A Phase 1 Clinical Trial to Assess the Safety and Pharmacokinetics of a Tenofovir Alafenamide/Elvitegravir Insert Administered Rectally for HIV Prevention.

BACKGROUND: On-demand topical products could be an important tool for human immunodeficiency virus (HIV) prevention. We evaluated the safety, pharmacokinetics, and ex vivo pharmacodynamics of a tenofovir alafenamide/elvitegravir (TAF/EVG, 20 mg/16 mg) insert administered rectally. METHODS: MTN-039 was a phase 1, open-label, single-arm, 2-dose study. Blood, rectal fluid, and rectal tissue were collected over 72 hours following rectal administration of 1 and 2 TAF/EVG inserts for each participant. RESULTS: TAF/EVG inserts were safe and well tolerated. EVG and tenofovir (TFV) were detected in blood plasma at low concentrations: median peak concentrations after 2 inserts were EVG 2.4 ng/mL and TFV 4.4 ng/mL. Rectal tissue EVG peaked at 2 hours (median, 2 inserts = 9 ng/mg) but declined to below limit of quantification in the majority of samples at 24 hours, whereas tenofovir diphosphate (TFV-DP) remained high >2000 fmol/million cells for 72 hours with 2 inserts. Compared to baseline, median cumulative log10 HIV p24 antigen of ex vivo rectal tissue HIV infection was reduced at each time point for both 1 and 2 inserts (P < .065 and P < .039, respectively). DISCUSSION: Rectal administration of TAF/EVG inserts achieved high rectal tissue concentrations of EVG and TFV-DP with low systemic drug exposure and demonstrable ex vivo inhibition of HIV infection for 72 hours. Clinical Trials Registration . NCT04047420.

Projecting the Potential Clinical and Economic Impact of Human Immunodeficiency Virus Prevention Resource Reallocation in Tennessee.

BACKGROUND: In 2023, Tennessee replaced $6.2 M in US Centers for Disease Control and Prevention (CDC) human immunodeficiency virus (HIV) prevention funding with state funds to redirect support away from men who have sex with men (MSM), transgender women (TGW), and heterosexual Black women (HSBW) and to prioritize instead first responders (FR), pregnant people (PP), and survivors of sex trafficking (SST). METHODS: We used a simulation model of HIV disease to compare the clinical impact of Current, the present allocation of condoms, preexposure prophylaxis (PrEP), and HIV testing to CDC priority risk groups (MSM/TGW/HSBW); with Reallocation, funding instead increased HIV testing and linkage of Tennessee-determined priority populations (FR/PP/SST). Key model inputs included baseline condom use (45%-49%), PrEP provision (0.1%-8%), HIV testing frequency (every 2.5-4.8 years), and 30-day HIV care linkage (57%-65%). We assumed Reallocation would reduce condom use (-4%), PrEP provision (-26%), and HIV testing (-47%) in MSM/TGW/HSBW, whereas it would increase HIV testing among FR (+47%) and HIV care linkage (to 100%/90%) among PP/SST. RESULTS: Reallocation would lead to 166 additional HIV transmissions, 190 additional deaths, and 843 life-years lost over 10 years. HIV testing reductions were most influential in sensitivity analysis; even a 24% reduction would result in 287 more deaths compared to Current. With pessimistic assumptions, we projected 1359 additional HIV transmissions, 712 additional deaths, and 2778 life-years lost over 10 years. CONCLUSIONS: Redirecting HIV prevention funding in Tennessee would greatly harm CDC priority populations while conferring minimal benefits to new priority populations.

Global HIV Incidence Analysis and Implications for Affordability Using Long-Acting Cabotegravir Versus Continuous and Event-Driven Oral Preexposure Prophylaxis.

BACKGROUND: The HIV Prevention Trials Network (HPTN) 083/084 trials showed up to 88% increased efficacy of long-acting cabotegravir (CAB-LA) versus continuous oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). However, CAB-LA's high price limits the number of people who can be treated within fixed prevention budgets. Global human immunodeficiency virus (HIV) prevention budgets are highly limited, with TDF/FTC widely available as a low-cost generic. In randomized clinical trials, event-driven TDF/FTC has shown similar preventive efficacy to continuous TDF/FTC. METHODS: A systematic review of global HIV incidence studies was conducted. Weighted incidence was calculated in each at-risk population. HIV infection rates were evaluated for 5 prevention strategies, with additional HIV testing, education, and service access costs assumed for each ($18 per person per year). Assumed efficacies were 90% (continuous CAB-LA), 60% (continuous TDF/FTC), and 60% (event-driven TDF/FTC). Using weighted incidence and an assumed 100 000 target population, annual HIV infection rates by population were calculated for each prevention strategy. RESULTS: Ninety-eight studies in 5 230 189 individuals were included. Incidence per 100 person-years ranged from 0.03 (blood donors) to 3.82 (people who inject drugs). Using the number needed to treat to benefit for each strategy, a mean incidence of 2.6 per 100 person-years in at-risk populations, and a 100 000 target population, current-price continuous CAB-LA cost $949 487 per HIV infection successfully prevented, followed by target-price CAB-LA ($11 453), continuous TDF/FTC ($4231), and event-driven TDF/FTC ($1923). CONCLUSIONS: High prices of CAB-LA limit numbers treatable within fixed budgets. Low-cost event-driven TDF/FTC consistently prevents the most HIV infections within fixed budgets.

Preferential Initiation of Long-Acting Injectable Versus Oral HIV Pre-Exposure Prophylaxis Among Women Who Inject Drugs.

Fifty-five of 62 women who inject drugs (WWID) selected long-acting cabotegravir (CAB-LA) over oral PrEP, and 51/55 received a first injection. More recent injection drug use and number of sexual partners were associated with selecting CAB-LA (P < .05). Findings provide preliminary evidence of a strong preference for longer-acting products among WWID.

Cascade analysis of awareness, willingness, uptake and adherence with regard to PrEP among young men who have sex with men (YMSM) in China: A comparison between students and non-students.

INTRODUCTION: In China, young men who have sex with men (YMSM) are one of the groups most at risk of HIV/AIDS. The uptake of pre-exposure prophylaxis (PrEP) among YMSM has not been well documented. A cascade analysis of awareness, willingness, use and adherence with regard to PrEP was conducted separately among YMSM students and non-students. METHODS: From 20 October to 30 December 2021, all adolescents aged 16-24 years were selected for the study from among MSM recruited from 31 provincial administrative regions in mainland China. Participants were included in a cross-sectional study of awareness, willingness, use and adherence with regard to PrEP among YMSM. Logistic regression modelling was used to identify factors associated with the four outcomes. RESULTS: Among 1014 student and 866 non-student YMSMs, respectively, 88.07% and 81.64% had heard of PrEP; 58.16% and 50.35% were willing to use PrEP; 7.59% and 7.62% had used PrEP; and 3.16% and 3.58% had adhered to PrEP. Among students, those living in high-risk areas and pilot cities and those who had engaged in commercial sex and group sex had a positive effect on PrEP use, and the same trends were found among non-students living in high-risk areas and pilot cities and those who had engaged in group sex. 'Daily oral' and 'flexible' PrEP use positively influenced adherence among both groups. CONCLUSIONS: A differentiation strategy of PrEP promotion should be implemented among YMSM. Material support for students, such as financial resources, should increase, while non-students should increase their level of perception of HIV risk.

Sexually transmitted and blood-borne infection risk reduction with methadone and buprenorphine/naloxone among people with prescription-type opioid use disorder: Findings from a Canadian pragmatic randomized trial.

INTRODUCTION: People who use drugs are disproportionally affected by sexually transmitted and blood-borne infections (STBBIs). While the benefits of methadone in reducing injecting-risk behaviours are well documented, less is known on its impacts on sexual-related risks, as well as its comparative effectiveness to buprenorphine/naloxone, particularly in the context of highly potent opioids. The aim of this study was to estimate the relative effects of buprenorphine/naloxone and methadone on injecting and STBBI risks among people with prescription-type opioid use disorder (POUD). METHODS: Secondary analysis of a pan-Canadian pragmatic 24-week randomized clinical trial comparing methadone and buprenorphine/naloxone models of care among 272 people with POUD (including licit or illicit opioid analgesics, fentanyl). The Risk Behaviour Survey was used to collect injecting and sexual risks at baseline, and weeks 12 and 24. RESULTS: In total, 210 participants initiated treatment (103 buprenorphine/naloxone and 107 methadone). At baseline, 113/205 (55.1%) participants reported recently injecting drugs, 37/209 (17.7%) unsafe injection practices and 67/162 (41.4%) high-risk sex. Both methadone and buprenorphine/naloxone were associated with reductions in the prevalence of injection drug use and high-risk sex at weeks 12 and 24 with no interactions between treatment arm and time. CONCLUSION: Methadone and buprenorphine/naloxone were similarly effective in reducing injecting and sexual risk behaviours among people with POUD. CLINICAL TRIALS REGISTRATION: clinicaltrials.gov NCT03033732.

"PrEPping" women's healthcare providers: motivational interviewing to support ending the HIV epidemic.

In 2018, cisgender women accounted for nearly 20% of new HIV infections, with women of color disproportionately affected. HIV pre-exposure prophylaxis uptake, adherence, and persistence are paramount to ending the HIV epidemic, but current strategies to promote it have not improved uptake among women. Alternatively, pre-exposure prophylaxis marketing and implementation have traditionally targeted men who have sex with men and transwomen. Women feel most comfortable turning to their primary care and reproductive health providers for HIV and pre-exposure prophylaxis counseling, but prescribing is the lowest among these providers. Thus, reframing pre-exposure prophylaxis counseling and education strategies is crucial to better engage providers and patients. Motivational interviewing is a person-centered counseling style for eliciting behavior change. Providers use 4 core skills-open-ended questions, affirmation, reflective listening, and summarizing-to empower individuals for behavior change, such as pre-exposure prophylaxis use. Motivational interviewing is brief, individualized, and effective in increasing pre-exposure prophylaxis uptake, regardless of patients' readiness to change. Primary care and reproductive health providers can employ motivational interviewing approaches with pre-exposure prophylaxis counseling to increase uptake among cisgender women and end the HIV epidemic.

Leveling Up PrEP: Implementation Strategies at System and Structural Levels to Expand PrEP Use in the United States.

PURPOSE OF REVIEW: Despite highly effective biomedical HIV pre-exposure prophylaxis (PrEP) options, suboptimal PrEP uptake impedes progress towards ending the epidemic in the United States of America (USA). Implementation science bridges what we know works in controlled clinical trial settings to the context and environment in which efficacious tools are intended to be deployed. In this review, we focus on strategies that target PrEP use barriers at the system or structural level, exploring the implications and opportunities in the context of the fragmented USA healthcare system. RECENT FINDINGS: Task shifting could increase PrEP prescribers, but effectiveness evidence is scarce in the USA, and generally focused in urban settings. Integration of PrEP within existing healthcare infrastructure concentrates related resources, but demonstration projects rarely present the resource implications of redirecting staff. Changing the site of service via expanded telehealth could improve access to more rural populations, though internet connectivity, technology access, and challenges associated with determining biomedical eligibility remain logistical barriers for some of the highest burden communities in the USA. Finally, a tailored care navigation and coordination approach has emerged as a highly effective component of PrEP service provision, attempting to directly modify the system-level determinants of PrEP use experienced by the individual. We highlight recent advances and evidence surrounding task shifting, integration, service delivery, and tailoring. With the exception of tailored care navigation, evidence is mixed, and the downstream impact and sustainability of task shifting and care integration require further attention. To maximize PrEP outcomes, research will need to continue to examine the interplay between individuals, clinics, and the healthcare system and associated policies within which they operate.

PrEP Method Switching: Will it Yield Greater Coverage of HIV Protection? Applying Lessons Learned from Family Planning to Guide Future Research in the Context of PrEP Choice.

PURPOSE OF REVIEW: Despite the growing availability of oral PrEP, coverage remains suboptimal. Through the introduction of additional PrEP methods, including vaginal rings and long-acting injectable formulations, health systems globally are on the cusp of offering PrEP methods that vary by route of administration, efficacy, and frequency of use. With PrEP choice, it will be important to explore PrEP use patterns to better understand how the ability to choose and switch products affects coverage and continuation. In this review, we draw parallels with family planning (FP) by summarizing how method choice and product switching affected contraceptive coverage globally, synthesize what is known about PrEP product switching, and outline evidence gaps to help guide future research on PrEP switching in the context of choice. RECENT FINDINGS: Decades of research in FP has demonstrated that product switching is common and can lead to more satisfaction and increases in contraceptive use. While research on PrEP product switching is nascent, findings suggest switching is common, and that providing more than one PrEP option can increase coverage. Key evidence gaps include understanding product switching in the context of full versus constrained choice, switching in the context of temporary need, and developing interventions that promote product switching for those who could benefit. Providing choice and allowing people to start, stop, and switch products according to their needs and desires is a core component of a rights-based approach to HIV prevention. More research is needed to better understand what drives use patterns, including switching, and how to leverage choice to improve coverage. Standard definitions -some of which have been proposed in this review-are needed to inform comparable measurement. Finally, there is a need to holistically frame PrEP use to acknowledge changes in need over the life course, thus making method switching a standard part of HIV prevention.

A 5-Year Review of the Impact of Lottery Incentives on HIV-Related Services.

PURPOSE OF REVIEW: Lottery incentives are an innovative approach to encouraging HIV prevention, treatment initiation, and adherence behaviours. This paper reviews the latest research on lottery incentives' impact on HIV-related services, and their effectiveness for motivating behaviours to improve HIV service engagement and HIV health outcomes. RECENT FINDINGS: Our review of ten articles, related to lottery incentives, published between 2018 and 2023 (inclusive) shows that lottery incentives have promise for promoting HIV-related target behaviours. The review highlights that lottery incentives may be better for affecting simpler behaviours, rather than more complex ones, such as voluntary medical male circumcision. This review recommends tailoring lottery incentives, ensuring contextual-relevance, to improve the impact on HIV-related services. Lottery incentives offer tools for improving uptake of HIV-related services. The success of lottery incentives appears to be mediated by context, the value and nature of the incentives, and the complexity of the target behaviour.

Getting HIV Pre-exposure Prophylaxis (PrEP) into Private Pharmacies: Global Delivery Models and Research Directions.

PURPOSE OF REVIEW: To provide an overview of the current state of HIV pre-exposure prophylaxis (PrEP) delivery via private sector pharmacies globally, to discuss the context-specific factors that have influenced the design and implementation of different pharmacy-based PrEP delivery models in three example settings, and to identify future research directions. RECENT FINDINGS: Multiple high- and low-income countries are implementing or pilot testing PrEP delivery via private pharmacies using a variety of delivery models, tailored to the context. Current evidence indicates that pharmacy-based PrEP services are in demand and generally acceptable to clients and pharmacy providers. Additionally, the evidence suggests that with proper training and oversight, pharmacy providers are capable of safely initiating and managing clients on PrEP. The delivery of PrEP services at private pharmacies also achieves similar levels of PrEP initiation and continuation as traditional health clinics, but additionally reach individuals underserved by such clinics (e.g., young men; minorities), making pharmacies well-positioned to increase overall PrEP coverage. Implementation of pharmacy-based PrEP services will look different in each context and depend not only on the state of the private pharmacy sector, but also on the extent to which key needs related to governance, financing, and regulation are addressed. Private pharmacies are a promising delivery channel for PrEP in diverse settings. Countries with robust private pharmacy sectors and populations at HIV risk should focus on aligning key areas related to governance, financing, and regulation that have proven critical to pharmacy-based PrEP delivery while pursuing an ambitious research agenda to generate information for decision-making. Additionally, the nascency of pharmacy-based PrEP delivery in both high- and low-and-middle-income settings presents a prime opportunity for shared learning and innovation.

"Your Package Could Not Be Delivered": The State of Digital HIV Intervention Implementation in the US.

PURPOSE OF REVIEW: Despite continuous innovations and federal investment to create digital interventions addressing the HIV prevention and care continua, these interventions have not reached people in the U.S. at scale. This article reviews what is known about U.S. implementation of digital HIV interventions and presents a strategy to cross the research-to-practice chasm for these types of interventions. RECENT FINDINGS: We conducted a narrative review of U.S.-based original research on implementation of digital HIV interventions and identified few studies reporting on implementation determinants, strategies, processes, or outcomes, particularly outside the context of effectiveness trials. To supplement the literature, in 2023, we surveyed 47 investigators representing 64 unique interventions about their experiences with implementation after their research trials. Respondents placed high importance on intervention implementation, but major barriers included lack of funding and clear implementation models, technology costs, and difficulty identifying partners equipped to deliver digital interventions. They felt that responsibility for implementation should be shared between intervention developers, deliverers (e.g., clinics), and a government entity. If an implementation center were to exist, most respondents wanted to be available for guidance or technical assistance but largely wanted less involvement. Numerous evidence-based, effective digital interventions exist to address HIV prevention and care. However, they remain "on the shelf" absent a concrete and sustainable model for real-world dissemination and implementation. Based on our findings, we call for the creation of national implementation centers, analogous to those in other health systems, to facilitate digital HIV intervention delivery and accelerate progress toward ending the U.S. epidemic.

Acetylsalicylic acid inhibition of the lipoxygenase pathway: Implications for HIV prevention.

BACKGROUND: 1.5 million new HIV infections occurred in 2021, suggesting new prevention methods are needed. Inflammation increases the risk for HIV acquisition by attracting HIV target cells to the female genital tract (FGT). In a pilot study, acetylsalicylic acid (ASA/Aspirin) decreased the proportion of FGT HIV target cells by 35 %. However, the mechanism remains unknown. METHODS: Women from Nairobi, Kenya took low-dose ASA (81 mg) daily for 6-weeks. Free oxylipins in the plasma were quantified by high-performance liquid chromatography-tandem mass spectroscopy. RESULTS: Oxylipins from 9 fatty acid substrates were detected, with more than one analyte from 4 substrates reduced post-ASA. Summary analysis found ASA downregulated cyclooxygenase and lipoxygenase but not cytochrome P450 activity with a lower n-6/n-3 oxylipin profile, reflecting reduced inflammation post-ASA. CONCLUSIONS: Inflammation is associated with increased lipoxygenase activity and HIV risk. Our data suggests ASA reduces inflammation through downregulation of oxylipins. Understanding how ASA reduces inflammation may lead to novel HIV prevention approaches.

Early Infant Male Circumcision Decisions in Zambia: Demographic and Familial Influences.

Public health initiatives in Zambia encourage the uptake of early infant male circumcision (EIMC) as an HIV prevention strategy. This study assessed EIMC parental decision-making during perinatal care in Lusaka, Zambia, focusing on the influence of sociodemographic factors, family, and friends. A longitudinal pilot perinatal intervention, Like Father Like Son (LFLS), was implemented among 300 couples attending antenatal clinics in four urban community health centers. Participants were assessed postpartum regarding subsequent EIMC decisions. Partners, religion, and marital status were associated with the EIMC decision-making. Large scale EIMC promotion interventions that target both parents during perinatal care should be explored.

Are HIV Prevention Services Reaching all LGBTQ+ Youth? An Intersectional Analysis in a National Sample.

Although research has examined disparities in HIV prevention behaviors, intersectional research is needed to understand who may be underserved. This study examines disparities in consistent condom use, HIV testing, and PrEP awareness and use across assigned sex, gender identity, sexual orientation, and racial/ethnic identity in a large sample of sexually active LGBTQ+ youth (mean age = 16.5) who completed the 2022 LGBTQ National Teen Survey. Four social identities were included as indicators in Chi-Square Automated Interaction Detection models to uncover disparate rates of HIV preventive behaviors. Generally, HIV testing and PrEP services were higher among gay/lesbian and queer youth assigned male, and lower among those assigned female. Certain LGBTQ+ youth may be systematically missed by these services, (e.g., those assigned female; those assigned male who also identify as bisexual, pansexual, asexual, questioning, or straight (and trans/gender diverse)). Providers should strive to serve populations who are not being reached by HIV prevention services.

RESUMEN: Aunque las investigaciones han examinado disparidades en los comportamientos de prevención del VIH, la aplicación de un esquema interseccional es necesario para entender quienes tienen menos acceso a los cuidados de la salud. Este estudio examina disparidides en el uso del condón, las pruebas de VIH y el conocimiento y el uso de profilaxis preexposición (PrEP) entre el sexo asignado, la identidad del género, la orientación sexual, la identidad racial/étnica) en una muestra nacional de jovenes (edad promedia = 16.5), LGBTQ+. Cuatro identidades sociales estuvieron incluidas como indicadores en el modelo de la Detección de la Interacción Automática de Chi-Square para detectar diferencias de comportamientos de prevención. Generalmente, el uso de las pruebas de VIH y los servicios de PrEP estaban mas alto entre los jovenes gay/lesbiana y queer asignados masculinos y mas bajo entre jóvenes asignadas femeninas. Es posible que ciertos jovenes LGBTQ+ estén omitidos de los servicios de las pruebas de VIH y PrEP, incluyendo jóvenes que fueron asignadas feminidas, ovenes bisexuales, pansexuales, asexuales, cuestionando, o heterosexuales (transgénero/a/e o de diversos géneros) que fueron asignados masculinos. Los profesionales de salud deben luchar para servir a las poblaciones que están fuera del alcance de los servicios preventivos del VIH.

PrEPárate: Evaluation of a Community-Driven PrEP Social Marketing Intervention Tailored to Latino/a/x Individuals.

Latino/a/x sexual minority men (SMM) and transgender women remain disproportionately impacted by HIV, with higher HIV incidence and lower uptake of pre-exposure prophylaxis (PrEP) than their non-Hispanic White peers. Disparities in PrEP uptake among Latino/a/x populations have been found to be due to structural, social, and personal barriers. Social marketing interventions have been shown to effectively address barriers and increase PrEP uptake in other populations, and thus offer potential as a tool to increase PrEP uptake for Latino/a/x populations. The PrEPárate campaign was developed through community based participatory research and ran from April to September 2022 in Cook County, Illinois. We conducted a mixed methods evaluation through surveys (N = 515) and semi-structured interviews with survey participants and community partners (N = 14). We examined cross-sectional associations of campaign exposure with PrEP awareness and uptake in adjusted multivariable regression models. We used rapid qualitative methods to analyze interviews and assess implementation outcomes following the RE-AIM framework. The campaign reached over 118,000 people on social media, with additional reach over public transit and local events. PrEPárate exposure was associated with increased PrEP awareness (aOR = 5.23; 95% CI [2.58, 10.63]) and PrEP uptake (aOR = 1.69; 95% CI [1.09, 2.62]). Survey respondents expressed that the campaign name, visuals, ambassadors, and distribution were effective in engaging the target audience. Community partners felt the campaign was implemented with fidelity to the original vision and identified future directions for PrEPárate. Social marketing campaigns, anchored in community engagement, may be an effective strategy to increase PrEP awareness and uptake among underserved Latino/a/x populations.

RESUMEN: Los hombres de minorías sexuales y las mujeres transgénero latinos siguen siendo desproporcionadamente afectados por el VIH, con una incidencia de VIH más alta y un menor uso de la Profilaxis Pre-Exposición (PrEP) que sus pares blancos no hispanos. Se ha encontrado que las disparidades en la adopción de PrEP entre las poblaciones latinas se deben a barreras estructurales, sociales y personales. Las intervenciones de mercadeo social han demostrado ser efectivas para eliminar los obstáculos e incrementar el uso de PrEP en otras poblaciones, y por lo tanto son una potencial herramienta para aumentar el uso de PrEP en las poblaciones latinas. La campaña PrEPárate fue desarrollada a través de investigación participativa basada en la comunidad, y se llevó a cabo desde abril hasta septiembre de 2022 en el Condado de Cook, Illinois. Realizamos una evaluación de métodos mixtos a través de encuestas (N = 515) y entrevistas semiestructuradas con participantes de la encuesta y socios comunitarios (N = 14). Se examinaron las asociaciones transversales de la exposición a la campaña con la consciencia y el uso de PrEP en modelos de regresión multivariable ajustados. Utilizamos métodos cualitativos rápidos para analizar entrevistas y evaluar los resultados de la implementación usando el marco RE-AIM. La campaña alcanzó a más de 118,000 personas en redes sociales, con un alcance adicional en el transporte público y eventos locales. La exposición a PrEPárate se asoció con un aumento en la consciencia de PrEP (aOR = 5.23; IC del 95% [2.58, 10.63]) y el uso de PrEP (aOR = 1.69; IC del 95% [1.09, 2.62]). Las participantes de la encuesta expresaron que el nombre de la campaña, las visuales, los embajadores, y la distribución fueron eficaces para atraer al público. Los socios comunitarios sintieron que la campaña se implementó con fidelidad a la visión original e identificaron direcciones futuras para PrEPárate. Las campañas de mercadeo social, basados en el aporte de la comunidad, pueden ser una estrategia efectiva para aumentar la consciencia y el uso de PrEP entre las poblaciones latinas desatendidas.

Pharmacologic Drug Detection and Self-Reported Adherence in the HPTN069/ACTG5305 Phase II PrEP Trial.

Adherence drives efficacy in PrEP clinical trials. We compared drug concentrations and self-reported adherence in HPTN069/ACTG5305, a double-blinded, randomized trial of the safety and tolerability of candidate PrEP regimens that included maraviroc (MVC), tenofovir (TDF), and emtricitabine (FTC). Plasma drug concentrations and self-reported adherence by computer-assisted self-interview (CASI) were assessed at study weeks 24 and 48. Descriptive statistics and a generalized linear model were used to assess the association between selected demographic factors, self-report of daily medication adherence and plasma drug concentrations consistent with daily adherence. Among 718 paired observations from 370 participants, 43% (306/718) reported daily adherence by CASI, 65% (467/718) had drug concentrations consistent with daily adherence and 11% (81/718) had CASI responses that reported daily adherence despite having drug concentrations consistent with less-than-daily adherence. In adjusted analyses, participants who were assigned male at birth (aOR 1.42 [95% CI 1.02, 1.97]), older (5-year increments aOR 1.10 [95% CI 1.09, 1.11]), White (aOR 2.2 [95% CI 1.88, 2.56]), had advanced education (aOR 3.89 [95% CI 2.97, 5.09]), were employed (aOR 1.89 [95% CI 1.50, 2.40]), or partnered/married (aOR 2 [95% CI 1.72, 2.32]) were more likely to have drug concentrations consistent with daily adherence. Participants who were not employed (aOR 2.7 [95% CI 1.31, 5.55]) or who were single/not partnered (aOR 2.33 [CI 95% 1.25, 4.34]) were more likely to have drug concentrations that did not reflect daily adherence despite self-reported PrEP adherence. These findings support the need for ongoing adherence counseling in clinical trials of new PrEP regimens.

History of Rectal Product Use and Country of Residence Influence Preference for Rectal Microbicide Dosage Forms Among Young Sexual and Gender Minorities: A Multi-country Trial Comparing Placebo Douche, Suppository, and Insert Products.

The DESIRE Study (MTN-035) explored product preference among three placebo rectal microbicide (RM) formulations, a rectal douche (RD), a suppository, and an insert, among 210 sexually active transgender people and men who have sex with men in five counties: the United States, Peru, Thailand, South Africa, and Malawi. Participants used each product prior to receptive anal sex (RAS) for 1 month, following a randomly assigned sequence, then selected their preferred product via computer assisted self-interview. In-depth interviews examined reasons for preference. We compared product preference and prior product use by country to explore whether geographic location and experience with the similar products impacted preference. A majority in the United States (56%) and Peru (58%) and nearly half in South Africa (48%) preferred the douche. Most in Malawi (59%) preferred the suppository, while half in Thailand (50%) and nearly half in South Africa (47%) preferred the insert. Participants who preferred the douche described it as quick and easy, already routinized, and serving a dual purpose of cleansing and protecting. Those who preferred the insert found it small, portable, discreet, with quick dissolution. Those who preferred the suppository found the size and shape acceptable and liked the added lubrication it provided. Experience with product use varied by country. Participants with RD experience were significantly more likely to prefer the douche (p = 0.03). Diversifying availability of multiple RM dosage forms can increase uptake and improve HIV prevention efforts globally.

RESUMEN: El estudio DESIRE (MTN-035) exploró la preferencia de producto entre tres formulaciones de microbicida rectal (MR) de placebo, una ducha rectal, un supositorio y un inserto, entre 210 personas transgénero y hombres que tienen sexo con hombres en cinco países: los Estados Unidos, Perú., Tailandia, Sudáfrica y Malawi. Los participantes utilizaron cada producto antes del sexo anal receptive (SAR) durante un mes, siguiendo una secuencia asignada al azar, luego seleccionaron su producto preferido mediante una autoentrevista asistida por computadora. Las entrevistas en profundidad examinaron los motivos de preferencia. Comparamos la preferencia de producto y el uso previo del producto por país para explorar si la ubicación geográfica y la experiencia con la forma farmacéutica impactaron la preferencia. Una mayoría en los Estados Unidos (56%) y Perú (58%) y casi la mitad en Sudáfrica (48%) prefirieron la ducha rectal. La mayoría en Malawi (59%) prefirió el supositorio, mientras que la mitad en Tailandia (50%) y casi la mitad en Sudáfrica (47%) prefirió el inserto. Los participantes que prefirieron la ducha rectal la describieron como rápida y fácil, ya parte de su rutina y que tenía el doble propósito de limpiar y proteger. Los que prefirieron el inserto lo consideraron pequeño, portátil, discreto y de rápida disolución. Los que prefirieron el supositorio encontraron que tenía un tamaño y forma aceptables y proveía lubricación adicional. La experiencia con el uso del producto varió según el país. Los participantes con experiencia con duchas rectales tenían significativamente más probabilidades de preferir la ducha rectal (p = 0,03). Diversificar la disponibilidad de múltiples formas farmacéuticas de MR puede aumentar la aceptación y mejorar los esfuerzos de prevención del VIH a nivel mundial.

Land-Based Retreats as a Method for Building Enabling Environments for HIV Prevention with Northern and Indigenous Adolescents in the Northwest Territories, Canada: Mixed-Methods Findings.

The Northwest Territories (NWT), Canada has high rates of sexually transmitted infections (STI) that elevate HIV acquisition risks. We conducted a mixed-methods study to explore the potential of land-based peer leader retreats (PLR) in building HIV prevention enabling environments among Northern and Indigenous youth in the NWT. PLRs are grounded in Indigenous principles and ways of knowing, acknowledging the land as a physical, spiritual, emotional, and intellectual being with the potential to facilitate (re)connection to culture, community, and self. We conducted one-week PLRs between 2016 and 2021 with adolescents aged 13-17 in the NWT. PLRs addressed HIV/STIs, safer sex, and gender equity. We conducted post-retreat focus groups (FGs) and pre/post-retreat surveys with youth participants (n = 353), and post-retreat FGs with PLR facilitators (n = 252). We applied thematic analysis to FGs and assessed pre/post-retreat changes in HIV/STI knowledge and safer sex efficacy (SSE) using paired sample t-tests. We assessed factors associated with post-test SSE and HIV/STI knowledge using multivariable linear regression. Youth participants (n = 353; mean age: 14.5, standard deviation [SD]: 1.3) were mostly Indigenous (71%) and women (66%). Participant narratives revealed PLRs enhanced technical communication (e.g., correct condom use). There were significant post-retreat HIV/STI knowledge increases; change score increases were lower for Indigenous participants. Qualitative narratives described how PLRs fostered transformative communication (e.g., sexual consent). There were significant post-retreat increases in SSE, and these were lower among men and sexually diverse (vs. heterosexual) participants. Land-based PLRs offer the potential to build technical and transformative communication to facilitate HIV prevention with youth in Canada's North.

Gay and Bisexual Men's Perceptions about a Potential HIV Vaccine within a Post-COVID-19 Era: A Qualitative Study.

To end the HIV epidemic, there is need for targeted strategies to reduce HIV incidence for those most vulnerable, including an HIV vaccine. This study seeks to understand the perceptions that non-PrEP using gay and bisexual men and other men who have sex with men (GBMSM) have about a potential HIV vaccine, while contextualizing their perspectives within the context of heightened vaccine hesitancy that has emerged since the COVID-19 pandemic. Between March and May of 2022, GBMSM (N = 20) participated in in-depth interviews, which assessed their perceptions about an HIV vaccine. Interviews were analysed using a codebook approach to thematic analysis. We oversampled for those unvaccinated against COVID-19 as a proxy for vaccine hesitation. Participants expressed a range of enthusiastic support, cautious optimism and skepticism when presented with the possibility of an HIV vaccine. Factors that drove willingness to receive an HIV vaccine included community-oriented altruism, individualized risk-benefit assessment, and/or the perception that a vaccine could provide a beneficial shift in sexual experiences. Participants also expressed hesitations about receiving an HIV vaccine, including concerns about potential side-effects and efficacy, as well as mistrust in the vaccine development process. Notably, participants often evaluated the vaccine in comparison to PrEP and condoms. Participants offered specific insights into information they would like to receive about an HIV and where/how they would like to receive it. Our findings can help inform future HIV vaccine implementation efforts by offering insights into the factors that motivate and deter GBMSM to receive an HIV vaccine.