The early-stage comprehensive costs of routine PrEP implementation and scale-up in Zambia

Introduction: Pre-exposure prophylaxis (PrEP) is effective at preventing HIV infection, but PrEP cost-effectiveness is sensitive to PrEP implementation and program costs. Preliminary studies indicate that, in addition to direct delivery cost, PrEP provision requires substantial demand creation and user support to encourage PrEP initiation and persistence. We estimated the cost of providing PrEP in Zambia through different PrEP delivery models. Methods: Taking a guidelines-based approach for visits, labs and drugs assuming fidelity to the expanded 2018 Zambian PrEP guidelines, we estimated the annual cost of providing PrEP per client for five delivery models: one focused on key populations (men-who-have-sex-with-men (MSM) and female sex workers (FSW), one on adolescent girls and young women (AGYW), and three integrated programs (operated within the HIV counselling and testing service at primary healthcare centres). Program start-up, provider, and user support costs were based on program expenditure data and number of PrEP sites and clients in 2018. PrEP clinic visit costs were based on micro-costing at two PrEP delivery sites (in 2018 USD). Results: The annual cost per PrEP client varied greatly by program type, from $394 (AGYW) to $760 in an integrated program. Cost differences were driven largely by volume (i.e. the number of clients initiated/model/site) which impacted the relative costs of program support and technical assistance assigned to each PrEP client. Direct service delivery costs, including staff and overheads, labs and monitoring, drugs and consumables ranged narrowly from $208-217/PrEP-user. Service delivery costs were a key component in the cost of PrEP, representing 36-65% of total costs. Reductions in service delivery costs per PrEP client are expected with further scale-up. Conclusions: The results show that, even when integrated into full service delivery models, accessing vulnerable, marginalised populations at substantial risk of HIV infection is likely to cost more than previously estimated due to the programmatic costs involved in community sensitization and user support. Improved data on individual client resource usage (e.g. drugs, labs, visits) and outcomes (e.g. initiation, persistence) is required to get a better understanding of the true resource utilization, cost and expected outcomes and annual costs of different PrEP programs in Zambia.

Where’S the “Everyday Black Woman”? an Intersectional Qualitative Analysis of Black Women’S Decision-Making Regarding HIV Pre-Exposure Prophylaxis (PrEP) in Mississippi

Background Black cisgender women in the U.S. South bear a disproportionate burden of HIV compared to cisgender women in other racial and ethnic groups and in any other part of the US. Critical to decreasing new HIV infections is the improved delivery of pre-exposure prophylaxis (PrEP) for Black cisgender women as it remains underutilized in 2021. Informed by intersectionality, the study sought to characterize the sociostructural influences on Black cisgender women’s deliberations about PrEP within the context of interlocking systems of oppression including racism, sexism, and classism. Methods Six focus groups were conducted with 37 Black women residing in Jackson, Mississippi. This sample was purposively recruited to include Black cisgender women who were eligible for PrEP but had never received a PrEP prescription. Results Six themes were identified as obstacles during PrEP deliberation among Black women: 1) limited PrEP awareness, 2) low perceived HIV risk, 3) concerns about side effects, 4) concerns about costs, 5) limited marketing, and 6) distrust in the healthcare system. Three themes were identified as facilitators during PrEP deliberations: 1) women’s empowerment and advocacy, 2) need for increased PrEP-specific education, and 3) the positive influence of PrEP-engaged women’s testimonials. Black women shared a limited awareness of PrEP exacerbated by the lack of Black women-specific marketing. Opportunities to support Black women-specific social marketing could increase awareness and knowledge regarding PrEP’s benefits and costs. Black women also shared their concerns about discrimination in healthcare and distrust, but they felt that these barriers may be addressed by patient testimonials from PrEP-engaged Black women, empowerment strategies, and directly addressing provider biases. Conclusions An effective response to PrEP implementation among Black women in the South requires developing programs to center the needs of Black women and carry out active strategies that prioritize peer advocacy while reinforcing positive and mitigating negative influences from broader social and historical contexts.

852. Bridging the Gap in PrEP Provider Training: An Implementation Science Study

Background Training healthcare providers in a variety of clinical settings to deliver pre-exposure prophylaxis (PrEP) is a key component of the Ending the HIV Epidemic (EHE) initiative. Self-efficacy, the individual’s belief in their ability to carry out the steps of PrEP delivery, is a core part of provider training and necessary for successful PrEP implementation. We characterized self-efficacy among providers from family planning (FP) clinics that do not provide PrEP to inform provider training strategies. Methods We surveyed providers (any clinical staff who could screen, counsel, or prescribe PrEP) from FP clinics in 18 Southern states (Feb-June 2018, N=325 respondents from 224 clinics not providing PrEP) using contraception- and PrEP-specific self-efficacy questions (overall and grouped into PrEP delivery steps: screening, initiation, and follow-up). We compared self-efficacy scores (5-point Likert scale) by prescriber status, between PrEP delivery steps, and used linear mixed models to analyze provider-, clinic-, and county-level covariates associated with overall PrEP self-efficacy. Results Among 325 FP providers, self-efficacy scores were lowest in the PrEP initiation step, higher in follow-up, and highest in screening (p < 0.0001, Table). Mean overall PrEP self-efficacy scores were significantly higher among prescribers compared to non-prescribers (p < 0.0001). However, providers reported lowest self-efficacy regarding insurance navigation for PrEP with no significant difference by prescriber status. The mixed model demonstrated overall PrEP self-efficacy was positively associated with favorable PrEP attitudes among non-prescribers, PrEP knowledge among prescribers, and contraception self-efficacy in both groups, but was not associated with availability of insurance navigation on-site or other covariates (Figure). Provider Self-Efficacy along the PrEP Delivery Model stratified by prescriber status Conclusion FP providers reported low confidence in their ability to perform the steps that comprise PrEP initiation. Provider training focused on elements of PrEP initiation are critical to improve PrEP implementation and EHE initiatives. Alternatively, programs employing referral or telehealth models to support the PrEP initiation step can successfully bridge this gap. Disclosures All Authors: No reported disclosures

856. Barriers to PrEP Implementation among Patient-Facing Staff in Three Urban Clinics

Background PrEP implementation has lagged in the US. The role of multidisciplinary staff in PrEP rollout has been neglected. We sought to identify barriers to PrEP implementation among 3 urban federally qualified health centers (FQHCs) in Connecticut that provide HIV and PrEP services in order to inform development of staff training. Methods A link to an anonymous survey was emailed to patient-facing staff members or posted at the end of staff trainings October 2020-April 2021. The survey requested demographics, duration of employment, and using 4 and 5 point Likert scales, ascertained knowledge and beliefs toward PrEP based on established scales, and perceived individual and systemic barriers to PrEP uptake. Results Among 101 respondents, 40% were 36-54yo, 22% were male, 68% were non-prescribing clinicians, and median duration of employment was 6 years (IQR 2-14). Among 32 (31%) prescribers (physicians, PAs, APRNs), 97% felt comfortable discussing sexual risk with patients, though 15% were not familiar with PrEP efficacy and safety data, 28% responded that PrEP use would encourage risky behaviors, 34% were concerned about side effects, 53% responded that educational and behavioral interventions should be attempted prior to prescribing PrEP, and 59% identified lack of provider training as a barrier. Among 69 (68%) non-prescribers, barriers to PrEP uptake included: patients don’t ask for PrEP (43%), lack of insurance (47%), lack of clinic guidelines/protocol (42%), and staff time for counseling (31%). Conclusion Prescribers and non-prescribers identified distinct individual and systemic barriers to PrEP uptake at FQHCs. Among prescribers, uncertainty regarding indications for and safety of PrEP exist, which will be addressed with targeted training. Non-prescribers identified the need for patient outreach, financial assistance, and counseling as the top priorities. The input of clinic multidisciplinary team members is essential to addressing barriers to PrEP implementation. Disclosures Sheela Shenoi, MD, MPH, Merck (Other Financial or Material Support, SS’s spouse worked for Merck pharmaceuticals 1997-2007 and retains company stock in his retirement account. There is no conflict of interest, but it is included in the interest of full disclosure.)

Integrating Pre-Exposure Prophylaxis Delivery in Public Health Family Planning Clinics: Lessons Learned From a Programmatic Implementation Project in Kenya

Sexually active African women are a priority population for HIV prevention due to the disproportionately high frequency of new HIV infections. Family planning (FP) clinics offer an already trusted platform that can be used to reach women for HIV prevention services, including pre-exposure prophylaxis (PrEP). In the recent PrEP Implementation in Young Women and Adolescent (PrIYA program), we piloted PrEP implementation in FP clinics in Kisumu, Kenya, and demonstrated that it was possible to integrate PrEP provision in FP systems with a program-dedicated staff. In this perspective, we describe experiences and strategies employed to introduce PrEP implementation in FP clinics and lessons learned. We identified the following lessons for PrEP introduction in FP clinics in Kenya: (1) possible to integrate and generate high enthusiasm for PrEP delivery in FP clinics but persistence on PrEP is a challenge, (2) involvement of national and regional stakeholders is critical for buy-in, contextualization, and sustainability, (3) delivery models that do not integrate fully with existing staff and systems are less sustainable, (4) creatinine testing at PrEP initiation may not be necessary, (5) fully integrated HIV and FP data systems need to be developed, and (6) incorporating implementation science evaluation is important to understand and document effective implementation strategies. In summary, integration of HIV prevention and FP services provides an opportunity to promote one-stop women-centered care efficiently. However, a broader focus on delivery models that utilize existing staff and novel strategies to help women identify their own risk for HIV are needed to ensure greater success and sustainability.

Readiness of US Federally Qualified Health Centers to Provide HIV Pre-exposure Prophylaxis

We report the results of a survey on HIV pre-exposure prophylaxis (PrEP) perceptions, capacity, and barriers at federally qualified health centers (FQHCs) in high–HIV burden jurisdictions in the United States. Health care workers at FQHCs identified multiple barriers to, and strategies for, improving PrEP implementation.

A cross-sectional survey of general practitioner knowledge, attitudes, and clinical experience of HIV PrEP

Aim Norway’s health scheme provides no-cost HIV pre-exposure prophylaxis (PrEP) when prescribed by a specialist, typically preceded by a general practitioner’s (GP) referral. The GP perspective with regard to PrEP implementation in Norway has yet to be captured. Subject and methods We explored PrEP knowledge, attitudes, and clinical experience of GPs in the Norwegian capital of Oslo, where HIV incidence and PrEP demand are highest. An anonymous survey was designed and distributed between November 2019 and February 2020. Univariate and multivariate logistic regression analyses were performed to identify determinants of GPs’ previous clinical PrEP experience (PrEP adoption). Results One hundred and seventeen GPs responded to the survey. GP PrEP adopters were more likely to: identify as men (aOR 2.1; 95% CI: 1.0–4.5); identify as lesbian, gay, or bisexual (LGB) (aOR 4.4; 95% CI: 1.4–14.5); have ≥ 10 LGB identifying patients on their list (aOR 4.4; 95% CI:1.8–10.4); and self-report higher levels of PrEP knowledge (aOR 2.4; 95% CI: 1.3–4.4). Conclusion Our findings suggest that GP PrEP knowledge is crucial to patient PrEP access. Educational interventions ought to be considered to enhance GP PrEP adoption capacities, such as easy-to-access PrEP guidelines and peer-based training opportunities in both online and in-person formats.

Defining the PrEP care continuum among recently incarcerated men at high risk for HIV infection (Preprint)

BACKGROUND HIV disproportionately impacts criminal justice (CJ)-involved individuals, including men who experience incarceration. Men make up the vast majority of those experiencing incarceration as well as those newly diagnosed with HIV infection. Pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention that significantly reduces the risk of HIV acquisition. However, implementation in CJ-systems is limited. Little is known about effective PrEP implementation and use in this unique public health context. OBJECTIVE This article describes a PrEP care continuum for men experiencing incarceration who are at increased risk of HIV acquisition, which can help conceptualize approaches to evaluating PrEP implementation. METHODS Men incarcerated in the Rhode Island Department of Corrections, a correctional system composed of all of the state's sentenced and awaiting trial population, are screened for HIV acquisition risk during the course of routine clinical care. Those identified at high risk for HIV acquisition are referred for evaluation for PrEP initiation and enrollment in this study. Individuals who express interest in initiating PrEP and consent to the study are then followed in a prospective longitudinal cohort. RESULTS The outlined study will enroll 100 men experiencing incarceration at high risk for HIV acquisition prior to release into the community. The goal is to initiate PrEP prior to incarceration and link individuals to PrEP providers in the community, capturing barriers and facilitators to PrEP use during this uniquely vulnerable time period for HIV acquisition. CONCLUSIONS Based on the proposed care continuum and what is known about HIV risk and prevention efforts in the CJ-context, we outline key future research efforts to better understand effective approaches to preventing HIV infection among this vulnerable population. The described approach presents a powerful public health opportunity to help end the HIV epidemic.