Long-acting Injectable Pre-exposure Prophylaxis Research Articles

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.

Assessing Preferences for Long-Acting Injectable Pre-Exposure Prophylaxis Among Young Adult Sexual Minority Men and Transgender Women

ObjectiveOral pre-exposure prophylaxis (PrEP) is effective in preventing HIV transmission. However, oral PrEP uptake is low, particularly among sexual and gender minority youth who are vulnerable to HIV infection. Alternative methods of PrEP delivery, such as long-acting injectable (LAI) PrEP may overcome barriers and be preferred. However, attitudes and preferences of younger sexual and gender minorities towards LAI PrEP have not been well studied. The purpose of this study is to describe preferences for initiating LAI PrEP among sexual and gender minority youth. MethodsWe analyzed data collected as part of an HIV prevention randomized trial from January 2022 to February 2023, using multiple regression to identify factors associated with a preference for LAI PrEP. ResultsThe study sample (N = 265) was 50% youth of color, mean age 25 years (SD=3.4, range=18–31), and primarily identified as gay (71%) and male (91%). Forty two percent had heard of LAI PrEP and 31% preferred LAI PrEP over other prevention methods. In multiple regression analysis, LAI PrEP preference was associated with identifying as White, previous PrEP experience, and perceived LAI PrEP efficacy. ConclusionsWe conclude that gaps in awareness exist for LAI PrEP, however it may be preferred over other prevention methods especially in White youth, those with PrEP experience and higher perceptions of its efficacy. More education and outreach are needed to prevent extension of existing race/ethnicity disparities in use of oral daily PrEP to LAI PrEP.

Barriers and Facilitators to Long-Acting Injectable HIV Pre-Exposure Prophylaxis Implementation in Primary Care Since Its Approval in the United States.

HIV pre-exposure prophylaxis (PrEP) is a highly effective method to mitigate the HIV epidemic, but uptake of PrEP has been slow and is associated with racial and gender disparities. Oral PrEP requires high levels of adherence to be effective, which may disadvantage certain high-risk groups. The first injectable HIV PrEP, a drug given every 2 months rather than as a daily pill, was approved by the US Food & Drug Administration in December 2021. A Family Medicine practice in a single health organization in the United States (November 2022 to February 2023). We conducted interviews with patients and key stakeholders to characterize factors affecting long-acting injectable (LAI) PrEP implementation. Data collection and analysis were guided by the Consolidated Framework for Implementation Research. Interviews were transcribed and analyzed using guided content analysis. Twenty-five patients (n = 13) and practice stakeholders (n = 12) were interviewed. Overall, stakeholders described a very low uptake of LAI PrEP. Barriers to LAI PrEP included a lack of awareness, insurance and access issues, a lack of streamlined workflow, and a trust in pills over injectables. Facilitators to LAI PrEP implementation included the absence of a pill burden, a culture of shared decision making, and pharmacy support. Although uptake has been slow, we have identified several promising strategies for improving rollout and implementation of LAI PrEP. Approaches that can bolster rollout of LAI PrEP include having an interdisciplinary care team that is supported by PrEP navigators and pharmacists and are informed by a patient-centered model of care to increase patient engagement and trust.

Understanding Attitudes of Postpartum Cisgender Women Toward Integration of HIV Prevention Services into Routine Prenatal and Postpartum Sexual Health Discussions.

Oral pre-exposure prophylaxis (PrEP) is an effective, user-controlled method for HIV prevention. However, awareness, uptake, and adherence to PrEP remain low among cisgender women (CGW). The prenatal and postpartum periods present an opportunity for delivery of comprehensive sexual health services that include HIV prevention education and services. However, little is known about postpartum CGW's attitudes toward integration of HIV prevention education and services into obstetric care in the US. We conducted semistructured interviews with 20 postpartum CGW in the Bronx, NY from July to November 2022 to explore their experiences with prenatal and postpartum sexual health care, examine their attitudes toward integration of HIV prevention services into obstetric sexual health care, and identify components of future implementation strategies. Transcripts were analyzed thematically using a framework approach. Among CGW interviewed, fewer than half reported prior knowledge of PrEP. Ten participants preferred long-acting injectable PrEP relative to six who preferred daily oral PrEP. Most participants reported no discussion of sex with their provider during pregnancy, and when discussions occurred, they focused on permission or prohibition of sexual activity. Participants described a reliance on providers to lead prenatal sexual health discussions. Even when not perceived as personally relevant, most respondents valued education on HIV prevention and PrEP services. In the postpartum period, sexual health discussions were similarly limited despite participants describing complex experiential sexual health concerns. This study supports the potential for integration of HIV prevention education and services into routine prenatal and postpartum sexual health discussions in an area of high HIV prevalence in the US.

Willingness and preferences for long-acting injectable PrEP among US men who have sex with men: a discrete choice experiment

IntroductionCabotegravir long-acting injectable HIV pre-exposure prophylaxis (LA-PrEP) was shown to be safe and effective in multiple clinical trials. Increasing uptake and persistence among populations with elevated risk for HIV acquisition,...

Willingness to Use Long-Acting Injectable PrEP Among PrEP Naïve Black and Hispanic Sexual Gender Minority Persons.

In December 2021, long-acting injectable pre-exposure prophylaxis (LAI-PrEP) was approved for the prevention of HIV in at-risk adults and adolescents. LAI-PrEP may address adherence issues of daily oral daily PrEP and PrEP stigma. However, studies assessing LAI-PrEP willingness among PrEP naive Black and Hispanic sexual and gender minority (SGM) persons- a group disproportionately impacted by the HIV epidemic in the United States - is rare. To assess the extent of and characteristics of willingness to use LAI-PrEP in a national sample of Black and Hispanic SGM who are self-reported that they have never used PrEP. We analyzed data from a national sample of Black and Hispanic SGM collected between March and August 2020. We used log-binomial regression models to assess characteristics associated with willingness to use LAI-PrEP. Of the overall sample (N = 380), the mean age was 24 (SD = 2.8) and the majority of the sample (54%, n = 205) reported willingness to use LAI-PrEP. In multivariable log-binomial regression models, PrEP stigma was independently associated with less [prevalence ratio (PR) = 0.7, 95% confidence interval (CI) = 0.6, 0.9], while number of sexual partners in the past 12 months was associated with a more willingness to use LAI-PrEP (PR = 1.1, 95% CI = 1.0, 1.2). Our findings highlight the persistence of PrEP stigma as a potential barrier to willingness to use LAI-PrEP in this sample of Black and Hispanic SGM who have never used PrEP. Additional work needs to be done to reduce PrEP stigma more broadly.

Co-designing strategies to implement long-acting injectable PrEP for sexual minority men in Chicago: a study protocol for an innovation tournament and implementation mapping

BackgroundParticipatory design approaches can improve successful selection and tailoring of implementation strategies by centering the voices of key constituents. To reduce incidence of the human immunodeficiency virus (HIV) in the USA, co-design of implementation strategies is needed for long-acting injectable cabotegravir (CAB-LA), a new form of HIV pre-exposure prophylaxis, among the disproportionately impacted population of sexual minority men (SMM). This manuscript describes the protocol for participatory design approaches (i.e., innovation tournament and implementation mapping) to inform implementation of CAB-LA among SMM (≥ 12 years), particularly Black and Latino populations, in Chicago.MethodsThis research incorporates innovative methods to accomplish two objectives: (1) to crowdsource ideas for the design of implementation strategies for CAB-LA through a virtual innovation tournament and (2) to leverage the ideas from the innovation tournament to operationalize implementation strategies for CAB-LA thorough the systematic process of implementation mapping. A committee of constituents with diverse expertise and perspectives (e.g., SMM, implementation scientists, HIV clinicians, public health leadership, and community partners) will provide input throughout the design process.DiscussionThis research will produce a menu of co-designed implementation strategies, which can guide plans for CAB-LA integration in Chicago and provide insights for other EHE regions. Further, as the first innovation tournament focused on HIV prevention, this research can provide a framework for participatory approaches across the care continuum. Given that the co-design of implementation strategies often does not involve the participation of individuals with lived experiences, this work will center the voices of those who will benefit most.

PrEP for people who use opioids: A NIDA clinical trials network survey study in Southern U.S. cities where HIV incidence is high

BackgroundPeople who use opioids (PWUO) are at increased risk for HIV. Pre-exposure prophylaxis (PrEP) is effective but underutilized as HIV prevention among PWUO. This study examined predictors of willingness to take daily oral PrEP and long-acting injectable (LAI) PrEP among PWUO across eight Southern urban cities with high HIV incidence. MethodsHIV-negative PWUO (N = 308) seeking services in community-based programs participated in this cross-sectional survey study. Measures included demographics, sexual risk behavior, substance use frequency, and awareness of and willingness to take oral and injectable PrEP. Data were analyzed using mixed-effects models. ResultsWillingness to take daily oral and LAI PrEP was moderately high (69.16% and 62.02%, respectively). Half had heard of PrEP, but only 4% had ever taken it. Only education and condomless vaginal sex predicted willingness to take oral PrEP. Only education predicted willingness to take LAI PrEP. Polysubstance use was prevalent, with substantial proportions of PWUO reporting frequent use of injection drugs (opioids or stimulants, 79.5%), non-injection opioids (73.3%), non-injection stimulants (71.1%), cannabis (62.6%), and hazardous drinking (29.6%). About 20% reported past-year condomless anal sex, and one-third reported past-year condomless vaginal sex. ConclusionsPWUO in this study were amenable to PrEP, particularly in light of education and condomless vaginal sex. Careful consideration for matching PrEP messaging to the PWUO audience is needed. PrEP promotion should expand beyond men who have sex with men to include groups such as these predominantly heterosexual, polysubstance-using PWUO with HIV risk who were open to both formulations of PrEP.

Long-acting Injectable PrEP Interest and General PrEP Awareness among People who Inject Drugs in the San Diego-Tijuana Border Metroplex.

Long-acting injectable HIV pre-exposure prophylaxis (LAI-PrEP) could help overcome multilevel challenges to HIV prevention for people who inject drugs (PWID), including those in the binational San Diego-Tijuana metroplex. Yet, general PrEP awareness and interest in LAI-PrEP remain underexplored among PWID. From 2020 to 2021, 562 HIV-negative PWID in San Diego and Tijuana completed surveys assessing general PrEP awareness and interest in oral and LAI-PrEP. Modified Poisson regression examined factors associated with general PrEP awareness. Multinomial logistic regression assessed factors associated with interest in both oral and LAI-PrEP, oral PrEP only, LAI-PrEP only, or neither. General PrEP awareness was low (18%) and associated with experiencing unsheltered homelessness (adjusted prevalence ratio [APR] = 1.50, 95% confidence interval [CI]: 0.96-2.33), past 6-month fentanyl injection (APR = 1.53, 95% CI: 1.04-2.25), and transactional sex (APR = 1.71, 95% CI: 1.06-2.76). Interest in oral PrEP only was most common (44%), followed by LAI-PrEP only (25%) and neither (16%). Compared to the odds of being interested in LAI-PrEP only, the odds of being interested in oral PrEP only were lower among those who were stopped by police (AOR = 0.38, 95% CI: 0.22-0.65), reported past 6-month fentanyl injection (AOR = 0.33, 95% CI: 0.20-0.56), polydrug use (AOR = 0.48, 95% CI: 0.27-0.86), injecting multiple times daily (AOR = 0.26, 95% CI: 0.14-0.46), receptive syringe use (AOR = 0.30, 95% CI: 0.19-0.49), and higher perceived HIV risk (AOR = 0.24, 95% CI: 0.15-0.39). Interest in LAI-PrEP was more common among PWID reporting social and structural factors that could interfere with oral PrEP adherence, suggesting LAI-PrEP implementation could increase PrEP coverage among those most vulnerable to HIV.

Intention and preference to use long-acting injectable PrEP among MSM in the Netherlands: a diffusion of innovation approach

ABSTRACT Long-acting injectable pre-exposure prophylaxis (LAI-PrEP) is efficacious in preventing HIV among men-who-have-sex-with-men (MSM) and will be soon available in Europe. This study investigated the intention and preference to use LAI-PrEP among MSM in the Netherlands by employing a diffusion of innovation approach. This study had a cross-sectional design nested within a cohort study established in 2017 to understand oral PrEP use among MSM. 309 MSM completed the survey on their awareness, interest, intention, and preference for LAI-PrEP in June 2022. Among them, 83% showed high/very-high interest in, and 63% showed high/very-high intention to use LAI-PrEP. A repeated innovator effect from the early adopters to LAI-PrEP was not observed. Early adopters did not show increased intention to use LAI-PrEP compared to other MSM subgroups, but neither did PrEP-naïve nor PrEP-discontinued MSM. However, among the 218 current oral PrEP users, suboptimal adherence was associated with preference for LAI-PrEP but not with intention to use it. In conclusion, our findings indicated that an effective, available, and affordable LAI-PrEP would be welcomed in the Netherlands, but that its introduction may not significantly expand PrEP coverage. However, the introduction of LAI-PrEP in the Netherlands could prove beneficial to MSM with suboptimal adherence to oral PrEP.

Perceptions and experiences of daily and long-acting pre-exposure prophylaxis (PrEP) among MSM in India.

Oral pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy with high efficacy. An increased willingness to use PrEP among at-risk Indian men who have sex with men (MSM) population has been reported; however, little is known about their real experiences that guide their key motivators, facilitators, and barriers with using oral and Long-Acting (LA) Injectable PrEP. We recruited participants (n = 18) through active MSM social media networks. The interviews were conducted using teleconferencing software. Interview topics included participants' sources of knowledge, experiences accessing daily PrEP, safe-sex behaviors while on PrEP, barriers and facilitators around PrEP, long-term goals with PrEP, perceptions around LA PrEP, and discussion around decision-making to switch from oral PrEP to LA PrEP. Transcripts were coded according to interview topics, and key themes were analyzed using a topical data analysis approach. Participants (median age 28 years, ranging from 18 to 40) reported a high perceived risk of HIV. This increased perceived risk was a key motivator for oral PrEP uptake. Most participants shared that they accessed PrEP through non-profit organizations serving the MSM community, where doctor consultations and medication were either free or subsidized. Even when participants reported high adherence to oral PrEP, they expressed discontent with the requirement to take it daily. High condom usage was reported concomitantly with PrEP use among most participants, except for a few who preferred bareback sex. Participants shared that they would prefer to continue PrEP until they are in a monogamous, exclusive relationship. The cost and affordability remained recurring themes, and while participants could afford oral PrEP, they wished it was cheaper, making it more accessible to the community at large. Most participants did not have prior knowledge of LA injectable PrEP but welcomed the intervention, alluding to cost and availability as the key decision-making factors affecting switching. MSM from India we interviewed adopted oral PrEP as an additional HIV prevention strategy to condoms through non-profit and private channels. Cost and broader access remains a concern among the MSM community. More acceptability research about long-acting PrEP is needed among MSM in the Indian context, and it is recommended for government interventions to include oral PrEP groups at higher risk of HIV acquisition.

Willingness to take long-acting injectable pre-exposure prophylaxis among men who have sex with men who participated in the CROPrEP study: a cross-sectional online study

IntroductionEvidence on the willingness of men who have sex with men (MSM) with oral pre-exposure prophylaxis (PrEP) experience, especially those with suboptimal adherence, to take long-acting injectable PrEP (LAI-PrEP) is critical to guide future LAI-PrEP implementation.ObjectiveThe objective was to assess the willingness of MSM with oral PrEP experience to take LAI-PrEP.MethodsMSM who participated in the China Real-world Study of Oral PrEP (CROPrEP) were enrolled in this study. Information on the willingness of MSM to take LAI-PrEP and potential correlates was collected using a structured online questionnaire. The main outcomes were the willingness of MSM to take LAI-PrEP and its association with HIV-related behaviours, sexually transmitted infections, and oral PrEP history. Logistic regression was used to identify correlates of the willingness of MSM to take LAI-PrEP.ResultsA total of 612 former CROPrEP participants (FCPs) were included in this study. There were 315 (51.5%) daily oral PrEP (D-PrEP) users and 297 (48.5%) event-driven oral PrEP (ED-PrEP) users at the last follow-up. Most FCPs (77.8%) were willing to take free LAI-PrEP. FCPs with no less than two sexual male partners (aOR = 1.54, [95% CI: 1.04, 2.29], P = 0.031), those with male partners with unknown HIV statuses (aOR = 2.04, [95% CI: 1.31, 3.18], P = 0.002), those with recreational drug use (aOR = 1.58, [95% CI: 1.05, 2.40], P = 0.030), and those with HSV-2 positivity (aOR = 2.15, [95% CI: 1.30, 3.57], P = 0.003) were more willing to take LAI-PrEP, while ED-PrEP users (aOR = 0.66, [95% CI: 0.45, 0.98], P = 0.037) and FCPs with suboptimal oral PrEP adherence (aOR = 0.58, [95% CI: 0.36, 0.94], P = 0.026) were less willing to take LAI-PrEP.ConclusionLAI-PrEP has good prospects for expanding PrEP coverage. However, FCPs with suboptimal oral PrEP adherence are less likely to take LAI-PrEP. Further intervention and implementation efforts are needed to improve the willingness of MSM to use LAI-PrEP, and sexual health should be considered during the discussion about PrEP initiation.

Low daily oral PrEP adherence and low validity of self-report in a randomized trial among PWID in Ukraine

BackgroundThe efficacy of daily oral pre-exposure prophylaxis (PrEP) in preventing HIV transmission among people who inject drugs (PWID) was demonstrated over a decade ago. However, only a few studies among PWID have since measured PrEP adherence using laboratory markers. MethodsIn this trial, we randomized recently injecting PWID in Kyiv, Ukraine, to receive daily oral TDF/FTC with or without SMS reminders. Enrollment and PrEP initiation took place at an HIV clinic. Subsequent visits at months 1, 3, and 6 were conducted at a community harm reduction center and included a structured interview, adherence counseling, PrEP dispensing, and dried blood spot collection. PrEP adherence was assessed using standard self-reported measures and TDF/FTC biomarkers. ResultsA total of 199 PWID (99 SMS, 100 No-SMS) were enrolled, of whom 24 % were women, with a median age of 37. At month 6, 79.4 % (158/199) of participants were retained, with 84 % (133/158) reporting opioid injection and 20 % (31/158) reporting stimulant injection in the past 30 days. 77 % (122/158) reported taking >95 % of PrEP doses in the past month, and 87 % reported taking the last dose within 2 days. Tenofovir diphosphate was detected in 17 % (28/158) of participants, and emtricitabine triphosphate was detected in 25 % (40/158). Only 3 % (5/158) had metabolite levels indicative of consistent PrEP uptake at 4+ doses per week. There was no association between the SMS intervention and TDF/FTC metabolite detection. ConclusionAdherence to daily oral PrEP among actively injecting PWID, without daily supervision or incentives, was extremely low, despite supportive counseling and SMS reminders. We also observed a high rate of discordance between self-report and classification by a validated biomarker of adherence. Given the scarcity of evidence and emerging data suggesting low oral PrEP adherence among PWID, additional implementation studies with TDF/FTC biomarkers are needed to study whether a sufficient level of adherence to daily PrEP is attainable among PWID, especially as long-acting injectable PrEP offers a promising alternative.

1549. Risk Factors, Risk Perception, and Long-acting PrEP Awareness and Interest among US Women: A National Survey

Abstract Background Cisgender women account for approximately 20% of incident HIV diagnoses in the US. However, only 10% of women who could benefit from HIV pre-exposure prophylaxis (PrEP) have been prescribed PrEP. US women face several challenges that may affect their seeking HIV prevention services, such as lack of PrEP awareness. Understanding these challenges may improve PrEP uptake, especially as innovative PrEP options, such as long-acting (LA) injectable PrEP, become available. This study explored interest in using LA-PrEP by factors that may increase risk of HIV acquisition. Methods Cisgender women were recruited between November 2021 – March 2022 though targeted social media ads on Facebook, Instagram, and Tinder to complete an online, self-administered survey. Eligible participants were cisgender women who were: 18+ years, current US residents, reported penetrative sex in the past six months, and reported an unknown or negative HIV status. The survey included questions on demographics, sexual health and behavior, LA-PrEP awareness, and LA-PrEP interest. Descriptive statistics were calculated using SAS v9.4. Results 1,834 eligible women completed the survey (median age: 28 years (IQR: 25, 33); Geography: South – 65%, West – 21%, Northeast – 7.3%, Midwest – 6.8%; Race: Black, non-Hispanic – 34%, White, non-Hispanic – 25%, Hispanic – 27%, Another race – 14%). Women were more likely to have heard of LA-PrEP if they had reported injection drug use in the past year (71%), had an STI diagnosis (70%) or HIV test (66%) in the past two years, and were currently using contraception (65%). Interest in using LA-PrEP was consistently high; the difference between LA-PrEP awareness and interest was greatest among women with non-private health insurance and those with perceived likelihood of future HIV acquisition. Conclusion Although interest in using LA-PrEP is high among US women, these results demonstrate the large gap between LA-PrEP awareness and interest in using it. Disclosures Tonia Poteat, PhD, MPH, PAC, Viiv Healthcare: Advisor/Consultant Supriya Sarkar, PhD, MPH, GlaxoSmithKline: Stocks/Bonds|Viiv Healthcare: Employee Leigh Ragone, MS, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employee Danielle Bogan, BSN, MPH,DrPH, ViiV Healthcare: Contract worker Keith Rawlings, MD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employee Alex R. Rinehart, PhD, ViiV Healthcare: Employee Vani Vannappagari, MBBS, MPH, PhD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employee

Preferences for Long-Acting PrEP Products Among Women and Girls: A Quantitative Survey and Discrete Choice Experiment in Eswatini, Kenya, and South Africa

While oral pre-exposure prophylaxis (PrEP) can substantially reduce HIV risk, there are important barriers to uptake and adherence. We explored preferences for long-acting injectable and implantable PrEP among women and girls in Eswatini, Kenya, and South Africa. We conducted an online quantitative survey and discrete choice experiment (DCE) among adolescent girls (15–17), young women (18–29), and adult women (30–49). Participants completed a survey about their demographics and behavior and a DCE with 5 attributes (format, insertion location, number of insertions, dual-protection, and palpability). We recruited 1236 respondents (Eswatini = 420; Kenya = 350; South Africa = 493) in May 2022. Most participants were sexually active (72%), nearly 29% of whom reported recently engaging in transactional sex. 46% had heard of oral PrEP, but of those, only 16% reported having ever used it. Product format and dual-protection were significant predictors of product choice. Relative to a 2-month injection, participants had 1.76 times the odds (95% CI 1.08–2.04) of choosing a 6-month injectable, and 1.70 the odds (95% CI 1.06–1.92) of choosing a 12-month removable implant. Compared to a single-indication product, respondents had 2.46 times the odds (95% CI 1.04–2.68) of preferring a product also protecting against pregnancy, and 2.81 the odds (95% CI 1.04–3.05) of choosing a product that also protected against STIs. Adolescent girls and women in these countries showed strong preferences for longer-acting PrEP product formats, as well as those offering dual-protection. Introduction of long-acting options could improve PrEP uptake and reduce HIV burdens in east and southern African settings.

Efficacy and safety of long-acting cabotegravir compared with daily oral tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection in cisgender men and transgender women who have sex with men 1 year after study unblinding: a secondary analysis of the phase 2b and 3 HPTN 083 randomised controlled trial

Injectable cabotegravir was superior to daily oral tenofovir disoproxil fumarate plus emtricitabine for HIV prevention in two clinical trials. Both trials had the primary aim of establishing the HIV prevention efficacy of long-acting injectable cabotegravir pre-exposure prophylaxis (PrEP) compared with tenofovir disoproxil fumarate plus emtricitabine daily oral PrEP. Long-acting PrEP was associated with diagnostic delays and integrase strand-transfer inhibitor (INSTI) resistance. This report presents findings from the first unblinded year of the HIV Prevention Trials Network (HPTN) 083 study. The HPTN 083 randomised controlled trial enrolled HIV-uninfected cisgender men and transgender women at elevated HIV risk who have sex with men, from 43 clinical research sites in Africa, Asia, Latin America, and the USA. Inclusion criteria included: a negative HIV serological test at the screening and study entry, undetectable HIV RNA levels within 14 days of study entry, age 18 years or older, overall good health as determined by clinical and laboratory evaluations, and a creatinine clearance of 60 mL/min or higher. Participants were randomly allocated to receive long-acting injectable cabotegravir or daily oral tenofovir disoproxil fumarate plus emtricitabine PrEP. After study unblinding, participants remained on their original regimen awaiting an extension study. HIV infections were characterised retrospectively at a central laboratory. Here we report the secondary analysis of efficacy and safety for the first unblinded year. The primary outcome was incident HIV infection. Efficacy analyses were done on the modified intention-to-treat population using a Cox regression model. Adverse events were compared across treatment groups and time periods (blinded vs unblinded). This trial is registered with ClinicalTrials.gov, NCT02720094. Of the 4488 participants who contributed person-time to the blinded analysis, 3290 contributed person-time to the first unblinded year analysis between May 15, 2020, and May 14, 2021. Updated HIV incidence in the blinded phase was 0·41 per 100 person-years for long-acting injectable cabotegravir PrEP and 1·29 per 100 person-years for daily oral tenofovir disoproxil fumarate plus emtricitabine PrEP (hazard ratio [HR] 0·31 [95% CI 0·17-0·58], p=0·0003). HIV incidence in the first unblinded year was 0·82 per 100 person-years for long-acting PrEP and 2·27 per 100 person-years for daily oral PrEP (HR 0·35 [0·18-0·69], p=0·002). Adherence to both study products decreased after study unblinding. Additional infections in the long-acting PrEP group included two with on-time injections; three with one or more delayed injections; two detected with long-acting PrEP reinitiation; and 11 more than 6 months after their last injection. Infection within 6 months of cabotegravir exposure was associated with diagnostic delays and INSTI resistance. Adverse events were generally consistent with previous reports; incident hypertension in the long-acting PrEP group requires further investigation. Long-acting injectable cabotegravir PrEP retained high efficacy for HIV prevention in men and transgender women who have sex with men during the first year of open-label follow-up, with a near-identical HR for HIV risk reduction between long-acting injectable cabotegravir and daily oral tenofovir disoproxil fumarate plus emtricitabine PrEP during the first year after unblinding compared with the blinded period. Extended follow-up further defined the risk period for diagnostic delays and emergence of INSTI resistance. Division of AIDS at the National Institute of Allergy and Infectious Diseases, ViiV Healthcare, and Gilead Sciences.

Willingness to use long-acting injectable PrEP among HIV-negative/unknown men who have sex with men in mainland China: A cross-sectional online survey.

Men who have sex with men (MSM) are at high risk of HIV acquisition. Long-acting injectable-pre-exposure prophylaxis (LAI-PrEP), requiring less frequent dosing, is being studied as an alternative method to daily oral HIV PrEP. With the addition of this potential new prevention method, it expands the scope for a wider user choice and is expected to increase the acceptability and uptake of HIV prevention measures. The aim of our study was to explore the willingness to use LAI-PrEP and associated influential factors. Participants were recruited from December 2020 to March 2021 through banner advertisements on web- and mobile app-based platforms on Blued, a large gay Chinese social media platform. MSM in our cross-sectional study was HIV-negative and currently lived in mainland China. Participants were asked about their willingness to use LAI-PrEP and reasons why they might be or not be willing to use LAI-PrEP. Multivariable logistic regression was used to analyze the factors associated with the willingness to use LAI-PrEP. In total, 969 participants met the inclusion criteria and finished the survey. Nearly twenty percent (19.5%) of participants had never tested for HIV; 66.8% of MSM had multiple male partners; and 51.6% of MSM engaged in condomless sex with their partner. About three-fifths (66.3%) of MSM were aware of PrEP, and only 3.9% of MSM had used PrEP before. The willingness to use LAI-PrEP among MSM was 74.0% (95% CI: 71.4%-76.6%). MSM with higher education levels were less likely to show a willingness to use LAI-PrEP (AOR = 0.56, 95%CI: 0.38-0.84). Participants who had a history of HIV test (AOR = 1.68, 95%CI: 1.11-2.55), were willing to use daily oral PrEP (AOR = 10.64, 95%CI:7.43-15.21), had multiple male sexual partners (AOR = 1.33, 95%CI:0.93-1.90), who used rush popper(AOR = 1.49, 95%CI:1.05-2.13), and who were aware of PEP (AOR = 1.66, 95%CI: 1.02-2.70) were more likely to show willingness to use LAI-PrEP. In our study, MSM had quite high awareness but low uptake of PrEP. As LAI-PrEP is expected to be approved for use in China in the future, our study of MSM highlights the need for key population-focused education programs about PrEP and healthy sexual behavior. This study also provides some evidence for LAI-PrEP use among the Chinese MSM population in the future.

High Propensity to Switch to Long-acting Injectable HIV PrEP with Cabotegravir in a Cohort of Oral PrEP Experienced Men who Have Sex with Men in Italy.

Aim was to investigate the propensity to switch to long-acting injectable HIV pre-exposure prophylaxis (PrEP) with cabotegravir among oral PrEP-experienced men who have sex with men. Out of 377 PrEP users, 325 (86.2%) were interested (would like = 210) or considering (would consider = 115) switch to long-acting PrEP. At multivariable analysis, the odds ratio of interest in long-acting PrEP in non-adherent vs. adherent individuals to oral PrEP was 5.03 (95%CI = 1.73-14.61,p = 0.003) and of consideration 1.63 (95%CI = 0.51-5.23,p = 0.410). We observed very high propensity to switch to long-acting PrEP, particularly among non-adherent users. Rapid availability of long-acting PrEP might address unmet needs of PrEP users in Italy.

The Perceived Added Value of Bimonthly Injectable Pre-Exposure Prophylaxis According to West African Men Who Have Sex with Men: A Focus Group Study.

Bimonthly long-acting injectable pre-exposure prophylaxis (LAI-PrEP) can become an important additional tool for HIV prevention among West African men who have sex with men (MSM). The objective was to explore the perceived added value of LAI-PrEP as an HIV prevention tool among MSM in Burkina Faso, Côte d'Ivoire, Mali, and Togo. We conducted eight focus group discussions among 62 HIV-negative MSM between April and May 2021. Participants were recruited via local community-based clinics. Data collection and analysis were guided by grounded theory and community-based participatory approaches. Participants were generally knowledgeable about HIV, and explained particular barriers for HIV prevention in their communities (e.g., denial of HIV). The added value of LAI-PrEP relative to condoms was similar to oral pre-exposure prophylaxis (PrEP) in terms of perceived advantages (e.g., improved sexual satisfaction) or disadvantages (e.g., no protection against other sexually transmitted infections). Compared with oral PrEP, LAI-PrEP was perceived to provide better protection against HIV and to be more convenient (e.g., no need to be mindful of intake and less risk for stigma). Concerns included fear of needles, doubts about efficacy, potential side effects, and difficulties for ensuring timely injections (e.g., when traveling abroad). The results demonstrate that injectable PrEP can be of particular interest to subgroups of West African MSM, although existing HIV prevention tools such as condoms and oral PrEP will remain valuable alongside of, or instead of, LAI-PrEP. Increasing awareness about HIV and tackling discrimination based on sexual orientation continue to be crucial factors to be addressed for HIV prevention.

Variation in Preferences for Long-Acting Injectable Pre-Exposure Prophylaxis Among US Men Who Have Sex with Men: A Latent Class Analysis.

Cabotegravir long-acting injectable HIV pre-exposure prophylaxis (LA PrEP) is efficacious, with a good safety profile, and was approved by the US Food and Drug Administration in December 2021. Understanding variations in potential user preferences for LA PrEP may inform implementation and subsequently improve uptake and community-level effectiveness. HIV-negative, sexually active men who have sex with men (MSM) aged ≥15 years were recruited online for the 2019 American Men's Internet Survey, before LA PrEP approval. Respondents completed a discrete-choice experiment (DCE) with hypothetical LA PrEP attributes (out-of-pocket cost, perceived side effects, injection frequency, perceived stigma, service location). Latent class analysis segmented respondents into groups based on their preferences for the attributes presented, and relative importance of preference weights and willingness-to-pay were calculated. While the majority had never used daily oral PrEP, 73% of the 2489 respondents were very or somewhat likely to use LA PrEP. Three latent classes were identified from 2241 respondents in the DCE. The "side effects-averse" class was the largest group (64% of respondents) and placed 61% relative importance on side effects. The "ambivalent" class (20% of respondents) placed higher importance on stigma (17% of relative importance) than other classes. The "cost-conscious" class (16% of respondents) placed higher relative importance (62%) on cost compared with other attributes and classes. Perceived side effects were an important hypothetical barrier for LA PrEP uptake among a large proportion of potential MSM users. Minimizing out-of-pocket costs is likely to increase uptake and may be important to equitable access. Tailored communication strategies are recommended for the different groups of potential LA PrEP users.