers. Nurses showed fidelity to PrEP prescribing guidelines. Nurse-led PrEP and patient-initiated continuing medical education (PICME) for primary care physicians are feasible strategies to increase PrEP uptake. Nurse-led PrEP delivery was preferred by most patients.

The case for prescribing PrEP in community mental health settings.

Pre-exposure prophylaxis (PrEP) is a biomedical HIV prevention modality that is up to 99% effective in preventing HIV acquisition through sex if taken as directed. People with serious mental illness (eg, schizophrenia and bipolar disorder) are at high risk of acquiring HIV due to sexual behaviours, injection drug use, social factors, and structural discrimination that limits access to all types of preventive health services. We seek to show the importance of prioritising access to PrEP for people living with serious mental illness treated in community mental health settings. We describe barriers to prescribing PrEP, including provider attitudes and provider knowledge gaps, patient attitudes and knowledge, and systems issues. We also address the concerns that community mental health clinic administrators might have about taking on the responsibility of offering PrEP. In summary, despite the barriers to prescribing PrEP in these settings, we believe that there is a unique opportunity for community mental health settings to help address the HIV epidemic by facilitating the prescribing of PrEP to the at-risk populations they currently serve.

"You can't have a PrEP program without a PrEP Coordinator": Implementation of a PrEP panel management intervention.

Lack of healthcare provider knowledge, capacity, and willingness to prescribe PrEP are barriers to PrEP delivery in clinical settings. We implemented the PrEP Optimization Intervention (PrEP-OI) combining a PrEP Coordinator with an online panel management tool to assist providers with PrEP uptake, persistence, and management in 12 San Francisco Department of Public Health Primary Care Clinics. Medical directors (N = 10) identified important factors to consider prior to implementation, including shortage of clinical space for coordinators, medical mistrust, language barriers, and limited lab hours, along with the need for education of providers and staff and patient outreach. Among 110 providers who completed a baseline survey, the majority had reservations in asking about sexual practices and having conversations about PrEP. Providers reported PrEP-OI increased their efficiency and capacity to manage PrEP patients, and served as a gateway to additional services. These results highlight the promise of a provider-based intervention to improve the PrEP continuum and maximize the impact of PrEP.

Ending the HIV Epidemic Among Persons Who Inject Drugs: A Cost-Effectiveness Analysis in Six US Cities.

BACKGROUND: Persons who inject drugs (PWID) are at a disproportionately high risk of HIV infection. We aimed to determine the highest-valued combination implementation strategies to reduce the burden of HIV among PWID in 6 US cities. METHODS: Using a dynamic HIV transmission model calibrated for Atlanta, Baltimore, Los Angeles, Miami, New York City, and Seattle, we assessed the value of implementing combinations of evidence-based interventions at optimistic (drawn from best available evidence) or ideal (90% coverage) scale-up. We estimated reduction in HIV incidence among PWID, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) for each city (10-year implementation; 20-year horizon; 2018 $ US). RESULTS: Combinations that maximized health benefits contained between 6 (Atlanta and Seattle) and 12 (Miami) interventions with ICER values ranging from $94 069/QALY in Los Angeles to $146 256/QALY in Miami. These strategies reduced HIV incidence by 8.1% (credible interval [CI], 2.8%-13.2%) in Seattle and 54.4% (CI, 37.6%-73.9%) in Miami. Incidence reduction reached 16.1%-75.5% at ideal scale. CONCLUSIONS: Evidence-based interventions targeted to PWID can deliver considerable value; however, ending the HIV epidemic among PWID will require innovative implementation strategies and supporting programs to reduce social and structural barriers to care.

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.

PrEP rollout in Africa: status and opportunity.

Following recommendations by the World Health Organization in 2015, and key clinical trials, countries in sub-Saharan Africa, the region with the highest burden of human immunodeficiency virus (HIV), developed policies that incorporate pre-exposure prophylaxis (PrEP) into national HIV-prevention strategies. By the end of 2019, more than one third of people receiving PrEP globally were in Africa. Crucial understandings gained from early rollout among at-risk populations, such as HIV-serodiscordant couples, adolescent girls and young women, female sex workers, and men who have sex with men, include the importance of strategies for maintaining persistent adherence to PrEP and novel approaches to making PrEP services accessible, simplified and efficient. This Perspective will discuss the current status of these programs and how to further widen their implementation.

Feasibility of establishing an HIV vaccine preparedness cohort in a population of the Uganda Police Force: Lessons learnt from a prospective study.

BACKGROUND: Members of uniformed armed forces are considered to be at high risk for HIV infection and have been proposed as suitable candidates for participation in HIV intervention studies. We report on the feasibility of recruitment and follow up of individuals from the community of the Uganda Police Force (UPF) for an HIV vaccine preparedness study. METHODS: HIV-negative volunteers aged 18-49 years, were identified from UPF facilities situated in Kampala and Wakiso districts through community HIV counselling and testing. Potential volunteers were referred to the study clinic for screening, enrolment and quarterly visits for one year. HIV incidence, retention rates were estimated and expressed as cases per 100 person years of observation (PYO). Rate ratios were used to determine factors associated with retention using Poisson regression models. RESULTS: We screened 560 to enroll 500 volunteers between November 2015 and May 2016. One HIV seroconversion occurred among 431 PYO, for an incidence rate of 0.23/100 PYO (95% confidence interval [CI]: 0.03-1.64). Overall, retention rate was 87% at one year, and this was independently associated with residence duration (compared to <1 year, 1 to 5 years adjusted rate ratio (aRR) = 1.19, 95%CI: 1.00-1.44); and >5 years aRR = 1.34, 95%CI: 0.95-1.37); absence of genital discharge in the last 3 months (aRR = 1.97, 95% CI: 1.38-2.83, absence of genital ulcers (aRR = 1.90, 95%CI: 1.26-2.87, reporting of new sexual partner in the last month (aRR = 0.57, 95%CI: 0.45-0.71, being away from home for more than two nights (aRR = 1.27, 95%CI: 1.04-1.56, compared to those who had not travelled) and absence of knowledge on HIV prevention (aRR = 2.67, 95%CI: 1.62-4.39). CONCLUSIONS: While our study demonstrates the feasibility of recruiting and retaining individuals from the UPF for HIV research, we did observe lower than anticipated HIV incidence, perhaps because individuals at lower risk of HIV infection may have been the first to come forward to participate or participants followed HIV risk reduction measures. Our findings suggest lessons for recruitment of populations at high risk of HIV infection.

Estimating the size of HIV-negative MSM population that would benefit from pre-exposure prophylaxis in Florida.

PURPOSE: This study aimed to estimate the size of the population of men who have sex with men (MSM) in Florida with high-risk behaviors that would indicate eligibility for pre-exposure prophylaxis (PrEP) use. METHODS: Three methods were used to estimate the MSM population. Estimates from the three methods were averaged, and the number of MSM living with HIV in each zone improvement plan (ZIP) code was subtracted. RESULTS: The average MSM estimate was 1-2184 men (1.5-22.9%) by ZIP code. The size of the MSM population with indications for PrEP use was highest when using estimates of MSM with more than one sex partner in the past year obtained from the National HIV Behavioral Surveillance system and lowest when the MSM estimate was multiplied by 24.7% (percentage of MSM with PrEP indications from other studies). CONCLUSION: Areas with high numbers of MSM with PrEP indications could be targeted with information to reduce HIV acquisition.

Interest and Knowledge of HIV Pre-Exposure Prophylaxis in a Unified Jail and Prison Setting.

Pre-exposure prophylaxis (PrEP) may be an effective approach to prevent HIV among people who are currently incarcerated or who have been recently released from incarceration. However, awareness and interest in PrEP are largely unknown in this population. This study assessed 417 incarcerated men's lifetime HIV risk engagement and gauged their interest and willingness to take PrEP. Twenty percent reported ever injecting drugs and 4% ever having sex with a man without a condom; 88% had never heard of PrEP. More White men had heard of PrEP, but higher percentages of men of color were interested in learning more about PrEP and willing to take PrEP to prevent HIV. Future interventions should focus on PrEP education and uptake among individuals who are incarcerated.

Expansion of HIV Preexposure Prophylaxis to 35 PEPFAR-Supported Early Program Adopters, October 2016-September 2018.

The U.S. President's Emergency Plan for AIDS Relief (PEPFAR), the largest bilateral funder of human immunodeficiency virus (HIV) prevention and control programs worldwide, currently supports implementation of preexposure prophylaxis (PrEP) to reduce HIV incidence among persons at substantial risk for infection, including female sex workers, men who have sex with men (MSM), and transgender women (hereafter referred to as key populations). Recent estimates suggest that 54% of all global new HIV infections in 2018 occurred among key populations and their sexual partners (1). In 2016, PEPFAR began tracking initiation of PrEP by key populations and other groups at high risk (2). The implementation and scale-up of PrEP programs across 35 PEPFAR-supported country or regional programs* was assessed by determining the number of programs reporting any new PrEP clients during each quarter from October 2016 to September 2018. As of September 2018, only 15 (43%) PEPFAR-supported country or regional programs had implemented PrEP programs; however, client volume increased by 3,351% over the assessment period in 15 country or regional programs. Scale-up of PrEP among general population clients (5,255%) was nearly three times that of key population clients (1,880%). Among key populations, the largest increase (3,518%) occurred among MSM. Factors that helped drive the success of these PrEP early adopter programs included initiation of national, regional, and multilateral stakeholder meetings; engagement of ministries of health and community advocates; revision of HIV treatment guidelines to include PrEP; training for HIV service providers; and establishment of drug procurement policies. These best practices can help facilitate PrEP implementation, particularly among key populations, in other country or regional programs to reduce global incidence of HIV infection.

A Pharmacist-Led, Same-Day, HIV Pre-Exposure Prophylaxis Initiation Program to Increase PrEP Uptake and Decrease Time to PrEP Initiation.

Mississippi has one of the highest rates of HIV in the United States, but has low pre-exposure prophylaxis (PrEP) uptake, particularly among black men who have sex with men (MSM) and women. From November 2018 to May 2019, patients at high risk of HIV who tested negative for HIV at a nonclinical testing center in Jackson, Mississippi, were referred to an on-site clinical pharmacist for same-day PrEP initiation. The pharmacist evaluated patients for medical contraindications to PrEP, but no baseline labs were obtained. The pharmacist provided a PrEP prescription and scheduled a clinical appointment for patients within 6 weeks, at which time they were evaluated by a clinician and completed baseline labs. The pharmacist evaluated 69 patients for PrEP; 57% were MSM, 77% were black, and 65% were uninsured. All patients received a PrEP prescription; 83% received the prescription the same day and 97% received it within 5 days. Fifty-three (77%) of 69 clients filled the prescription; 87% of whom filled it within 1 week. Only 23 (43%) of 53 clients who filled their prescription attended their initial clinical appointment within 6 weeks of obtaining PrEP. There were no differences in PrEP initiation or retention by patient sex/gender. This pilot program suggests that an on-site pharmacist working in a nonclinical testing center in the southern United States can successfully initiate PrEP among predominately low-income black MSM. Future efforts should seek to better integrate laboratory testing into this demedicalized model of PrEP and to improve retention in care.

The only way is up: priorities for implementing long-acting antiretrovirals for HIV prevention and treatment.

PURPOSE OF REVIEW: Long-acting HIV treatment and prevention (LAHTP) can address some of the achievement gaps of daily oral therapy to bring us closer to achieving Joint United Nations Programme on HIV/AIDS Fast-track goals. Implementing these new technologies presents individual-level, population-level, and health systems-level opportunities and challenges. RECENT FINDINGS: To optimize LAHTP implementation and impact, decision-makers should define and gather relevant data to inform their investment case within the existing health systems context. Programmatic observations from scale-up of antiretroviral therapy, oral preexposure prophylaxis, voluntary medical male circumcision, and family planning offer lessons as planning begins for implementation of LAHTP. Additional data intelligence should be derived from formative studies, pragmatic clinical trials, epidemiologic and economic modeling of LAHTP. Key implementation issues that need to be addressed include optimal communication strategies for demand creation; target setting; logistics and supply chain of commodities needed for LAHTP delivery; human resource planning; defining and operationalizing monitoring and evaluating metrics; integration into health systems. SUMMARY: Successful LAHTP implementation can bolster treatment and prevention coverage levels if implementation issues outlined above are proactively addressed in parallel with research and development so that health systems can more rapidly integrate new technologies as they gain regulatory approval.

Profilaxis preexposición al VIH en España: situación política y administrativa / HIV pre-exposure prophylaxis (PrEP) in Spain: political and administrative situation

Este estudio se ha centrado en las actuaciones a nivel político y administrativo que se han realizado en España en relación con la implementación de la profilaxis preexposición (PrEP) al VIH. Se ha analizado todo tipo de iniciativas formales por parte de los actores políticos y administrativos implicados. Las fuentes utilizadas son las fuentes oficiales públicas. Hasta febrero de 2018, la PrEP no ha sido implementada. La decisión depende de los niveles estatal y autonómico. El Ministerio de Sanidad y algunas Comunidades Autónomas trabajan en diversas intervenciones sin establecer un calendario de implementación. Los partidos políticos por su parte han promovido escasas iniciativas relacionadas con la implementación de la PrEP. En el terreno jurídico, se han producido vaivenes legales relacionados con la extensión de la patente. El papel de los órganos intergubernamentales e interdepartamentales es vital para la implementación de la PrEP

This study focuses on actions at the political and administrative level in Spain in relation to the implementation of pre-exposure prophylaxis (PrEP). We analysed a whole range of different formal initiatives taken by the political and administrative actors involved. The information was obtained from official public data sources. As of February 2018, PrEP had not been implemented. The decision is dependent on both state and regional governments. The Ministry of Health and some Autonomous Regions are working on different interventions, but without providing an implementation timetable. The political parties have kept a very low profile in terms of initiatives related to the implementation of PrEP. From a legal point of view, proceedings are passing back and forth with the extension of the patent. The role of intergovernmental and interdepartmental institutions is very important for the implementation of PrEP in Spain

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.