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Adolescent girls and young women (AGYW) are disproportionately affected by HIV, and oral pre-exposure prophylaxis (PrEP) can reduce HIV acquisition. The purpose of this scoping review was to synthesize results from interventions along the PrEP continuum for AGYW to inform research and programs. We searched electronic databases for studies published between January 2012-July 2021 and conducted secondary reference searching. Studies were included if they assessed interventions to increase PrEP interest, uptake, or continuation among AGYW. Results were synthesized narratively. Of 2168 citations identified, 50 studies were eligible for inclusion, and 20 contained AGYW-specific data. Among cisgender and transgender AGYW, studies overall demonstrated a positive impact on PrEP interest and uptake but generally attained suboptimal continuation rates. Results demonstrate feasibility of deploying PrEP across diverse settings-particularly when interventions are layered, tailored to AGYW, and include differentiated delivery-but also highlight knowledge gaps and the need for more holistic metrics of success., (© 2023. The Author(s).)

Objective: HIV remains a significant burden, despite expanding HIV prevention tools. Long-acting injectable cabotegravir (CAB-LA) is a new preexposure prophylaxis (PrEP) product. We reviewed existing evidence to determine the efficacy and safety of CAB-LA as PrEP to inform global guidelines., Design: Systematic review and meta-analysis., Methods: We systematically reviewed electronic databases and conference abstracts for citations on CAB-LA from January 2010 to September 2021. Outcomes included HIV infection, adverse events, drug resistance, pregnancy-related adverse events, and sexual behavior. We calculated pooled effect estimates using random-effects meta-analysis and summarized other results narratively., Results: We identified 12 articles/abstracts representing four multisite randomized controlled trials. Study populations included cisgender men, cisgender women, and transgender women. The pooled relative risk of HIV acquisition comparing CAB-LA to oral PrEP within efficacy studies was 0.21 (95% confidence interval: 0.07-0.61), resulting in a 79% reduction in HIV risk. Rates of adverse events were similar across study groups. Of 19 HIV infections among those randomized to CAB-LA with results available, seven had integrase strand transfer inhibitor (INSTI) resistance. Data on pregnancy-related adverse events were sparse. No studies reported on sexual behavior., Conclusions: CAB-LA is highly efficacious for HIV prevention with few safety concerns. CAB-LA may lead to an increased risk of INSTI resistance among those who have acute HIV infection at initiation or become infected while taking CAB-LA. However, results are limited to controlled studies; more research is needed on real-world implementation. Additional data are needed on the safety of CAB-LA during pregnancy (for mothers and infants) and among populations not included in the trials., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: A substantial number of new HIV infections in sub-Saharan Africa occur within stable couples. Biomedical prevention (pre-exposure prophylaxis, PrEP) and treatment (antiretroviral therapy, ART) can provide benefits to sexual partners and can be used to prevent infection within HIV serodiscordant couples. However, research is typically focused on individuals, not dyads, even when the intervention may directly or indirectly impact sexual partners. Gaps remain in understanding best practices for recruitment, informed consent, and intervention implementation in studies involving HIV prevention and treatment among heterosexual serodiscordant couples. This qualitative study was undertaken to understand and describe decision-making and dyadic-level influence among members of serodiscordant couples regarding (1) participation in a dyadic-based research study involving HIV self-testing and access to PrEP, and (2) utilization of PrEP and ART., Methods: This qualitative study was nested within an observational cohort study assessing the acceptability of home-based couples' HIV self-testing and uptake of dyadic care for serodiscordant couples involving facilitated referral for HIV-positive partners and access to PrEP for HIV-negative partners. Semi-structured in-depth interviews were conducted among a subset of study participants (n = 22) as well as individuals involved in serodiscordant relationships who chose not to participate (n = 9). Interviews focused on couples' decision-making regarding study participation and dyadic-level influence on medication use. Interviews were transcribed verbatim and translated from Kiswahili into English. Data were analyzed using thematic analysis., Results: Three major themes were identified: (1) HIV as "two people's secret" and the elevated role of partner support in serodiscordant relationships; (2) the intersectional role of HIV-status and gender on decision-making; (3) the relational benefits of PrEP, including psychosocial benefits for the couple that extend beyond prevention., Conclusions: The study found that couples made joint decisions regarding study participation and uptake of HIV-related medication. Relational autonomy and dyadic-level influence should be considered within research and programs involving HIV serodiscordant couples.

Introduction: Ensuring a correct and timely HIV diagnosis is critical. WHO publishes guidelines on HIV testing strategies that maximise the likelihood of correctly determining one's HIV status. A review of national HIV testing policies in 2014 found low adherence to WHO guidelines. We updated this review to determine adherence to current recommendations., Methods: We conducted a comprehensive policy review through April 2018. We extracted data on HIV testing strategies, recommendations on HIV retesting prior to antiretroviral therapy (ART) initiation and pre-exposure prophylaxis (PrEP)-related HIV testing information. Descriptive analyses disaggregated by region were conducted to ascertain adherence to recommendations and to describe testing strategy characteristics., Results: Of 91 policies included, 26% (n=24/91) adhered to WHO recommendations. Having a two-assay testing strategy to rule-in HIV infection as opposed to the recommended three-assay testing strategy was a major reason for non-adherence. Of 72 country policies providing sufficient information, 31% (n=22) recommended retesting for HIV prior to initiating ART. Of 25 countries and two regions reporting PrEP-related HIV testing guidelines, almost all recommended testing prior to initiating PrEP and every 3 months during PrEP use., Conclusions: Global adherence to WHO recommendations for HIV testing strategies have improved since 2014 but remain low. We found adherence existed on a continuum. Such a system provides insights into how countries can move towards adherence by making relatively minor changes to testing strategies. Guidance from WHO on the role of new HIV testing technologies within testing algorithms and identifying ways to simplify testing guidance is warranted., Competing Interests: Competing interests: The authors declare no competing interests. The contents in this article are those of the authors and do not necessarily reflect the view of the World Health Organization., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Pre-exposure prophylaxis (PrEP) is a promising intervention to prevent HIV acquisition, with benefits both to the individual and to population-level health. PrEP is an opportunity to complement ongoing public health efforts to eliminate HIV. For women, PrEP can also serve as a gateway to access sexual and reproductive health (SRH) services. Clinical efficacy of PrEP was initially reported in women using a 1% tenofovir vaginal gel in 2010, followed by an efficacy trial of oral PrEP using TDF/FTC in men who have sex with men (MSM). Since then, further trials have reported efficacy in oral PrEP containing tenofovir in women and heterosexual men, while the subsequent trials for women using tenofovir gel reported no efficacy, stemming from difficulties in achieving adequate adherence. In an effort to offer women additional choices to oral PrEP, alternative modalities are being tested in clinical research, including long-acting injectable formulations and intra-vaginal rings. In 2015, a meta-analysis of clinic trials and open-label extension studies led to the World Health Organization (WHO) strongly recommending the provision of oral PrEP containing tenofovir for any person at substantial risk of HIV infection, irrespective of gender or population group. Currently, PrEP services for women around the world, including those who are either pregnant or breastfeeding, remain limited. Outside sub-Saharan Africa, most PrEP programmes are focused on MSM. South Africa, Kenya, and the USA have the greatest utilization of oral PrEP by women. Yet, since 2012, of the estimated > 300,000 people globally who have initiated PrEP, a minority are women. In this narrative review, we examine the most recent literature on clinical and implementation PrEP research among women. We highlight the high burden of disease related to common sexually transmitted infections (STIs) in women, and the opportunity to integrate PrEP and other HIV prevention services, STI case management, and family planning services, as part of a more robust package of SRH services. Raising awareness on PrEP amongst women and their healthcare providers, minimizing gaps in access, and ensuring adherence and persistence of PrEP during periods of risk are critical issues if PrEP can have a meaningful impact on reducing HIV incidence in women globally.

Daily oral pre-exposure prophylaxis (PrEP) is the use of antiretroviral drugs by HIV-negative people to prevent HIV infection. WHO released new guidelines in 2015 recommending PrEP for all populations at substantial risk of HIV infection. To prepare these guidelines, we conducted a systematic review of values and preferences among populations that might benefit from PrEP, women, heterosexual men, young women and adolescent girls, female sex workers, serodiscordant couples, transgender people and people who inject drugs, and among healthcare providers who may prescribe PrEP. A comprehensive search strategy reviewed three electronic databases of articles and HIV-related conference abstracts (January 1990-April 2015). Data abstraction used standardised forms to categorise by population groups and relevant themes. Of 3068 citations screened, 76 peer-reviewed articles and 28 conference abstracts were included. Geographic coverage was global. Most studies (N = 78) evaluated hypothetical use of PrEP, while 26 studies included individuals who actually took PrEP or placebo. Awareness of PrEP was low, but once participants were presented with information about PrEP, the majority said they would consider using it. Concerns about safety, side effects, cost and effectiveness were the most frequently cited barriers to use. There was little indication of risk compensation. Healthcare providers would consider prescribing PrEP, but need more information before doing so. Findings from a rapidly expanding evidence base suggest that the majority of populations most likely to benefit from PrEP feel positively towards it. These same populations would benefit from overcoming current implementation challenges with the shortest possible delay.

Objective: Preexposure prophylaxis (PrEP) offers a promising new approach to HIV prevention. This systematic review and meta-analysis evaluated the evidence for use of oral PrEP containing tenofovir disoproxil fumarate as an additional HIV prevention strategy in populations at substantial risk for HIV based on HIV acquisition, adverse events, drug resistance, sexual behavior, and reproductive health outcomes., Design: Rigorous systematic review and meta-analysis., Methods: A comprehensive search strategy reviewed three electronic databases and conference abstracts through April 2015. Pooled effect estimates were calculated using random-effects meta-analysis., Results: Eighteen studies were included, comprising data from 39 articles and six conference abstracts. Across populations and PrEP regimens, PrEP significantly reduced the risk of HIV acquisition compared with placebo. Trials with PrEP use more than 70% demonstrated the highest PrEP effectiveness (risk ratio = 0.30, 95% confidence interval: 0.21-0.45, P < 0.001) compared with placebo. Trials with low PrEP use did not show a significantly protective effect. Adverse events were similar between PrEP and placebo groups. More cases of drug-resistant HIV infection were found among PrEP users who initiated PrEP while acutely HIV-infected, but incidence of acquiring drug-resistant HIV during PrEP use was low. Studies consistently found no association between PrEP use and changes in sexual risk behavior. PrEP was not associated with increased pregnancy-related adverse events or hormonal contraception effectiveness., Conclusion: PrEP is protective against HIV infection across populations, presents few significant safety risks, and there is no evidence of behavioral risk compensation. The effective and cost-effective use of PrEP will require development of best practices for fostering uptake and adherence among people at substantial HIV risk.

Introduction: Pre-exposure prophylaxis (PrEP) is an important HIV prevention option. Two randomized trials have provided efficacy evidence for long-acting injectable cabotegravir (CAB-LA) as PrEP. In considering CAB-LA as an additional PrEP modality for people at substantial risk of HIV, it is important to understand community response to injectable PrEP. We conducted a systematic review of values, preferences and perceptions of acceptability for injectable PrEP to inform global guidance. Methods: We searched nine databases and conference websites for peer-reviewed and grey literature (January 2010-September 2021). There were no restrictions on location. A two-stage review process assessed references against eligibility criteria. Data from included studies were organized by constructs from the Theoretical Framework of Acceptability. Results: We included 62 unique references. Most studies were observational, cross-sectional and qualitative. Over half of the studies were conducted in North America. Men who have sex with men were the most researched group. Most studies (57/62) examined injectable PrEP, including hypothetical injectables (55/57) or placebo products (2/57). Six studies examined CAB-LA specifically. There was overall interest in and often a preference for injectable PrEP, though there was variation within and across groups and regions. Many stakeholders indicated that injectable PrEP could help address adherence challenges associated with daily or on-demand dosing for oral PrEP and may be a better lifestyle fit for individuals seeking privacy, discretion and infrequent dosing. End-users reported concerns, including fear of needles, injection site pain and body location, logistical challenges and waning or incomplete protection. Discussion: Despite an overall preference for injectable PrEP, heterogeneity across groups and regions highlights the importance of enabling end-users to choose a PrEP modality that supports effective use. Like other products, preference for injectable PrEP may change over time and end-users may switch between prevention options. There will be a greater understanding of enacted preference as more end-users are offered anti-retroviral (ARV)-containing injectables. Future research should focus on equitable implementation, including real-time decision-making and how trained healthcare providers can support choice. Conclusions: Given overall acceptability, injectable PrEP should be included as part of a menu of prevention options, allowing end-users to select the modality that suits their preferences, needs and lifestyle. [ABSTRACT FROM AUTHOR]

Introduction: Globally, over half of the estimated new HIV infections now occur among key populations, including men who have sex with men, sex workers, people who inject drugs, transgender individuals, and people in prisons and other closed settings, and their sexual partners. Reaching epidemic control will, for many countries, increasingly require intensified programming and targeted resource allocation to meet the needs of key populations and their sexual partners. However, insufficient funding, both in terms of overall amounts and the way the funding is spent, contributes to the systematic marginalization of key populations from needed HIV services. Discussion: The Joint United Nations Programme on HIV/AIDS (UNAIDS) has recently highlighted the urgent need to take action to end inequalities, including those faced by key populations, which have only been exacerbated by the COVID‐19 pandemic. To address these inequalities and improve health outcomes, key population programs must expand the use of a trusted access platform, scale up differentiated service delivery models tailored to the needs of key populations, rollout structural interventions and ensure service integration. These critical program elements are often considered "extras," not necessities, and consequently costing studies of key population programs systematically underestimate the total and unitary costs of services for key populations. Findings from a recent costing study from the LINKAGES project suggest that adequate funding for these four program elements can yield benefits in program performance. Despite this and other evidence, the lack of data on the true costs of these elements and the costs of failing to provide them prevents sufficient investment in these critical elements. Conclusions: As nations strive to reach the 2030 UNAIDS goals, donors, governments and implementers should reconsider the true, but often hidden costs in future healthcare dollars and in lives if they fail to invest in the community‐based and community‐driven key population programs that address structural inequities. Supporting these efforts contributes to closing the remaining gaps in the 95‐95‐95 goals. The financial and opportunity cost of perpetuating inequities and missing those who must be reached in the last mile of HIV epidemic control must be considered. [ABSTRACT FROM AUTHOR]