Pre-exposure Prophylaxis Modalities Research Articles

Concepciones de usuarios sobre nuevas vías de administración de profilaxis pre-exposición para el VIH

Abstract This article aims to discuss the expectations of Homosexual Men, Bisexual Men and a Transgender Woman, who use or want to use an oral pre-exposure prophylaxis (PrEP) for the human immunodeficiency virus (HIV) about PrEP modalities. Sixteen PrEP users, who are followed up in the BCN Checkpoint, were interviewed,. The interviews were audio-recorded, subjected to thematic categorical analysis within the theoretical framework from the praxiographic perspective. They are all adapted to the use of daily oral and event-based PrEP. In relation to the new PrEP modalities (monthly pill; intramuscular injection every two months; subcutaneous injection every six months), they are all very receptive to these possibilities, but they lack information on the specificities of each and specific assessment of their needs. Comments about the use of oral PrEP are positive, and expectations regarding the new PrEP modalities are visibly high. However, the most important thing for the interviewees is the guarantee that they will have follow-up appointments to continue taking care of their affective-sexual health, which is not dependent on the type of PrEP modalities.

Users' expectations of the new pre-exposure prophylaxis for the HIV modalities.

This article aims to discuss the expectations of Homosexual Men, Bisexual Men and a Transgender Woman, who use or want to use an oral pre-exposure prophylaxis (PrEP) for the human immunodeficiency virus (HIV) about PrEP modalities. Sixteen PrEP users, who are followed up in the BCN Checkpoint, were interviewed,. The interviews were audio-recorded, subjected to thematic categorical analysis within the theoretical framework from the praxiographic perspective. They are all adapted to the use of daily oral and event-based PrEP. In relation to the new PrEP modalities (monthly pill; intramuscular injection every two months; subcutaneous injection every six months), they are all very receptive to these possibilities, but they lack information on the specificities of each and specific assessment of their needs. Comments about the use of oral PrEP are positive, and expectations regarding the new PrEP modalities are visibly high. However, the most important thing for the interviewees is the guarantee that they will have follow-up appointments to continue taking care of their affective-sexual health, which is not dependent on the type of PrEP modalities.

Perinatal outcomes associated with pre-exposure prophylaxis for HIV prevention during pregnancy: a systematic review and meta-analysis

The World Health Organization (WHO) recommends tenofovir disoproxil fumarate (TDF)-based oral pre-exposure prophylaxis (PrEP), the dapivirine vaginal ring, and long-acting intramuscular injectable cabotegravir (CAB-LA) for HIV prevention in populations at substantial risk of HIV infection. Pregnancy is a period of elevated risk of maternal HIV infection and transmission to the infant. This systematic review and meta-analysis assessed the risk of adverse perinatal outcomes among HIV-negative pregnant women with exposure to any PrEP modality. We conducted a systematic review by searching Medline, EMBASE, CINAHL, Global Health, the Cochrane Library, WHO ICTR, ISRCTN, PACTR, and ClinicalTrials.gov for studies published between 1 January 2000 and 29 August 2023. We included studies reporting on the association of antenatal exposure to any PrEP modality with 13 perinatal outcomes: preterm birth (PTB), very PTB, spontaneous PTB, spontaneous very PTB, low birthweight (LBW), very LBW, term LBW, preterm LBW, small for gestational age (SGA), very SGA, miscarriage, stillbirth, or neonatal death (NND). Quality assessments of included studies were performed. Fixed-effect meta-analyses were conducted to calculate odds ratios (ORs) and 95% confidence intervals (95% CIs). The protocol is registered with PROSPERO, CRD42022339825. Of 18,598 citations identified, 13 studies (eight randomised controlled trials (RCTs) and five cohort studies), assessing 8712 pregnant women in Africa, were included. Oral PrEP, compared to no PrEP, was not associated with PTB in meta-analyses of six RCTs (OR 0.73, 95% CI 0.43-1.26; I2=0.0%) or five unadjusted cohort studies (OR 0.84, 95% CI 0.69-1.03; I2=0.0%), but was associated with a reduced risk of PTB in three adjusted cohort studies (aOR 0.67; 95% CI 0.52-0.88, I2=0.0%). There was no association of oral PrEP with LBW, vLBW, SGA, or NND, compared to no PrEP. There was no association with PTB when oral TDF/emtricitabine (FTC) PrEP, oral TDF PrEP, and tenofovir vaginal gel were compared to each other. There was no association of the dapivirine vaginal ring with PTB or NND, compared to placebo or oral TDF/FTC PrEP. We found no data on CAB-LA. We found no evidence of adverse perinatal outcomes associated with PrEP exposure during pregnancy. Our findings support the WHO recommendation to provide oral PrEP to women of reproductive age and pregnant women. More data is needed to assess the safety of all PrEP modalities in pregnancy. None.

Barriers to Oral PrEP: A Qualitative Study of Female Sex Workers, PrEP Prescribers, Policymakers, and Community Advocates in Morocco.

In 2017, Morocco became the first Arab country to incorporate pre-exposure prophylaxis (PrEP) in its HIV-prevention program. Yet no research has been published on PrEP from Morocco. Although female sex workers are one of the target populations of PrEP in Morocco, their enrollment in PrEP is lower than men who have sex with men. In this study, we conducted 38 semi-structured interviews with female sex workers, physicians who prescribe PrEP, policymakers, and community advocates to identify problems associated with access to and use of PrEP. We also investigated preferences for daily oral, vaginal ring, and long-acting injectable PrEP. A reflexive thematic analysis revealed seven themes: PrEP stigma; stigmatization and criminalization of sex work; one size doesn't fit all; knowledge and misconceptions about PrEP; economic burden; inconvenience of PrEP pills; and preferred PrEP modalities. This paper discusses the implications of the findings for increasing access and use of PrEP in Morocco.

"Protected Means Armed": Perspectives on Pre-Exposure Prophylaxis (PrEP) Among Women Who Engage in Sex Work and Use Drugs in Kazakhstan.

Pre-exposure prophylaxis (PrEP) for HIV prevention has recently become available in Kazakhstan, but women engaged in sex work who use drugs (WESW-UD) could benefit from tailored approaches to support uptake and adherence. To better understand how best to support WESW-UD at each stage of the PrEP continuum (awareness, acceptability, uptake, and adherence), we analyzed data from 30 in-depth interviews and four focus groups with 48 WESW-UD from two cities in Kazakhstan. We conducted thematic analysis to characterize perceptions, barriers, and motivators within each step of the PrEP continuum. Participants reported low awareness, but high interest in PrEP. Motivating factors included optimizing health and increased confidence. Participants expressed many preferences and concerns regarding PrEP modality and delivery. Participants also described how organizational mistrust and social support can prevent or facilitate PrEP uptake or adherence. Kazakhstan's scale-up of PrEP should consider the needs and preferences of WESW-UD to ensure equitable access.

Adherence to Oral Pre-Exposure Prophylaxis Intervention by Transgender Women: A Systematic Review.

Prevalence of human immunodeficiency virus (HIV) is higher in transgender populations. Pre-exposure prophylaxis (PrEP) intervention is successful in reducing HIV acquisition. We aimed to investigate the adherence to oral PrEP by HIV-negative transgender women (TW). We followed the Cochrane Handbook for Systematic Reviews of Interventions and the PRISMA Statement. We searched in WoS, OVID, Scopus, MEDLINE, and the Cochrane Central Register of Controlled Trials databases. Participation and adherence to the intervention were low for TW compared to cisgender men who have sex with men (cMSM), and it was measured mostly by self-report (72.7%) or tenofovir-diphosphate/emtricitabine triphosphate dried blood spot (45.5%). Awareness should increase and the effect of oral PrEP on gender-affirming hormone therapy should be explained to TW at the beginning of the trials. One limitation is that our sample size was dominated by two Thai studies with TW sex workers. Future studies should evaluate adherence to new PrEP modalities.

Health Information on Pre-Exposure Prophylaxis From Search Engines and Twitter: Readability Analysis.

Pre-exposure prophylaxis (PrEP) is proven to prevent HIV infection. However, PrEP uptake to date has been limited and inequitable. Analyzing the readability of existing PrEP-related information is important to understand the potential impact of available PrEP information on PrEP uptake and identify opportunities to improve PrEP-related education and communication. We examined the readability of web-based PrEP information identified using search engines and on Twitter. We investigated the readability of web-based PrEP documents, stratified by how the PrEP document was obtained on the web, information source, document format and communication method, PrEP modality, and intended audience. Web-based PrEP information in English was systematically identified using search engines and the Twitter API. We manually verified and categorized results and described the method used to obtain information, information source, document format and communication method, PrEP modality, and intended audience. Documents were converted to plain text for the analysis and readability of the collected documents was assessed using 4 readability indices. We conducted pairwise comparisons of readability based on how the PrEP document was obtained on the web, information source, document format, communication method, PrEP modality, and intended audience, then adjusted for multiple comparisons. A total of 463 documents were identified. Overall, the readability of web-based PrEP information was at a higher level (10.2-grade reading level) than what is recommended for health information provided to the general public (ninth-grade reading level, as suggested by the Department of Health and Human Services). Brochures (n=33, 7% of all identified resources) were the only type of PrEP materials that achieved the target of ninth-grade reading level. Web-based PrEP information is often written at a complex level for potential and current PrEP users to understand. This may hinder PrEP uptake for some people who would benefit from it. The readability of PrEP-related information found on the web should be improved to align more closely with health communication guidelines for reading level to improve access to this important health information, facilitate informed decisions by those with a need for PrEP, and realize national prevention goals for PrEP uptake and reducing new HIV infections in the United States.

Adolescent Girls and Young Women's Experiences with Disclosing Oral PrEP or Dapivirine Vaginal Ring Use: a Multi-Country Qualitative Analysis.

Effective use of oral pre-exposure prophylaxis (PrEP) has been low among adolescent girls and young women (AGYW) in Eastern and Southern Africa, partly due to stigma and opposition from key influencers. Understanding AGYW's experiences of disclosure of different PrEP modalities to key influencers may inform strategies to motivate uptake and adherence. We analyzed qualitative in-depth interviews and focus group discussions data from 119 participants in the MTN-034/REACH (Reversing the Epidemic in Africa with Choices in HIV Prevention) study of oral PrEP and the dapivirine vaginal ring (ring) to explore AGYW's disclosure experiences. We found that AGYW disclosure experiences varied across influencers and product type. The ring was disclosed less often to most influencers, except partners, because it was discreet. Oral PrEP was disclosed more often, because pills were more common and to avoid HIV stigma given that oral PrEP resembled HIV treatment. Ultimately, disclosure typically led most key influencers to support product use through reminders and encouragement. While disclosure yielded positive support from influencers, further community awareness of both PrEP products is essential to reduce potential opposition and perceived stigma.Clinical Trial Number: NCT03593655.

The Promise of Pre-Exposure Prophylaxis - Examining Awareness, Knowledge, and Willingness to use Different Modalities Among US-Based African Immigrants.

This study aims to describe and understand the relationship between sociodemographic factors and PrEP awareness, and willingness to use a PrEP modality (oral or injectable).Despite the availability of effective prevention tools such as HIV preexposure prophylaxis (PrEP), African immigrants in the United States are disproportionately affected by HIV. Although PrEP can significantly reduce HIV infection in this population, research evidence on PrEP outcomes, such as awareness, knowledge, and willingness to use, is extremely limited. Between April and May 2022, 92 participants completed an online survey assessing their awareness, knowledge, and willingness to use oral or injectable PrEP. The association between sociodemographic characteristics and PrEP-related measures was examined using descriptive and Pearson's chi-squared or Fisher's exact tests. Participants (N = 92) were born between 1990 and 1999 (46.7%), female (70.76%) and highly educated (59.6%). About 52.2% were unaware of PrEP, and 65.6% were willing to use a PrEP modality. Findings indicate that individuals who reported being aware of PrEP demonstrated a high level of knowledge regarding the medication. Having a healthcare provider was associated with PrEP awareness and willingness to use, while educational status was associated with PrEP awareness. 51.1% of participants were willing to use an oral pill for prevention and 47.8% were willing to use injectable PrEP. Our findings highlight the need for PrEP-related research and interventions for African immigrants to increase awareness and provide options for HIV prevention, as African immigrants are currently not well-represented in PrEP delivery systems in the US.

Preferences and acceptability for long-acting PrEP agents among pregnant and postpartum women with experience using daily oral PrEP in South Africa and Kenya.

Long-acting pre-exposure prophylaxis (PrEP) options could overcome barriers to oral PrEP persistence during pregnancy and postpartum. We evaluated long-acting PrEP preferences among oral PrEP-experienced pregnant and postpartum women in South Africa and Kenya, countries with high PrEP coverage with pending regulatory approvals for long-acting injectable cabotegravir and the dapivirine vaginal ring (approved in South Africa, under review in Kenya). From September 2021 to February 2022, we surveyed pregnant and postpartum women enrolled in oral PrEP studies in South Africa and Kenya. We evaluated oral PrEP attitudes and preferences for long-acting PrEP methods in multivariable logistic regression models adjusting for maternal age and country. We surveyed 190 women in South Africa (67% postpartum; median age 27 years [IQR = 22-32]) and 204 women in Kenya (79% postpartum; median age 29 years [IQR = 25-33]). Seventy-five percent of participants reported oral PrEP use within the last 30 days. Overall, forty-nine percent of participants reported negative oral PrEP attributes, including side effects (21% South Africa, 30% Kenya) and pill burden (20% South Africa, 25% Kenya). Preferred PrEP attributes included long-acting method, effectiveness, safety while pregnant and breastfeeding, and free medication. Most participants (75%, South Africa and Kenya) preferred a potential long-acting injectable over oral PrEP, most frequently for a longer duration of effectiveness in South Africa (87% South Africa, 42% Kenya) versus discretion in Kenya (5% South Africa, 49% Kenya). Eighty-seven percent of participants preferred oral PrEP over a potential long-acting vaginal ring, mostly due to concern about possible discomfort with vaginal insertion (82% South Africa, 48% Kenya). Significant predictors of long-acting PrEP preference included past use of injectable contraceptive (aOR = 2.48, 95% CI: 1.34, 4.57), disliking at least one oral PrEP attribute (aOR = 1.72, 95% CI: 1.05, 2.80) and preferring infrequent PrEP use (aOR = 1.58, 95% CI: 0.94, 2.65). Oral PrEP-experienced pregnant and postpartum women expressed a theoretical preference for long-acting injectable PrEP over other modalities, demonstrating potential acceptability among a key population who must be at the forefront of injectable PrEP rollout. Reasons for PrEP preferences differed by country, emphasizing the importance of increasing context-specific options and choice of PrEP modalities for pregnant and postpartum women.

Strategies to improve PrEP uptake among West African men who have sex with men: a multi-country qualitative study.

West African men who have sex with men (MSM) remain at substantial risk of contracting HIV. Pre-exposure prophylaxis (PrEP) can be an effective game-changer in reducing the number of HIV infections in MSM communities. To optimize the roll-out of PrEP, we need to better understand how we can increase its uptake. The objective of this study was to explore the perceptions of West African MSM toward PrEP and their proposed strategies to overcome barriers to PrEP uptake within their communities. Between April 2019 and November 2021, we conducted 12 focus group discussions with 97 MSM not taking PrEP, and 64 semi-structured interviews with MSM taking PrEP, in Burkina Faso, Côte d'Ivoire, Mali, and Togo. Data collection and analysis were guided and conducted by local research teams, enabling a community-based participatory approach. A coordinating researcher collaborated with these local teams to analyze the data guided by a grounded theory approach. The results show that participants were generally positive toward PrEP and that MSM communities have become more aware of PrEP for the study. We identified three main strategies for increasing PrEP uptake. First, participants proposed to raise awareness and improve knowledge of HIV as they considered the self-perceived risk of MSM in their communities to be low. Second, because of existing misconceptions and false information, participants proposed to improve the dissemination of PrEP to allow for informed choices, e.g., via peers or PrEP users themselves. Third, as oral PrEP also entails a risk of being associated with HIV or homosexuality, strategies to avoid stigmatization (e.g., hiding pills) were deemed important. These findings indicate that the roll-out of oral PrEP and other future PrEP modalities should be accompanied by raising awareness and improving knowledge on HIV, and wide dissemination of information that focuses on the health-promoting aspect of these tools. Tailored delivery and long-acting PrEP modalities will be important to avoid potential stigmatization. Sustained efforts to prevent discrimination and stigmatization based on HIV status or sexual orientation continue to be highly important strategies to address the HIV epidemic in West Africa.

An Exploratory Study of the PrEP Modality Preferences Among a Convenience Sample of Parents of Sexual and Gender Minority Adolescents

PurposeParents' attitudes toward contraceptive delivery methods have been shown to impact their adolescents' use of contraceptive methods. However, little is known about the HIV pre-exposure prophylaxis (PrEP) delivery method attitudes of parents of sexual and gender minority (SGM) adolescents assigned male at birth (AMAB). This exploratory, mixed-method formative study examined the PrEP delivery method preferences among a convenience sample of 33 parents of SGM adolescents AMAB who live in Texas. MethodsParticipants completed an online survey, where they selected their preferred PrEP method for their SGM adolescent AMAB to use: PrEP as a daily oral pill, a bimonthly injectable, or a yearly implant. Parents answered an open-ended question about their reasons for choosing their preferred method. We analyzed data through descriptive statistics and inductive content analysis. ResultsFindings from this convenience sample suggest that there is not one PrEP delivery method that parents of SGM adolescents AMAB prefer: one third of parents (33.3%) selected PrEP as a daily oral pill, 45.5% selected PrEP as a bimonthly injectable, and 21.2% selected PrEP as an annual implant. Parents cited multiple reasons for selecting a delivery method over another, with the most prevalent reasons being adherence (57.6%), access or cost (21.2%), and generic convenience or ease (21.2%). DiscussionFindings from this formative exploratory study sets the stage for future research and intervention development in increasing parental knowledge, preferences, and preference motivations for PrEP delivery methods.

Readiness to Provide Oral and Injectable PrEP for Sexual and Gender Minority Youth Among Healthcare Providers and Clinics in the U.S. Northeast

PurposeTo examine readiness to provide oral and injectable pre-exposure prophylaxis (PrEP) for sexual and gender minority youth (SGMY) and to explore decision-making for HIV prevention strategies (e.g., condom use, daily and event-driven oral PrEP, and injectable PrEP) among healthcare providers. MethodsBetween February and April 2022, we recruited 31 prescribing providers (M.Ds, D.Os, P.As, and N.Ps) practicing in primary care and specialized clinics in the U.S. Northeast for focus groups or individual interviews. Focus groups and interview transcripts were analyzed using thematic analysis. ResultsMost providers specialized in Pediatrics (42%) or Adolescent Medicine (23%) and 58% had previously prescribed PrEP. Main barriers to PrEP readiness were low PrEP knowledge, limited time for visits, and competing clinical priorities. Organizational factors such as routine HIV/STI testing, PrEP-specific electronic health records templates, and specialized staff (e.g., PrEP navigators) promoted PrEP readiness. Providers held positive attitudes toward injectable PrEP to promote adherence among SGMY, yet barriers to implementation of this modality were identified (e.g., patient anxiety about needles, additional staffing needs). Providers described event-driven oral PrEP as an option for SGMY with episodic HIV risk. Assurances of conditional confidentiality, including preventing disclosure of sensitive information through insurance forms, and shared decision-making facilitated conversations about HIV prevention with SGMY. DiscussionFuture PrEP implementation efforts for SGMY should consider combined efforts targeting provider knowledge about PrEP modalities (e.g., decision aids) and clinic organizational factors (e.g., routine HIV/STI testing, resources to assist providers and patients in navigating the multiple steps between prescription and adherence to PrEP).

Preferences for PrEP modalities among gay, bisexual, and other men who have sex with men from Brazil, Mexico, and Peru: a cross-sectional study.

Pre-exposure prophylaxis (PrEP) scale-up is urgent to reduce new HIV cases among gay, bisexual, and other men who have sex with men (MSM) in Latin America. Different PrEP modalities may increase PrEP uptake and adherence, especially among young MSM. To assess preferences for PrEP modalities among MSM from Brazil, Mexico, and Peru. Cross-sectional web-based study (March-May 2018) targeting MSM through advertisements on Grindr, Hornet, and Facebook. We included MSM aged ⩾ 18 years and who reported HIV-negative status. We assessed preferences for PrEP modalities with the following question: 'Considering that all following PrEP modalities were available, which one would you prefer considering a scale from 1 to 3 (1 = most preferred): daily oral PrEP, event-driven PrEP (ED-PrEP), and long-acting injectable PrEP'. We assessed factors associated with each most preferred PrEP modality per country using multivariable logistic regression models. A total of 19,457 MSM completed the questionnaire (Brazil: 58%; Mexico: 31%; Peru: 11%); median age was 28 years [interquartile range (IQR): 24-34]. Overall, injectable PrEP was the most preferred modality [42%; 95% confidence interval (CI): 41-43], followed by daily PrEP (35%; 95% CI: 34-35), and ED-PrEP (23%; 95% CI: 23-24). In multivariable models, preferring injectable PrEP was associated with PrEP awareness in all three countries, while PrEP eligibility only in Brazil. Preferring daily PrEP was associated with younger age and lower income in Brazil and Mexico, and lower education only in Brazil. The odds of preferring ED-PrEP were lower among MSM aware and eligible for PrEP in Brazil and Mexico. Long-acting injectable PrEP was the preferred PrEP modality among MSM in Brazil, Mexico, and Peru, especially those aware and eligible for PrEP. Public health interventions to increase PrEP modalities literacy and availability in Latin America are urgent especially among MSM of young age, lower income, and lower education.

Single dose topical inserts containing tenofovir alafenamide fumarate and elvitegravir provide pre- and post-exposure protection against vaginal SHIV infection in macaques.

Vaginal products for HIV prevention that can be used on-demand before or after sex may be a preferable option for women with low frequency or unplanned sexual activity or who prefer not to use daily or long-acting pre-exposure prophylaxis (PrEP). We performed dose ranging pharmacokinetics (PK) and efficacy studies of a vaginally applied insert containing tenofovir alafenamide fumarate (TAF) and elvitegravir (EVG) in macaques under PrEP or post-exposure prophylaxis (PEP) modalities. PK studies were performed in 3 groups of pigtailed macaques receiving inserts with different fixed-dose combinations of TAF and EVG (10/8, 20/16 and 40/24mg). PrEP and PEP efficacy of a selected insert was investigated in a repeat exposure vaginal SHIV transmission model. Inserts were administered 4 h before (n=6) or after (n=6) repeated weekly SHIV exposures. Infection outcome was compared with macaques receiving placebo inserts (n=12). Dose ranging studies showed rapid and sustained high drug concentrations in vaginal fluids and tissues across insert formulations with minimal dose proportionality. TAF/EVG (20/16mg) inserts were selected for efficacy evaluation. Five of the 6 animals receiving these inserts 4 h before and 6/6 animals receiving inserts 4 h after SHIV exposure were protected after 13 challenges (p=0.0088 and 0.0077 compared to placebo, respectively). The calculated PrEP and PEP efficacy was 91.0% (95% CI=32.2%-98.8%) and 100% (95% CI=undefined), respectively. Inserts containing TAF/EVG provided high protection against vaginal SHIV infection when administered within a 4 h window before or after SHIV exposure. Our results support the clinical development of TAF/EVG inserts for on-demand PrEP and PEP in women. Funded by CDC intramural funds, an interagency agreement between CDC and USAID (USAID/CDC IAA AID-GH-T-15-00002), and by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID) under a Cooperative Agreement (AID-OAA-A-14-00010) with CONRAD/Eastern Virginia Medical School.

Preferences Across Pre-Exposure Prophylaxis Modalities Among Young Men Who Have Sex with Men in the United States: A Latent Class Analysis Study.

Access to daily oral pre-exposure prophylaxis (PrEP) is suboptimal among young cisgender men who have sex with men (YMSM) in the United States. Next-generation modalities that do not involve daily oral regimens may mitigate some of the barriers to PrEP use. We identified latent classes of YMSM based on health care decision-making patterns and examined associations between latent classes and access to health care and PrEP modality preferences (i.e., daily and event-driven oral, rectal douches, broadly neutralizing antibodies, subcutaneous implants, and an injectable). Between October 2020 and June 2021, we administered an online survey to 737 YMSM. Latent class analysis (LCA) identified groups of YMSM based on communication with providers, stigma and mistrust in health care, and autonomy in sexual health decisions. Logistic regression examined associations between class membership and health care access, and exploded logit regression examined associations between class membership and ranked PrEP modality preferences. LCA identified three classes: shared decision-making (high communication with providers and high autonomy); provider-led decision-making (high communication and low autonomy); and patient-driven decision-making (low communication and high autonomy). Shared decision-making was associated with higher access to health care in comparison with the other classes. Across all classes, YMSM preferred daily oral PrEP over all next-generation PrEP modalities. Preferences for daily oral PrEP over next-generation PrEP modalities were particularly marked among the patient-driven decision-making class. Shared decision-making is associated with access to health care and HIV prevention and higher acceptability of next-generation PrEP modalities, and should be considered as part of future interventions to promote use of daily oral and next-generation PrEP.

"How PrEPared are you?": Knowledge of and attitudes toward PrEP among overseas-born and newly arrived gay, bisexual, and other men who have sex with men in Australia.

IntroductionOverseas-born and newly arrived gay and bisexual men and men who have sex with men (GBMSM) are at higher risk of acquiring HIV in comparison to Australian-born GBMSM. Pre-exposure prophylaxis (PrEP) is subsidized by the Australian government under Medicare, Australia's universal health insurance scheme, however many members of this population are Medicare-ineligible, which could prevent them from accessing PrEP. We wanted to explore participants' knowledge of and attitudes toward PrEP and their opinions of new PrEP modalities, namely injectable PrEP and PrEP implants.MethodsWe conducted in-depth qualitative interviews between February 2021 to September 2021 with 22 overseas-born, newly arrived (<5 years in Australia) GBMSM of varying PrEP use. We asked their opinions of PrEP and their preferences of new PrEP modalities. Interviews were audio recorded and transcribed verbatim. We conducted a reflexive thematic analysis to interpret the data.ResultsParticipants' views reflect the intersections between systemic factors, such as Medicare ineligibility and the high cost of PrEP, with socio-cultural factors, such as lack of knowledge about PrEP, internalized stigma stemming from homo- and sex-negativity, and stigmatizing attitudes toward PrEP and PrEP users. For participants who were on PrEP, being community connected, having a positive relationship with doctors and nurses, and being informed of the option to purchase PrEP from overseas pharmacies at a low cost helped them to overcome some of these barriers. Additionally, there was a strong preference for injectable PrEP but not PrEP implants. Participants stressed the importance of providing a comprehensive information about PrEP specific to this population and to make PrEP free for all.ConclusionsWe concluded that resources about PrEP specific to this population that address both systemic and socio-cultural factors are needed, and for these resources to be available in languages other than English. This is to coincide with on-going advocacy to increase the capacity of publicly funded sexual health clinics to provide multilingual PrEP services for people without Medicare, and to make PrEP free for all. These combined strategies have the potential to increase PrEP knowledge and uptake among this population.

The predictive value of macaque models of preexposure prophylaxis for HIV prevention.

We review macaque models for preexposure prophylaxis (PrEP) for HIV prevention and highlight their role in advancing currently approved and novel PrEP agents. The development of the repeat low dose simian HIV (SHIV) challenge models represented a significant advancement in preclinical PrEP modeling that has allowed the investigation of PrEP under conditions that better mimic HIV exposures in humans. These models incorporate relevant drug pharmacology to inform drug correlates of PrEP protection. Models of rectal, vaginal, and penile infection are now available and have been found to predict clinical efficacy of all the currently approved PrEP strategies including daily oral PrEP with the combination of emtricitabine and tenofovir disoproxil fumarate or tenofovir alafenamide, and a long-acting formulation of the integrase inhibitor cabotegravir. These models are being used to test new PrEP modalities including the nucleoside reverse transcriptase-translocation inhibitor islatravir and long-acting capsid inhibitors. The SHIV models have also been supplemented by sexually transmitted infection co-infections with Chlamydia trachomatis, Treponema pallidum or Trichomonas vaginalis to assess the impact of inflammation on PrEP efficacy. Clinical efficacy validated current PrEP macaque models supporting their continued use to advance novel PrEP agents to improve global PrEP coverage.

Long-Acting Injectable Human Immunodeficiency Virus Pre-Exposure Prophylaxis Preferred Over Other Modalities Among People Who Inject Drugs: Findings from a Qualitative Study in California.

People who inject drugs (PWID) have extraordinarily low uptake of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) despite high levels of need. Long-acting PrEP modalities hold promise for HIV prevention among PWID, but product preferences remain poorly understood. From September to November 2021, we conducted qualitative interviews with 28 HIV-negative, adult (≥18 years) PWID in San Diego County, CA, to explore their perspectives on daily oral PrEP pills and long-acting PrEP modalities (i.e., injections, implants, intravaginal rings, and broadly neutralizing antibodies), which we explained using standard scripts. Thematic analysis identified variations in PrEP modality interest and acceptability. We identified three key factors across the 28 interviews that appeared to influence PrEP modality preferences: perceived convenience of use, invasiveness, and familiarity (based on past experience). Overall, most participants preferred injectable PrEP over other modalities because they viewed injectable medications as convenient, noninvasive, and familiar. While injectable PrEP was recently approved for use in the United States and was most the acceptable PrEP modality in this sample, our findings suggest that intervention and implementation research is urgently needed to improve our understanding of strategies that could support access, uptake, and sustained adherence to longer-acting PrEP for PWID.

Clinic-Level Strategies for Mitigating Structural and Interpersonal HIV Pre-Exposure Prophylaxis Stigma.

Uptake of and persistence on pre-exposure prophylaxis (PrEP) in the United States have been limited. The potential of new PrEP modalities to increase access will be hindered if underlying structural and interpersonal barriers-including, insurance coverage, initiation and maintenance clinical protocols, provider bias, stigma, and lack of trust in health care-are not adequately addressed. We conducted in-person and telephone-based recorded interviews with 32 US-based clinical and nonclinical PrEP providers spanning the PrEP implementation continuum (clinicians, counselors, and support staff). Providers were recruited at biomedical HIV prevention conferences and networks to explore barriers to and strategies for PrEP implementation. Providers provided care to clients spanning adolescents to adulthood and a variety of genders across all geographic regions of the United States. To directly mitigate stigma, providers called for clinic-level interventions to normalize and universalize PrEP education and services, counseling and other services that center patients' lived experiences and circumstance, staffing and community engagement models that value patients, and implementation of specific programs and processes that facilitate access to services. To address disparities in access, PrEP implementation should acknowledge the interconnectedness of stigma and structural barriers to care.