Pre-exposure Prophylaxis Delivery Research Articles

"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.

Challenges and Solutions to STI Control in the Era of HIV and STI Prophylaxis.

This article reviews current efforts to control bacterial sexually transmitted infections (STIs) among HIV pre-exposure prophylaxis (PrEP) users and outlines the opportunities and challenges to controlling STIs within HIV PrEP programs. The incidence of STIs continues to rise globally especially among HIV PrEP users, with an estimated 1 in 4 PrEP users having a curable bacterial STI. STIs and HIV comprise a syndemic needing dual interventions. The majority of STIs are asymptomatic, and when testing is available, many STIs occur in extragenital sites that are missed when relying on urine testing or genital swabs. Optimal testing and treatment, including testing for antimicrobial resistance, pose difficulties in high income countries and is essentially non-existent in most low- and middle-income countries. Novel STI primary prevention strategies, like doxycycline post-exposure prophylaxis (PEP) for STI prevention, have proven to be highly efficacious in some populations. A few jurisdictions have issued normative guidelines and position statements for doxycycline PEP; however, clinical standards for implementation and data on public health impact are limited. STI incidence rates are high and rising in sexually active populations. Sexual health programs should leverage the expansion of HIV PrEP delivery services to integrate STI testing, surveillance, and novel STI prevention services.

Understanding the social and structural context of oral PrEP delivery: an ethnography exploring barriers and facilitators impacting transgender women who engage in street-based sex work in Baltimore, Maryland

Transgender women who sell sex (TWSS) experience high rates of HIV acquisition. Antiretrovirals for pre-exposure prophylaxis (PrEP) represent an efficacious HIV prevention strategy. The social and structural factors affecting PrEP delivery amongst TWSS are underexplored in the literature. We conducted ethnographic research to examine how multilevel social and structural factors manifest in TWSS’s lived experiences and affect PrEP delivery and use. Twenty-four transgender women were recruited from the SAPPHIRE cohort and completed interviews focused on barriers and facilitators to PrEP engagement in the context of street-based sex work. Stakeholder interviews (N = 7) were also conducted. Our findings suggest there are unique features of the risk environment that can collectively impede PrEP use among TWSS.

Telehealth effectiveness for pre-exposure prophylaxis delivery in Brazilian public services: the Combine! Study.

Pre-exposure prophylaxis (PrEP) delivery based on user needs can enhance PrEP access and impact. We examined whether telehealth for daily oral PrEP delivery could change the indicators of care related to prophylactic use in five Brazilian public HIV clinics (testing centres, outpatient clinics and infectious disease hospitals). Between July 2019 and December 2020, clients on PrEP for at least 6 months could transition to telehealth or stay with in-person follow-up. Clients were clinically monitored until June 2021. A desktop or mobile application was developed, comprising three asynchronous consultations and one annual in-person consultation visit. Predictors influencing telehealth preference and care outcomes were examined. The analysis encompassed intent-to-treat (first choice) and adjustments for sexual practices, schooling, age, duration of PrEP use and PrEP status during the choice period. Of 470 users, 52% chose telehealth, with the adjusted odds ratio (aOR) increasing over time for PrEP use (aOR for 25-months of use: 4.90; 95% CI: 1.32-18.25), having discontinued PrEP at the time of the choice (aOR: 2.91; 95% CI: 1.40-6.06) and having health insurance (aOR: 1.91; 95% CI: 1.24-2.94) and decreasing for those who reported higher-risk behaviour (aOR for unprotected anal sex: 0.51; 95% CI: 0.29-0.88). After an average follow-up period of 1.6 years (95% CI: 1.5-1.7), the risk of discontinuing PrEP (not having the medication for more than 90 days) was 34% lower with telehealth (adjusted hazard ratio: 0.66; 95% CI: 0.45-0.97). When adjusted by mixed linear regression, no differences in adherence (measured by mean medication possession rate) were found between in-person and telehealth (p = 0.486) or at pre- and post-telehealth follow-ups (p = 0.245). Sexually transmitted infections increased between the pre-follow-up and post-follow-up choices and were not associated with in-person or telehealth (p = 0.528). No HIV infections were observed. Our findings indicate that telehealth for PrEP delivery can enhance service rationalization and reinforce the prevention cascade. This approach reduces prophylaxis interruptions and is mainly preferred by individuals with lower demands for healthcare services.

Factors that influence adolescent girls and young women's re-initiation or complete discontinuation from daily oral PrEP use: a qualitative study from Eastern Cape Province, South Africa.

Adolescent girls and young women (AGYW) face barriers that jeopardize their prevention-effective use of daily oral pre-exposure prophylaxis (PrEP). We sought to understand factors that influence AGYW's prolonged breaks in PrEP use, and their decisions to re-initiate or discontinue using PrEP in the context of a community-based adherence support intervention. In-depth interviews (IDIs) were conducted between December 2019 and April 2021 with purposively selected AGYW (aged 16-25) enrolled in the Community PrEP Study (CPS) in Buffalo City Metro Health District, Eastern Cape Province, South Africa. AGYW were offered monthly PrEP for 24 months at two community-based study sites. Interview guides were informed by the Information-Motivation-Behavioural Skills Model, and data were analysed using illustrative code reports and a case analysis. A total of 603 participants were enrolled and initiated on PrEP in the parent study. Fifty-three IDIs were conducted with 50 CPS participants. Findings revealed that external factors (e.g. local movement, school holidays and medication side-effects) and social conflicts (e.g. discretion and partner mistrust) directly influenced breaks in PrEP usage. A decrease in one's self-perception of HIV risk prolonged the duration of these "PrEP breaks." Once PrEP refill visits were missed, some AGYW delayed returning for refills out of fear of being scolded by study staff. The differences between those participants who eventually re-initiated PrEP and those who disengaged from PrEP use can be attributed to social support and encouragement, level of familiarity with PrEP, risk perceptions, self-initiated discussions with staff and diminishing side effects. Despite implementing a community-based PrEP delivery platform and behavioural intervention that included support for daily oral PrEP adherence and disclosure, participants struggled with consistent daily oral PrEP use. Unpredictable life events, including local movement and schooling schedules, in addition to being judged for their perceived behaviours, pose a challenge for consistent pill pick-up for AGYW and habit formation. Long-acting injectable PrEP may mitigate a number of these external barriers. Interventions that integrate long-term planning skills, how to navigate existing social judgements and how to access sources of social support may further improve habit formation for PrEP use, regardless of its formulation.

Exploring user and stakeholder perspectives from South Africa and Uganda to refine microarray patch development for HIV PrEP delivery and as a multipurpose prevention technology.

Oral HIV pre-exposure prophylaxis (PrEP) is highly effective, but alternative delivery options are needed to reach more users. Microarray patches (MAPs), a novel drug-delivery system containing micron-scale projections or "microneedles" that deliver drugs via skin, are being developed to deliver long-acting HIV PrEP and as a multipurpose prevention technology to protect from HIV and unintended pregnancy. We explored whether MAP technology could meet user and health system needs in two African countries. Researchers in South Africa and Uganda conducted 27 focus group discussions, 76 mock-use exercises, and 31 key informant interviews to explore perceptions about MAPs and specific features such as MAP size, duration of protection, delivery indicator, and health system fit. Participants included young women and men from key populations and vulnerable groups at high risk of HIV and/or unintended pregnancy, including adolescent girls and young women; female sex workers and men who have sex with these women; and men who have sex with men. In Uganda, researchers also recruited young women and men from universities and the community as vulnerable groups. Key stakeholders included health care providers, sexual and reproductive health experts, policymakers, and youth activists. Qualitative data were transcribed, translated, coded, and analyzed to explore perspectives and preferences about MAPs. Survey responses after mock-use in Uganda were tabulated to assess satisfaction with MAP features and highlight areas for additional refinement. All groups expressed interest in MAP technology, reporting perceived advantages over other methods. Most participants preferred the smallest MAP size for ease of use and discreetness. Some would accept a larger MAP if it provided longer protection. Most preferred a protection duration of 1 to 3 months or longer; others preferred 1-week protection. Upper arm and thigh were the most preferred application sites. Up to 30 minutes of wear time was considered acceptable; some wanted longer to ensure the drug was fully delivered. Self-administration was valued by all groups; most preferred initial training by a provider. Potential users and stakeholders showed strong interest in/acceptance of MAP technology, and their feedback identified key improvements for MAP design. If a MAP containing a high-potency antiretroviral or a MAP containing both an antiretroviral and hormonal contraceptive is developed, these products could improve acceptability/uptake of protection options in sub-Saharan Africa.

Pre-exposure prophylaxis service among men who have sex with men in Malaysia: findings from a discrete choice experiment

Men who have sex with men (MSM) in Malaysia are disproportionately affected by HIV. As pre-exposure prophylaxis (PrEP) is being introduced, we assessed population-based PrEP delivery preferences among MSM in Malaysia. We conducted a discrete choice experiment through an online survey among 718 MSM. The survey included 14 choice tasks presenting experimentally varied combinations of five attributes related to PrEP delivery (i.e., cost, dosing strategy, clinician interaction strategy, dispensing venue, and burden of visits to start PrEP). We used latent class analysis and Hierarchical Bayesian modeling to generate the relative importance of each attribute and preference across six possible PrEP delivery programs. PrEP dosing, followed by cost, was the most important attribute. The participants were clustered into five preference groups. Two groups (n = 290) most commonly preferred on-demand, while the other three preferred injectable PrEP. One group (n = 188) almost exclusively considered cost in their decision-making, and the smallest group (n = 86) was substantially less interested in PrEP for reasons unrelated to access. In simulated scenarios, PrEP initiation rates varied by the type of program available to 55·0% of MSM. Successful PrEP uptake among Malaysian MSM requires expanding beyond daily oral PrEP to on-demand and long-acting injectable PrEP, especially at affordable cost.

The Fidelity of a Pharmacy-Based Oral HIV Pre-Exposure Prophylaxis Delivery Model in Kenya.

HIV pre-exposure prophylaxis (PrEP) delivery at private pharmacies is a promising new differentiated service delivery model that may address barriers to PrEP delivery at public health care facilities. We measured the fidelity of this model (ie, delivery as intended) in a pilot study in Kenya. Five private, retail pharmacies in Kisumu and Thika Counties. Trained pharmacy providers delivered PrEP services, including identifying eligible clients, counseling on HIV risk, assessing PrEP safety, testing for HIV, and dispensing PrEP. Pharmacy clients completed surveys that assessed the fidelity of the services received after each visit. Standardized client actors (ie, mystery shoppers) were trained on 4 different case scripts, then made unannounced pharmacy visits, and then completed a 40-item checklist that assessed the fidelity and quality of service delivery components. From November 2020 to December 2021, 287 clients initiated and 159 (55%) refilled PrEP. At initiation, most clients were counseled on PrEP adherence (99%, 284 of 287) and potential side effects (97%, 279 of 287) and all received provider-assisted HIV self-testing before PrEP dispensing (findings consistent across refill visits). Nine standardized client actors completed 15 pharmacy visits. At each visit, most actors were asked about their behaviors associated with HIV risk (80%, 12/15) and all were counseled on PrEP safety and side effects. All actors reported that pharmacy providers treated them with respect. In this first pilot study of pharmacy-delivered PrEP services in Africa, the fidelity of service delivery was high, suggesting that trained providers at private pharmacies can deliver quality PrEP services.

Selecting implementation strategies to improve implementation of integrated PrEP for pregnant and postpartum populations in Kenya: a sequential explanatory mixed methods analysis

BackgroundThere is a higher risk for HIV acquisition during pregnancy and postpartum. Pre-exposure prophylaxis (PrEP) is recommended during this period for those at high risk of infection; integrated delivery in maternal and child health (MCH) clinics is feasible and acceptable but requires implementation optimization.MethodsThe PrEP in Pregnancy, Accelerating Reach and Efficiency study (PrEPARE; NCT04712994) engaged stakeholders to prioritize determinants of PrEP delivery (using Likert scores) and prioritize PrEP delivery implementation strategies. Using a sequential explanatory mixed methods design, we conducted quantitative surveys with healthcare workers at 55 facilities in Western Kenya and a stakeholder workshop (including nurses, pharmacists, counselors, and county and national policymakers), yielding visual plots of stakeholders’ perceived feasibility and effectiveness of the strategies. A stepwise elimination process was used to identify seven strategies for empirical testing. Facilitator debriefing reports from the workshop were used to qualitatively assess the decision-making process.ResultsAmong 146 healthcare workers, the strongest reported barriers to PrEP delivery were insufficient providers and inadequate training, insufficient space, and high volume of patients. Sixteen strategies were assessed, 14 of which were included in the final analysis. Among rankings from 182 healthcare workers and 44 PrEP policymakers and implementers, seven strategies were eliminated based on low post-workshop ranking scores (bottom 50th percentile) or being perceived as low feasibility or low effectiveness for at least 50% of the workshop groups. The top seven strategies included delivering PrEP within MCH clinics instead of pharmacies, fast-tracking PrEP clients to reduce waiting time, delivering PrEP-related health talks in waiting bays, task shifting PrEP counseling, task shifting PrEP risk assessments, training different providers to deliver PrEP, and retraining providers on PrEP delivery. All top seven ranked strategies were grouped into bundles for subsequent testing. Facilitator debriefing reports generally aligned with rankings but noted how stakeholders’ decision-making changed when considering the impact of strategies on facility staff and non-PrEP clients.ConclusionsThe most impactful barriers to integrated PrEP delivery in MCH clinics were insufficient staffing and space. Implementation strategies prioritized through multiple methods of stakeholder input focused on co-location of services and increasing clinic efficiency. Future testing of these stakeholder-prioritized strategy bundles will be conducted to assess the effectiveness and implementation outcomes.

Collaborative PrEP Implementation Strategies for Latino Men Who have Sex with Men: A Health Center-Community Consensus Process

Community-based organizations (CBOs) deliver services in culturally-responsive ways, and could effectively partner with health centers to deliver HIV pre-exposure prophylaxis (PrEP) to Latino men who have sex with men (LMSM). However, few such models exist. We conducted a planning study in collaboration with three CBOs serving LMSM to identify optimal PrEP delivery strategies for health centers and CBOs to implement jointly. We established a Community Expert Panel (CEP) of eight client-facing CBO and health center staff. Over 6 months, the panel met monthly to identify collaborative strategies for PrEP delivery, using a modified Delphi method consisting of the following steps: (1) brainstorming strategies; (2) rating strategies on acceptability, appropriateness and feasibility; (3) review of data from qualitative focus group discussions with CBO clients; and (4) final strategy selection. The panel initially identified 25 potential strategies spread across three categories: improving communication between health centers and CBOs; using low-barrier PrEP options (e.g. telemedicine), and developing locally-relevant, culturally-sensitive outreach materials. Focus groups with CBO clients highlighted a desire for flexible options for PrEP-related care and emphasized trust in CBOs. The final package of strategies consisted of: (1) a web-based referral tool; (2) telemedicine appointments; (3) geographically-convenient options for lab specimen collection; (4) tailored print and social media; and (5) regular coaching sessions with CBO staff. Through a community-engaged process, we identified a package of PrEP delivery strategies that CBOs and health centers can implement in partnership, which have the potential to overcome barriers to PrEP for LMSM.

Patient perspectives on the role of nurses in HIV pre-exposure prophylaxis care (PrEP-RN).

In response to ongoing new HIV diagnoses among gay, bisexual, and other men who have sex with men (gbMSM) and limited access points for HIV pre-exposure prophylaxis (PrEP) care, we established Canada's first nurse-led HIV prevention service in Ottawa, Canada-PrEP-RN. As part of this service, registered nurses became the primary provider in PrEP delivery and monitoring. To (1) gather patients' sentiments and experiences related to nurse-led PrEP and (2) identify the implications for nurses working in sexual healthcare. Qualitative interviews were conducted with 14 gbMSM participants who had received, or were presently enrolled in, HIV prevention care from nurses in the PrEP-RN clinic. Interview transcripts were reviewed and analyzed using thematic analysis. Our analysis revealed two major themes of: The Sexual Health Nurse as the Expert and Patients Reliance on Nurses. The first theme discussed patients' positive attitudes toward nurses, in terms of the knowledge nurses possessed and the kind and efficient services they. The accommodating nature of nurses, however, led patients to become dependent on their care, which was the focus of the second theme. This reliance on nurses created challenges when patients transitioned from PrEP-RN to alternate providers for ongoing care. These findings were examined to understand the effect of patients' perceptions of nurses on nursing practice. Despite patients' confidence in nurses' ability to provide PrEP care, the expectations they placed onto nurses to address the totality of their needs created competing demands for nurses to be both a leader in HIV prevention care-and fulfill the image of the caring, healthcare 'hero', which created feelings of moral distress among nurses. As increasing initiatives focus on task-shifting of healthcare roles to nurses, understanding the patients' perspective is essential in maintaining effective nurse-patient relationships.

Comparison of methods to engage diverse stakeholder populations in prioritizing PrEP implementation strategies for testing in resource-limited settings: a cross-sectional study

BackgroundThere is a lack of consensus about how to prioritize potential implementation strategies for HIV pre-exposure prophylaxis (PrEP) delivery. We compared several prioritization methods for their agreement and pragmatism in practice in a resource-limited setting.MethodsWe engaged diverse stakeholders with clinical PrEP delivery and PrEP decision-making experience across 55 facilities in Kenya to prioritize 16 PrEP delivery strategies. We compared four strategy prioritization methods: (1) “past experience surveys” with experienced practitioners reflecting on implementation experience (N = 182); (2 and 3) “pre- and post-small-group ranking” surveys before and after group discussion (N = 44 and 40); (4) “go-zone” quadrant plots of perceived effectiveness vs feasibility. Kendall’s correlation analysis was used to compare strategy prioritization using the four methods. Additionally, participants were requested to group strategies into three bundles with up to four strategies/bundle by phone and online survey.ResultsThe strategy ranking correlation was strongest between the pre- and post-small-group rankings (Tau: 0.648; p < 0.001). There was moderate correlation between go-zone plots and post-small-group rankings (Tau: 0.363; p = 0.079) and between past-experience surveys and post-small-group rankings (Tau: 0.385; p = 0.062). For strategy bundling, participants primarily chose bundles of strategies in the order in which they were listed, reflecting option ordering bias. Neither the phone nor online approach was effective in selecting strategy bundles. Participants agreed that the strategy ranking activities conducted during the workshop were useful in prioritizing a final set of strategies.ConclusionsBoth experienced and inexperienced stakeholder participants’ strategy rankings tended to prioritize strategies perceived as feasible. Small group discussions focused on feasibility and effectiveness revealed moderately different priorities than individual rankings. The strategy bundling approach, though less time- and resource-intensive, was not effective. Future research should further compare the relative effectiveness and pragmatism of methodologies to prioritize implementation strategies.

Integrating PrEP in maternal and child health clinics in Kenya: analysis of a service availability and readiness assessment (SARA) survey.

Risk of HIV acquisition is high during pregnancy and postpartum, and pre-exposure prophylaxis (PrEP) is recommended for peripartum populations. Integrating PrEP into maternal and child health (MCH) clinics is feasible and acceptable. Understanding clinics' service availability and readiness is essential for effective scale up. The PrEP in Pregnancy, Accelerating Reach and Efficiency study (PrEPARE; NCT04712994) engaged PrEP-experienced facilities previously linked to a programmatic or research study in Western Kenya to document available services and commodities via a modified service availability and readiness assessment (SARA) survey with 20 PrEP tracer items covering: staffing/guidelines, services/equipment, and medicines/commodities. Facilities' prior study engagement occurred between 2017 and 2019; SARA survey data was collected between April 2020 and June 2021. Descriptive statistics were stratified by prior study engagement. ANOVA tests assessed associations between facility characteristics and gaps. Fisher's tests assessed differences in commodity availability and stockouts. Of the 55 facilities surveyed, 60% had received PrEP training in the last two years, 95% offered PrEP integrated into MCH, and 64% and 78% had both auditory and visual privacy in PrEP and HIV testing service (HTS) delivery spaces, respectively. Supervision frequency was heterogeneous, but 82% had received a supervision visit within 3 months. Availability of commodities was variable and the most commonly unavailable commodities were PrEP in MCH (71% available) and risk assessment screening tool (RAST) and PrEP cards (60% and 75% available, respectively). The number of service and commodity gaps per facility ranged from zero to eight (median: 3; IQR: 2, 5). The most frequent gaps were: PrEP training and risk assessment cards (40% each), lack of privacy in PrEP (36%) and HIV testing services (31%) spaces, PrEP pills in MCH (29%), and PrEP cards (25%). There were no differences in mean number of gaps by county, previous study engagement, or public vs. private status. Level 4 facilities had fewer gaps (mean 2.2) than level 2, 3, and 5 facilities (mean 5.7, 4.5, and 5.3 respectively; p < 0.001). PrEP service availability and readiness was generally high across MCH facilities. However, there is a need for increased frequency of provider training and supportive supervision focused on fidelity. To address key commodity stockouts such as PrEP pills, implementation of electronic logistics management information systems may be needed. Targeting these gaps is essential to effectively scale up integrated PrEP delivery, especially among facilities with limited infrastructure.

Trajectories of PrEP use among men who have sex with men: a pooled analysis of two prospective, observational cohort studies.

Daily and event-driven oral pre-exposure prophylaxis (PrEP) reduce the risk of HIV acquisition. PrEP use can vary over time, yet little is known about the trajectories of PrEP use irrespective of the chosen PrEP regimens among men who have sex with men (MSM). Using data from a mobile, web-based diary application collected daily from 17 August 2015 until 6 May 2018, we analysed PrEP use and sexual behaviour in two large cohorts, AMPrEP (Amsterdam, the Netherlands) and Be-PrEP-ared (Antwerp, Belgium). In both cohorts, participants could choose between daily and event-driven oral PrEP every 3 months. We used group-based trajectory modelling to identify trajectories of PrEP use over time and their determinants. In addition, we estimated the incidence rate of chlamydia, gonorrhoea and syphilis within these trajectories. We included 516 MSM (n = 322 AMPrEP; n = 194 Be-PrEP-ared), of whom 24% chose event-driven PrEP at PrEP initiation. Participants contributed 225,015 days of follow-up (median = 508 days [IQR = 429-511]). Four distinct PrEP use trajectories were identified: ≤2 tablets per week ("low frequency," 12% of the total population), 4 tablets per week ("variable," 17%), "almost daily" (31%) and "always daily" (41%). Compared to participants with "low frequency" PrEP use, participants with "variable" (odds ratio [OR] = 2.18, 95% confidence interval [CI] = 1.04-4.60) and "almost daily" PrEP use were more often AMPrEP participants (OR = 2.64, 95% CI = 1.27-5.49). "Almost daily" PrEP users were more often employed (OR = 6.76, 95% CI = 2.10-21.75) and were younger compared to participants with "low frequency" PrEP use. In addition, the number of days on which anal sex occurred was lower among participants with "low frequency" PrEP use compared to the other groups (all p<0.001). Compared to "low frequency" PrEP users, the incidence rates of chlamydia and gonorrhoea were higher for participants with "almost daily" and "always daily" PrEP use. We uncovered four distinct PrEP use trajectories, pointing to different patterns of PrEP use in practice beyond the two-regimen dichotomy. These trajectories were related to sexual behaviour and rates of sexually transmitted infection. Tailoring PrEP care according to different PrEP use patterns could be an important strategy to improve efficient PrEP delivery.

Increased PrEP uptake and PrEP-RN coincide with decreased HIV diagnoses in men who have sex with men in Ottawa, Canada.

We sought to evaluate if increased uptake of HIV pre-exposure prophylaxis (PrEP) correlated to population-level changes in human immunodeficiency virus (HIV) epidemiology, in a setting with an integrated PrEP delivery system centred on a public health nurse-led PrEP clinic and referral process. This study was conducted in Ottawa, Canada, where all positive HIV test results are reported to the public health units. Risk factor information is also collected by nurses and subsequently entered into a provincial database. We extracted these data for Ottawa from 2017 to 2021 and restricted our analyses to first-time diagnoses. We identified 154 persons with a new HIV diagnosis. Over this period, the number of new diagnoses among men who have sex with men, the group most targeted for PrEP, decreased by 50%-60%. We did not identify changes in the number of new diagnoses based on race, intravenous drug use or among women. Increasing PrEP uptake in Ottawa in 2017 to 2021 coincided with a significant decrease in new HIV diagnoses among men who have sex with men. PrEP uptake in Ottawa, particularly by those most at risk, is likely supported by an integrated approach via PrEP-RN, a nurse-led public health program where individuals diagnosed with syphilis or rectal gonorrhea or chlamydia receive an automatic offer of PrEP. While these findings cannot causally link PrEP-RN or PrEP with this reduction in new HIV diagnoses, these changes in HIV epidemiology in Ottawa occurred exclusively among the group targeted for PrEP. These data highlight the efficacy and importance of PrEP.

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.

A Qualitative Study of Barriers and Facilitators to Integrating Medications for Opioid Use Disorder and HIV Preexposure Prophylaxis for Adolescents and Young Adults.

The syndemic of substance use and human immunodeficiency virus (HIV) is a well-recognized global phenomenon that threatens to undermine the priorities outlined by the National Institutes of Health "Ending the HIV Epidemic" initiative. There are few published studies on preexposure prophylaxis (PrEP) for adolescents and young adults (AYAs) with opioid use disorder (OUD) despite increasing availability of biomedical prevention options and Centers for Disease Control and Prevention recommendations to offer PrEP to this group. Healthcare providers who previously prescribed medications for OUD (MOUDs) and/or PrEP for AYA were purposively sampled. Audio-recorded in-depth individual interviews were conducted using chart-stimulated recall to explore barriers and facilitators to integrated MOUD and HIV prevention services. Interviews were double-coded, and qualitative analysis was performed using a modified grounded theory. Of 19 providers sampled, most were physicians (63%). All recommended HIV screening at varying intervals; however, few counseled on (19%) or prescribed (11%) PrEP to patients on MOUD. Barriers to PrEP prescriptions included patient-level (ie, stigma surrounding PrEP use, adherence challenges, and competing social or mental healthcare needs), provider (perception of low risk, lack of training/experience), and system-level factors (including restricted visit types). Facilitators of PrEP prescriptions included patient-initiated requests, electronic health record system reminders, and the availability of consistent support staff (ie, navigators, certified recovery specialists). Our study confirms that discussions about HIV prevention and PrEP prescriptions may be rare for AYA patients receiving MOUD. Further research is needed to develop interventions that increase the integration of PrEP delivery within the context of OUD care among this key AYA population.

Feasibility and acceptability of peer-delivered HIV self-testing and PrEP for young women in Kampala, Uganda

BackgroundAdolescent girls and young women (AGYW) account for 29% of new HIV infections in Uganda despite representing just 10% of the population. Peer support improves AGYW linkage to HIV care and medication adherence. We evaluated the feasibility and acceptability of peer delivered HIV self-tests (HIVST) and oral pre-exposure prophylaxis (PrEP) to young women in Uganda.MethodsBetween March and September 2021, we conducted a pilot study of 30 randomly selected young women, aged 18–24 years, who had received oral PrEP for at least three months, but had suboptimal adherence as measured by urine tenofovir testing (< 1500 ng/ml). Participants were offered daily oral PrEP and attended clinic visits three and six months after enrollment. Between clinic visits, participants were visited monthly by trained peers who delivered HIVST and PrEP. Feasibility and acceptability of peer-delivered PrEP and HIVST (intervention) were measured by comparing actual versus planned intervention delivery and product use. We conducted two focus groups with young women, and five in-depth interviews with peers and health workers to explore their experiences with intervention delivery. Qualitative data were analyzed using thematic analysis.ResultsAt baseline, all 30 enrolled young women (median age 20 years) accepted peer-delivered PrEP and HIVST. Peer delivery visit completion was 97% (29/30) and 93% (28/30) at three and six months, respectively. The proportion of participants with detectable tenofovir in urine was 93% (27/29) and 57% (16/28) at months three and six, respectively. Four broad themes emerged from the qualitative data: (1) Positive experiences of peer delivered HIVST and PrEP; (2) The motivating effect of peer support; (3) Perceptions of female controlled HIVST and PrEP; and (4) Multi-level barriers to HIVST and PrEP use. Overall, peer delivery motivated young women to use HIVST and PrEP and encouraged persistence on PrEP by providing non-judgmental client-friendly services and adherence support.ConclusionPeer delivery of HIVST and oral PrEP was feasible and acceptable to this sample of young women with suboptimal PrEP adherence in Uganda. Future larger controlled studies should evaluate its effectiveness among African AGWY.

Effect of 6-Month HIV Preexposure Prophylaxis Dispensing With Interim Self-testing on Preexposure Prophylaxis Continuation at 12 Months

Daily oral HIV preexposure prophylaxis (PrEP) delivery requires quarterly clinic visits for HIV testing and drug refilling that are costly to health systems and clients. To evaluate whether 6-month PrEP dispensing supported with interim HIV self-testing (HIVST) results in noninferior PrEP continuation outcomes at 12 months compared with standard quarterly clinic visits. This randomized noninferiority trial was conducted from May 2018 to May 2021 with 12 months of follow-up among PrEP clients aged 18 years or older who were returning for their first refill at a research clinic in Kiambu County, Kenya. Participants were randomized 2:1 to (1) 6-month PrEP dispensing with semiannual clinic visits and interim HIVST at 3 months or (2) standard-of-care (SOC) PrEP delivery with 3-month dispensing, quarterly clinic visits, and clinic-based HIV testing. Prespecified 12-month outcomes included recent HIV testing (any in past 6 months), PrEP refilling, and PrEP adherence (detectable tenofovir-diphosphate concentrations in dried blood spots). Binomial regression models were used to estimate risk differences (RDs), and a 1-sided 95% CI lower bound (LB) of -10% or greater was interpreted as noninferior. A total of 495 participants were enrolled, with 329 enrolled in the intervention group and 166 enrolled in the SOC group; 330 (66.7%) were women, 295 (59.6%) were in serodifferent relationships, and the median (IQR) age was 33 (27-40) years. At 12 months, 241 individuals in the intervention group (73.3%) and 120 in the SOC group (72.3%) returned to clinic. In the intervention group, recent HIV testing was noninferior (230 individuals [69.9%]) compared with the SOC group (116 [69.9%]; RD, -0.33%, 95% CI LB, -7.44%). PrEP refilling in the intervention group (196 [59.6%]) was inconclusive compared with the SOC group (104 [62.7%]; RD, -3.25%; 95% CI LB, -10.84%), and PrEP adherence was noninferior in the intervention group (151 [45.9%]) compared with the SOC group (70 [42.2%]; RD, 4.96%; 95% CI LB, -2.46%). No HIV seroconversions were observed over the follow-up period. In this analysis of secondary trial end points at 1 year, semiannual PrEP dispensing with interim HIVST resulted in noninferior recent HIV testing and PrEP adherence compared with SOC quarterly PrEP dispensing. This novel model has the potential to optimize PrEP delivery. ClinicalTrials.gov Identifier: NCT03593629.

Using qualitative comparative analysis to understand the conditions that produce successful PrEP implementation in family planning clinics

BackgroundTitle X-funded family planning clinics have been identified as optimal sites for delivery of pre-exposure prophylaxis (PrEP) for HIV prevention to U.S. women. However, PrEP has not been widely integrated into family planning services, especially in the Southern U.S., and data suggest there may be significant implementation challenges in this setting.MethodsTo understand contextual factors that are key to successful PrEP implementation in family planning clinics, we conducted in-depth qualitative interviews with key informants from 38 family planning clinics (11 clinics prescribed PrEP and 27 did not). Interviews were guided by constructs from the Consolidated Framework for Implementation Research (CFIR), and qualitative comparative analysis (QCA) was used to uncover the configurations of CFIR factors that led to PrEP implementation.ResultsWe identified 3 distinct construct configurations, or pathways, that led to successful PrEP implementation: (1) high “Leadership Engagement” AND high “Available Resources”; OR (2) high “Leadership Engagement” AND NOT located in the Southeast region; OR (3) high “Access to Knowledge and Information” AND NOT located in the Southeast region. Additionally, there were 2 solution paths that led to absence of PrEP implementation: (1) low “Access to Knowledge and Information” AND low “Leadership Engagement”; OR (2) low “Available Resources” AND high “External Partnerships”.DiscussionWe identified the most salient combinations of co-occurring organizational barriers or facilitators associated with PrEP implementation across Title X clinics in the Southern U.S. We discuss implementation strategies to promote pathways that led to implementation success, as well as strategies to overcome pathways to implementation failure. Notably, we identified regional differences in the pathways that led to PrEP implementation, with Southeastern clinics facing the most obstacles to implementation, specifically substantial resource constraints. Identifying implementation pathways is an important first step for packaging multiple implementation strategies that could be employed by state-level Title X grantees to help scale up PrEP.