Pre-exposure prophylaxis (PrEP) has the potential to prevent new HIV infections, but it is unclear how state policies governing sexual and reproductive health services (SRH) impact access for cisgender women. The objective of this review is to identify barriers to PrEP access for cisgender women in the United States. Using the CDC Atlas Program, 20 states with the highest HIV incidence among cisgender women were included in this analysis. Through a search conducted in May-July 2022 of CDC, PrEPWatch.org, and other State Department and Insurance websites, Medicaid expansion status, pharmacist PrEP prescribing laws, financial support programs, and Traditional Medicaid coverage of PrEP, HIV testing, and emergency contraception were reviewed. Of the included states, nearly half did not expand Medicaid at the state level. Emergency contraception and HIV testing was covered under Traditional Medicaid for almost all included states, but insurance stipulations and eligibility requirements remain. Although PrEP is covered under all Traditional Medicaid plans, six states require pre-authorization. Three states have HIV testing mandates, four allow pharmacists to prescribe PrEP and six have financial support programs to cover the cost of PrEP. Medicaid expansion, pre-authorization requirements for PrEP prescriptions and emergency contraception, and limitations on pharmacist prescribing abilities were identified as barriers to SRH access for cisgender women. Medicaid expansion should be prioritized as an approach to expanding access to HIV prevention services at the state level.

With increasing importance being given to preexposure prophylaxis (PrEP) for human immunodeficiency virus prevention among men who have sex with men (MSM) and transgender persons (TG), we undertook a systematic review and meta-analysis of PrEP awareness and acceptability among these key populations in India, and their sociodemographic and behavioral determinants. The systematic review was registered with PROSPERO (CRD42023390508). Studies were included if they provided quantitative data on PrEP awareness or acceptability among MSM or TG in India. MEDLINE, Scopus, Web of Science, and Embase were searched from inception to February 29, 2024, using keywords and database-specific terms. Relevant websites were also searched. Critical appraisal was done using the Joanna Briggs Institute Checklist for Prevalence Studies. Random-effects meta-analysis was done for common outcomes reported by the studies. Reporting was as per the Preferred Reporting Items for Systematic Reviews and Meta-analyses 2020 statement. Ten studies providing cross-sectional data, mostly from South West India, were included for qualitative synthesis. All were conducted in settings where PrEP was not available. The pooled prevalence among MSM and TG was 18.7% (95% confidence interval [CI] 8.7%, 28.7%) for awareness and 79.8% (95% CI 57.4%, 100.0%) for willingness to use daily oral PrEP. This review highlights the felt need for PrEP among MSM and TG in India. Further research is needed to understand user attitudes in different parts of the country.

Pre-exposure prophylaxis (PrEP), including daily oral, on-demand, and long-acting injectable (LAI), is a promising HIV prevention intervention for men who have sex with men (MSM). We conducted a systematic review on engagement with the PrEP continuum among MSM in China. A total of 756 studies were initially identified and 36 studies were included (N = 26,021). In the 20 studies (N = 13,886) examining PrEP awareness, 32.4% (95% CI: 25.1-40.7) of MSM were aware of PrEP. In the 25 studies (N = 18,587) examining willingness, 54.5% (95% CI: 41.9-66.5) MSM indicated they were willing to use PrEP. The pooled prevalence of PrEP uptake from 9 studies (N = 6,575) was 4.9% (95% CI: 1.4-15.8%), while pooled estimates of adequate adherence from five studies (N = 2,344) among MSM on PrEP was 40.7% (95% CI: 20.0-65.2%). Subgroup analyses suggested studies conducted after 2015 (versus before) tended to report higher awareness and uptake. Awareness was highest for daily oral PrEP, followed by on-demand, and LAI PrEP; willingness to use was highest for LAI PrEP. The operationalization of willingness and adherence constructs varied across studies and complicated the interpretation of pooled estimates. This review revealed gaps in the PrEP care continuum among MSM in China, with relatively low awareness and uptake (in contrast to willingness and adherence) as the major potential barriers to widespread implementation and the need for a unified approach to defining and measuring PrEP outcomes.

Pre-exposure prophylaxis (PrEP) is a pivotal intervention among HIV prevention strategies. We aimed to narratively revise the topic of HIV acute infection in the setting of PrEP exposure with a focus on diagnostic options, clinical features, and future PrEP perspectives, with a particular focus on users with high adherence to PrEP. We searched the main databases (PubMed, Embase, and Scopus) with the keywords \"PrEP\" or \"Pre-Exposure Prophylaxis\" and \"HIV\" or \"PLWH\" and \"breakthrough\" or \"acute infection\" or \"primary infection\". We included all randomized clinical trials and non-experimental studies (both case reports and observational studies) ever published. In the present narrative review, we revise the diagnostic challenges related to HIV diagnosis in the setting of PrEP and the clinical characteristics and symptoms of breakthrough infections. We discuss the management of acute HIV infection during PrEP and the new challenges that arise from the use of long-acting drugs for PrEP. Our review underlines that although extremely rare, HIV seroconversions are still possible during PrEP, even in a context of high adherence. Efforts to promptly identify these events must be included in the PrEP follow-up in order to minimize the chance of overlooked HIV breakthrough infections and thus exposure to suboptimal concentrations of antiretrovirals.

OBJECTIVE: People who use or would benefit from pre-exposure prophylaxis (PrEP) for HIV infection are disproportionately affected by sexually transmitted infections (STIs). Integrating STI services when offering PrEP fosters synergies and efficiencies in response to HIV/STI and promotes people-centred care. Including guidance on STI interventions for people on PrEP may facilitate implementation and uptake. We conducted a global review of national PrEP guidance documents and analysed the inclusion of recommendations for the provision of STI services by country level of income.
METHODS: We searched national PrEP guidance documents published by WHO Member States through the WHO, the Joint United Nations Programme on HIV/AIDS (UNAIDS) databases, the PrEPWatch repository and Google. Information on a range of STI-related interventions was extracted from documents available by October 2023.
RESULTS: Of the 113 national PrEP guidance documents retrieved, STIs were mentioned in 77% (90/117). Viral hepatitis B testing and vaccination were recommended by most high-income countries (HICs) and low-income and middle-income countries (LMICs). Recommendation for syphilis testing was prominent in HICs (91%) and moderately noted in LMICs (68%). Gonorrhoea and chlamydia testing was recommended frequently in HICs (88%) and 42% in LMICs. However, the review noted that, to a much lesser extent, specific type of testing for these pathogens was mentioned. Recommendation for quarterly STI testing for syphilis, gonorrhoea and chlamydia was ubiquitous, while the need to offer STI partner services was rarely mentioned.
CONCLUSIONS: PrEP services offer an opportunity for improved and expanded STI services, increasing person-centred care and addressing STI epidemics alongside HIV. Our review highlights the strengths and gaps in incorporating critical STI interventions into national PrEP normative guidance. Addressing these gaps through a stepwise approach and increasing targeted testing and partner services can help improve quality of care and support an effective response to HIV and other STIs.

Pre-exposure prophylaxis (PrEP) is pivotal in curbing HIV transmission and is integral to the national plan to end the HIV epidemic in the United States (US). Nonetheless, widespread PrEP adoption faces barriers. Telehealth delivery models for PrEP, or telePrEP, can enhance PrEP access and adherence by providing flexible care remotely. This study presents a systematic review of telePrEP programs in the US, aiming to describe model characteristics and summarize clinical, implementation, and equity outcomes. We reviewed studies published from 2012 to 2023. We included articles that described telePrEP systems in the US and measured PrEP care continuum outcomes (awareness, initiation, uptake, adherence) or acceptability of the intervention by program users. Eight articles describing six distinct telePrEP initiatives met our inclusion criteria. Studies described models implemented in community-based, academic, and commercial settings, with most programs using a direct-to-client telePrEP model. Across studies, clients reported high acceptability of the telePrEP programs, finding them easy to use, convenient, and helpful as a tool for accessing HIV prevention services. No programs were offering injectable PrEP at the time these studies were conducted. Data was limited in measuring PrEP retention rates and the reach of services to underserved populations, including Black and Latinx communities, transgender individuals, and cis-gender women. Findings underscore the potential of telePrEP to bolster the reach of PrEP care and address structural barriers to access. As telehealth models for PrEP care gain prominence, future research should concentrate on refining implementation strategies, enhancing equity outcomes, and expanding services to include injectable PrEP.
RESULTS: La profilaxis preexposición (PrEP) es fundamental para frenar la transmisión del VIH y es parte integral del plan nacional para acabar con la epidemia del VIH en los Estados Unidos (EE. UU.). Sin embargo, la adopción generalizada de la PrEP enfrenta barreras. Los modelos de entrega de PrEP a través de la telesalud (telePrEP) pueden mejorar el acceso y la adherencia a la PrEP al proporcionar atención medica flexible de forma remota. Este estudio presenta una revisión sistemática de la literatura sobre los programas de telePrEP en los EE. UU., con el objetivo de describir las características del modelo y resumir los resultados clínicos, resultados de implementación y resultados de equidad. Revisamos estudios publicados entre 2012 y 2023. Incluimos artículos que describían sistemas de telePrEP en los EE. UU. y medían los resultados del continuo de atención de la PrEP (conciencia, iniciación, adopción, adherencia) o la aceptabilidad de la intervención por parte de los usuarios del programa. Los ocho artículos que describen las seis iniciativas distintas de telePrEP cumplieron nuestros criterios de inclusión. Los estudios describieron modelos implementados en entornos comunitarios, académicos y comerciales, y la mayoría de los programas utilizaron un modelo de telePrEP dirigido directamente al cliente. En todos los estudios, los clientes reportaron una alta aceptabilidad hacia los programas de telePrEP, encontrándolos fáciles de usar, convenientes y útiles como herramienta para acceder a los servicios de prevención del VIH. Ningún programa ofrecía PrEP inyectable en el momento en que se realizaron estos estudios. Los datos fueron limitados para medir las tasas de retención de la PrEP y el alcance de los servicios a las poblaciones desatendidas, incluyendo las comunidades Negras y Latines, las personas transgénero y las mujeres cisgénero. Los hallazgos subrayan el potencial de la telePrEP para reforzar el alcance de la atención de la PrEP y abordar las barreras estructurales de acceso. A medida que los modelos de telesalud para la atención de la PrEP ganan protagonismo, las investigaciones futuras deberan concentrarse en refinar las estrategias de implementación, mejorar los resultados de equidad y expandir los servicios para incluir la PrEP inye`ctable.

Despite the widespread use of pre-exposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) transmission, scant information on HIV drug resistance mutations (DRMs) has been gathered over the past decade. This review aimed to estimate the pooled prevalence of pre-exposure prophylaxis and its two-way impact on DRM.
We systematically reviewed studies on DRM in pre-exposure prophylaxis according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis 2020 guidelines. PubMed, Cochrane, and SAGE databases were searched for English-language primary studies published between January 2001 and December 2023. The initial search was conducted on 9 August 2021 and was updated through 31 December 2023 to ensure the inclusion of the most recent findings. The registration number for this protocol review was CRD42022356061.
A total of 26,367 participants and 562 seroconversion cases across 12 studies were included in this review. The pooled prevalence estimate for all mutations was 6.47% (95% Confidence Interval-CI 3.65-9.93), while Tenofovir Disoproxil Fumarate/Emtricitabine-associated drug resistance mutation prevalence was 1.52% (95% CI 0.23-3.60) in the pre-exposure prophylaxis arm after enrolment. A subgroup analysis, based on the study population, showed the prevalence in the heterosexual and men who have sex with men (MSM) groups was 5.53% (95% CI 2.55-9.40) and 7.47% (95% CI 3.80-12.11), respectively. Notably, there was no significant difference in the incidence of DRM between the pre-exposure prophylaxis and placebo groups (log-OR = 0.99, 95% CI -0.20 to 2.18, I2 = 0%; p = 0.10).
Given the constrained prevalence of DRM, the World Health Organization (WHO) advocates the extensive adoption of pre-exposure prophylaxis. Our study demonstrated no increased risk of DRM with pre-exposure prophylaxis (p > 0.05), which is consistent with these settings. These findings align with the previous meta-analysis, which reported a 3.14-fold higher risk in the pre-exposure prophylaxis group than the placebo group, although the observed difference did not reach statistical significance (p = 0.21).
Despite the low prevalence of DRM, pre-exposure prophylaxis did not significantly increase the risk of DRM compared to placebo. However, long-term observation is required to determine further disadvantages of extensive pre-exposure prophylaxis use. PROSPERO Number: CRD42022356061.

Implementation of pre-exposure prophylaxis (PrEP) to prevent HIV transmission is suboptimal in the United States, particularly among people who use drugs (PWUD). PrEP research among PWUD is scarce, and the factors that impact implementation are largely unknown. Therefore, we conducted a scoping review of implementation determinants (i.e., barriers and facilitators), as well as the change methods (implementation strategies and adjunctive interventions) that have been evaluated to increase PrEP implementation and use among PWUD. We identified 32 peer-reviewed articles assessing determinants and five that evaluated change methods. Determinants were coded using the updated Consolidated Framework for Implementation Research (CFIR), which is an established framework to understand the multilevel barriers and facilitators associated with implementation. Findings indicate that most research was conducted among PrEP recipients (i.e., patients), focusing on awareness and willingness to use PrEP, with less focus on factors impacting clinicians and service delivery systems. Moreover, very few change methods have been evaluated to improve clinician adoption and adherence to CDC guidelines for PrEP provision and/or recipient uptake and adherence to PrEP. Future research is needed that focuses on factors impacting implementation from a clinician standpoint as well as innovative change methods to increase PrEP awareness, reach, adoption, and sustained adherence to guidelines. Implementation Science offers a wealth of knowledge to speed up the effort to end the HIV epidemic in the United States.

For people at risk of HIV infection, pre-exposure prophylaxis (PrEP) can reduce the risk of infection in anticipation of exposure to HIV. The effectiveness of PrEP relies upon a user\'s adherence to their PrEP regimen. We sought to assess the effect of PrEP adherence interventions compared to usual care or another intervention for people at risk of HIV. We searched electronic databases from 2010 onwards for randomized controlled trials (RCTs) involving persons at risk of HIV randomized to an adherence promoting intervention vs usual care or another intervention. We used network meta-analyses to compare PrEP adherence for all participant populations. Certainty of evidence was assessed using Confidence in Network Meta-Analysis (CINeMA). 21 trials (N = 4917) were included in qualitative analysis (19 in network meta-analyses (N = 4101)). HIV self-testing interventions with adherence feedback elements improved adherence compared to usual care (risk ratio (RR): 1.83, 95%CI 1.19, 2.82). In contrast, HIV self-testing alone was inferior to HIV self-testing with adherence feedback (RR: 0.58, 95%CI 0.37-0.92). Reminders alone also were inferior to HIV self-testing with adherence feedback on adherence (RR: 0.53, 95%CI 0.34-0.84) and had similar effects on adherence as usual care (RR: 0.98, 95%CI: 0.86-1.11). Interventions with only one component were inferior for adherence than those with two components (RR: 0.74, 95%CI 0.62-0.88) and those with three components (RR: 0.78, 95%CI 0.65-0.93). The certainty of evidence was moderate for HIV self-testing plus adherence feedback and interventions with two or three components. When designing future PrEP adherence interventions, we recommend strategies with more than one but no more than three components.

Pre-exposure prophylaxis (PrEP) availability through the Pharmaceutical Benefits Scheme provides real potential for the elimination of HIV transmission in Australia, as evidenced by a rapid decline in HIV incidence among gay and bisexual men (GBM). However, HIV elimination will not be possible without also extending PrEP to other populations, including cisgender women. We conducted a scoping review to examine the extent to which PrEP access for cisgender women has been considered in Australia. A comprehensive search across five databases, grey literature, and hand search of references was conducted. A single reviewer conducted title and abstract screening and two reviewers completed full-text screening and data extraction. Nineteen documents were included in the final review and included both peer-reviewed journal articles and guidelines and strategies. Focused discussion of cisgender women\'s use of PrEP was largely missing from the literature and, although their use of PrEP is supported in some relevant guidelines, little has been done to actively develop strategies to inform cisgender women about PrEP as a precursor to prescribing for HIV prevention. Healthcare providers\' narrow view of PrEP as being the domain of GBM further limits cisgender women\'s potential access. If HIV elimination in Australia is to be a reality, we need to develop mechanisms to specifically engage with cisgender women about PrEP.