HIV Pre-exposure Prophylaxis Programs Research Articles

Acceptability and Feasibility of Implementing a Home-Based HIV Pre-Exposure Prophylaxis Program in an Urban Clinic.

Personal and structural barriers to HIV pre-exposure prophylaxis (PrEP) care result in its underutilization and premature discontinuation. A home-based PrEP program comprised of telemedicine visits and/or self-administered lab testing may address some of these barriers. Our objective was to assess the acceptability and feasibility of a home-based PrEP program among stakeholders at an urban HIV and primary care clinic. We used the consolidated framework for implementation research to evaluate determinants of successful implementation of the program. We surveyed and interviewed PrEP patients and their health care team. In a baseline survey of PrEP users (n = 112) administered between May 2021 and August 2022, 65% expressed interest in switching to the home-based PrEP program. Seventeen patients over the course of follow-up through December 2023 started home-based PrEP, including 12 patients who completed both a telemedicine visit and a self-administered lab kit, and 5 patients who completed only a telemedicine visit. Of these, over 80% had positive feedback on the telemedicine visits. Survey results demonstrated excellent acceptability and feasibility of the lab kits. Patients indicated in interviews that the home-based PrEP program provided the strong advantage of convenience. Despite mixed feelings from PrEP providers on telemedicine visits (n = 5), most felt that the program made PrEP care delivery easier for patients and would encourage their patients to use the program if it were a good fit. Barriers to program success included shipping delays and staff turnover during program implementation. In conclusion, uptake of the home-based program was low but program participants expressed high acceptability.

Absence of Lymphogranuloma Venereum Among Men Who Have Sex With Men With Rectal Chlamydia trachomatis Infections Within an HIV Preexposure Prophylaxis Program in Hanoi, Vietnam.

Absence of Lymphogranuloma Venereum Among Men Who Have Sex With Men With Rectal Chlamydia trachomatis Infections Within an HIV Preexposure Prophylaxis Program in Hanoi, Vietnam.

Routine Testing for Chlamydia trachomatis and Neisseria gonorrhoeae Infections within an HIV Pre-Exposure Prophylaxis Program in Hanoi, Vietnam: Implications for Low- and Middle-Income Countries.

Data on Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) infections within HIV pre-exposure prophylaxis (PrEP) programs in low- and middle-income countries (LMICs) are limited. Our study reports the prevalence, anatomical distribution, and correlates of NG and CT infections within an HIV PrEP program in Hanoi, Vietnam. From January-December 2022, HIV PrEP program clients who were male at birth, ≥16 years old, reported ≥1 male sex partner in the prior 12 months, were enrolled. A questionnaire collected sociodemographics, sexual behaviors, and clinical data. CT/NG testing was performed on self-collected urine, rectal, and pharyngeal specimens. Multivariate logistic regression was used to identify factors associated with CT and NG infections. There were 529 participants enrolled, the median age was 25.1 years. The overall prevalence of CT or NG was 28.9% (153/529). The prevalence of NG was 14.3% and highest for pharyngeal infections (11.7%), while for CT, the prevalence was 20.4% and highest for rectal infections (14.0%). Symptoms in the prior week were reported by 45.8% (70/153) of those with CT or NG infections. Condomless anal sex (aOR= 1.98; 95% CI: 1.27, 3.08) and sexualized drug use in the prior 6 months (aOR= 1.68; 95% CI: 1.07, 2.65) were associated with CT/NG infections. Our study found a high prevalence of NG and CT infections, including pharyngeal and rectal infections, within an HIV PrEP program in Hanoi, Vietnam. The findings underscore the need for further research on CT/NG prevention and the development of evidence-based guidelines for CT/NG screening in HIV PrEP programs in LMIC settings.

Mycoplasma genitalium Infections Among Participants in an HIV Pre-exposure Prophylaxis Program in Hanoi, Vietnam.

Mycoplasma genitalium causes a sexually transmitted infection and is also emerging as an important antimicrobial resistant pathogen. Data on M. genitalium infections among men who have sex with men (MSM) in low-resource settings are sparse. From January to December 2022, participants in an HIV pre-exposure prophylaxis (PrEP) program in Hanoi, Vietnam were enrolled into the study. Demographic, behavioral, and clinical characteristics were collected. Self-collected urine, rectal, and pharyngeal specimens were tested for M. genitalium using the Alinity m STI Assay (Abbott Molecular, USA). Univariate and multivariate logistic regression were performed to assess for factors associated with infections. Among 477 participants, the median age was 25.3 years (21.7-29.6) and 92.2% (n = 440) identified as MSM; 48.6% had ≥2 sex partners and 38.1% reported condomless anal sex in the prior month. The overall prevalence of M. genitalium infection was 10.9% (52/477); 7.3% (34/464) rectal, 3.2% (15/476) urethral, and 1.9% (9/476) pharyngeal. Infections were asymptomatic in 71.2% (37/52). Among those with M. genitalium , 30.7% (16/52) were co-infected with either Neisseria gonorrhoeae or Chlamydia trachomatis. Among those reporting rectal (n = 51) or urethral (n = 35) symptoms, but without C. trachomatis or N. gonorrhoeae co-infections, five (9.8%) had rectal infections and one (2.9%) had urethral infection. Participants with M. genitalium were more likely to be asymptomatic than participants without M. genitalium (adjusted odds ratio, 1.93; 95% confidence interval, 1.01-3.71). Mycoplasma genitalium infections were common among primarily MSM engaged in an HIV PrEP program in Vietnam. The prevalence was highest in rectal specimens and nearly three quarters of M. genitalium infections were asymptomatic. Testing for M. genitalium infections among those with symptoms is important to enable pathogen-directed therapy. Additional research on antimicrobial resistance and treatment strategies for M. genitalium in low-resource settings is needed.

HIV Care Continuum and Preexposure Prophylaxis Program in Federal Bureau of Prisons, United States.

In 2019, the US Department of Health and Human Services launched the Ending the HIV Epidemic in the US initiative (EHE) with the goal of reducing new HIV infections by 90% by 2030. This initiative identifies 4 pillars (diagnose, treat, prevent, and respond) to address the HIV epidemic in the United States. To advance the EHE goals, the Federal Bureau of Prisons (FBOP) has implemented interventions at all points of the HIV care continuum. The FBOP has addressed the EHE pillar of prevention through implementing preexposure prophylaxis, developing a strategy to decrease the risk of new HIV infection, and providing guidance to FBOP healthcare providers. This article describes the implementation of programs to improve the HIV care continuum and end the epidemic of HIV within the FBOP including a review of methodology to implement an HIV preexposure prophylaxis program.

Protocol for a systematic review and critical discourse analysis of research on HIV pre-exposure prophylaxis programme use among gay, bisexual, and other men who have sex with men

Background HIV pre-exposure prophylaxis (PrEP) is a pill that prevents the transmission of HIV from sexual partners living with HIV; it is frequently taken by gay, bisexual, and other men who have sex with men (gbMSM). PrEP is often provided through formal PrEP programmes. Research on these programmes may employ discourses shaped by heteronormativity and homophobia. Given that expert language influences how HIV prevention is understood and delivered, problematic discourses in research likely extends into PrEP programme implementation. This review will use critical discourse analysis (CDA) to explore research on PrEP programme implementation for gbMSM. Within this literature, we will identify interpretive repertoires used to discuss gbMSM; the subject positions afforded to gbMSM; and the implications of these interpretive repertoires and subject positions for gbMSM engaging with HIV PrEP programmes. Methods Relevant articles will be identified through timebound searching (2012-present) in ProQuest ASSIA, EBSCOhost PsycInfo, OVID Medline, OVID Embase, and EBSCOhost CINAHL, with forward and backward citation searching of included studies. Grey literature will be identified through ProQuest and Google Scholar. Screening will be conducted by two independent reviewers, who will conduct double screening for titles, abstracts, and full texts. Data will be analysed and synthesised using CDA informed by critical realism (CR). CDA focuses on relationships between language and power, including how language enables inequality. The analytic process will explore the background of included studies, identify overarching themes, analyse external and internal relations in included studies, and interpret the meaning of identified themes and relations. Conclusions Highlighting issues with discourses in PrEP implementation may enhance reflective engagement with assumptions underlying this research, preventing further stigmatisation of gbMSM’s sexual and protective practices. As PrEP programmes become more common globally, more diverse and inclusive perspectives in PrEP programme research may inform interventions that enhance their acceptability and ultimately their implementation.

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.

Screening for monkeypox virus infections in men who have sex with men in a sexual health clinic in Hanoi, Viet Nam.

Screening for monkeypox virus infections in men who have sex with men in a sexual health clinic in Hanoi, Viet Nam.

2211. High prevalence of Chlamydia trachomatis and Neisseria gonorrhoeae identified through routine screening for rectal, pharyngeal, and urethral infections within a HIV pre-exposure prophylaxis program in Hanoi, Vietnam

Abstract Background Pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention and is being scaled up globally. Patients on PrEP have high rates of bacterial STIs, like Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), thus routine screening is recommended. However, access to screening tests for STIs are limited in many low-resource settings. The objectives of this study were to determine the prevalence of CT and NG among participants in Vietnam’s first PrEP program. Methods From January through April 2022 participants in the PrEP program at the Sexual Health Promotion Clinic in Hanoi, Vietnam were recruited to study STI prevalence. Study participants completed a survey collecting demographic, behavioral and clinical characteristics. Participants self-collected urine, rectal, and pharyngeal specimens for nucleic-acid testing. Participants positive for NG had an additional specimen collected for culture and antibiotic susceptibility. Results In total, 108 participants were enrolled, median age was 24 years (IQR: 22– 28). All were male and reported having sex with men in the prior 12 months. The median number of sex partners in the prior 1 month was 1 (IQR: 1 – 2). Symptoms within the prior week were reported by 41.7% (45/108) – 19.4% reported rectal, 15.7% reported urethral, and 26.9% reported pharyngeal symptoms. The overall prevalence of CT or NG infections was 31.5% (34/108). The prevalence of CT was 24.1% (26/108); by anatomic site, there were 17 (15.7%) rectal, 10 (9.3%) pharyngeal, and 6 (5.6%) urethral infections. The prevalence of NG was 13.0% (14/108); there were 12 (11.1%) pharyngeal, 9 (8.3%) rectal, and 0 urethral infections. Among participants reporting any symptoms, CT prevalence was 26.7% (12/45) and NG prevalence 13.3% (6/45). All infections were treated. Conclusion The prevalence of CT and NG was very high among this population of young MSM in a PrEP program in Hanoi, Vietnam. A high proportion of CT infections were rectal (65%) and 86% of NG infections were pharyngeal. These findings highlight the need for expanded access to extragenital nucleic-acid testing among PrEP programs in low- and middle-income countries. Studies demonstrating the benefit of CT/NG screening and treatment within PrEP programs are urgently needed. Disclosures Jeffrey Klausner, MD MPH, Cepheid: Advisor/Consultant|Cepheid: Grant/Research Support|Cepheid: Research equipment and supplies.

Public Health Implications of Adapting HIV Pre-exposure Prophylaxis Programs for Virtual Service Delivery in the Context of the COVID-19 Pandemic: Systematic Review.

BackgroundThe novel coronavirus disease COVID-19 caused by SARS-CoV-2 threatens to disrupt global progress toward HIV epidemic control. Opportunities exist to leverage ongoing public health responses to mitigate the impacts of COVID-19 on HIV services, and novel approaches to care provision might help address both epidemics.ObjectiveAs the COVID-19 pandemic continues, novel approaches to maintain comprehensive HIV prevention service delivery are needed. The aim of this study was to summarize the related literature to highlight adaptations that could address potential COVID-19–related service interruptions.MethodsWe performed a systematic review and searched six databases, OVID/Medline, Scopus, Cochrane Library, CINAHL, PsycINFO, and Embase, for studies published between January 1, 2010, and October 26, 2021, related to recent technology-based interventions for virtual service delivery. Search terms included “telemedicine,” “telehealth,” “mobile health,” “eHealth,” “mHealth,” “telecommunication,” “social media,” “mobile device,” and “internet,” among others. Of the 6685 abstracts identified, 1259 focused on HIV virtual service delivery, 120 of which were relevant for HIV prevention efforts; 48 pertained to pre-exposure prophylaxis (PrEP) and 19 of these focused on evaluations of interventions for the virtual service delivery of PrEP. Of the 16 systematic reviews identified, three were specific to PrEP. All 35 papers were reviewed for outcomes of efficacy, feasibility, and/or acceptability. Limitations included heterogeneity of the studies’ methodological approaches and outcomes; thus, a meta-analysis was not performed. We considered the evidence-based interventions found in our review and developed a virtual service delivery model for HIV prevention interventions. We also considered how this platform could be leveraged for COVID-19 prevention and care.ResultsWe summarize 19 studies of virtual service delivery of PrEP and 16 relevant reviews. Examples of technology-based interventions that were effective, feasible, and/or acceptable for PrEP service delivery include: use of SMS, internet, and smartphone apps such as iText (50% [95% CI 16%-71%] reduction in discontinuation of PrEP) and PrEPmate (OR 2.62, 95% CI 1.24-5.5.4); telehealth and eHealth platforms for virtual visits such as PrEPTECH and IowaTelePrEP; and platforms for training of health care workers such as Extension for Community Healthcare Outcomes (ECHO). We suggest a virtual service delivery model for PrEP that can be leveraged for COVID-19 using the internet and social media for demand creation, community-based self-testing, telehealth platforms for risk assessment and follow-up, applications for support groups and adherence/appointment reminders, and applications for monitoring.ConclusionsInnovations in the virtual service provision of PrEP occurred before COVID-19 but have new relevance during the COVID-19 pandemic. The innovations we describe might strengthen HIV prevention service delivery during the COVID-19 pandemic and in the long run by engaging traditionally hard-to-reach populations, reducing stigma, and creating a more accessible health care platform. These virtual service delivery platforms can mitigate the impacts of the COVID-19 pandemic on HIV services, which can be leveraged to facilitate COVID-19 pandemic control now and for future responses.

Nurse-led safer opioid supply and HIV pre-exposure prophylaxis: a novel pilot project.

Introduction:HIV pre-exposure prophylaxis (PrEP) is an effective intervention for preventing HIV infections yet is largely unknown to and underutilized among people who use drugs.Methods:To better provide services to this group, we present a prospective, single-group interventional study involving the creation of a partnership between a safer opioid supply program and an HIV PrEP program, both of which were nurse-led.Results:Overall, HIV PrEP was offered to 42 individuals within the safer opioid supply program, resulting in 55% (n = 23) acceptance. Almost half of the group that accepted PrEP identified as female, and nearly all participants were homeless and did not have a primary care provider. While it was challenging to obtain routine PrEP follow-up labs per guideline recommendations due to poor venous access, most participants were able to successfully stay on PrEP and maintained good medication adherence. There were no PrEP discontinuations due to renal impairment and no participants tested positive for HIV.Conclusion:This novel integration of programs appeared to be a highly effective way to expand access to HIV prevention among people who use drugs. Given the historical and current mistreatment of people who use drugs within the healthcare system, rapport and trust were essential to the uptake of HIV PrEP services. Further, the importance of infectious disease screening among people who use drugs is underscored, and built-in program flexibility and low barrier access is essential.

The demographic features and outcome indicators of the Barbados HIV Pre-exposure Prophylaxis Program, 2018-2019.

ABSTRACTObjective.To assess the demographics, risk profiles and outcome indicators of one of the few government-supported programs on pre-exposure prophylaxis (PrEP) in the English-speaking Caribbean.Methods.Chart review of all persons enrolled into the national PrEP Program from its inception on March 1st 2018 to November 30th 2019, with a descriptive summary analysis of the data extracted.Results.Of the 134 persons enrolled into the program most identified as men who have sex with men (67.9%), followed by men who have sex with men and women (14.9%); there were 20 persons, mostly men (85%), in sero-discordant relationships. PrEP uptake was 96%; however, the continuation rate (continuing for three consecutive months after initiation) was 61.5%. Continuation status for many could not be ascertained due to loss-to-follow-up. PrEP-associated toxicity prevalence was 2.3%, although side-effects occurred in 52% (mostly gastrointestinal). HIV positivity during the study period was 1.5%.Conclusions.Uptake of Barbados’ national PrEP Program is excellent but fairly low continuation rates and the HIV positivity rate indicate the need for improved pre-ART initiation education and follow-up processes. Service utilisation is mainly by men who have sex with men, and provision expansion to other civil society partners and private practitioners, as well as increased public awareness could increase access by other high-risk groups.

Population-level effectiveness of a national HIV preexposure prophylaxis programme in MSM.

Objective:The aim of this study was to evaluate Scotland's national HIV preexposure prophylaxis (PrEP) programme in relation to PrEP uptake and associated population-level impact on HIV incidence among MSM.Design:A retrospective cohort study within real-world implementation.Methods:Comparison of HIV diagnoses from national surveillance data and HIV incidence within a retrospective cohort of HIV-negative MSM attending sexual health clinics from the National Sexual Health information system between the 2-year periods pre(July 2015–June 2017) and post(July 2017–June 2019) introduction of PrEP.Results:Of 16 723 MSM attending sexual health services in the PrEP period, 3256 (19.5%) were prescribed PrEP. Between pre-PrEP and PrEP periods, new HIV diagnoses among MSM declined from 229 to 184, respectively [relative risk reduction (RRR): 19.7%, 95% confidence interval (95% CI) 2.5–33.8]; diagnosed recently acquired infections declined from an estimated 73 to 47, respectively (35.6%, 95% CI 7.1–55.4). Among MSM attending sexual health clinics, HIV incidence per 1000 person-years declined from 5.13 (95% CI 3.90–6.64) pre-PrEP to 3.25 (95% CI 2.30–4.47) in the PrEP period (adjusted IRR 0.57, 95% CI 0.37–0.87). Compared with the pre-PrEP period, incidence of HIV was lower in the PrEP period for those prescribed PrEP (aIRR 0.25, 95% CI 0.09–0.70) and for those not prescribed PrEP (aIRR 0.68, 95% CI 0.43–1.05).Conclusion:We demonstrate national population-level impact of PrEP for the first time in a real-world setting. HIV incidence reduced in MSM who had been prescribed PrEP and, to a lesser extent, in those who had not. Promotion of the benefits of PrEP needs to extend to MSM who do not access sexual health clinics.

Response to: Acceptability and Feasibility of a Pharmacist-Led HIV Pre-exposure Prophylaxis Program in the Midwestern United States.

Response to: Acceptability and Feasibility of a Pharmacist-Led HIV Pre-exposure Prophylaxis Program in the Midwestern United States.

High prevalence of Mycoplasma genitalium infection and macrolide resistance in patients enrolled in HIV pre-exposure prophylaxis program

ObjectivesLimited data on Mycoplasma genitalium infection has been reported among PrEP users. The aim of this study was to estimate the prevalence and macrolide resistance of M. genitalium infection among enrollees in a French PrEP program. Patients and methodsM. genitalium infection screening was systematically and prospectively proposed to patients of the Bordeaux PrEP program (between January 2016 and February 2017). Macrolide resistance was evaluated in M. genitalium-positive patients. ResultsAmong 89 clients, M. genitalium infection prevalence was 10% (mainly asymptomatic) with a high rate of macrolide resistance (58%). ConclusionsBecause of a high level of macrolide resistance, a systematic search for M. genitalium macrolide resistance associated-mutations may be recommended in PrEP users before initiating the antibiotic therapy.

HIV Pre-exposure Prophylaxis Program Implementation Using Intervention Mapping

HIV pre-exposure prophylaxis has been proven to be an effective tool in HIV prevention. However, numerous barriers still exist in pre-exposure prophylaxis implementation. The framework of Intervention Mapping was used from August 2016 to October 2017 to describe the process of adoption, implementation, and maintenance of an HIV prevention program from 2012 through 2017 in Houston, Texas, that is nested within a county health system HIV clinic. Using the tasks outlined in the Intervention Mapping framework, potential program implementers were identified, outcomes and performance objectives established, matrices of change objectives created, and methods and practical applications formed. Results include the formation of three matrices that document program outcomes, change agents involved in the process, and the determinants needed to facilitate program adoption, implementation, and maintenance. Key features that facilitated successful program adoption and implementation were obtaining leadership buy-in, leveraging existing resources, systematic evaluation of operations, ongoing education for both clinical and nonclinical staff, and attention to emergent issues during launch. The utilization of Intervention Mapping to delineate the program planning steps can provide a model for pre-exposure prophylaxis implementation in other settings.

Acceptance of HIV Pre-Exposure Prophylaxis (PrEP) Program at STD Clinic

Daily pre-exposure prophylaxis (PrEP) is highly effective in reducing risk of HIV infection from sex and drug injection, yet utilization remains low due to lack of knowledge among patients and providers, as well as access. HIV PrEP program was initiated at a sexually transmitted diseases (STD) clinic. 85 patients were enrolled at the STD program run by a local department of health over an 18-month period. Majority of patients were uninsured or on public assistance. Average duration of treatment was 9 months. Two individuals HIV seroconverted during the observation period. Overall, HIV PrEP was well accepted in a high-risk STD Clinic population. There continues to be need for greater public awareness to effectively implement PrEP along with other prevention strategies to reduce HIV infection in a real world setting

HIV Pre-exposure Prophylaxis Programs Incorporating Social Applications Can Reach At-Risk Men Who Have Sex With Men for Successful Linkage to Care in Missouri, USA

HIV Pre-exposure Prophylaxis Programs Incorporating Social Applications Can Reach At-Risk Men Who Have Sex With Men for Successful Linkage to Care in Missouri, USA

S01.3 Delivery of hiv/sti prevention interventions: prevention cascades

The HIV treatment cascade has been a powerful illustrative tool used to explore the performance of HIV treatment programs. The cascade steps through the recruitment of HIV-infected individuals into treatment programs and the effectiveness of those programs, and despite its conceptual flaws provides an intuitively appealing snapshot of performance. Because of its advocacy potential attempts have been made to generate a prevention cascade, covering those HIV positive and negative or to integrate prevention into the treatment cascade generating a ‘prevention, treatment and care cascade’. However, these tend to diminish the focus on prevention, confuse different interventions and do not provide a simple scheme through which to measure performance. Here we explore the required elements for prevention cascades for HIV and other sexually transmitted infections and identify the steps linking the delivery of interventions with their use in populations. Starting from the susceptible population at risk we can consider whether the intervention is available to them, whether they uptake the intervention, whether they adhere to the intervention and what the efficacy of the intervention is. Cascades for the delivery, use and effectiveness of prevention products should be able to identify who has been protected, what the key failures in protection are and the relative importance of system and product characteristics. In explaining theoretically how we might think about prevention programs we hope that empirical studies will consider adopting this framework, which has guided some thinking about voluntary medical male circumcision programs and HIV pre-exposure prophylaxis programs. In HIV treatment global targets and indicators have been set based on the treatment cascade and without similar targets for other prevention interventions they are likely to be neglected.