Pre-exposure Prophylaxis Products Research Articles

The Global Impact of Diversifying PrEP Options: Results of an International Discrete Choice Experiment of Existing and Potential PrEP Strategies with Gay and Bisexual Men and Physicians.

To improve current and future use of existing (oral, injectable) and potential future (implants, douches) pre-exposure prophylaxis (PrEP) products, we must understand product preferences relative to one another, among gay and bisexual men (GBM), and physicians who prescribe PrEP. We completed an online discrete choice experiment (DCE) with separate groups of GBM and/or physicians from the United States, South Africa, Spain, and Thailand. Participants were presented information on PrEP products, including daily pills, event-driven pills (2-1-1 regimen), injections, subdermal implants (dissolvable, removable), and rectal douches. Next, they completed a choice exercise in which they were shown 10 screens, each presenting 3 of the aforementioned products at a time with 11 attributes for physicians and 10 attributes for GBM. For the attributes that were not constant, one level was shown per screen for each product. Participants selected the product they preferred most and rated their likelihood to select (GBM) or recommend (physicians) that product. Data were modeled using hierarchical Bayes estimation; resulting model coefficients were used to develop attribute importance measures and product preferences. For GBM across all countries, if all aforementioned PrEP products were on the market at the same time, over 90% of GBM would use some form of PrEP; 100% of physicians would recommend at least one of the PrEP products. There were variations in product preference by country. GBM in the United States and Thailand preferred the injection (21.7%, 22.9%, respectively), while the dissolvable implant was preferred in South Africa and Spain (19.9%, 19.8%, respectively). In the United States, South Africa, and Spain (where physician data were available), physicians were most likely to recommend the dissolvable implant (37.2%, 40.6%, 38.3%, respectively).

Exploring linkages: addressing the relationship between the climate crisis and HIV prevention with recommendations for emerging pre-exposure prophylaxis programs.

Short- and long-term impacts of the climate crisis continue to be felt across the public health landscape. Many individuals marginalized by the climate crisis also navigate a higher likelihood of exposure to HIV. By understanding this relationship, we can better position HIV prevention, and pre-exposure prophylaxis (PrEP) programs specifically, to meet user needs in communities experiencing the effects of the climate crisis. In support, we propose four recommendations for mitigating the impact of the climate crisis on those who may benefit from PrEP: (1) leverage existing and emerging research and lived experience to intentionally target and appropriately reach individuals affected by the climate crisis who may need or want PrEP; (2) emphasize the need for more climate-resilient PrEP products within the research and development pipeline; (3) build a continued understanding of the role of the climate crisis-HIV relationship in product introduction through national collaboration; and (4) strengthen the integration of PrEP service delivery and response to intimate partner violence. The PrEP market is set for rapid expansion with the introduction of new prevention methods to enable choice. To be comprehensively responsive to potential PrEP users, we must consider and address how the climate crisis changes not only the environmental landscape, but the prevention ecosystem.

Qualitative focus group discussions exploring PrEP method and service delivery preferences among female sex workers and their managers in four Zambian provinces

ObjectivesTo describe the experiences of oral HIV pre-exposure prophylaxis (PrEP) use, preferences comparing oral PrEP to future long-acting PrEP products (the dapivirine vaginal ring (PrEP ring) and injectable cabotegravir (CAB...

Likelihood-based inferences for active-arm trial with counterfactual incidence based on recency assay

Abstract Objectives The approach of using HIV recency assay to estimate the counterfactual incidence rate is being used as the primary efficacy method in a few ongoing large-scale HIV pre-exposure prophylaxis (PrEP) trials, and the current available approach for the inference is based on the Wald method that leverages the asymptotic distribution of the estimators. One issue with the Wald test is that it does not work well when the number of HIV infections are small in the active arm, and it fails to work when there are zero HIV infections. As future long-acting PrEP products are becoming more efficacious, it is very likely that a small or zero number of infections will be observed in HIV prevention trials, especially for subgroup analyses or interim analyses, hence there is a pressing need to develop inference methods that work under such scenarios. Methods It is well known that when the sample size is small to moderate, likelihood ratio tests are more reliable than Wald tests in terms of actual error probabilities coming close to matching nominal levels. In this manuscript we derive the likelihood ratio test and the likelihood-based confidence intervals for HIV prevention trials based on recency assays. Results Compared with the Wald test, the proposed method works when there are zero infections. Additionally, unlike the Wald test, the p-value from the likelihood ratio test is an increasing function with respect to the number of infections, which is a desirable property as otherwise it will cause confusions. Conclusions For HIV PrEP trials based on recency assay, the likelihood-based p-value and confidence interval can be preferable to the Wald based inference methods when the number of HIV infections is expected to be small.

Creating allies: qualitative exploration of young women’s preferences for PrEP methods and parents’ role in PrEP uptake and user support in urban and rural Zambia

BackgroundZambian adolescent girls and young women (AGYW) have high HIV incidence and face barriers to the use of pre-exposure prophylaxis (PrEP). Parental support improves PrEP use and adherence in some settings, but negative parental attitudes toward HIV prevention may inhibit engagement with AGYW. We explored perceptions of future PrEP methods among AGYW and parents and parent-youth engagement on HIV prevention and PrEP use.MethodsWe conducted a qualitative descriptive study among AGYW and parents of AGYW in five provinces in Zambia in September–October 2021. We conducted 10 focus group discussions (FGDs) and four in-depth interviews (IDIs) with AGYW participants (n = 87) and seven FGDs and four IDIs among parents of AGYW (n = 62). All FGDs and IDIs were audio-recorded, transcribed verbatim, and analyzed to identify qualitative themes.ResultsMost AGYW participants preferred the discreet nature and longer duration of injectable PrEP compared to the PrEP ring and oral PrEP. Many AGYWs reported inability to disclose PrEP use to their parents due to lack of parental support based on cultural taboos against premarital sex. Nevertheless, AGYW participants said they would like to talk to their parents about PrEP so their parents could support their use. Many parents also described difficulties discussing PrEP with their daughters because of cultural and religious beliefs about abstinence from sex before marriage. However, parents acknowledged that the threat of HIV is real and said they need PrEP knowledge and guidance on speaking with their children about HIV prevention and PrEP.ConclusionsAlthough many parents are currently not playing a role in daughters’ decisions about PrEP use, both parents and AGYW are willing to engage with each other on HIV prevention issues. To foster parent-child engagement, HIV prevention programs should not only provide information about PrEP but also address social norms that impede discussion of HIV prevention and equip both parents and AGYW with skills and support for such conversations. Community sensitization is also needed as new PrEP products are introduced, to create an enabling environment for parent-child engagement by increasing awareness, countering misconceptions, and reducing stigma.

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 estimates of oral pre-exposure prophylaxis for HIV prevention in cisgender women with partial adherence.

Pre-exposure prophylaxis (PrEP) with tenofovir (TFV) disoproxil fumarate and emtricitabine administered orally daily is effective in preventing human immunodeficiency virus (HIV) acquisition in both men and women with sufficient adherence; however, the adherence-efficacy relationship in cisgender women has not been well established. We calculated the adherence-efficacy curve for cisgender women by using HIV incidence and plasma TFV concentration data from three trials (FEM-PrEP, VOICE and Partners PrEP). We imputed TFV diphosphate (TFV-DP) concentrations, a measure of long-term adherence, from TFV quantification by using data from the HIV Prevention Trials Network 082 study, which measured both TFV-DP and TFV concentrations. Two, four and seven pills per week reduced HIV incidence by 59.3% (95% credible interval (CrI) 29.9-95.8%), 83.8% (95% CI 51.7-99.8%) and 95.9% (95% CI 72.6-100%), respectively. Our adherence-efficacy curve can be validated and updated by HIV prevention studies that directly measure TFV-DP concentrations. The curve suggests that high adherence confers high protection in cisgender women. However, the lower efficacy with partial adherence highlights the need for new PrEP products and interventions to increase adherence.

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 Future of Pre-Exposure Prophylaxis (PrEP) for HIV Prevention: A Global Qualitative Consultation on Provider Perspectives on New Products and Differentiated Service Delivery

Differentiated service delivery and new products, such as long-acting injectable cabotegravir (CAB-LA) and the dapivirine vaginal ring (DVR), could increase uptake and use of pre-exposure prophylaxis (PrEP) for HIV prevention. We explored PrEP provider perspectives on differentiated PrEP service delivery and new PrEP products to inform World Health Organization (WHO) guidelines and programme implementation. 150 PrEP providers who participated in a WHO survey were randomly selected and 67 were invited for interviews based on geographic representation, provider cadre, gender, experience with community-based PrEP service delivery, and familiarity with new PrEP products. Semi-structured interviews were conducted virtually. Key themes were inductively extracted relating to differentiated service delivery and benefits and concerns regarding new PrEP products. 30 PrEP providers from 24 countries were interviewed. Across regions, providers were supportive of differentiated service delivery to respond to clients’ needs and preferences, maintain services during COVID-19, and ensure access for priority populations that may face access challenges. Providers welcomed prospects of offering CAB-LA to their clients but had concerns about HIV testing, costs, and the need for clinic-based services, including staff who can administer injections. Providers felt the DVR was potentially important for some cisgender women, especially young clients and female sex workers, and raised fewer concerns compared to injectable PrEP. Providers’ views are critical for the development of guidelines and implementing programmes that will best serve PrEP users. Understanding areas where provider capacities and biases may create barriers can define opportunities for training and support to ensure that providers can deliver effective programmes.

A topical rectal douche product containing Q-Griffithsin does not disrupt the epithelial border or alter CD4+ cell distribution in the human rectal mucosa

To reduce HIV transmission, locally applied pre-exposure prophylaxis (PrEP) products for anorectal use will be important complements to oral and injectable PrEP products already available. It is critical to preserve an intact rectal epithelium and avoid an influx of mucosal HIV target cells with such product use. In this phase 1 clinical trial, we evaluated application of a topical rectal douche product containing Q-Griffithsin (Q-GRFT). Colorectal tissue samples were obtained via sigmoidoscopy at baseline, 1 and 24 h after single-dose exposure in 15 healthy volunteers. In situ staining for epithelial junction markers and CD4+ cells were assessed as an exploratory endpoint. A high-throughput, digitalized in situ imaging analysis workflow was developed to visualize and quantify these HIV susceptibility markers. We observed no significant differences in epithelial distribution of E-cadherin, desmocollin-2, occludin, claudin-1, or zonula occludens-1 when comparing the three timepoints or Q-GRFT versus placebo. There were also no differences in %CD4+ cells within the epithelium or lamina propria in any of these comparisons. In conclusion, the rectal epithelium and CD4+ cell distribution remained unchanged following topical application of Q-GRFT. In situ visualization of HIV susceptibility markers at mucosal sites could be useful to complement standard product safety assessments.

Brief Report: Refusal of Daily Oral PrEP: Implementation Considerations and Reported Likelihood of Using Various HIV Prophylaxis Products in a Diverse Sample of MSM.

An important subgroup of gay, bisexual, and other men who have sex with men (MSM) with behavioral indications refuse daily oral pre-exposure prophylaxis (PrEP) when recommended by a provider. Emerging HIV prophylaxis products (eg, injectable, event-driven) offer more options to MSM who refuse daily PrEP. In this article, we assess reasons for refusal and likelihood to use various products among MSM who refused PrEP. MSM who reported anal sex without condoms or PrEP and refused daily oral PrEP in the past 6 months were recruited through clinics, community venues, and online in Atlanta, Chicago, and Raleigh-Durham. Men were asked their main reason for recently refusing daily PrEP and likelihood of using various PrEP options in the future. Bivariate and multivariable regression models were used to estimate associations. MSM (n = 93; 70% Black, 48% age 18-29 years) reported their main reason for refusing daily PrEP were potential side effects (35%), a daily pill regimen (22%), and not having enough information (18%). Reported likelihood of using PrEP products was 58% for penile gel, 54% for event-driven oral, 52% for injectable, and 50% for daily PrEP. MSM who reported daily regimen as the main reason for refusing PrEP had greater odds of likelihood to use an injectable [adjusted odds ratio (AOR) = 5.21, 95% confidence interval (CI): 1.32 to 20.52]. Younger men (18-29 vs 30+ years) had greater odds of likelihood to use condoms (AOR = 3.40, 95% CI: 1.15 to 10.04) and daily PrEP (AOR = 2.76, 95% CI: 1.06 to 7.16); there were no product preference differences by race. Most men who refused daily PrEP indicated likelihood of using some form of PrEP in the future.

Interrogating the promise of long-acting HIV pre-exposure prophylaxis.

Oral HIV pre-exposure prophylaxis (PrEP) is a well-established product that provides a safe and highly effective way for individuals to protect themselves against HIV infection. However, hopes of a significant reduction in HIV incidence have been disappointing because of low uptake, adherence challenges to a daily pill regimen, and consistently high discontinuation rates within 6 months of initiation. Long-acting agents have been long awaited for their potential to facilitate adherence and to offer a choice between PrEP products. As the first long-acting agents enter the market, with more poised to follow, questions around how to integrate long-acting agents into oral PrEP platforms, and what the potential advantages and pitfalls of this integration will be, now need to be considered.

Facilitating Next-Generation Pre-Exposure Prophylaxis Clinical Trials Using HIV Recent Infection Assays: A Consensus Statement from the Forum HIV Prevention Trial Design Project.

Standard-of-care HIV pre-exposure prophylaxis (PrEP) is highly efficacious, but uptake of and persistence on a daily oral pill is low in many settings. Evaluation of alternate PrEP products will require innovation to avoid the unpractically large sample sizes in noninferiority trials. We propose estimating HIV incidence in people not on PrEP as an external counterfactual to which on-PrEP incidence in trial subjects can be compared. HIV recent infection testing algorithms (RITAs), such as the limiting antigen avidity assay plus viral load used on specimens from untreated HIV positive people identified during screening, is one possible approach. Its feasibility is partly dependent on the sample size needed to ensure adequate power, which is impacted by RITA performance, the number of recent infections identified, the expected efficacy of the intervention, and other factors. Screening sample sizes to support detection of an 80% reduction in incidence for 3 key populations are more modest, and comparable to the number of participants in recent phase III PrEP trials. Sample sizes would be significantly larger in populations with lower incidence, where the false recency rate is higher or if PrEP efficacy is expected to be lower. Our proposed counterfactual approach appears to be feasible, offers high statistical power, and is nearly contemporaneous with the on-PrEP population. It will be important to monitor the performance of this approach during new product development for HIV prevention. If successful, it could be a model for preventive HIV vaccines and prevention of other infectious diseases.

2080. Differences in Hormonal Measures Among Transgender Individuals Assigned Male at Birth Switching from Tenofovir Disoproxil Fumarate/Emtricitabine to Tenofovir Alafenamide/Emtricitabine for Pre-Exposure Prophylaxis

Abstract Background There are concerns among transgender (TG) individuals about the effect of changing pre-exposure prophylaxis (PrEP) products on hormone concentrations. The objective of this study was to compare hormone concentrations among TG individuals assigned male at birth (AMAB) who switched from tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) to tenofovir alafenamide/emtricitabine (TAF/FTC) for PrEP. Methods An observational cohort study was performed among a subset of TG individuals AMAB enrolled in a clinical trial evaluating TAF/FTC for PrEP. Inclusion criteria for this study were ≥18 years old, TG identity, HIV negative, use of both TDF/FTC and TAF/FTC for ≥12 weeks, and availability of stored blood samples for hormone measurement while on both medications. Estradiol, testosterone (total and free) and sex hormone binding globulin were quantified at two time points: once while on ≥12 weeks of TDF/FTC and after ≥12 weeks on F/TAF. Median hormone concentrations were compared using related-samples Wilcoxon Signed Rank Test. Results Thirty participants met inclusion criteria with mean age of 35.9 ± standard deviation 9.7 years. There were 20 (67%) participants who identified as TG female. The remaining identified as gender non-conforming. Most participants self-identified as either Caucasian (40%), Hispanic or Latino/a/x (33%), Black (13.3%) or Asian (13.3%). Gender affirming therapy was used by 20 (67%) participants. The median (interquartile range, IQR) duration of TDF/FTC use before switching to TAF/FTC was 48 (15 – 60) weeks. Hormone values during TDF/FTC and TAF/FTC by use of gender affirming therapy is displayed in the Figure. Hormonal Values Before and After Switching PrEP Products, by Use of Gender Affirming Therapy Conclusion Switching to TAF-based PrEP was not associated with significant changes in hormone values among TG individuals AMAB. Disclosures Nimish Patel, PharmD, PhD, Gilead: Grant/Research Support Jill Blumenthal, MD, Gilead: Grant/Research Support Sheldon Morris, MD, Gilead: Grant/Research Support.

End-user research in support of long-acting systemic antiretroviral delivery systems: insights from qualitative research with providers and target users in South Africa

While oral pre-exposure prophylaxis (PrEP) has been shown to reduce the risk of HIV, challenges such as adhering to a daily-dosing regimen and persistence have emerged as barriers for at-risks populations in South Africa. This qualitative research sought to investigate perceptions of and preferences for a long-acting, biodegradable implantable PrEP product designed to address these barriers. To identify and understand motivators, barriers, and preferences for the PrEP implant, we conducted qualitative in-depth interviews (IDIs) among health care providers (HCPs) and target end-users (young women, adolescent girls, and female sex workers) in urban and rural/peri-urban regions of Gauteng Province, South Africa. The IDIs focused on defining values, beliefs, habits, lifestyles, influencers, and information channels for potential PrEP implant end-users. We conducted 36 IDIs across health care providers and target end-user respondent segments. Respondents had generally positive reactions to the PrEP implant. Most end-users felt that some undesirable aspects of the implant (e.g., side effects, pain during insertion, potential scarring, and inability to removeimplant) would be offset by having a highly effective, and long-lasting HIV prevention product. Although some HCPs believed the implantable PrEP would lead to increases in promiscuity and risky sexual behavior, most HCPs saw value in the PrEP implant's long duration of protection, its biodegradability, and the likelihood of higher adherence relative to oral PrEP. This study is a first step toward further research needed to demonstrate the demand for a biodegradable, long-acting implantable PrEP and suggests such a product would be accepted by end-users and HCPs in South Africa. This study indicates the need to develop more convenient, discreet, long-acting, and highly effective biomedical HIV prevention options for at-risk populations.

Preferences Among Physicians and Men Who Have Sex with Men (MSM) for a Long-Acting, Removable Implant for HIV Prevention: A Discrete Choice Study.

A longer acting, removable implant for HIV prevention has the potential to improve uptake of HIV pre-exposure prophylaxis (PrEP) by removing the need for daily adherence to an oral tablet, reducing potential side effects, and eliminating concerns about residual drug following injections. To end the HIV epidemic, we must understand the needs and preferences of groups most affected by HIV (e.g., men who have sex with men; MSM), and the physicians who prescribe PrEP to them. This article describes a discrete choice experiment to estimate the preference share for the implant within a competitive context of other PrEP products (including the oral tablet, dissolvable implant, and injection) and evaluate the impact of potential implant attributes. Physicians who had prescribed oral PrEP (n = 75) and MSM at risk for HIV (n = 175) completed a web-based survey that prompted decision-making about PrEP product preferences. The findings from both physicians and MSM demonstrated that the removable implant could capture a meaningful portion of the preference share, making it feasible to advance in the development pipeline as an important addition to the biomedical HIV prevention toolkit. Among MSM, specifically, the cost of treatment was the most important attribute impacting product preference. Our findings inform implant developers and future payers (e.g., commercial manufacturers, insurance companies) about specific device attributes that will likely affect MSM's willingness to use and physicians' willingness to prescribe this HIV prevention strategy.

Preferences for pre-exposure prophylaxis for HIV: A systematic review of discrete choice experiments.

SummaryBackgroundWe aimed to systematically review the health preference literature using discrete choice experiments (DCEs), an attribute-based stated preference method, to investigate patient preferences for HIV pre-exposure prophylaxis (PrEP).MethodsA search in PubMed, Scopus, CINAHL, and Embase was conducted on July 1, 2021, and updated on November 3, 2021. We used two concepts to create our search strategy: (1) discrete choice experiments/conjoint analysis/best-worst scaling, and (2) HIV PrEP.The study is registered in PROSPERO (CRD42021267026).FindingsIn total, 1060 studies were identified, and 18 were included in the analysis. Various attributes were examined, including dosing regimen, type of PrEP products, side effects, other side benefits, cost, effectiveness, dispensing venue, and additional support services. Dosing frequency, cost, the effectiveness of PrEP, dispensing venue, and side effects were the most common attributes examined in DCEs. Despite significant heterogeneity in preferences across subpopulations, overall, the most important attributes were cost (28%, 5/18), effectiveness (28%, 5/18) followed by dosing frequency (17%, 3/18).InterpretationNotably, in studies where all of these three attributes were examined, some individuals would trade effectiveness for cost or vice versa. Ensuring PrEP is low cost or free, widely disseminating information of its effectiveness and advancements in reducing dosing frequency could accelerate the uptake of PrEP for those who would benefit from PrEP the most.FundingNone.

Long-acting injectable cabotegravir: implementation science needed to advance this additional HIV prevention choice.

Long-acting injectable cabotegravir: implementation science needed to advance this additional HIV prevention choice.

HIV Pre-exposure Prophylaxis Implant Stated Preferences and Priorities: Results of a Discrete Choice Experiment Among Women and Adolescent Girls in Gauteng Province, South Africa

For adolescent girls (AG) and young women (YW), adherence barriers may limit the effectiveness of daily oral HIV pre-exposure prophylaxis (PrEP). Due to its low-burden and long-lasting product attributes, PrEP implants could remove some of the critical adherence barriers of oral PrEP products for individuals at risk of HIV. To explore stated preferences for a long-acting PrEP implant, we conducted a quantitative survey and discrete choice experiment with AG (ages 15–17), YW (18–34), and female sex workers (FSW; ≥ 18) in Gauteng Province, South Africa. We completed 600 quantitative surveys across the three subgroups of women. Respondents stated preference for an implant that provided longer HIV protection (24 months versus 6 months) and required a single insertion. They stated that they preferred a biodegradable implant that could be removed within 1 month of insertion. Respondents had no preference for a particular insertion location. Overall, 78% of respondents said they would be likely (33%) or very likely (45%) to use a PrEP implant were one available, with the majority (82%) stating preference for a product that would provide dual protection against HIV and unintended pregnancies. To reduce their risk of HIV, AG, YW, and FSW in our survey reported a strong willingness to use long-acting, highly-effective, dissolvable PrEP implants.

PrEParing for NextGen: Cognitive Interviews to Improve Next Generation PrEP Modality Descriptions for Young Men Who have Sex with Men.

Next generation PrEP formulations may circumvent factors that impede daily oral pre-exposure prophylaxis (PrEP) use among young men who have sex with men (YMSM). We conducted video-based cognitive interviews with 20 YMSM (age 16-24) recruited in the US Northeast to assess participants' attitudes and comprehension of written descriptions of next generation PrEP modalities. Participants were predominately racial/ethnic minorities and half used daily oral PrEP. We identified four main areas for improvement of descriptions: defining scientific terms and balancing medical jargon and casual language; referencing more established products to contextualize PrEP formulations (e.g., hormonal implants); ensuring clarity and reducing redundancy; and including imagery (e.g., rectal douche applicator). The refined descriptions serve as exemplar text that may be used in future studies examining YMSM's preferences across next generation PrEP modalities. Accurate descriptions of next generation PrEP products strengthen measurement accuracy and can help roll-out products that become approved for clinical use.