Using an Equity in Research Framework to Develop a Community-Engaged Intervention to Improve Preexposure Uptake Among Black Women Living in the United States South.

ABSTRACT: In the U.S. South, over half of new HIV diagnoses occur among Black Americans with research lagging for women who face increased HIV rates and low PrEP uptake, among other health inequities. Community engaged research is a promising method for reversing these trends with established best practices for building infrastructure, implementing research, and translating evidence-based interventions into clinical and community settings. Using the 5Ws of Racial Equity in Research Framework (5Ws) as a racial equity lens, the following paper models a review of a salon-based intervention to improve PrEP awareness and uptake among Black women that was co-developed with beauty salons, stylists, and Black women through an established community advisory council. In this paper we demonstrate how the 5Ws framework was applied to review processes, practices, and outcomes from a community-engaged research approach. The benefits of and challenges to successful collaboration are discussed with insights for future research and community impact.

Cost-effectiveness of different intervention strategies of HIV in Zhejiang, China.

OBJECTIVE: Mass screening for HIV and preexposure prophylaxis (PrEP) may be effective measures for reducing the probability of HIV transmission. Our study aimed to determine the cost-effectiveness of preliminary screening in the general population, PrEP for HIV-negative spouses in serodiscordant couples, or both approaches in Zhejiang Province. DESIGN: From a policy-maker's perspective, a Markov model was constructed to compare four strategies over a 30-year horizon. METHODS: In the Markov model, the implementation intensities of the strategies varied from 50 to 100%. Different strategies were evaluated by the reduction of unfavorable clinical outcomes, saved life-years, quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), and net monetary benefits (NMBs). RESULTS: The PrEP-screening strategy reduced the most unfavorable clinical outcomes and saved the most life-years and QALYs from 2023 to 2052. It always gained the maximum QALYs and NMB, while its ICER was always lower than the willingness-to-pay (WTP). The NMB of the PrEP-screening strategy gradually increased as the implementation intensity increased. CONCLUSION: With adequate manpower and policies, we suggest implementing the PrEP-screening strategy in Zhejiang Province, suggesting that the broader the population coverage of the strategy, the better. In addition, the PrEP strategy is an alternative.

Effectiveness of nirsevimab introduction against respiratory syncytial virus in the Valencian Community: A preliminary assessment.

Respiratory syncytial virus (RSV) represents a high burden of disease in children and the primary cause of hospitalization, especially in children under 1 year old. In the Valencian Community (Spain), nirsevimab, a long-acting monoclonal antibody, was introduced for the RSV 2023-2024 season as a universal pre-exposure prophylaxis for high-risk children and those under 6 months old. This study examines its impact, coverage, and effectiveness. The campaign achieved 88.5 % coverage and 73.7 % of effectiveness. Analysis of over 27,000 susceptible children (over 24,000 immunized), showed that those immunized exhibited a threefold reduction in RSV incidence compared to non-immunized ones. To prevent one case, the number needed to immunize (NNI) was 63. Hospitalizations due to acute respiratory infections were almost two times lower in immunized children compared to non-immunized ones (0.9 % vs 1.6 %, respectively). These first results showcase the preliminary positive impact of this public health intervention.

Experiences of oral pre-exposure prophylaxis use among heterosexual men accessing sexual and reproductive health services in South Africa: a qualitative study.

INTRODUCTION: South African men face a substantial burden of HIV and are less likely to test for HIV and initiate antiretroviral therapy if tested positive and more likely to die from AIDS-related causes than women. In addition to condoms and circumcision, guidelines provide for the use of daily oral pre-exposure prophylaxis (PrEP) as an HIV prevention intervention for any men who recognize their need and request PrEP. However, heterosexual men have not been a focus of PrEP programmes, and since its introduction, there is limited literature on PrEP use among men in South Africa. This study explores the experiences, motivators and barriers to oral PrEP use among heterosexual men accessing primary healthcare services in South Africa. METHODS: This study forms part of a mixed-methods implementation science study aimed at generating evidence for oral PrEP introduction and conducted in primary healthcare clinics in South Africa since 2018. Men aged ≥15 years who initiated oral PrEP and enrolled in a parent cohort study were purposefully invited to participate in an in-depth interview (IDI). Between March 2020 and May 2022, 30 men participated in IDIs exploring their motivators for PrEP use, and experiences with accessing health services. Interviews were audio recorded, transcribed and analysed thematically. RESULTS: The final analysis included 28 heterosexual men (18-56 years old). Motivations to initiate PrEP included fear of acquiring HIV, self-perceived vulnerability to HIV and mistrust in relationships; health systems factors which motivated PrEP use included the influence of healthcare providers, educational materials and mobile services. Perceived reduction in HIV vulnerability and changing proximity to partners were reasons for PrEP discontinuation. Side effects, daily-pill burden and stigma were noted as challenges to PrEP use. Health system barriers to PrEP use included limited PrEP availability, school and work demands, and inconsistent mobile clinic schedules. CONCLUSIONS: Our study reports on the experiences of heterosexual men accessing oral PrEP in real-world settings and contributes to the limited literature among this population. We highlight multiple levels which could be strengthened to improve men's PrEP use, including individual support, education among partners and communities, and addressing health system barriers to access.

A behavioral economics approach to enhancing HIV preexposure and postexposure prophylaxis implementation.

PURPOSE OF REVIEW: The 'PrEP cliff' phenomenon poses a critical challenge in global HIV PrEP implementation, marked by significant dropouts across the entire PrEP care continuum. This article reviews new strategies to address 'PrEP cliff'. RECENT FINDINGS: Canadian clinicians have developed a service delivery model that offers presumptive PEP to patients in need and transits eligible PEP users to PrEP. Early findings are promising. This service model not only establishes a safety net for those who were not protected by PrEP, but it also leverages the immediate salience and perceived benefits of PEP as a natural nudge towards PrEP use. Aligning with Behavioral Economics, specifically the Salience Theory, this strategy holds potential in tackling PrEP implementation challenges. SUMMARY: A natural pathway between PEP and PrEP has been widely observed. The Canadian service model exemplifies an innovative strategy that leverages this organic pathway and enhances the utility of both PEP and PrEP services. We offer theoretical insights into the reasons behind these PEP-PrEP transitions and evolve the Canadian model into a cohesive framework for implementation.

In the fight against HIV/AIDS: the arduous implementation of government-funded pre-exposure prophylaxis programme in Taiwan.

INTRODUCTION: The government-funded pre-exposure prophylaxis (PrEP) programme was targeted to those aged under 30 years or serodiscordant couples and implemented in September 2018-October 2020 in Taiwan. The study aimed to examine the effectiveness of the programme and the relationship between sexually transmitted disease (STD) and HIV seroconversion. METHODS: This study was a retrospective cohort analysis with questionnaires designed for participants who joined the aforementioned programme in the PrEP-designated hospitals. The questionnaires included sociodemographic factors, sexual risk behaviours, number and types of sexual partners, and usage of narcotics filled in at the beginning of the programme and every 3 months. The McNemar test was used for the paired questionnaire analysis. The HIV seroconversion status among STD-notified patients nationwide was confirmed by using the data linkage method, followed up until October 2021 with stratification of PrEP programme participation or not. RESULTS: The programme recruited 2155 people. 11 participants (0.5%) had seroconversion within the programme, while 26 (1.2%) had seroconversion after withdrawing from the programme. Overall, 1892 subjects with repeated questionnaires were included in the analysis for behaviour changes with median follow-up of 289 days. After joining the programme, 94.7% of them claimed that they had sexual behaviours: the rate of those who had condomless sex rose to 5.5% (p<0.001) and the rate of those who used narcotics decreased to 2% (p<0.001), compared with their response in the pre-questionnaire. Notably, the frequency of non-use of narcotics in recent 3 months increased from 16.9% to 38.4% in the pre-questionnaire and post-questionnaire responses, among the 177 who had claimed narcotics usage in recent 12 months (p=0.003). More HIV seroconversion was found among patients with STD who did not join the programme than those who joined the programme (8.7% vs 4.9%, p=0.031). CONCLUSIONS: The government-funded programme showed HIV case reduction and positive changes in health behaviours except for condomless sex which had increased prevalence. The reduction of HIV cases was also observed among people with STD. More resources should be allocated to the PrEP programme.

Avoiding Shots in the Dark: Learning from the Past To Inform the Implementation of Long-Acting Injectable Pre-Exposure Prophylaxis for Black American Cisgender Women.

The FDA's approval of long-acting injectable cabotegravir pre-exposure prophylaxis (LAI PrEP) as an alternative to daily oral PrEP represents a crucial development in HIV prevention, particularly for American Black cisgender women who face high HIV-1 risks. Yet, uptake may be hindered by racial and gender inequities. Addressing these requires learning from the roll-out of oral PrEP, creating culturally tailored PrEP campaigns, and enhancing provider training to meet Black women's needs. Tools for discussing PrEP within personal relationships and product preference research tailored to Black women's needs are essential for effective LAI PrEP delivery. Deliberative implementation of LAI PrEP must employ strategies that are community-sensitive, -responsive, and -inclusive. It should prioritize the incorporation of Black women's voices in decision-making and should promote community-led strategies. By addressing historical injustices and fostering trust, healthcare systems can enhance LAI PrEP uptake by Black women. Emphasizing a community-centered approach that ensures health equity and acknowledges the crucial role that social media and Black-led organizations play in promoting PrEP awareness and adoption within Black communities is necessary for successful implementation.

A Behavioral Economic Examination of Sexual Behaviors in the Era of Pre-exposure Prophylaxis via Explanatory Sequential Mixed Methods.

Pre-exposure prophylaxis (PrEP) use may be associated with condom use decisions. The current investigation examined sexual decision-making in the context of PrEP among young adult men who have sex with men (MSM) between 18 and 30 years old, using an explanatory sequential mixed methods design. For the quantitative aim, 99 MSM currently taking PrEP (i.e., PrEP-experienced) and 140 MSM not currently taking PrEP (i.e., PrEP-naive) completed an online survey, including the Sexual Delay Discounting Task (SDDT), which captures likelihood of condom use. For the qualitative aim, 15 people from each group were interviewed about their (1) conceptualizations of risky sex and (2) ways they manage their sexual risk. Participants were, on average, 25.69 years old (SD = 3.07) and 64% White. Results from the quantitative aim revealed, controlling for covariates, PrEP-experienced participants exhibited significantly lower likelihood of (1) using an immediately available condom and (2) waiting for a delayed condom (i.e., sexual delay discounting) compared to PrEP-naive participants. Qualitative themes explaining what young adult MSM consider to be risky sex included: (1) any sex as risky sex, (2) risky sex as "sex without a conversation," and (3) risky sex as sex with risk for physical harm. Themes on ways young adult MSM manage sexual risk were classified as proactive, reactive, and passive. Results suggest that PrEP use is related to condom use decisions. Taken together, quantitative differences in sexual delay discounting, but qualitatively similar conceptualizations and management of risky sex, suggest that the SDDT may be a useful tool in sex research to capture processes (i.e., delay discounting) underlying sexual decision-making that may be missed by traditional self-reports. Implications of results, including potentially providing (good quality) condoms with every PrEP prescription, and future research topics are discussed.

High PrEP acceptability and need for tailored implementation in Cambodian key populations: results from a qualitative assessment.

The HIV epidemics in Cambodia is concentrated in key populations (KPs). Pre-exposure prophylaxis (PrEP) has been officially approved in the country since 2019. However, its use may still be controversial after a PrEP clinical trial was interrupted in Cambodia after being deemed unethical in 2004. In this context, it was necessary to evaluate PrEP acceptability and administration preferences of KPs in Cambodia, with a view to increasing roll-out and uptake. We conducted a qualitative study in 2022 comprising six focus groups and four semi-structured individual interviews with transgender women, men who have sex with men, male entertainment workers, venue-based female entertainment workers (FEW), street-based FEW, and PrEP users who participated in a PrEP pilot study that started in 2019. Overall, KPs positively perceived PrEP, with some reservations. They preferred daily, community-based PrEP to event-driven, hospital-based PrEP, and highlighted that injectable PrEP would be a potential option if it became available in Cambodia. We recommend (i) proposing different PrEP regimens and PrEP delivery-models to broaden PrEP acceptability and adherence in Cambodia (ii) increasing the number of community-based organisations and improving the services they offer, (iii) rolling out injectable PrEP when it becomes officially available, and (iv) improving PrEP side effects information.

HIV pre-exposure prophylaxis and its implementation in the PrEP Impact Trial in England: a pragmatic health technology assessment.

BACKGROUND: HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV acquisition. To enable routine commissioning of PrEP in England, we aimed to establish population need, duration of need, PrEP uptake, and duration of use in attendees of sexual health services (SHS) in England. METHODS: The Impact Trial was a prospective, open-label, single-arm, multicentre trial conducted at 157 SHS across England between Oct 13, 2017, and July 12, 2020. Clinicians assessed HIV-negative attendees for their risk of HIV acquisition to identify those who were eligible to participate and receive either daily or event-based oral PrEP (tenofovir disoproxil maleate with emtricitabine), as appropriate. Eligible participants were aged 16 years or older, considered HIV-negative on the day of enrolment, and willing to adhere to the trial procedures. Non-trial attendees are mutually exclusive of trial participants and included SHS attendees who were not recruited to the Impact Trial at any point. They include HIV-negative individuals aged 16 years or older who attended a participating SHS at least once after recruitment at that SHS had begun and before Feb 29, 2020. The main outcomes assessed were PrEP need, uptake, and use, and HIV and sexually transmitted infection (STI) incidence. Data are presented up to Feb 29, 2020, before the introduction of COVID-19 control measures. The study is registered with ClinicalTrials.gov, NCT03253757. FINDINGS: In this analysis, we include 21 356 of 24 268 participants enrolled before Feb 29, 2020. 20 403 participants (95·5%) were men who have sex with men (MSM). Uptake of PrEP among SHS attendees clinically assessed and coded as eligible was 21 292 (57·1%) of 37 289. 18 400 trial participants had at least one post-enrolment visit and a median of 361 days of follow-up (IQR 143-638); 14 039 (75·9%) of these had enough PrEP prescribed to provide protection for 75% of their follow-up time. Among MSM, HIV incidence was 0·13 (95% CI 0·08-0·19) per 100 person-years in trial participants (27 seroconversions) and 0·95 (95% CI 0·88-1·03) per 100 person-years in non-trial attendees (587 seroconversions; proportionate reduction of 86·8%, 95% CI 80·2-91·6). 18 607 bacterial STIs were recorded (incidence 68·1 per 100 person-years in trial participants who were MSM). 4343 (24·4%) MSM participants were diagnosed with two or more STIs, accounting for 14 800 (79·5%) of all 18 607 diagnoses. INTERPRETATION: PrEP need was higher than initially estimated by an expert stakeholder group. The high proportion of follow-up time protected by PrEP suggests that the need for protection persisted throughout trial participation for most participants. HIV incidence among MSM trial participants was low. The large unmet need for PrEP suggests that greater provision is required to maximise the potential of a national programme. The high incidence of bacterial STIs among participants, concentrated within a subgroup of PrEP users, presents an opportunity for tailored STI control measures. FUNDING: NHS England.

Awareness of and willingness to use oral pre-exposure prophylaxis (PrEP) for HIV prevention among sexually active adults in Malawi: results from the 2020 Malawi population-based HIV impact assessment.

BACKGROUND: The World Health Organization recommends Pre-Exposure Prophylaxis (PrEP) for all populations at substantial risk of HIV infection. Understanding PrEP awareness and interest is crucial for designing PrEP programs; however, data are lacking in sub-Saharan Africa. In Malawi, oral PrEP was introduced in 2018. We analyzed data from the 2020 Malawi Population-based HIV Impact Assessment (MPHIA) to assess PrEP awareness and factors associated with PrEP interest in Malawi. METHODS: MPHIA 2020 was a national cross-sectional household-based survey targeting adults aged 15 + years. Oral PrEP was first described to the survey participants as taking a daily pill to reduce the chance of getting HIV. To assess awareness, participants were asked if they had ever heard of PrEP and to assess interest, were asked if they would take PrEP to prevent HIV, regardless of previous PrEP knowledge. Only sexually active HIV-negative participants are included in this analysis. We used multivariable logistic regression to assess sociodemographic factors and behaviors associated with PrEP interest. All results were weighted. RESULTS: We included 13,995 HIV-negative sexually active participants; median age was 29 years old. Overall, 15.0%, 95% confidence interval (CI): 14.2-15.9% of participants were aware of PrEP. More males (adjusted odds ratio (aOR): 1.3, 95% CI: 1.2-1.5), those with secondary (aOR: 1.5, 95% CI: 1.2-2.0) or post-secondary (aOR: 3.4, 95% CI: 2.4-4.9) education and the wealthiest (aOR: 1.6, 95% CI: 1.2-2.0) were aware of PrEP than female, those without education and least wealthy participants, respectively. Overall, 73.0% (95% CI: 71.8-74.1%) of participants were willing to use PrEP. Being male (aOR: 1.2; 95% CI: 1.1-1.3) and having more than one sexual partner (aOR: 1.7 95% CI: 1.4-1.9), were associated higher willingness to use PrEP. CONCLUSIONS: In this survey, prior PrEP knowledge and use were low while PrEP interest was high. High risk sexual behavior was associated with willingness to use PrEP. Strategies to increase PrEP awareness and universal access, may reduce HIV transmission.

[Evaluating the introduction of HIV pre-exposure prophylaxis as a benefit of statutory health insurance (EvE-PrEP) : Highly effective protection against HIV without an increase in sexually transmitted infections]. / Evaluation der Einführung der HIV-Präexpositionsprophylaxe als Leistung der gesetzlichen Krankenversicherung (EvE­PrEP) : Hocheffektiver Schutz vor HIV und keine Zunahme von sexuell übertragbaren Infektionen.

BACKGROUND: We investigated the impact of HIV pre-exposure prophylaxis (PrEP) as a new service of the statutory health insurance (SHI) on the incidence of HIV and other sexually transmitted infections (STIs) in Germany. In addition, PrEP needs and access barriers were analyzed. METHODS: The following data were evaluated as part of the evaluation project: HIV and syphilis notification data and extended surveillance by the Robert Koch Institute (RKI), pharmacy prescription data, SHI routine data, PrEP use in HIV-specialty care centers, Checkpoint, the BRAHMS and PrApp studies, as well as a community board. RESULTS: The majority of PrEP users were male (98-99%), primarily aged between 25-45 years, and predominantly of German nationality or origin (67-82%). The majority were men who have sex with men (99%). With regard to HIV infections, PrEP proved to be highly effective. There were only isolated cases of HIV infections (HIV incidence rate 0.08/100 person years); in most cases the suspected reason was low adherence. The incidences of chlamydia, gonorrhea, and syphilis did not increase but remained almost the same or even decreased. A need for information on PrEP for people in trans*/non-binary communities, sex workers, migrants, and drug users emerged. Needs-based services for target groups at increased risk of HIV are necessary. DISCUSSION: PrEP proved to be a very effective HIV prevention method. The partly feared indirect negative influences on STI rates were not confirmed in this study. Due to the temporal overlap with the containment measures during the COVID-19 pandemic, a longer observation period would be desirable for a conclusive assessment.

Health Outcomes and Cost-effectiveness of Monoclonal SARS-CoV-2 Antibodies as Pre-exposure Prophylaxis.

Importance: Pre-exposure prophylaxis with neutralizing SARS-CoV-2 monoclonal antibodies (mAbs PrEP) prevents infection and reduces hospitalizations and the duration thereof for COVID-19 and death among high-risk individuals. However, reduced effectiveness due to a changing SARS-CoV-2 viral landscape and high drug prices remain substantial implementation barriers. Objective: To assess the cost-effectiveness of mAbs PrEP as COVID-19 PrEP. Design, Setting, and Participants: For this economic evaluation, a decision analytic model was developed and parameterized with health care outcome and utilization data from individuals with high risk for COVID-19. The SARS-CoV-2 infection probability, mAbs PrEP effectiveness, and drug pricing were varied. All costs were collected from a third-party payer perspective. Data were analyzed from September 2021 to December 2022. Main Outcomes and Measures: Health care outcomes including new SARS-CoV-2 infections, hospitalization, and deaths. The cost per death averted and cost-effectiveness ratios using a threshold for prevention interventions of $22 000 or less per quality-adjusted life year (QALY) gained. Results: The clinical cohort consisted of 636 individuals with COVID-19 (mean [SD] age 63 [18] years; 341 [54%] male). Most individuals were at high risk for severe COVID-19, including 137 (21%) with a body mass index of 30 or higher, 60 (9.4%) with hematological malignant neoplasm, 108 (17%) post-transplantation, and 152 (23.9%) who used immunosuppressive medication before COVID-19. Within the context of a high (18%) SARS-CoV-2 infection probability and low (25%) effectiveness the model calculated a short-term reduction of 42% ward admissions, 31% intensive care unit (ICU) admissions, and 34% deaths. Cost-saving scenarios were obtained with drug prices of $275 and 75% or higher effectiveness. With a 100% effectiveness mAbs PrEP can reduce ward admissions by 70%, ICU admissions by 97%, and deaths by 92%. Drug prices, however, need to reduce to $550 for cost-effectiveness ratios less than $22 000 per QALY gained per death averted and to $2200 for ratios between $22 000 and $88 000. Conclusions and Relevance: In this study, use of mAbs PrEP for preventing SARS-CoV-2 infections was cost-saving at the beginning of an epidemic wave (high infection probability) with 75% or higher effectiveness and drug price of $275. These results are timely and relevant for decision-makers involved in mAbs PrEP implementation. When newer mAbs PrEP combinations become available, guidance on implementation should be formulated ensuring a fast rollout. Nevertheless, advocacy for mAbs PrEP use and critical discussion on drug prices are necessary to ensuring cost-effectiveness for different epidemic settings.

A Transgender Chatbot (Amanda Selfie) to Create Pre-exposure Prophylaxis Demand Among Adolescents in Brazil: Assessment of Acceptability, Functionality, Usability, and Results.

BACKGROUND: HIV incidence rates have increased in adolescent men who have sex with men (AMSM) and adolescent transgender women (ATGW). Thus, it is essential to promote access to HIV prevention, including pre-exposure prophylaxis (PrEP), among these groups. Moreover, using artificial intelligence and online social platforms to create demand and access to health care services are essential tools for adolescents and youth. OBJECTIVE: This study aims to describe the participative process of developing a chatbot using artificial intelligence to create demand for PrEP use among AMSM and ATGW in Brazil. Furthermore, it analyzes the chatbot's acceptability, functionality, and usability and its results on the demand creation for PrEP. METHODS: The chatbot Amanda Selfie integrates the demand creation strategies based on social networks (DCSSNs) of the PrEP1519 study. She was conceived as a Black transgender woman and to function as a virtual peer educator. The development process occurred in 3 phases (conception, trial, and final version) and lasted 21 months. A mixed methodology was used for the evaluations. Qualitative approaches, such as in-depth adolescent interviews, were used to analyze acceptability and usability, while quantitative methods were used to analyze the functionality and result of the demand creation for PrEP based on interactions with Amanda and information from health care services about using PrEP. To evaluate Amanda's result on the demand creation for PrEP, we analyzed sociodemographic profiles of adolescents who interacted at least once with her and developed a cascade model containing the number of people at various stages between the first interaction and initiation of PrEP (PrEP uptake). These indicators were compared with other DCSs developed in the PrEP1519 study using chi-square tests and residual analysis (P=.05). RESULTS: Amanda Selfie was well accepted as a peer educator, clearly and objectively communicating on topics such as gender identity, sexual experiences, HIV, and PrEP. The chatbot proved appropriate for answering questions in an agile and confidential manner, using the language used by AMSM and ATGW and with a greater sense of security and less judgment. The interactions with Amanda Selfie combined with a health professional were well evaluated and improved the appointment scheduling. The chatbot interacted with most people (757/1239, 61.1%) reached by the DCSSNs. However, when compared with the other DCSSNs, Amanda was not efficient in identifying AMSM/ATGW (359/482, 74.5% vs 130/757, 17.2% of total interactions, respectively) and in PrEP uptake (90/359, 25.1% vs 19/130, 14.6%). The following profiles were associated (P<.001) with Amanda Selfie's demand creation, when compared with other DCS: ATGW and adolescents with higher levels of schooling and White skin color. CONCLUSIONS: Using a chatbot to create PrEP demand among AMSM and ATGW was well accepted, especially for ATGW with higher levels of schooling. A complimentary dialog with a health professional increased PrEP uptake, although it remained lower than the results of the other DCSSNs.

The future of HIV pre-exposure prophylaxis adherence: reducing barriers and increasing opportunities.

The effectiveness of HIV pre-exposure prophylaxis (PrEP) hinges on adherence, which has been restricted by multifaceted barriers. Uptake of PrEP has been impeded by poor access resulting from high costs, provider uncertainty, discrimination, stigma, and poor understanding within the health-care community and the public of who can benefit from PrEP. Other important barriers to adherence and persistence over time relate to individuals (eg, depression) and their community, partners, and family (eg, poor support), and their effects vary substantially with each person, population, and setting. Despite these challenges, key opportunities for improving PrEP adherence exist, including novel delivery systems, tailored individual interventions, mobile health and digital health interventions, and long-acting formulations. Objective monitoring strategies will help to improve adherence interventions and alignment of PrEP use with the need for HIV prevention (ie, prevention-effective adherence). The future of PrEP adherence lies in person-centred approaches to service delivery that meet the needs of individuals while creating supportive environments and facilitating health-care access and delivery.

Achieving the "Ending the HIV Epidemic in the U.S." incidence reduction goals among at-risk populations in the South.

INTRODUCTION: Antiretroviral medication coverage remains sub-optimal in much of the United States, particularly the Sothern region, and Non-Hispanic Black or African American persons (NHB) continue to be disproportionately impacted by the HIV epidemic. The "Ending the HIV Epidemic in the U.S." (EHE) initiative seeks to reduce HIV incidence nationally by focusing resources towards the most highly impacted localities and populations. This study evaluates the impact of hypothetical improvements in ART and PrEP coverage to estimate the levels of coverage needed to achieve EHE goals in the South. METHODS: We developed a stochastic, agent-based network model of 500,000 individuals to simulate the HIV epidemic and hypothetical improvements in ART and PrEP coverage. RESULTS: New infections declined by 78.6% at 90%/40% ART/PrEP and 94.3% at 100%/50% ART/PrEP. Declines in annual incidence rates surpassed 75% by 2025 with 90%/40% ART/PrEP and 90% by 2030 with 100%/50% ART/PrEP coverage. Increased ART coverage among NHB MSM was associated with a linear decline in incidence among all MSM. Declines in incidence among Hispanic/Latino and White/Other MSM were similar regardless of which MSM race group increased their ART coverage, while the benefit to NHB MSM was greatest when their own ART coverage increased. The incidence rate among NHB women declined by over a third when either NHB heterosexual men or NHB MSM increased their ART use respectively. Increased use of PrEP was associated with a decline in incidence for the groups using PrEP. MSM experienced the largest absolute declines in incidence with increasing PrEP coverage, followed by NHB women. CONCLUSIONS: Our analysis indicates that it is possible to reach EHE goals. The largest reductions in HIV incidence can be achieved by increasing ART coverage among MSM and all race groups benefit regardless of differences in ART initiation by race. Improving ART coverage to > 90% should be prioritized with a particular emphasis on reaching NHB MSM. Such a focus will reduce the largest number of incident cases, reduce racial HIV incidence disparities among both MSM and women, and reduce racial health disparities among persons with HIV. NHB women should also be prioritized for PrEP outreach.

Ending the HIV epidemic PrEP equity recommendations from a rapid ethnographic assessment of multilevel PrEP use determinants among young Black gay and bisexual men in Atlanta, GA.

BACKGROUND: Efforts to mitigate HIV transmission among gay and bisexual men have not been sufficient to level persistent racial inequities which now extend to the use of daily oral pre-exposure prophylaxis (PrEP) for HIV prevention. Community-involved ethnographic research is crucial to galvanizing collaboration between patients, researchers, and policymakers to identify the social determinants of emerging PrEP inequities. In partnership with community key informants, we conducted a Rapid Ethnographic Assessment (REA) of multilevel PrEP use determinants among young Black gay and bisexual (YBGBM) men in the metropolitan Atlanta area to inform the development and coordination of local HIV programs. METHODS: In the assessment, we drew upon the perspectives of local clinicians, community-based organization leaders, health educators, and PrEP clients to identify barriers and facilitators to PrEP use among YBGBM through interviews (N = 23). Data were collected from September 2020 -to January 2021 and were analyzed through a staged deductive-inductive thematic analysis. The themes were later summarized and presented to community stakeholder participants to facilitate member-checking. RESULTS: Our analyses revealed structural, cultural, relationship, and developmental factors which shaped PrEP use. The most prominent being "ease of access to PrEP" (structural level), "provider support" (interpersonal), and "life-stage traits" (individual). Our results also contribute novel information concerning the axes of intersectional stigma (spatial, racial, sexual identity, and HIV) among YBGBM in Atlanta and its divergent effects on PrEP use. CONCLUSION: Increased PrEP use among YBGBM, particularly among those living in the south, is essential to ending the domestic HIV epidemic. Altogether, our results emphasize the need for PrEP program modifications, which increase flexibility in methods and modes of access and are culturally adapted to the needs of YBGBM. There is also a need for resources that holistically focus on mental health, trauma, and racism as critical components of support.

Predicted effects of the introduction of long-acting injectable cabotegravir pre-exposure prophylaxis in sub-Saharan Africa: a modelling study.

BACKGROUND: Long-acting injectable cabotegravir pre-exposure prophylaxis (PrEP) is recommended by WHO as an additional option for HIV prevention in sub-Saharan Africa, but there is concern that its introduction could lead to an increase in integrase-inhibitor resistance undermining treatment programmes that rely on dolutegravir. We aimed to project the health benefits and risks of cabotegravir-PrEP introduction in settings in sub-Saharan Africa. METHODS: With HIV Synthesis, an individual-based HIV model, we simulated 1000 setting-scenarios reflecting both variability and uncertainty about HIV epidemics in sub-Saharan Africa and compared outcomes for each with and without cabotegravir-PrEP introduction. PrEP use is assumed to be risk-informed and to be used only in 3-month periods (the time step for the model) when having condomless sex. We consider three groups at risk of integrase-inhibitor resistance emergence: people who start cabotegravir-PrEP after (unknowingly) being infected with HIV, those who seroconvert while on PrEP, and those with HIV who have residual cabotegravir drugs concentrations during the early tail period after recently stopping PrEP. We projected the outcomes of policies of cabotegravir-PrEP introduction and of no introduction in 2022 across 50 years. In 50% of setting-scenarios we considered that more sensitive nucleic-acid-based HIV diagnostic testing (NAT), rather than regular antibody-based HIV rapid testing, might be used to reduce resistance risk. For cost-effectiveness analysis we assumed in our base case a cost of cabotegravir-PrEP drug to be similar to oral PrEP, resulting in a total annual cost of USD$144 per year ($114 per year and $264 per year considered in sensitivity analyses), a cost-effectiveness threshold of $500 per disability-adjusted life years averted, and a discount rate of 3% per year. FINDINGS: Reflecting our assumptions on the appeal of cabotegravir-PrEP, its introduction is predicted to lead to a substantial increase in PrEP use with approximately 2·6% of the adult population (and 46% of those with a current indication for PrEP) receiving PrEP compared with 1·5% (28%) without cabotegravir-PrEP introduction across 20 years. As a result, HIV incidence is expected to be lower by 29% (90% range across setting-scenarios 6-52%) across the same period compared with no introduction of cabotegravir-PrEP. In people initiating antiretroviral therapy, the proportion with integrase-inhibitor resistance after 20 years is projected to be 1·7% (0-6·4%) without cabotegravir-PrEP introduction but 13·1% (4·1-30·9%) with. Cabotegravir-PrEP introduction is predicted to lower the proportion of all people on antiretroviral therapy with viral loads less than 1000 copies per mL by 0·9% (-2·5% to 0·3%) at 20 years. For an adult population of 10 million an overall decrease in number of AIDS deaths of about 4540 per year (-13 000 to -300) across 50 years is predicted, with little discernible benefit with NAT when compared with standard antibody-based rapid testing. AIDS deaths are predicted to be averted with cabotegravir-PrEP introduction in 99% of setting-scenarios. Across the 50-year time horizon, overall HIV programme costs are predicted to be similar regardless of whether cabotegravir-PrEP is introduced (total mean discounted annual HIV programme costs per year across 50 years is $151·3 million vs $150·7 million), assuming the use of standard antibody testing. With antibody-based rapid HIV testing, the introduction of cabotegravir-PrEP is predicted to be cost-effective under an assumed threshold of $500 per disability-adjusted life year averted in 82% of setting-scenarios at the cost of $144 per year, in 52% at $264, and in 87% at $114. INTERPRETATION: Despite leading to increases in integrase-inhibitor drug resistance, cabotegravir-PrEP introduction is likely to reduce AIDS deaths in addition to HIV incidence. Long-acting cabotegravir-PrEP is predicted to be cost-effective if delivered at similar cost to oral PrEP with antibody-based rapid HIV testing. FUNDING: Bill & Melinda Gates Foundation, National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Cost-effectiveness analysis of the daily HIV pre-exposure prophylaxis in men who have sex with men in Barcelona.

INTRODUCTION: Pre-Exposure Prophylaxis (PrEP) for HIV prevention has been implemented in several countries. Previous literature has shown that its cost-effectiveness (and, under some specifications, cost-saving character) is dependent on the reduction in price due to generics, the time-horizon and its effectiveness. The intervention has never been studied in Catalonia after the approval of the PrEP, a territory with extensive implementation. METHODS: Economic evaluation of the implementation of HIV pre-exposition prophylaxis using administrative data from Men who have Sex with Men (MSM) who receive the treatment (at the generic price) compared with non-implementation. A deterministic compartmental model and a social perspective with a micro-costing approach over the time horizon 2022-2062 are used. A baseline 86% effectiveness of PrEP is assumed. RESULTS: Daily oral PrEP is found to be cost-saving: discounted savings in costs are attained after 16 years, and after 40 years they reach 81 million euros. In terms of health indicators, 10,322 additional discounted QALYs are generated by the intervention. Results are sensitive to sexual behavioral patterns among MSM, the price of PrEP (reduced if offered on-demand), its effectiveness and the discount rate. CONCLUSIONS: The use and promotion of PrEP in Catalonia is predicted to result in substantial health and monetary benefits because of reductions in HIV infections. Short-term investments in the promotion of PrEP will result in important cost-savings in the long term.