Oral Pre-exposure Prophylaxis Research Articles

ALIGNMENT OF PREP USE WITH POTENTIAL HIV EXPOSURE IN YOUNG WOMEN AND MEN IN UGANDA.

Despite high oral pre-exposure prophylaxis (PrEP) uptake among young heterosexual cisgender women, early discontinuation is frequent. It is unclear whether this aligns with potential HIV exposure. Young women 16-25 years and ≥1 of their male partners were enrolled in separate but linked longitudinal HIV PrEP studies in Kampala, Uganda from 2018-2021. Data on sexual behavior, PrEP use, STI positivity, and Y chromosome DNA (Yc DNA; a marker for condomless sex) were collected at enrollment and quarterly visits. Potential HIV exposure was defined as one of the following in the past 3 months: any STI, detection of Yc DNA, condomless vaginal sex, or multiple sex partners. Alignment between potential HIV exposure and PrEP use by participants was examined using GEE regression. 88 young women (median age=20.6, IQR 19.5-22.0) and 124 male partners (median age=23.5, IQR 21.0-26.0) were included. Women and men were dispensed PrEP in 66.9% and 60.5% of their first linked visits, respectively. PrEP dispensation was more common when women or men self-reported condomless vaginal sex and multiple sex partners, or when women had Yc DNA detected in vaginal swabs. Men's self-report of multiple partners (aPR=1.56, p=0.012) and the detection of Yc DNA (aPR=1.52, p=0.040) were significantly associated with women's PrEP dispensation. Women and their male partners may align their PrEP use with their HIV risk behaviors, providing some reassurance that PrEP discontinuation in young people often aligns with sexual behavior. Greater attention to measurement of and mismatches in PrEP discontinuation and potential HIV exposure is needed.

Preexposure Prophylaxis and Intimate Partner Violence Among Gay, Bisexual, and Other Men Who Have Sex With Men: A Global Scoping Review of the Literature.

Men who have sex with men (MSM) experience intimate partner violence (IPV) and are at an elevated risk of HIV acquisition. Preexposure prophylaxis (PrEP) is an effective preventative measure against HIV. However, its adoption and consistent use among MSM, especially those experiencing IPV, is low. This scoping review summarizes literature relevant to HIV PrEP, focusing on MSM who experience IPV. Of the 110 studies identified, eight eligible studies met the inclusion and exclusion criteria. Most of these were conducted in the United States, focusing exclusively on adult MSM. Most studies evaluated daily oral PrEP. The studies assessed the impact of IPV on respondent's knowledge, willingness, preference, and PrEP use and revealed varying levels of association between IPV and PrEP. Future research is essential to develop practice guidelines and policy to enhance PrEP uptake in this vulnerable population.

Progress Toward UNAIDS Global HIV Pre-Exposure Prophylaxis Targets: CDC-Supported Oral Pre-Exposure Prophylaxis - 37 Countries, 2017─2023.

Oral pre-exposure prophylaxis (PrEP) reduces HIV acquisition risk from sex by 99% and from injection drug use by ≥74% when used as recommended. The Joint United Nations Programme on HIV/AIDS (UNAIDS) has set a goal of 21.2 million persons using (initiating or continuing) PrEP globally in 2025. In 2016, CDC, with the U.S. President's Emergency Plan for AIDS Relief, joined ministries of health to implement PrEP globally. PrEP is beneficial for persons at substantial risk for acquiring HIV, including but not limited to key populations, which include female sex workers, men who have sex with men, persons in prisons and other enclosed settings, persons who inject drugs, and transgender persons. Annual country targets were used to guide scale-up. In 2023, CDC supported 856,816 PrEP initiations, which represents nearly one quarter of the 3.5 million persons globally who either initiated or continued PrEP that year. During 2017-2023, CDC supported PrEP initiations for 2,278,743 persons, 96.0% of whom were in sub-Saharan Africa. More than one half (64.0%) were female and 44.9% were aged 15-24 years. Overall, CDC achieved 118.7% of its PrEP initiation targets for the 7-year period. Among PrEP initiations for key populations, the majority in sub-Saharan Africa were female sex workers, whereas in Southeast Asia, Eurasia, and the Americas, the majority were men who have sex with men. Continued rapid scale-up is needed to meet the UNAIDS goal to end HIV as a public health threat.

Tenofovir Disoproxil Fumarate/Emtricitabine Prophylaxis Has No Effect on Bone Mineral Density and Bone Mineral Content in African Breastfeeding Women Receiving Pre-Exposure Prophylaxis for HIV.

Tenofovir disoproxil fumarate (TDF) when used as preexposure prophylaxis (PrEP) in pregnancy is considered safe overall however there is insufficient evidence of its effect on maternal bone. We compared bone mineral density (BMD) and content (BMC) at the lumbar spine (LS) and hip of African breastfeeding women exposed and not exposed to TDF-containing PrEP in a randomized control trial (RCT). This is a secondary data analysis of an RCT where pregnant women were randomized to initiating PrEP in pregnancy or delayed initiation of PrEP until breastfeeding cessation. BMD and BMC at the LS and hip were measured using dual-energy x-ray absorptiometry (DXA) at 6, 26, 50, and 74 weeks postpartum. In an exploratory analysis, BMD at the hip and LS were evaluated against varying Tenofovir (TFV) levels during pregnancy. Of 300 women in the RCT who had a DXA at 6 weeks postpartum, 102 (66%) women in the Immediate PrEP arm and 105 (72%) in the Delayed PrEP arm had a 74-week DXA scan. Adjusting for breastfeeding duration and body mass index (BMI), there were no significant differences in BMD or BMC at the hip and LS between treatment arms. There was no consistent dose-effect of TFV-DP detected during pregnancy on BMD at the hip (p=0.231) or the LS (p=0.277). After adjusting for breastfeeding and BMI, TDF when given as oral preexposure prophylaxis during pregnancy had no deleterious effect on BMD and BMC at the hip and LS of African breastfeeding women.

Leveraging international stakeholders’ experiences with oral PrEP costs to accelerate implementation of the monthly dapivirine vaginal ring: A qualitative study

BackgroundCosting and financing systematic implementation are recognized barriers to human immunodeficiency virus (HIV) prevention. In the absence of empiric implementation and economic data, perspectives from international stakeholders involved in developing and supporting daily oral pre-exposure prophylaxis (PrEP) policy, and programs can provide critical insights for developing costed plans to support and accelerate the rollout of novel long-acting PrEP (LA-PrEP) methods, such as the monthly dapivirine vaginal ring (PrEP ring).MethodsWe interviewed stakeholders from purposively selected international organizations about anticipated PrEP-ring implementation costs, evidence gaps and key process steps for developing a costed rollout plan template (CRPT). We deductively analysed interviews.ResultsThe 27 stakeholders (11 donors, 10 nongovernmental, 4 academic/research, 2 multilateral) identified 10 cost-related themes: 7 for planning and implementation and 3 for financing, costing and budgeting. Planning and implementation cost considerations included: (1) actionable target setting; (2) multilevel communication strategies for awareness-raising, demand creation, client-level adherence and choice counselling; (3) human resources, encompassing task shifting and integration into non-HIV services; (4) supply chain costs, including commodities, manufacturing diversification, packaging and forecasting; (5) laboratory infrastructure and monitoring; (6) updated health information systems and metrics to monitor and evaluate multiple methods integrated into HIV, non-HIV and de-medicalized delivery settings; and (7) technical assistance and knowledge management. Themes for financing, costing and budgeting comprised: (8) cost and budget analyses, such as cost–effectiveness; (9) economic evidence gaps on service integration; and (10) innovative or co-financing for sustainable and equitable allocation of limited financial resources to support accelerated PrEP-ring delivery. We organized these themes within the CRPT.ConclusionsThe CRPT could expedite planning and enhance the pace and scale of optimized, systematic and sustainable delivery of PrEP methods. Further research is needed to evaluate use cases of the CRPT.

Health System Factors Influencing the Integration of Pre-Exposure Prophylaxis into Antenatal and Postnatal Clinic Services in Cape Town, South Africa.

Oral pre-exposure prophylaxis (PrEP) is an effective and safe option to prevent HIV acquisition and vertical HIV transmission in pregnant and breastfeeding women. Understanding health system factors influencing the integration of PrEP into care for pregnant and breastfeeding women is key to increasing access. We explored managers' and health care workers' (HCWs) experiences with integrating PrEP into antenatal care and postnatal care services in primary health care clinics in Cape Town, South Africa. This exploratory qualitative study used codebook thematic analysis, where HCWs were purposively, heterogeneously sampled from an implementation science study. Semistructured individual interviews were conducted with 9 managerial-level staff, and 3 focus group discussions were conducted with HCWs (nurses, midwives, and HIV counselors) providing PrEP (6-7 HCWs per group) between November 2022 and January 2023 (N=28). Interview guides covered health system facilitators, barriers, and recommendations. The Health Systems Dynamics framework guided data analysis and presentation of results. PrEP integration into antenatal care services was described as acceptable and feasible; however, changes to HIV testing policy and indicators in breastfeeding women are needed to integrate PrEP into postnatal clinics, together with identification of mother and baby as a dyad in visits. Results showed that supportive policies facilitated wider, simplified PrEP provision. The availability and accessibility of prescribing nurses and lay HIV counselors, PrEP (both within facilities and in communities), and information about PrEP for implementers and pregnant and breastfeeding women will be pivotal to facilitating integration. Facilitators for PrEP integration include task-shifting PrEP education and identification of women for PrEP initiation to HIV counselors, changes to national guidelines defining who can prescribe PrEP, revision and integration of PrEP training for HCWs, community-level interventions for PrEP demand creation and stigma reduction, and provision of differentiated PrEP delivery options.

Has the switch to sexual risk behaviour screening impacted deferrals for pre- and post-exposure prophylaxis therapy for human immunodeficiency virus?

Canadian Blood Services defers donors during and for 4 months after oral pre-exposure or post-exposure prophylaxis (PrEP/PEP) for human immunodeficiency virus (HIV) because of concerns about altered viral kinetics. We assessed the impact of the switch from a time-based deferral for men who have sex with men (MSM) to sexual risk behaviour criteria on PrEP/PEP deferrals. Data on PrEP/PEP deferral codes were extracted from our National Epidemiology Database for the 22 months before (Period 1) and after (Period 2) the criteria change. PEP deferrals remained stable (2.3 vs. 1.7 per 100,000 donations in Periods 1 and 2, p = 0.2892), about 45% and 33%, respectively, of these donors who reported a recent needle stick injury. PrEP deferrals increased from 5.9 to 12.4 per 100,000 (p = 0.0001); approximately 30% of donors in both periods had other HIV risk factor deferrals. Donors deferred for PrEP use alone were more likely to be male, first-time users and younger than other donors. The switch to sexual risk behaviour led to a small increase in deferrals for PrEP. We may not be measuring the full impact of deferral criteria because potential donors may self-defer and PrEP use is increasing.

The PrEP cascade in a sample of HIV-negative or unknown status adolescent and young adult transgender women in Peru

Background Transgender women are a key population in the HIV epidemic globally, including in Peru. This cross-sectional epidemiological study characterized the pre-exposure prophylaxis (PrEP) cascade in adolescent and young adult transgender women in Peru to inform roll-out of early HIV prevention efforts. Methods Between February-July 2022, a community-recruited sample of HIV-negative or status unknown young transgender women ( n = 140) in Peru completed a socio-behavioral survey and biological testing for HIV and bacterial STIs. Logistic regression models estimated the association of sociodemographic, healthcare, and behavioral factors to PrEP indication and willingness. Results Median age was 22 years (range = 16-24 years); 65.7% reported sex work and 28.6% homelessness. Overall, 45.7% had a PrEP indication based on past 6 months HIV behavioral risk profiles. In a multivariable model, sex work (aRR = 2.27; 95% CI = 1.24-4.17) and homelessness (aRR = 1.27; 95% CI = 1.00-1.60) were associated with PrEP indication. More than one-third (38.6%) had never been HIV tested; 25.3% were tested >1 year ago. Only 34.3% heard of daily oral PrEP, 8.6% reported ever PrEP use, and 5.0% current PrEP use. Nearly half (49.3%) reported willingness to take daily oral PrEP. In a multivariable model, younger age was associated with increased willingness to use PrEP (aRR = 0.92; 95% CI = 0.87-0.98). Highest ranked PrEP preferences were a daily oral pill (35.7%), implant (32.1%), and injection by a provider (10.0%). Conclusions PrEP indication and willingness were high in this sample, but HIV testing and PrEP uptake were low. Findings highlight opportunities for age-responsive and contextually-relevant interventions to increase HIV prevention among young transgender women in Peru.

Qualitative exploration of the barriers and facilitators to community pharmacy PrEP delivery for UK pharmacists and underserved community members using the COM-B model of behaviour change

ObjectivesExpanding delivery of oral pre-exposure prophylaxis (PrEP) to community pharmacies could improve access, aligning well with the UK government’s goals to eliminate new HIV acquisitions by 2030. Using the Capability,...

HIV Pre-exposure prophylaxis (PrEP) Modalities and Service Delivery Preferences Among Black Cisgender Emerging and Older Adult Women in Baltimore, Maryland.

Black cisgender women are disproportionately affected by HIV across the United States (US). Moreover, emerging adults continue to be significantly affected compared to women in older age groups. Yet in 2024, Black cisgender women and emerging adult women comprise a small fraction of HIV pre-exposure prophylaxis (PrEP) users in the US. This study examined PrEP modality, service delivery, and marketing and communication preferences by age among Black cisgender women in Baltimore, Maryland. Between October 2021 and April 2023, twelve Black cisgender PrEP-inexperienced emerging (18 to 29 years) and fourteen older (30 to 44 years) adult women were purposively recruited to participate in an in-depth interview. Interview topics included PrEP modality, service delivery, and marketing and communication preferences among the two currently approved modalities (oral and injectable) and the two modalities under investigation (ring and implant). Interviews were audio-recorded, transcribed verbatim, and analyzed using a combination of a deductive and inductive approach. Six follow-up member-checking interviews were also conducted. Emerging adult women preferred oral PrEP, but older adult women preferred long-acting injectable (LAI) forms of PrEP. Oral PrEP was preferred because it was considered the most common modality for other medications, whereas LAI was preferred because it didn't necessitate no daily administration. Emerging Black adult women reported challenges with adhering to the routine PrEP three-month follow-up period, such as transport, scheduling appointments, conflicts with school engagements, and being in a period of transition into adulthood where they experience structural changes (e.g., health insurance). Transport was the only reported challenge for older adult women for follow-up. Both age groups preferred longer follow-up periods to refill their PrEP prescriptions and to obtain PrEP from a trusted physician (e.g., OBGYN). Both groups of Black women expressed a preference for PrEP to be advertised through diverse means including social media campaigns, sexual health forums, peer groups on college campuses, and by featuring Black women in PrEP commercials. To improve PrEP equity and initiation among current and emerging PrEP modalities, it is crucial to better integrate the lived experiences and preferences of Black cisgender women and enhance their representation in PrEP messaging.

Preferences for Starting Daily, On-Demand, and Long-Acting Injectable HIV Preexposure Prophylaxis Among Men Who Have Sex With Men in the United States (2021-2022): Nationwide Online Cross-Sectional Study.

Long-acting (LA) injectable preexposureprophylaxis (PrEP) and on-demand PrEP may improve overall PrEP uptake among men who have sex with men (MSM), but little is understood about the PrEP option preferences of MSM in practical scenarios where they may choose between various PrEP options. This study aims to examine the preferences for starting various PrEP options among a US nationwide online convenience sample of MSM from September 2021 to February 2022. Participants reporting no prior HIV diagnosis were provided brief descriptions of each PrEP option and were asked, "If [PrEP option] were available from your local doctor and you could access it for free, would you go to your doctor in the next month to start [PrEP option]?" Those who said "yes" to multiple options were asked to rank them in order of preference. MSM currently taking daily oral (DO) PrEP were asked whether they would switch to on-demand or LA PrEP options. Log binomial models were created to examine the association between willingness to start or switch to on-demand and LA PrEP with various sociodemographic and behavioral factors. In the analytic sample (N=7760), among the participants who did not use any PrEP in the past 12 months (n=5108, 66%), 54% (n=2445) reported willingness to start at least 1 PrEP option and 41% (n=1845) of participants showed interest in starting multiple PrEP options. Overall, the highest willingness was reported for on-demand PrEP (n=2235, 44%), followed by DO PrEP (n=2174, 43%) and LA PrEP (n=1482, 29%). LA PrEP was ranked first among those interested in multiple options. Characteristics associated with ranking LA PrEP as a first option to start PrEP versus DO or on-demand PrEP were region of residence (residing in the West vs Northeast), report of sexually transmitted infection diagnosis in the past year, report of illicit drug use other than marijuana in the past year, and prior awareness of LA PrEP. Among current DO PrEP users (n=2379, 31%), 58% (n=1386) were willing to switch to on-demand or LA PrEP, and LA PrEP was ranked first among participants who were open to switching to both options. Willingness to switch to LA PrEP was higher among those who used illicit drugs other than marijuana in the past year, who heard of LA PrEP prior to the survey, and those who took 15 or less doses of oral PrEP in the last 30 days. LA PrEP was the highest-ranked option among most MSM who were willing to try multiple options or switch from DO PrEP. These findings highlight that LA PrEP might fill coverage gaps among MSM who use illicit drugs, have had a recent sexually transmitted infection diagnosis, and have less than optimal DO PrEP adherence.

Enhancing daily oral PrEP adherence with digital communications: Protocol for a systematic review and meta-analysis.

Pre-exposure prophylaxis (PrEP) stands as an effective tool in preventing HIV transmission among individuals at risk of HIV infection. However, the effectiveness of daily oral PrEP is contingent on the adherence of its users, which can pose a challenge for many individuals. Various studies have explored different interventions aimed at bolstering PrEP adherence. One recurring type of intervention revolves around digital communication (e.g., SMS, mobile applications) to send reminders for PrEP usage. The objective of our systematic review and meta-analysis is to address the following research question: What is the effectiveness of digital communication interventions in enhancing daily oral PrEP adherence among individuals at a heightened risk of HIV infection? This paper presents our study protocol. We will conduct searches across four health-related databases: Embase, PubMed, Web of Science, and PsycINFO. We will also explore other sources, including clinical trials registries and grey literature. Our search will be restricted to original randomized controlled trials published in English, French, and Spanish conducted since 2012, when PrEP was approved, to today. To ensure rigor, three reviewers will perform the systematic review and meta-analysis. This systematic review will adhere to the guidelines outlined in the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Our primary outcome of interest is proper daily oral PrEP adherence, which we will measure using association metrics (e.g., odds ratios). This review will offer insights into the effectiveness of utilizing digital communication methods to assist individuals at risk of HIV in improving their PrEP adherence. International Prospective Register for Systematic Reviews (PROSPERO) number CRD42023471269.

Pre-Exposure Prophylaxis for the Prevention of HIV-1: An Assessment of Oral Pre-Exposure Prophylaxis Usage Patterns, First Evidence of HIV-1, and HIV-1 Risk Factors in the United States.

In clinical trials, once-daily oral tenofovir-based pre-exposure prophylaxis (PrEP) significantly reduced HIV-1 acquisition risk; however, this was highly dependent on medication adherence and persistence. We report clinical characteristics, PrEP usage patterns, first evidence of HIV-1, and associated risk factors among adults with commercial insurance using oral PrEP in the United States using health plan claims from the IQVIA PharMetrics® Plus database between January 1, 2015, and March 31, 2020, from individuals who newly initiated emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or FTC/tenofovir alafenamide (TAF) for daily PrEP. Overall, 25,419 individuals were included (FTC/TDF, n = 24,232; FTC/TAF, n = 1187), with generally similar characteristics reported during the 6-month baseline period across cohorts. Mean follow-up length was 504 and 77 days for FTC/TDF and FTC/TAF, respectively, corresponding with the 2019 approval of FTC/TAF for PrEP. Similarly, mean PrEP use duration was 354 and 68 days for FTC/TDF and FTC/TAF, respectively. PrEP breaks (>90-day gap) were observed in 11.1% of individuals using FTC/TDF, with a mean break duration of 249 days; 20.0% of individuals using FTC/TDF and 7.3% using FTC/TAF had ≥1 sexually transmitted infection diagnosis during follow-up. From 6 to 12 months of follow-up, mean FTC/TDF proportion of days covered (PDC; 0.74 vs. 0.67) and persistence (70.2% vs. 57.4%) decreased; real-world PDC and persistence were lower than reported in globally conducted clinical trials. First evidence of HIV-1 was infrequent among individuals using FTC/TDF (0.6%), though 60.3% had PrEP on hand when HIV-1 definition was met; high-risk sexual behavior, syphilis, and gonorrhea were the most important risk factors.

Gene expression of tight junctions in foreskin is not affected by HIV pre-exposure prophylaxis.

Tight junctions (TJs) serve as permeability filters between the internal and external cellular environment. A large number of proteins have been identified to be localized at the TJs. Due to limitations in tissue collection, TJs in the male genital tract have been understudied. We analysed the transcriptomics of 132 TJ genes in foreskin tissue of men requesting voluntary medical male circumcision (VMMC) and enrolled in the Combined HIV Adolescent Prevention Study (CHAPS) trial conducted in South Africa and Uganda (NCT03986970). The trial evaluated the dose requirements for event-driven HIV pre-exposure prophylaxis (PrEP) with emtricitabine-tenofovir (FTC-TDF) or emtricitabine-tenofovir alafenamide (FTC-TAF) during insertive sex. A total of 144 participants were randomized to either control arm or one of 8 PrEP arms (n=16/arm), receiving oral FTC-TDF or FTC-TAF over one or two days. Following in vivo oral PrEP dosing and VMMC, the expression level of three important TJ proteins (CLDN-1, OCN and ZO-1) was measured ex vivo in foreskin tissue by Western blot. The expression of cytokine genes implicated in TJ regulation was determined. Non-parametric Kruskal-Wallis tests were used to compare TJ gene expression and protein levels by type of PrEP received, and Spearman's correlation coefficients were calculated to assess whether TJ gene expression levels were related to cytokine gene levels or to PrEP drug concentrations and their active intracellularly phosphorylated metabolites. A high level of expression in foreskin tissue was found for 118 (of 132) TJ genes analysed; this finding contributed to create a map of TJ components within the male genital tract. Importantly, PrEP regimens tested in the CHAPS trial did not affect the expression of TJ genes and the analysed proteins in the foreskin; thus, further supporting the safety of this prevention strategy against HIV-1 transmission during insertive sex. Additionally, we identified the level of several cytokines' genes to be correlated to TJ gene expression: among them, IL-18, IL-33 and VEGF. TJs can limit viral entry into target cells; to affect this biological function viruses can reduce the expression of TJ proteins. Our study, on the expression and regulation of TJs in the foreskin, contribute important knowledge for PrEP safety and further design of HIV-1 prophylaxis.

Therapeutic drug monitoring of tenofovir disoproxil and emtricitabine in oral HIV pre-exposure prophylaxis (PrEP) users who have undergone gastrointestinal surgery.

Oral HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV, but its efficacy depends on adequate absorption of drug, which may decrease following gastrointestinal surgery. Clinicians across eight Genito-urinary Medicine clinics in the United Kingdom submitted data on PrEP users with history of gastrointestinal surgery who were referred to a national complex PrEP multi-disciplinary team between June 2021 and April 2023. Anonymised data were submitted on demographics, surgical history, PrEP regimen, and results of therapeutic drug monitoring (TDM) and HIV screening tests. Descriptive analyses were performed in SPSS version 29. Nine cases described cis-gender men-who-have-sex-with-men (MSM) with median age of 47.4 years (IQR = 43 - 56.5) taking tenofovir disoproxil (TDF)/emtricitabine (FTC) daily (n = 8) or event-based (n = 1) as PrEP. Median time between PrEP initiation and TDM was 53 days (IQR = 8.5-1705). The mean (±SD) trough concentration of tenofovir (TFV) and FTC were 90.2 ± 27.7ng/mL and 76.0 ± 45.9ng/mL, respectively. All patients had a negative HIV test at follow-up. Plasma trough concentrations of TFV observed in our cohort taking TDF/FTC were above the expected concentrations associated with PrEP efficacy as previously described in the literature, suggesting that PrEP can be safely given in this population, with TDM used for reassurance.

Transforming HIV prevention: the promise of long-acting preexposure prophylaxis in high HIV burden settings.

Recent research on efficacy and safety of long-acting preexposure prophylaxis (PrEP) holds the promise to transform HIV prevention in high HIV burden settings. We review emerging findings regarding early end-user acceptability of long-acting PrEP modalities, feasibility of integrating long-acting PrEP into health systems, and considerations regarding drug resistance and cost. Long-acting PrEP, particularly injectables, was found to be highly acceptable among individuals across key populations in high HIV burden settings. Concerns around use of long-acting PrEP highlight the importance of choice and ability to switch methods. Existing provider-level barriers to oral PrEP implementation (e.g., overburdened staff, training gaps) may impact long-acting PrEP rollout - however, utilization of PrEP implementation strategies such as task-shifting, timely PrEP training for all providers, differentiated service delivery, and integration with sexual health services, may mitigate barriers. Studies modeling injectable PrEP scale-up demonstrate substantial benefits in HIV mortality reduction, outweighing risks of increased integrase inhibitor resistance, but also highlight the urgency of pricing long-acting PrEP to ensure access and affordability. Long-acting PrEP could be a game changer in HIV prevention in high burden settings. There is an urgent need for rapid scale production and price reductions to ensure access in high HIV burden settings. Implementation strategies are needed to address individual and provider-level barriers.

Advances in HIV management and challenges in Japan: Current situation of pre-exposure prophylaxis in Tokyo.

Since the world's first case series of human immunodeficiency virus (HIV) infection were reported, more than 40 decades have passed. The advancement of HIV treatment and prevention has progressed drastically. Especially, the efficacy of pre-exposure prophylaxis (PrEP) for HIV prevention has been proven by a number of trials and the number of new HIV cases has declined over the years due to the large-scale and rapid implementation of PrEP and universal HIV treatment in multiple countries. However, in Japan, PrEP is not approved or officially supported as of June 2024. Despite of the absence of top-down movement, men who have sex with men (MSM)-friendly private clinics initiated prescriptions of generic medicines for oral PrEP with necessary tests in Tokyo, which greatly contributed to improve access to PrEP. It is of note that current situation of bottom-up PrEP implementation using generic medicines in Tokyo is obviously cost-saving, which is needless to evaluate. However, expense of PrEP is fully out-of-pocket, which will hinder those with low or no income from accessing PrEP services despite the low prices of generic medicines. Furthermore, current PrEP implementation based on user-friendly clinics is functioning only in Tokyo. The role of public health authorities is important to solve these financial and geographical disparities in accessing PrEP services, without impairing existing virtues of accessibility and cost-saving in the current system.

Initiation and continued use of oral pre-exposure prophylaxis among pregnant and postpartum women in South Africa (PrEP-PP): a demonstration cohort study

When used effectively, oral pre-exposure prophylaxis (PrEP; tenofovir disoproxil fumarate and emtricitabine) prevents maternal HIV acquisition and reduces the risk of vertical transmission. Our study aimed to better understand PrEP initiation, continued use, and adherence in pregnant and postpartum women. The PrEP in Pregnancy and Postpartum (PrEP-PP) study is a demonstration cohort study that enrolled pregnant women aged 16 years and older without HIV attending their first antenatal care visit in Cape Town, South Africa, between Aug 29, 2019, and Oct 10, 2021. Eligible, consenting women were followed up quarterly up to 12 months postpartum with regular HIV testing and offer of PrEP with ongoing adherence counselling. The primary outcome was distribution of women across the PrEP cascade (ie, initiation and continuation up to 12 months postpartum) with crude and adjusted hazard ratios (HRs). We also report on HIV incidence by pregnancy and postpartum status. Overall, 1195 pregnant women were recruited and followed up (median age 26 years, IQR 23-31; median gestational age 21 weeks, IQR 15-31); 1009 (84·4%) started PrEP at enrolment. Among women who initiated PrEP at enrolment, 668 (67·5%) of 990 continued PrEP at the 1-month follow-up, 485 (49·9%) of 972 continued at 3 months, 392 (39·4%) of 994 at 6 months, and 275 (27·4%) of 1005 at 12 months. Of 186 women who did not accept PrEP at enrolment, 70 (37·6%) of 186 subsequently initiated PrEP. Overall, 200 (18·6%) of 1076 women continued PrEP at 12 months postpartum. Of 186 women who did not initiate PrEP at baseline, 70 (37·6%) subsequently initiated PrEP during the study. Factors associated with PrEP discontinuation up to 12 months postpartum included being married or cohabiting (adjusted HR 1·32, 95% CI 1·16-1·50), condomless sex since last visit (1·43, 1·23-1·65), reporting intimate partner violence (2·03, 1·59-2·59), or depression in the past 12 months (1·53, 1·14-2·05). Overall, 16 women seroconverted over 1673·8 woman-years (HIV incidence rate 0·96 per 100 woman-years, 95% CI 0·49-1·42); 14 discontinued PrEP use and two never initiated PrEP. HIV incidence was 0·28 per 100 woman-years during pregnancy (95% CI 0·22-0·33), and the incidence rate ratio was 1·77 per 100 woman-years (0·53-5·90) 0-6 months postpartum and 2·19 per 100 woman-years (0·61-7·83) 6-12 months postpartum compared with pregnant women. There is an urgent need for the integration of PrEP into antenatal and postnatal care and interventions that address barriers to continued use, including targeted counselling during pregnancy and postpartum to reduce PrEP discontinuation. National Institute of Mental Health and Fogarty International, US National Institutes of Health. For the French translation of the abstract see Supplementary Materials section.

Hoping to Adhere? Examining the Relationship Between Hope and Pre-exposure Prophylaxis Willingness, Adherence, and Persistence Among Young Women in South Africa and Zimbabwe (HPTN 082).

Hope is a powerful psychological construct which is linked to positive health. Greater hope is associated with improved antiretroviral therapy adherence; however, less is known about the impact of hope on oral pre-exposure prophylaxis (PrEP) outcomes. HIV Prevention Trials Network 082, was an open-label PrEP study among young women (ages 16-25) in South Africa and Zimbabwe. Hope was measured at baseline and follow-up using a subset of the Hope for the Future Scale (score range 6-24) and PrEP willingness was measured using a subscale of the HIV Prevention Readiness Measure (score range 6-30). Intracellular tenofovir-diphosphate (TFV-DP) concentrations were obtained from dried blood spot samples at weeks 13, 26, and 52; high PrEP adherence was defined as TFV-DP concentrations ≥ 700 fmol/punch. Persistence was defined as TFV-DP > 16 fmol/punch at weeks 26 and 52. Linear regression and generalized estimating equations were used to assess the relationship between hope and PrEP willingness, adherence, and persistence. The median age of participants (n = 432) was 21years (interquartile range [IQR]: 19-22). The mean hope score at baseline was 21.0 (SD = 3.4). Although hope was positively associated with PrEP willingness (β = 0.22, 95% CI 0.15, 0.37), it was not associated with high PrEP adherence (aRR = 1.00, 95% CI 0.96, 1.05), or persistence at follow-up (aRR = 1.02, 95% CI 0.99, 1.05). While cultivating hope may be an important strategy in building willingness to take oral PrEP, it may not be enough to sustain PrEP adherence or persistence.

Acceptability of six-monthly PrEP dispensing supported with interim HIV self-testing to simplify PrEP delivery in Kenya: findings from qualitative research

BackgroundIn Africa, dispensing oral HIV pre-exposure prophylaxis (PrEP) within already strained public health facilities has led to prolonged waiting periods and suboptimal experiences for clients. We sought to explore the acceptability of dispensing PrEP semiannually with interim HIV self-testing (HIVST) versus quarterly PrEP dispensing with clinic-based HIV testing to optimize clinic-delivered PrEP services.MethodsWe conducted a qualitative study within a non-inferiority individual-level randomized controlled trial testing the effect of six-monthly PrEP dispensing with HIVST compared to the standard-of-care three-monthly PrEP dispensing on PrEP clinical outcomes in Kenya (ClinicalTrials.gov: NCT03593629). Eligible participants were ≥ 18 years, refilling PrEP for the first time, and either in an HIV serodifferent relationship (men and women) or singly enrolled (women only). A subset of participants in the intervention group completed serial in-depth interviews (IDIs) at enrollment, six months, and 12 months. We utilized stratified purposive sampling to ensure representation across participant groups. We analyzed our qualitative data thematically using a combination of inductive and deductive approaches, the latter guided by the Theoretical Framework of Acceptability (TFA).ResultsBetween May 2018 and June 2021, we conducted 120 serial IDIs with 55 participants; 64% (35/55) were in a serodifferent relationship, 64% (35/55) were women, and the median age was 32 years (IQR 27–40). Overall, participants found this novel PrEP delivery model highly acceptable; it was well-liked, private (TFA construct: affective attitude), and less burdensome (TFA construct: burden) compared to standard PrEP delivery. Additionally, participants were confident in their ability to participate in the intervention (TFA construct: self-efficacy). Some participants, however, highlighted model disadvantages, including fewer opportunities for in-person counseling and potentially less accurate HIV testing (TFA construct: opportunity costs). Ultimately, most participants reported that the intervention allowed them to achieve their HIV prevention goals (TFA construct: perceived effectiveness) and that their confidence in at-home HIVST and PrEP continuation increased following each semiannual clinic visit.ConclusionsSemiannual PrEP clinic visits supported with six-monthly drug dispensing and interim HIVST was acceptable among PrEP users who experienced the intervention in Kenya. More comprehensive pre-intervention counseling and training on HIVST may help alleviate the client concerns presented, which were often resolved over time with intervention experience.