Pre-exposure Prophylaxis Provision Research Articles

HIV Pre-exposure Prophylaxis Use among Men Experiencing Incarceration in the United States: A Prospective Cohort Study

Background: Pre-exposure prophylaxis (PrEP) is an effective approach to preventing HIV acquisition and is recommended for populations overrepresented in carceral systems given the overlap with populations disproportionately impacted by HIV. However, few studies have focused on PrEP initiation outcomes in a carceral setting to maximize public health impact. Setting: This study was conducted in a unified jail/prison system within the state of Rhode Island located in the United States. Methods: A prospective observational cohort of men initiating PrEP within a jail setting were enrolled in this trial. Men were referred by providers, staff, or after self-presenting for HIV preventive care, these individuals were offered enrollment in the study which involved evaluation for clinical PrEP eligibility, PrEP initiation while incarcerated, continuation upon community re-entry and linkage to a community PrEP provider post-release. Results: A total of (N=100) men in the jail facility (e.g. “intake”) were enrolled in the cohort. Of the 100 men enrolled, 83% were determined to be PrEP eligible through standard clinical evaluation, 37% were prescribed PrEP, and 26% initiated PrEP while incarcerated. In total, 5% of enrolled individuals were linked successfully to PrEP care in the community. Conclusion: Our findings suggest preliminary feasibility and acceptability of initiating PrEP within a jail setting. There were significant challenges across the PrEP care continuum that can be used to inform future studies and practice.

Adapting mHealth Interventions (PrEPmate and DOT Diary) to Support PrEP Retention in Care and Adherence Among English and Spanish-Speaking Men Who Have Sex With Men and Transgender Women in the United States: Formative Work and Pilot Randomized Trial.

A growing number of mobile health (mHealth) technologies are being developed to support HIV preexposure prophylaxis (PrEP) adherence and persistence; however, most tools have focused on men who have sex with men (MSM), and few are available in Spanish. To maximize the potential impact of these tools in reducing gender and racial/ethnic disparities and promoting health equity, mHealth tools tailored to Spanish-speaking people and transgender women are critically needed. The aim of this study is to adapt and tailor 2 mHealth technologies, PrEPmate and DOT Diary, to support daily PrEP adherence and persistence among Spanish-speaking MSM and English- and Spanish-speaking transgender women and to evaluate the feasibility and acceptability of these tools. PrEPmate, an interactive, bidirectional, text messaging intervention that promotes personalized communication between PrEP users and providers, and DOT Diary, a mobile app that promotes self-management of PrEP use and sexual health through an integrated electronic pill-taking and sexual activity diary, were previously developed for English-speaking MSM. We conducted 3 focus groups with 15 English- and Spanish-speaking transgender women and MSM in San Francisco and Miami to culturally tailor these tools for these priority populations. We then conducted a 1-month technical pilot among 21 participants to assess the usability and acceptability of the adapted interventions and optimize the functionality of these tools. Participants in focus groups liked the "human touch" of text messages in PrEPmate and thought it would be helpful for scheduling appointments and asking questions. They liked the daily reminder messages, especially the fun facts, gender affirmations, and transgender history topics. Participants recommended changes to tailor the language and messages for Spanish-speaking and transgender populations. For DOT Diary, participants liked the adherence tracking and protection level feedback and thought the calendar functions were easy to use. Based on participant recommendations, we tailored language within the app for Spanish-speaking MSM and transgender women, simplified the sexual diary, and added motivational badges. In the technical pilot of the refined tools, mean System Usability Scale scores were 81.2/100 for PrEPmate and 76.4/100 for DOT Diary (P=.48), falling in the "good" to "excellent" range, and mean Client Satisfaction Questionnaire scores were 28.6 and 28.3 for PrEPmate and DOT Diary, respectively (maximum possible score=32). Use of both tools was high over the 1-month pilot (average of 10.5 messages received from each participant for PrEPmate; average of 17.6 times accessing the DOT Diary app), indicating good feasibility for both tools. Using a user-centered design approach, we culturally tailored PrEPmate and DOT Diary to support daily PrEP use among Spanish-speaking MSM and English- and Spanish-speaking transgender women. Our positive findings in a technical pilot support further testing of these mHealth interventions in an upcoming comparative effectiveness trial.

HIV Pre-Exposure Prophylaxis Education in Family Medicine Clerkships: A CERA Study.

Little is known about human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) education in family medicine clerkships during medical school. Our study aimed to describe coverage of PrEP education in family medicine clerkships and explore barriers if this education was absent. Data were collected through the 2023 Council of Academic Family Medicine (CAFM) Education Research Alliance (CERA) Family Medicine Clerkship Director Survey. We inquired about provision of PrEP to patients, faculty expertise with PrEP, PrEP curriculum in the clerkship, barriers to including PrEP in the clerkship curriculum, and willingness of directors to add PrEP online modules to the clerkship if available. The response rate was 56.8% (96/169). Nine participants did not complete the PrEP questions and were excluded from analyses. Nearly two-thirds of clerkship directors perceived PrEP as an important topic in the family medicine clerkship; however, only one-third of clerkships included PrEP curriculum through clinical experiences (58.5%), didactics (17.1%), or both (14.6%). Barriers to including PrEP were lack of time in the curriculum (63.5%) and having other more important topics to cover (25.7%), but 38.9% said they would include PrEP in the clerkship if free online modules were available. Clerkships were more likely to include PrEP curriculum in the family medicine clerkship if they had faculty with sufficient expertise or if clerkship directors believed it was important to teach PrEP in the curriculum. Offering accessible educational content can enhance educational opportunities on PrEP for medical students.

Estimating the costs and perceived benefits of oral pre-exposure prophylaxis (PrEP) delivery in ten counties of Kenya: a costing and a contingent valuation study.

Kenya included oral PrEP in the national guidelines as part of combination HIV prevention, and subsequently began providing PrEP to individuals who are at elevated risk of HIV infection in 2017. However, as scale-up continued, there was a recognized gap in knowledge on the cost of delivering oral PrEP. This gap limited the ability of the Government of Kenya to budget for its PrEP scale-up and to evaluate PrEP relative to other HIV prevention strategies. The following study calculated the actual costs of oral PrEP scale-up as it was being delivered in ten counties in Kenya. This costing also allowed for a comparison of various models of service delivery in different geographic regions from the perspective of service providers in Kenya. In addition, the analysis was also conducted to understand factors that indicate why some individuals place a greater value on PrEP than others, using a contingent valuation technique. Data collection was completed between November 2017 and September 2018. Costing data was collected from 44 Kenyan health facilities, consisting of 23 public facilities, 5 private facilities and 16 drop-in centers (DICEs) through a cross-sectional survey in ten counties. Financial and programmatic data were collected from financial and asset records and through interviewer administered questionnaires. The costs associated with PrEP provision were calculated using an ingredients-based costing approach which involved identification and costing of all the economic inputs (both direct and indirect) used in PrEP service delivery. In addition, a contingent valuation study was conducted at the same 44 facilities to understand factors that reveal why some individuals place a greater value on PrEP than others. Interviews were conducted with 2,258 individuals (1,940 current PrEP clients and 318 non-PrEP clients). A contingent valuation method using a "payment card approach" was used to determine the maximum willingness to pay (WTP) of respondents regarding obtaining access to oral PrEP services. The weighted cost of providing PrEP was $253 per person year, ranging from $217 at health centers to $283 at dispensaries. Drop-in centers (DICEs), which served about two-thirds of the client volume at surveyed facilities, had a unit cost of $276. The unit cost was highest for facilities targeting MSM ($355), while it was lowest for those targeting FSW ($248). The unit cost for facilities targeting AGYW was $323 per person year. The largest percentage of costs were attributable to personnel (58.5%), followed by the cost of drugs, which represented 25% of all costs. The median WTP for PrEP was $2 per month (mean was $4.07 per month). This covers only one-third of the monthly cost of the medication (approximately $6 per month) and less than 10% of the full cost of delivering PrEP ($21 per month). A sizable proportion of current clients (27%) were unwilling to pay anything for PrEP. Certain populations put a higher value on PrEP services, including: FSW and MSM, Muslims, individuals with higher education, persons between the ages of 20 and 35, and households with a higher income and expenditures. This is the most recent and comprehensive study on the cost of PrEP delivery in Kenya. These results will be used in determining resource requirements and for resource mobilization to facilitate sustainable PrEP scale-up in Kenya and beyond. This contingent valuation study does have important implications for Kenya's PrEP program. First, it indicates that some populations are more motivated to adopt oral PrEP, as indicated by their higher WTP for the service. MSM and FSW, for example, placed a higher value on PrEP than AGYW. Higher educated individuals, in turn, put a much higher value on PrEP than those with less education (which may also reflect the higher "ability to pay" among those with more education). This suggests that any attempt to increase demand or improve PrEP continuation should consider these differences in client populations. Cost recovery from existing PrEP clients would have potentially negative consequences for uptake and continuation.

HIV pre-exposure prophylaxis programme preferences among sexually active HIV-negative transgender and gender diverse adults in the United States: a conjoint analysis.

Current implementation efforts have failed to achieve equitable HIV pre-exposure prophylaxis (PrEP) provision for transgender and gender-diverse (trans) populations. We conducted a choice-based conjoint analysis to measure preferences for key attributes of hypothetical PrEP delivery programmes among a diverse online sample predominantly comprised of transmasculine and nonbinary individuals in the United States. Between April 2022 and June 2022, a national online survey with an embedded conjoint analysis experiment was conducted among 304 trans individuals aged ≥18 years in the United States to assess five PrEP programme attributes: out-of-pocket cost; dispensing venue; frequency of visits for PrEP-related care; travel time to PrEP provider; and ability to bundle PrEP-related care with gender-affirming hormone therapy services. Participants responded to five questions, each of which presented two PrEP programme scenarios and one opt-out option per question and selected their preferred programme in each question. We used hierarchical Bayes estimation and multinomial logistic regression to measure part-worth utility scores for the total sample and by respondents' PrEP status. The median age was 24 years (range 18-56); 75% were assigned female sex at birth; 54% identified as transmasculine; 32% as nonbinary; 14% as transfeminine. Out-of-pocket cost had the highest attribute importance score (44.3%), followed by the ability to bundle with gender-affirming hormone therapy services (18.7%). Minimal cost-sharing ($0 out-of-pocket cost) most positively influenced the attribute importance of cost (average conjoint part-worth utility coefficient of 2.5 [95% CI 2.4-2.6]). PrEP-experienced respondents preferred PrEP delivery in primary care settings (relative utility score 4.7); however, PrEP-naïve respondents preferred pharmacies (relative utility score 5.1). Participants preferred programmes that offered PrEP services without cost-sharing and bundled with gender-affirming hormone therapy services. Bolstering federal regulations to cover PrEP services and prioritizing programmes to expand low-barrier PrEP provision are critical to achieving equitable PrEP provision. Community-engaged implementation research conducted by and in close collaboration with trans community stakeholders and researchers are needed to streamline the design of patient-centred PrEP programmes and develop implementation strategies that are salient to the diverse sexual health needs of trans patients.

The path towards an HIV-free generation: engaging adolescent boys and young men (ABYM) in sub-Saharan Africa from lessons learned and future directions

ABSTRACT This paper highlights the pressing need to address the HIV epidemic among adolescent boys and young men (ABYM) in sub-Saharan Africa. Despite progress in HIV prevention, ABYM still experience low diagnosis rates, treatment adherence, and linkage to care. The paper emphasizes ABYM’s vulnerability due to societal norms, limited healthcare access, and economic pressures. It calls for gender-responsive interventions, including comprehensive sexual education, youth-friendly health services, community engagement, and targeted outreach. Comprehensive sexual education is pivotal in HIV prevention for ABYM, providing them with age-appropriate sexual health knowledge and safer sexual practices to reduce HIV incidence. Harmful masculine norms must be countered to promote respectful relationships, benefiting boys, men, and their partners. Inadequate access to youth-friendly health services hampers HIV prevention. Establishing spaces with confidential, non-judgmental care offering testing, counselling, circumcision, and provision of pre-exposure prophylaxis (PrEP) is essential, especially considering ABYM’s unique clinic experiences. Engaging communities, leaders, educators, and peers combats stigma and discrimination. ABYM’s input in intervention design, targeted outreach, and innovative technology enhances effectiveness of HIV prevention programmes. Economic factors should also be addressed. Comprehensive multi-sectoral interventions, including conditional cash transfers, effective for AGYW, could benefit ABYM. Addressing structural factors alongside behaviour change and social support is key.

Estimating The Impact Of Out-Of-Pocket Cost Changes On Abandonment Of HIV Pre-Exposure Prophylaxis.

Oral HIV pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV. Several different developments in the US either threaten to increase or promise to decrease PrEP out-of-pocket costs and access in the coming years. In a sample of 58,529 people with a new insurer-approved PrEP prescription, we estimated risk-adjusted percentages of patients who abandoned (did not fill) their initial prescription across six out-of-pocket cost categories. We then simulated the percentage of patients who would abandon PrEP under hypothetical changes to out-of-pocket costs, ranging from $0 to more than $500. PrEP abandonment rates of 5.5percent at $0 rose to 42.6percent at more than $500; even a small increase from $0 to $10 doubled the rate of abandonment. Conversely, abandonment rates that were 48.0percent with out-of-pocket costs of more than $500 dropped to 7.3percent when those costs were cut to $0. HIV diagnoses were two to three times higher among patients who abandoned PrEP prescriptions than among those who filled them. These results imply that recent legal challenges to the provision of PrEP with no cost sharing could substantially increase PrEP abandonment and HIV rates, upending progress on the HIV/AIDS epidemic.

Legislation expanding pharmacist scope of practice to furnish Human Immunodeficiency Virus pre‐exposure prophylaxis: A content analysis

AbstractIntroductionApproximately 1.2 million persons in the United States have indications for human immunodeficiency virus (HIV) pre‐exposure prophylaxis (PrEP) yet utilization remains low. Alternative models for PrEP access, such as community pharmacy programs where pharmacists may prescribe and dispense HIV PrEP medications, may help improve rates of utilization. Individual states have begun to pass laws governing expanded pharmacist practice for provision of PrEP.MethodsAn internet search was conducted from January 2022 to June 2023 to identify United States legislative bills which support the independent provision of PrEP by pharmacists. A content analysis was conducted of the bill text to conceptualize key components, compare these across states, and hypothesize implications for implementation and pharmacy practice.ResultsTwelve states (Arkansas, California, Colorado, Nevada, Utah, New Mexico, Virginia, Oregon, Illinois, Maine, Rhode Island, and Connecticut) with legislation supporting pharmacist‐furnished HIV PrEP were identified. Content analysis revealed differences in required pharmacist training, conditions for furnishing PrEP, total amount of PrEP permitted for dispensing, and discussions of pharmacist‐provided laboratory testing and reimbursement.ConclusionPharmacist‐furnished PrEP is rapidly gaining support as a means to expand access to HIV prevention tools. State‐to‐state differences in legislation will have an impact on implementation and scalability of these models. It will be important to observe states that were early adopters of this type of legislation and who experienced challenges in implementing such programs in order to refine the new legislation being presented in other states.

The potential benefits of long-acting injectable cabotegravir in pregnant and breastfeeding women and their infants.

Pregnant and breastfeeding women (PBW) in sub-Saharan Africa have high HIV incidence rates and associated risk of vertical transmission to their infants. Oral preexposure prophylaxis (PrEP) and injectable PrEP (long-acting cabotegravir, or CAB-LA) can potentially reduce this HIV transmission, but population-level impacts are uncertain. We extended a previously developed model of HIV and PrEP in South Africa to allow for variable PrEP duration and preference in PBW. We considered three potential scenarios for PrEP provision to PBW: oral PrEP only, CAB-LA only, and allowing oral/CAB-LA choice, with uptake and retention assumptions informed by South African data, each compared with a 'base' scenario without PrEP for PBW. Without PrEP for PBW, the model estimates 1.31 million new infections will occur between 2025 and 2035 in South African adults and children, including 100 000 in PBW, 16 800 in infants at/before birth, and 35 200 in children through breastmilk. In the oral PrEP-only scenario, these numbers would reduce by 1.2% (95% CI: 0.7-1.7%), 8.6% (4.8-12.9%), 4.0% (2.1-5.8%), and 5.3% (3.0-8.2%) respectively. In the CAB-LA-only scenario, the corresponding reductions would be 6.1% (2.9-9.6%), 41.2% (19.8-65.0%), 12.6% (6.0-19.4%), and 29.5% (13.9-46.8%), respectively, and in the oral/CAB-LA choice scenario, similar reductions would be achieved [5.6% (3.4-8.0%), 39% (23.4-55.9%), 12.4% (7.4-16.8%) and 27.6% (16.5-39.9%) respectively]. CAB-LA has the potential to be substantially more effective than oral PrEP in preventing HIV acquisition in PBW and vertical transmission, and can also modestly reduce HIV incidence at a population level.

Effect of implementation strategies on pre-exposure prophylaxis persistence among female sex workers in South Africa: an interrupted time series study

A disproportionate number of new HIV infections in South Africa are among female sex workers; pre-exposure prophylaxis (PrEP) for HIV prevention is freely available to female sex workers in the country, but unique barriers challenge PrEP persistence. TB HIV Care, a large South African non-profit organisation that provides daily oral PrEP (tenofovir disoproxil fumarate and emtricitabine), has implemented multiple strategies to improve PrEP persistence. We aimed to evaluate the effect of different implementation strategies on PrEP persistence in a large-scale real-world setting. In this interrupted time series study, we estimated level changes in 1-month oral PrEP persistence associated with roll-out of various implementation strategies among female sex workers across nine districts in South Africa. We used routinely collected data from TB HIV Care programme files from June 7, 2016, to April 30, 2021. Poisson regression of 1-month persistence was used to assess the effect of these strategies. In secondary analyses, we tested the association between each of the strategies and 4-month persistence. The median 1-month PrEP persistence for female sex workers was 33% (IQR 27-40). SMS support and refill reminders were associated with an 11% relative increase in 1-month persistence (risk ratio [RR] 1·11, 95% CI 1·02-1·26) and clinical mentoring for PrEP providers was associated with a 127% relative increase (RR 2·27, 95% CI 1·94-2·66) among female sex workers. The loyalty rewards programme was negatively associated with 1-month persistence (RR 0·71, 95% CI 0·67-0·83). Although clinical mentoring improved 4-month persistence, SMS support text messages had no significant effect. Identification and subsequent use of clinical mentoring for PrEP providers and SMS support and refill reminders might improve the usefulness of PrEP overall to prevent new HIV infections among female sex workers. PrEP persistence remains an important issue, and strategies to build on our findings are needed. National Institute of Mental Health and National Institute of Allergy and Infectious Diseases.

965. Projecting the Potential Clinical and Economic Impact of HIV Prevention Resource Reallocation in Tennessee

Abstract Background In 2023, the State of Tennessee rejected $6.2M in US Centers for Disease Control and Prevention (CDC) HIV prevention funding, redirecting support away from men who have sex with men (MSM), transgender women (TGW), people who inject drugs (PWID), and heterosexual Black women (HSBW), and towards first responders (FR), pregnant people (PP), and survivors of sex trafficking (SST). Methods We used a microsimulation model of HIV to compare the clinical impact of Current, present allocation of condoms, pre-exposure prophylaxis (PrEP), and HIV testing to CDC priority risk groups (MSM/TGW/PWID/HSBW); with Reallocation, diverting funds to increase HIV testing and linkage of Tennessee-determined priority populations (FR/PP/SST). We simulated Tennesseans with undiagnosed and incident HIV. Model inputs included condom use (45-67%), PrEP use (0.2-8%), HIV testing frequency (every 2.5-4.8 years), and 30-day linkage to HIV care (56-65%). We assumed Reallocation would reduce condom use (-4%), PrEP provision (-26%), and HIV testing (-47%) in MSM/TGW/PWID/HSBW while it would increase HIV testing among FR (+47%) and 30-day linkage to HIV care (to 100%/90%) among PP/SST; we varied these assumptions in sensitivity analyses. We conservatively assumed no impact of Reallocation on people with HIV already in care. 10-year model outcomes included HIV transmissions, numbers diagnosed and virologically suppressed, deaths, life-years lost, and cost/death averted. Results Over 10 years, Current would lead to 6,678 total HIV transmissions, 1,989 deaths, and 85,270 life-years in Tennessee (Table 1). Reallocation would lead to 178 additional HIV transmissions, 219 additional HIV deaths, and 985 more life-years lost; more people would be undiagnosed and fewer would be virologically suppressed (Figure 1). Under Current, Tennessee would spend $263,830/death averted; under Reallocation, $4,133,330/death averted, a 1,470% increase in cost/death averted (Table 2). Results were most sensitive to reductions in HIV testing rates under Reallocation.Figure 1.Number of simulated people with HIV in Tennessee who have undiagnosed HIV, compared to people who have diagnosed HIV and are virologically suppressed at 10 years Figure 1 presents the projected number of people with HIV across each risk group who are undiagnosed (light shade) compared to those who are diagnosed and virologically suppressed (dark shade) at 10 years under the Current (blue) and Reallocation (gray) scenarios. Under Current, there are fewer total people with undiagnosed HIV, and more people with diagnosed HIV at year 10 compared with Reallocation. Reallocation does increase the number of people with HIV who are virologically suppressed amongst first responders, pregnant people, and survivors of sex trafficking; however, the increase is relatively small compared to the decrease in virologic suppression among men who have sex with men, transgender women, people who inject drugs, and heterosexual Black women. *Survivors of sex trafficking are assumed to be diagnosed when freed from sex trafficking in Current and Reallocation, but in Reallocation the linkage to HIV care is assumed to increase from 56% to 90%. Conclusion Reallocation of HIV prevention funding in Tennessee would greatly harm MSM/TGW/PWID/HSBW, confer minimal benefits for FR/PP/SST, and cannot be justified on either clinical or epidemiological grounds. Disclosures Allison Agwu, MD, MSc, Gilead: Board Member|Gilead: Grant/Research Support|Merck: Advisor/Consultant|Merck: Grant/Research Support|ViiV: Board Member

HIV pre-exposure prophylaxis provision by U.S. health centers in 2021.

The aim of this study was to assess HIV preexposure prophylaxis (PrEP) provision in U.S. health centers. The U.S. Ending the HIV Epidemic (EHE) initiative designated health centers as the main healthcare system through which PrEP scale-up occurs. Health centers offer primary care to over 30 million disproportionately uninsured, racially or ethnically minoritized, and low-income patients. This study is the first to assess PrEP provision across health centers, including characteristics of clinics, patient populations, and policies associated with PrEP prescribing. The Health Resources and Services Administration's Uniform Data System contained aggregate data on PrEP prescriptions and patient sociodemographics at health centers from January 1 through December 31, 2021, in 50 U.S. states, the District of Columbia, and eight U.S. territories. We compared patient demographics and availability of Medicaid expansion and PrEP assistance programs at health centers that prescribed vs. those that did not prescribe PrEP. Across 1375 health centers serving 30 193 278 patients, 79 163 patients were prescribed PrEP. Health centers that prescribed any PrEP had higher proportions of sexual, gender, racial, and ethnic minority patient populations compared with health centers that prescribed no PrEP. Compared with health centers that prescribed no PrEP, a higher proportion of health centers that prescribed PrEP were located in designated high-priority jurisdictions of the EHE initiative or states with Medicaid expansion or public PrEP assistance programs. Health centers are critical for scaling up PrEP in minoritized populations disproportionately affected by HIV, facilitated through federal and state-level policies. These findings highlight service gaps and inform future interventions to optimize PrEP implementation and support EHE initiative goals.

The Use of HIV Pre-exposure Prophylaxis Among Men Accessing Routine Sexual and Reproductive Health Services in South Africa

PurposeThis study describes a cohort of men seeking oral pre-exposure prophylaxis (PrEP) services and explores their patterns of PrEP use within an implementation project seeking to integrate PrEP provision within sexual and reproductive health services in public health clinics in South Africa. MethodsRoutine program and survey data from 364 males initiated on oral PrEP between July 2020 and May 2022 were analyzed. PrEP use was examined, including time to first discontinuation and restart patterns. Factors associated with early PrEP discontinuation and PrEP restart were analyzed. ResultsDespite primarily focusing on access for adolescent girls and young women, PrEP services reached males with HIV prevention needs. PrEP use for ≤1 month (early discontinuation) was high at 58%; however, 18% restarted on PrEP, with 4% restarting repeatedly. Having depression symptoms was associated with early PrEP discontinuation (adjusted odds ratio [AOR]: 1.71, 95% CI [confidence interval]: 1.06–2.78). Those ≥25 years were less likely to discontinue early, as were those with a partner treated for a sexually transmitted infection in the preceding three months (AOR: 0.33, 95% CI: 0.13–0.84) and those who had been circumcised (AOR: 0.59, 95% CI: 0.36–0.96). Those 18–20 years old were less likely to restart PrEP than those ≥25 years (AOR: 0.43, 95% CI: 0.19–0.97), as were those whose partner's HIV status was unknown (AOR: 0.33, 95% CI: 0.12–0.88). DiscussionThis study identified interest and uptake of oral PrEP among an underrepresented population of predominantly heterosexual males seeking sexual and reproductive health services. It found high rates of early PrEP discontinuation, with a subset returning to restart PrEP. Further research is needed to determine whether these periods of PrEP use are associated with periods of HIV risk.

Online-Mediated HIV Pre-exposure Prophylaxis Care and Reduced Monitoring Frequency for Men Who Have Sex With Men: Protocol for a Randomized Controlled Noninferiority Trial (EZI-PrEP Study).

Daily and event-driven HIV pre-exposure prophylaxis (PrEP) with oral tenofovir-emtricitabine is highly effective to prevent HIV in men who have sex with men (MSM). PrEP care generally consists of in-clinic monitoring every 3 months that includes PrEP dispensing, counseling, and screening for HIV and sexually transmitted infections (STIs). However, the optimal frequency for monitoring remains undetermined. Attending a clinic every 3 months for monitoring may be a barrier for PrEP. Online-mediated PrEP care and reduced frequency of monitoring may lower this barrier. The primary objective of this study is to establish the noninferiority of online PrEP care (vs in-clinic care) and monitoring every 6 months (vs every 3 months). The secondary objectives are to (1) examine differences between PrEP care modalities regarding incidences of STIs, HIV infection, and hepatitis C virus infection; retention in PrEP care; intracellular tenofovir-diphosphate concentration; and satisfaction, usability, and acceptability of PrEP care modalities; and (2) evaluate associations of these study outcomes with sociodemographic, behavioral, and psychological characteristics. This study is a 2×2 factorial, 4-arm, open-label, multi-center, randomized, controlled, noninferiority trial. The 4 arms are (1) in-clinic monitoring every 3 months, (2) in-clinic monitoring every 6 months, (3) online monitoring every 3 months, and (4) online monitoring every 6 months. The primary outcome is a condomless anal sex act with a casual partner not covered or insufficiently covered by PrEP (ie, "unprotected act") as a proxy for HIV infection risk. Eligible individuals are MSM, and transgender and gender diverse people aged ≥18 years who are eligible for PrEP care at 1 of 4 participating sexual health centers in the Netherlands. The required sample size is 442 participants, and the planned observation time is 24 months. All study participants will receive access to a smartphone app, which contains a diary. Participants are requested to complete the diary on a daily basis during the first 18 months of participation. Participants will complete questionnaires at baseline and 6, 12, 18, and 24 months. Dried blood spots will be collected at 6 and 12 months for assessment of intracellular tenofovir-diphosphate concentration. Incidence rates of unprotected acts will be compared between the online and in-clinic arms, and between the 6-month and 3-month arms. Noninferiority will be concluded if the upper limit of the 2-sided 97.5% CI of the incidence rate ratio is <1.8. The results of the main analysis are expected in 2024. This trial will demonstrate whether online PrEP care and monitoring every 6 months is noninferior to standard PrEP care in terms of PrEP adherence. If noninferiority is established, these modalities may lower barriers for initiating and continuing PrEP use and potentially reduce the systemic burden for PrEP providers. ClinicalTrials.gov NCT05093036; https://tinyurl.com/28b8ndvj. DERR1-10.2196/51023.

HIV Preexposure Prophylaxis Provision among Adolescents: 2018 to 2021.

HIV preexposure prophylaxis (PrEP) is safe, effective, and was approved for adolescents in 2018. Adolescents and young adults make up 20% of HIV diagnoses in the United States. Our objective was to describe trends in adolescents prescribed PrEP during 2018 through 2021 and characteristics of these adolescents and their PrEP providers. We identified adolescents aged 13 to 19 years with oral PrEP prescriptions during 2018 through 2021 in a national pharmacy database using a validated algorithm. We assessed trends by calculating the overall percentage change and estimated annual percentage change with 95% confidence intervals. We described characteristics of adolescents and their PrEP providers in 2021. We performed χ2 analyses to assess differences by sex and age group. The number of adolescents prescribed PrEP increased 76.2% from 2018 to 2021 (estimated annual percentage change: 18.0% [95% confidence interval: 16.6-19.5]), despite decreases in 2020. We observed increases among all sex and age groups, with larger increases among older adolescents aged 18 to 19 years. The majority of the 6444 adolescents prescribed PrEP in 2021 were male (82.6%) and aged 18 to 19 years (87.8%). Among 2455 physician PrEP providers, 29.6% were pediatricians, with varying specialty distributions by adolescent age group (P < .001). Among the 217 pediatricians who prescribed PrEP to adolescents aged 13 to 17 years, 67.7% were general pediatricians. PrEP provision for adolescents has increased, largely among older and male adolescents. The availability of PrEP provides an important opportunity for pediatric providers to take an active role in HIV prevention.

Effectiveness, Acceptability, and Feasibility of a Telehealth HIV Pre-Exposure Prophylaxis Care Intervention Among Young Cisgender Men and Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

Despite its promise for HIV prevention, the uptake of pre-exposure prophylaxis (PrEP) has been slow, and there have been substantial inequities in PrEP access. Young men who have sex with men and transgender women of color are most in need of PrEP and least likely to have that need fulfilled. PrEP telehealth care, which provides remote PrEP care via electronic communication, seems well suited to address several of the challenges of PrEP provision, including discomfort with stigmatizing and difficult-to-access health care systems, transportation challenges, and privacy concerns, and address disparities in PrEP access. Research suggests that PrEP telehealth care has promise and is a favored option for many prospective recipients of PrEP. However, despite growing attention to telehealth approaches as an avenue for increasing access to PrEP amidst the COVID-19 pandemic, there have been no published randomized controlled trials (RCTs) on PrEP telehealth care to date, making it difficult to draw strong conclusions about the advantages or disadvantages of telehealth compared with usual PrEP care. We developed PrEPTECH, a telehealth intervention that focuses specifically on alleviating issues of stigma, access, cost, and confidentiality for young people with risk factors for HIV infection who are seeking PrEP care. Leveraging data from the 2017 observational pilot study, we redesigned and enhanced PrEPTECH. This study aims to assess the effectiveness, acceptability, and feasibility of a telehealth HIV PrEP care intervention, PrEPTECH, in increasing PrEP uptake. This is the protocol for an RCT of young cisgender men and transgender women who have sex with men in 4 regions within the United States: the San Francisco Bay Area, California; Los Angeles County, California; Miami-Dade County, Florida; and Broward County, Florida. Participants in the intervention arm received access to a web-based telehealth program, PrEPTECH, which offers a fully web-based pathway to PrEP, whereas those in the control arm received access to a dynamic web page containing publicly available informational resources about PrEP. Follow-up data collection occurred at 3 and 6 months. An analysis will be conducted on outcomes, including PrEP initiation, persistence, adherence, coverage, and medication prescription, as well as PrEPTECH acceptability and feasibility. The study was funded in 2019 and received institutional review board approval in 2020. The PrEPTECH intervention was developed over the next 1.5 years. Study recruitment was launched in February 2022 and completed in September 2022, with 229 participants recruited in total. Data collection was completed in April 2023. The results of this RCT will offer valuable evidence regarding the effectiveness, acceptability, and feasibility of telehealth HIV PrEP care interventions among young cisgender men and transgender women who have sex with men. ClinicalTrials.gov NCT04902820; https://clinicaltrials.gov/ct2/show/NCT04902820. PRR1-10.2196/47932.

Considerations for PrEP Implementation at Federally Qualified Health Centers in Mississippi: Perspectives From Staff and Patients.

Pre-exposure prophylaxis (PrEP) uptake remains low in the southeastern United States ("the South"), likely owing to overlapping structural barriers, including the lack of nearby PrEP providers. Federally qualified health centers (FQHCs) are potential sites through which to expand PrEP availability in the South, and telemedicine is promising for these services. This study investigated considerations for PrEP implementation at FQHCs and the use of telemedicine through qualitative interviews with 19 FQHC staff and 17 PrEP-eligible patients in Mississippi. Results indicated that existing infrastructure and policies at FQHCs can support PrEP implementation and that additional needed resources include more education for providers and strategies to advertise PrEP services. Findings suggest that using telemedicine for PrEP can address some regional implementation barriers (e.g., transportation problems and confidentiality concerns) but may present new ones (e.g., concerns about patients performing home HIV/STI testing procedures). Results can inform future PrEP implementation efforts in the South.

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.

Policymakers’ and healthcare providers’ perspectives on the introduction of oral pre-exposure prophylaxis for key populations in Ghana

BackgroundKey populations (KPs) such as female sex workers (FSWs), men who have sex with men (MSM), people who inject drugs (PWID), and their partners contribute more than a quarter (27.5%) of new HIV infection in Ghana. Oral pre-exposure prophylaxis (PrEP) can substantially reduce HIV acquisition among this group. While the available research indicates KPs willingness to take PrEP in Ghana, little is known about the position of policymakers and healthcare providers on the introduction of PrEP for KPs.MethodsQualitative data were collected from September to October 2017 in the Greater Accra (GA) and Brong-Ahafo (BA) regions of Ghana. Key informant interviews were conducted with 20 regional and national policymakers and supplemented with In-depth Interviews with 23 healthcare providers to explore their level of support for PrEP and their perspectives on challenges and issues to consider for oral PrEP implementation in Ghana. Thematic content analysis was used to unearth the issues emerging from the interviews.ResultsPolicymakers and healthcare providers in both regions expressed strong support for introducing PrEP for KPs. Key concerns regarding oral PrEP introduction included potential for behavioral disinhibition, non-adherence and side effects of medication, cost and long-term financial implications, and stigma related to HIV and key populations. Participants stressed the need to integrate PrEP into existing services and the provision of PrEP should start with high risk groups like sero-discordant couples, FSWs and MSM.ConclusionsPolicymakers and providers recognize the value of PrEP in cubing new HIV infections but have concerns about disinhibition, non-adherence, and cost. Therefore, the Ghana health service should roll-out a range of strategies to address their concerns including: sensitization with providers to mitigate underlying stigma towards KPs, particularly MSM, integration of PrEP into existing services, and innovative strategies to improve continued use of PrEP.

Protocol for WeExPAnd: a prospective, mixed-methods pilot demonstration study to increase access to pre-exposure prophylaxis among women vulnerable to HIV infection in the Southern USA

IntroductionAfrican American women (AA), particularly those living in the Southeastern USA, experience disproportionately high rates of HIV infection. Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention tool that may...