Antiretroviral Pre-exposure Prophylaxis Research Articles

HIV-related public stigma in the era of “Undetectable = Untransmittable”: a population-based study in Hong Kong

BackgroundWhile global efforts are increasingly relying upon biomedical advancements such as antiretroviral therapy and pre-exposure prophylaxis (PrEP) to end the HIV epidemic, HIV-related stigma remains a concern. This study aimed to assess the general public’s awareness and perception of “Undetectable = Untransmittable” (U = U) and PrEP, and the patterns of public stigma towards people living with HIV (PLWH) and their determinants in an Asian Pacific city.MethodsA population-based, self-administrated online survey was conducted between 10–20 March 2023. All adults aged ≥ 18 years and currently living in Hong Kong were eligible. Participants’ socio-demographic characteristics, awareness and perception of U = U and PrEP, as well as HIV-related stigma drivers, experience and practices were collected. Latent class analysis was used to delineate population subgroups based on their stigma profiles as reflected by 1.) fear of infection, 2.) concern about socioeconomic ramification of the disease, 3.) social norm enforcement, 4.) perceived stigma in the community, and 5.) stigmatising behaviours and discriminatory attitudes. Memberships of identified subgroups were then correlated with sociodemographic factors, awareness and perception of U = U and PrEP, using multinominal logistic regression.ResultsResponses from a total of 3070 participants (55% male; 79% aged 18–54) were analysed. A majority, 69% and 81%, indicated that they had never heard of U = U and PrEP respectively, and only 39–40% of participants perceived these to be effective in protection from HIV. Four distinct subgroups were identified, namely “Low stigma” (37%), “Modest stigma” (24%), “Moderate stigma” (24%), and “High stigma” (15%). Compared with “Low stigma”, lack of awareness of and/or negative perceptions towards U = U and/or PrEP, not knowing any PLWH were associated with increased odds of higher stigma group membership. Lower educational level and not in employment were associated with increased odds of membership in “Moderate stigma” and “High stigma”. While older people were more likely to belong to “High stigma”, female were more likely to belong to “Moderate stigma”. “Modest stigma” included more younger people who were economically active.ConclusionTwo-thirds of participants endorsed modest-to-high HIV-related stigma, suggesting the prevalence of HIV-related stigma was high among the general population in Hong Kong. Tailored interventions targeting specific stigma drivers and manifestations of individuals as reflected from the stigma profiles of distinct subgroups could form an important strategy for stigma reduction.

Development of normal reference intervals for renal function in pregnancy: a secondary analysis of clinical trial data

Background Due to its potential nephrotoxicity, screening for pre-existing renal function disorders has become a routine clinical assessment for initiating Tenofovir diphosphate fumarate (TDF)-containing antiretroviral treatment (ART) or pre-exposure prophylaxis (PrEP) in pregnant and non-pregnant adults. We aimed to establish reference values for commonly used markers of renal function in healthy pregnant women of African origin. Methods Pregnant women ≥18 years, not living with HIV, and at 14–28 weeks gestation were enrolled in a PrEP clinical trial in Durban, South Africa between September 2017 and December 2019. Women were monitored 4-weekly during pregnancy until six months postpartum. We measured maternal weight and serum creatinine (sCr) at each visit and calculated creatinine clearance (CrCl) rates using the Cockcroft–Gault (CG) and Modification of Diet in Renal Disease (MDRD) formulae. Reference ranges for sCr and CrCl by CG and MDRD calculations were derived from the mean ± 2SD of values for pregnancy and postdelivery. Results Between 14-–and 40 weeks gestation, 249 African women not exposed to TDF-PrEP contributed a total of 1193 renal function values. Postdelivery, 207 of these women contributed to 800 renal function values. The normal reference range for sCr was 30–57 and 32–60 umol/l in the 2nd and 3rd trimesters of pregnancy. Normal reference ranges for CrCl using the MDRD calculation were 129–282 and 119–267 ml/min/1.73m2 for the 2nd and 3rd trimesters, respectively. Using the CG method of calculation, normal reference ranges for CrCl were 120—304 and 123–309 ml/min/1.73m2 for the 2nd and 3rd trimesters respectively. In comparison, the normal reference range for sCr, CrCl by MDRD and CG calculations postpartum was 40–77 umol/l, 92–201, and 90–238 ml/min/1.73m2, respectively. Conclusions In African women, the Upper Limit of Normal (ULN) for sCr in pregnancy is approximately 20% lower than 6 months postnatally. Inversely, the Lower Limit of Normal (LLN) for CrCl using either MDRD or CG equation is approximately 35% higher than 6 months postnatally. We provide normal reference ranges for sCr and CrCl for both methods of calculation and appropriate for the 2nd and 3rd trimesters of pregnancy in African women.

Intimate Partner Violence and Adherence to PrEP and ART Among Ugandan HIV Serodifferent Couples.

Intimate partner violence (IPV) is associated with increased risk of HIV acquisition and reduced engagement in HIV care. There is limited understanding of the ways in which IPV exposure and other maladaptive relationship dynamics may influence adherence to antiretroviral treatment (ART) and pre-exposure prophylaxis (PrEP) for individuals in committed, HIV serodifferent partnerships. We used binomial generalized linear mixed-effect regression models to evaluate the association between IPV exposure and ART/PrEP adherence among members of serodifferent couples in Uganda. Secondarily, we assessed the association between relationship powerlessness and ART/PrEP adherence. We enrolled and followed both partners in 149 heterosexual serodifferent couples. The partner living with HIV was female in 64% of couples. IPV exposure was associated with low ART adherence (15% vs. 5% in quarters with no IPV, odds ratio: 4.78, 95% confidence interval: 1.48 to 15.42), but not low PrEP adherence (33% vs. 36%, P = 0.69). Among HIV-negative individuals, those reporting moderate relationship powerlessness were less likely to have poor PrEP adherence compared with those with low relationship powerlessness (20% vs. 30%, odds ratio: 0.57, 95% confidence interval: 0.36 to 0.90). We observed no association between relationship powerlessness and ART adherence. We found that IPV exposure was associated with low adherence to ART and that relationship powerlessness was associated with good adherence to PrEP. These findings contribute to the evidence base outlining the influence of IPV and relationship power on ART/PrEP adherence for individuals in HIV serodifferent unions.

How Would You Manage HIV Pre-exposure Prophylaxis in This Patient With Medical Comorbidities? : Grand Rounds Discussion From Beth Israel Deaconess Medical Center.

Despite advances in treatment, HIV infection remains an important cause of morbidity and mortality, with more than 30 000 new cases diagnosed in the United States each year. There are several interventions traditionally used to prevent HIV transmission, but these vary in effectiveness and there are challenges to their implementation. In 2014, the Centers for Disease Control and Prevention published initial guidance on the use of antiretroviral pre-exposure prophylaxis (PrEP) to prevent transmission of HIV infection in persons at risk based on multiple studies that showed it to be highly efficacious in various populations. It was updated in 2021 to reflect new drug options. The U.S. Preventive Services Task Force also recently updated its recommendations for PrEP, which strongly support its use in persons at risk. Despite its well-established effectiveness, the implementation of PrEP in clinical practice has been variable, especially among populations underserved by the medical system and marginalized by society. Fewer than one third of persons in the United States who are eligible for PrEP currently receive it. Here, 2 physicians experienced in HIV PrEP debate how best to identify patients who might benefit from PrEP, how to decide what regimen to use, and how to monitor therapy.

Impact of war on HIV-related healthcare services and health workers in eastern Ukraine: a qualitative study

ABSTRACT The 2022 Russian invasion of Ukraine has caused serious challenges for healthcare workers (HCWs) and HIV-related healthcare services. This study assessed the effects of the invasion on HCWs wellbeing and on continuity of HIV services, using in-depth interviews with HCWs from facilities offering HIV antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) services in the Donetsk region of Eastern Ukraine. A directed content analysis, with both inductive and deductive approaches, was conducted. Ten HCWs (6 [60%] doctors, 4 [40%] nurses; 9 [90%] female) were interviewed. Six respondents were displaced from their homes and worksites, and all described stress and threats to emotional wellbeing. HCWs used online consultations, encrypted mobile communication, and multi-month dispensing to support continuity of ART and PrEP services. They noted immediate needs for psychological and financial support, and access to laptop computers and mobile communications to ensure continuity of HIV services. Priorities for restoration of services include repair of health facilities, restoration of laboratory services and supply chains, and return of personnel and patients. HCWs made innovative, rapid adaptations to HIV services to keep ART and PrEP services running, demonstrating the resolve of Ukrainian HCWs to maintain continuity of HIV services despite the disruptions of war.

A pilot program of HIV pre-exposure prophylaxis in Thai youth.

There are gaps in knowledge and experience of antiretroviral pre-exposure prophylaxis (PrEP) delivery in adolescents. This pilot study enrolled Thai adolescents 14-20 year-old without HIV who reported risk behaviour. All participants were offered daily tenofovir/emtricitabine (TDF-FTC) and followed for 24 weeks. HIV testing, renal function, bone density scan, and sexually transmitted infection (STI) testing including syphilis serology and urine molecular testing for gonorrhoea and C. trachomatis were performed at baseline and weeks 12 and 24. Adherence was evaluated through intracellular tenofovir diphosphate (TFV-DP) levels in dried blood spots. Of the 61 enrolled adolescents, median age 18.1 (IQR: 14.8-20.9) years, 46 (75.4%) were males and 36 (59%) were MSM. Retention to week 24 was 80.3%. One third (36%) had TFV-DP levels consistent with taking ≥6 pills/week at week 12 and 29% at week 24. The factors associated with taking ≥6 pills/week were being MSM (adjusted odds ratio [aOR]: 53.2, 95% CI: 1.6-1811; p = 0.027), presence of STI at baseline (aOR: 9.4, 95% CI: 1.5-58.5; p = 0.016), and self-report of decreased condom use while taking PrEP (aOR: 8.7, 95% CI: 1.4-56.6; p = 0.023). 31% had an STI at baseline and this declined to 18% at week 24. No renal or bone toxicity was observed and there were no HIV seroconversions. Daily oral PrEP with FTC-TDF in high-risk Thai adolescents is feasible, accepted, well-tolerated, and had no increased risk compensation; however, low adherence was a major challenge. Adolescent-specific PrEP strategies including long-acting modalities are needed for successful HIV prevention.

Perceptions of and preferences for PrEP use among African American women and providers in the U.S. South: a qualitative study

Objective African American (AA) women in the U.S. South experience significant HIV incidence, and efforts to support antiretroviral pre-exposure prophylaxis (PrEP) uptake and maintenance among this group have been insufficient. This study aimed to explore perceptions, attitudes, and implementation preferences surrounding PrEP use for AA women in the U.S. South. Methods and Measures The study team conducted qualitative interviews with AA cisgender women clients (n = 21) and their providers (n = 20) in Federally Qualified Health Centers and HIV clinics in Alabama. The research team employed directed qualitative content analysis to analyze interview data. Results Five themes emerged: a) inconsistent access to PrEP and PrEP knowledge, b) need for improving low PrEP awareness, c) managing hesitancy to prescribe or use PrEP, d) perceived HIV vulnerability and inherent stigma, and e) normalizing PrEP as part of routine sexual healthcare to increase uptake and maintenance. Interviews revealed an openness towards PrEP as an HIV prevention strategy for AA, cisgender women in Alabama. Conclusion Improving PrEP uptake and maintenance among AA women in the U.S. South must go beyond increasing awareness to improving PrEP access and trust through visibility of AA women’s PrEP use and incorporating PrEP education and services into routine sexual healthcare.

Feasibility of Implementing a Low-Barrier Long-Acting Injectable Antiretroviral Program for HIV Treatment and Prevention for People Experiencing Homelessness.

Long-acting (LA) antiretrovirals may provide meaningful benefit to people who use drugs and people experiencing homelessness (PEH) who face disproportionate structural and psychosocial barriers in adhering to daily oral HIV antiretroviral therapy or pre-exposure prophylaxis (PrEP), but their use in these populations has not been studied. The Maria X. Martinez Health Resource Center is a low-barrier (eg, no appointment) community-based clinic serving San Francisco PEH. A multidisciplinary care model with robust monitoring and outreach support was developed to provide LA antiretroviral therapy (ART) and LA-PrEP to eligible patients experiencing difficulties adhering to oral antiretrovirals. Feasibility was assessed by evaluating the rates of HIV viremia and on-time injections among patients receiving LA antiretrovirals over the first 24 months of program implementation. Between November 2021 and November 2023, 33 patients initiated LA-ART or LA-PrEP (median age, 37 years; 27% transgender/nonbinary; 73% non-White; 27% street homeless; 52% sheltered homeless; 30% with opioid use disorder; 82% with methamphetamine use disorder). Among 18 patients with HIV, 14 initiated LA-ART injections with detectable viremia (median CD4 count, 340 cells/mm 3 ; mean log 10 viral load, 3.53; SD, 1.62), 8 had never previously been virally suppressed, and all but 1 achieved or maintained virologic suppression (mean, 9.67 months; SD, 8.30). Among 15 LA-PrEP patients, all remained HIV negative (mean, 4.73 months; SD, 2.89). Of 224 total injections administered, 8% were delayed >7 days. The implementation of LA antiretrovirals is feasible in low-barrier, highly supportive clinical settings serving vulnerable PEH. Expansion of such programs will be critical in ending the HIV epidemic.

Examination of Incidence of Sexually Transmitted Infections in the Ending the HIV Epidemic Priority Counties of the United States, 2005-2019.

The incidence of sexually transmitted infections (STIs) has been increasing in the United States, and this trend has continued alongside expanding/changing human immunodeficiency virus (HIV) prevention strategies, moving from reliance solely on behavioral interventions like condoms to biomedical methods like oral and injectable antiretroviral preexposure prophylaxis (PrEP). In 2019, the Ending the HIV Epidemic (EHE) initiative was released to prioritize resource allocation to the 50 jurisdictions in the United States with the highest HIV incidence, providing an opportunity to monitor STI incidence in a national group of discrete, geographic units and identify trends and differences across jurisdictions. Using existing data from the US CDC and Census Bureau, a retrospective analysis was conducted to examine the incidence of STIs in 49 of the 50 EHE priority counties between 2005 and 2019. This timeframe was divided into 2 periods representing a before and after entry into the biomedical era of HIV prevention: P1 (2005-2011) and P2 (2012-2019). A total of 49 EHE counties were included in this analysis, representing 27.4% of the total US population. Entry into the biomedical HIV prevention era was associated with an increase in STI incidence in 28 EHE counties and a decrease in 14 EHE counties. The greatest percent increase in total STI incidence was in the District of Columbia (+12.1%; incidence rate ratio = 1.121 [1.115, 1.127]; P < 0.001) and the greatest percent decrease was identified in Orleans Parish, LA (-8.7%; incidence rate ratio = 0.913 [0.908, 0.919]; P < 0.001). Rising STI rates in the biomedical era of HIV prevention represent missed opportunities for comprehensive sexual and preventive healthcare. County-level data provide actionable insight for reducing STI incidence. The EHE counties that have experienced decreases in STI incidence while being in the biomedical era may provide models of best practice, which may be scaled in other jurisdictions.

Potential contribution of PrEP uptake by adolescents 15-17 years old to achieving the "Ending the HIV Epidemic" incidence reduction goals in the US South.

The "Ending the HIV Epidemic" (EHE) initiative seeks to reduce new HIV infections in the U.S. by prioritizing federal resources towards highly impacted populations. Antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are essential for reaching EHE goals. Adolescents are often at increased risk for HIV because they may lack agency in negotiating their sexual partnerships and may not have the same access to treatment and prevention as adults. This study estimates the potential contribution of expanded PrEP coverage among adolescents ages 15-17 to achieving the EHE goals in the South. An HIV-transmission model was built to simulate the HIV epidemic in the South. Increased ART and PrEP uptake were systematically varied with and without PrEP eligibility including individuals age<18. Prioritizing PrEP for adolescents had a negligible impact on incidence. At 50% uptake among eligible adolescents and 90% ART coverage, including adolescents only improved the percentage of infections averted from 80.1% to 80.3%. In 10 of 15 scenarios explored, there was no reduction in new infections when PrEP eligibility was expanded to include adolescents age<18. At 95% ART coverage at the population-level incidence among adolescents declined by over 80%, but PrEP uptake among adolescents did not contribute to additional declines in incidence among adolescents. Prioritizing PrEP for adolescents did not significantly contribute to reaching EHE incidence reductions goal. Focusing resources to specific adolescent populations at risk, such sexual minority males in high incidence settings, will remain an important public health goal outside the context of EHE.

Social, Structural, Behavioral, and Clinical Barriers Influencing Pre-exposure Prophylaxis (PrEP) Use Among Young Black Men Who Have Sex with Men in the South: A Qualitative Update to a 2016 Study.

Antiretroviral pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV. Despite its promise, PrEP use is low, especially among young Black men who have sex with men (YBMSM). The prevalence of HIV in Mississippi (MS) is among the highest in the United States, with the bulk of new infections occurring amongst YBMSM living in Jackson, MS. We recruited 20 PrEP-eligible YBMSM and 10 clinic staff from MS health clinics between October 2021 and April 2022. Data were collected remotely using in-depth interviews and a brief survey, which lasted approximately 45-60min. Interview content included PrEP knowledge/experiences, HIV risk perception, and PrEP use barriers and facilitators. Qualitative data were coded then organized using NVivo. Using thematic analysis methodology, data were assessed for current barriers to PrEP use. An array of barriers were identified by participants. Barriers included structural factors (cost of PrEP, lack of discreet clinics, time commitment, competing interests); social factors (unaware of HIV risk, stigma and homophobia, fear that partners would find out about PrEP use, not knowing anyone on PrEP); behavioral factors (sexual risk factors, denial, less priority for prevention vs treatment); and clinical factors (misunderstood side effects, fear PrEP won't work). Significant barriers to PrEP use among YBMSM stem from structural, social, behavioral, and clinical factors. These results will inform intervention efforts tailored to mitigate barriers and improve PrEP uptake among YBMSM in the southern United States.

Implementing an Automated Prediction Model to Improve Prescribing of HIV Preexposure Prophylaxis

Summary Antiretroviral preexposure prophylaxis (PrEP) is nearly 100% effective at decreasing HIV acquisition but is underused in priority populations. Primary care clinicians need tools to help them identify persons likely to benefit from PrEP use and prescribe it when appropriate. The researchers developed and validated an automated decision support tool with interactive alerts in the electronic health record to increase PrEP discussions and prescribing in primary care. They piloted the tool at three federally qualified health centers and assessed feasibility, acceptance by clinicians, and preliminary impact on PrEP care. Of 33,803 patients who visited the pilot clinics from July 2022 through January 2023, providers received PrEP alerts at the point of care for 2.2% of patients, demonstrating feasibility. Although numbers of PrEP prescriptions remained low, the proportion of all patients with new PrEP prescriptions was 4.5 times higher at pilot clinics compared with matched control clinics (0.09% vs. 0.02%). Implementation of the decision support tool was associated with a statistically nonsignificant 5.5% increase in HIV tests per 100 patients. In qualitative interviews, providers said the tool facilitated PrEP discussions with patients, particularly for those patients who would not have initiated discussions because of stigma. The researchers found that acceptance, use, and impact of machine-learning models for PrEP depends on collaborating with and building trust among providers, including blending a data-driven approach to identifying patients at increased risk for HIV acquisition with providers’ traditional decision-making framework. These approaches could be useful for health care organizations seeking to implement automated prediction models across all areas of medicine.

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.

Acceptability of a Combination Adherence Strategy to Support HIV Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence During Pregnancy and Breastfeeding in Malawi.

In two parallel pilot studies, we implemented a combination adherence intervention of patient-centered counselling and adherence supporter training, tailored to support HIV treatment (i.e., antiretroviral therapy) or prevention (i.e., pre-exposure prophylaxis, or PrEP) during pregnancy and breastfeeding. Using a mixed-methods approach, we evaluated the intervention's acceptability. We investigated engagement, satisfaction, and discussion content via survey to all 151 participants assigned to the intervention arm (51 women living with HIV, 100 PrEP-eligible women without HIV). We also conducted serial in-depth interviews with a subgroup (n = 40) at enrollment, three months, and six months. In the quantitative analysis, the vast majority reported high satisfaction with intervention components and expressed desire to receive it in the future, if made available. These findings were supported in the qualitative analysis, with favorable comments about counselor engagement, intervention content and types of support received from adherence supporters. Overall, these results demonstrate high acceptability and provide support for HIV status-neutral interventions for antiretroviral adherence.

Emergent infection: atypical clinical cases of monkeypox (updated review)

Abstract. The international emergency caused by monkeypox has forced the world to pay attention to this infection, as it has spread beyond endemic regions and no control measures have been developed. The virus began to be transmitted to humans not only by contact, but also by airborne droplets, fecal-oral, and vertical. There have been cases of in-hospital spread, outbreaks after eating contaminated animal meat, and swimming in water. Pregnant women, children under 8 years of age, and HIV-infected people require special attention due to the risk of complications. Therefore, it is important for doctors of all levels to be aware of new ways of spreading the infection, atypical manifestations of the disease for differential diagnosis, timely detection and further treatment. Aim. To conduct an up-to-date literature review of clinical cases of monkeypox in people at increased risk of developing atypical course and complications - in HIV-infected people (due to the virus's damage to the immune system) and children under 8 years of age (due to insufficiently formed immunity). Materials and Мethods. Scientific articles from the google scholar database were analyzed, among which 7 articles with 9 different case descriptions were selected to conduct an in-depth study of clinical cases among people from different non-endemic countries who have insufficient immunity (WHO experts consider African and Asian countries to be endemic). Results. Most of the atypical cases were observed among homosexual men receiving antiretroviral therapy or pre-exposure prophylaxis for HIV infection. The characteristic rash appeared after unprotected oral or anal sex on the corresponding body parts. As for the disease in young children who do not have their own immunity, the mechanism of transmission was contact or vertical. Conclusions. Our analysis of the literature shows the prevalence of monkeypox in the male gender group with non-traditional sexual orientation. Based on the analysis, HIV-infected homosexuals, mostly men, are the main risk group for infection with this emergent orthopoxvirus. At the same time, people with primary and secondary immunodeficiency conditions remain particularly vulnerable. It is important that the atypical clinical course complicates timely clinical and laboratory diagnosis and even the initiation of treatment, which can lead to severe and fatal complications (in endemic regions among children and debilitated HIV-infected persons). It is advisable to take timely anti-epidemic measures with the implementation of specific prophylaxis for vulnerable categories of persons (listed above, as well as occupational risk groups), along with an increase in epidemic surveillance and strict infection control in compliance with International Health Regulations at checkpoints along the entire state border.

Analysis of Knowledge Level and Use of Antiretroviral Pre-Exposure and Post-Exposure Prophylaxis Among MSM - China, 2019-2022.

Men who have sex with men (MSM) in China have a high rate of human immunodeficiency virus (HIV) infection. Pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) have been shown to be effective in preventing HIV, which may help to contain the HIV epidemic among MSM. This study found that knowledge and usage of PrEP were low among MSM, indicating that this population is at high risk for HIV infection. Promotion of PrEP and PEP among MSM is necessary to reduce the risk of HIV infection in this population. PrEP and PEP are novel HIV prevention strategies that have been demonstrated to be effective and safe. To further reduce HIV transmission among MSM in China, it is necessary to promote the use of PrEP and PEP.

Study protocol for an efficacy trial of the “PrEP for Health” intervention to increase HIV PrEP use among people who inject drugs

BackgroundHIV incidence has recently increased among people who inject drugs (PWID) across the United States, with outbreaks occurring in states with long-standing syringe service programs (SSPs) including Massachusetts (MA). Antiretroviral pre-exposure prophylaxis (PrEP) is an evidence-based HIV prevention strategy recommended for PWID, but uptake in this marginalized population is extraordinarily low.MethodsWe describe the design and procedures for a National Institute on Drug Abuse (NIDA)-funded (R01) randomized controlled trial (RCT) testing the efficacy of “PrEP for Health,” a multicomponent behavioral intervention to increase PrEP uptake, adherence, and persistence among HIV-negative PWID attending SSPs in two areas of the U.S. Northeast that are heavily affected by injection-related HIV transmission. Participants are equally randomized to receive the “PrEP for Health” intervention (involving individually tailored HIV and PrEP education, motivational interviewing, problem-solving skills and planning, and ongoing navigation support) or an enhanced standard of care (eSOC) control condition involving a brief educational video on the utility of PrEP for HIV prevention. Co-primary outcomes are PrEP uptake (using medical/pharmacy records) and adherence (using tenofovir quantification in hair samples); a secondary outcome is PrEP persistence (using medical/pharmacy records) over 12 months. Major assessments occur at baseline, 1-, 3-, 6-, and 12-month follow-up visits. Planned analyses will examine intervention efficacy, specific hypothesized conceptual mediators of the intervention effect (e.g., self-perceived HIV risk; PrEP knowledge, interest in use, motivation, and behavioral skills) and epidemiologically linked moderators (e.g., age; gender; condomless vaginal or anal sex).DiscussionFindings from our extensive preliminary research with the study population revealed that a multicomponent, theory-based intervention targeting PrEP knowledge, motivation, self-efficacy, behavioral skills, and structural barriers to PrEP access is urgently needed for PWID who are at risk of HIV acquisition. We also learned that SSPs represent a highly acceptable service setting for delivering such interventions. In this study, we are evaluating the efficacy of the “PrEP for Health” intervention. If efficacious, findings from our implementation evaluation could help guide its dissemination to diverse SSPs and possibly other community-based settings accessed by this population.Trial registrationClinicalTrials.gov number NCT04430257, registered June 12, 2020.

Two Models for Increasing the Scope and Activities of Human Immunodeficiency Virus Partner Services Programs: Preliminary Findings From the Fast Track Project.

We sought to develop a novel strategy for expanding an existing human immunodeficiency virus (HIV) partner services (PS) model to provide comprehensive sexual health services, including sexually transmitted infection testing, a virtual telemedicine visit, and access to immediate start medication (antiretroviral treatment, preexposure or postexposure prophylaxis). Fast Track was a National Institutes of Health-funded implementation science trial in New York City to pilot and refine the new strategy, and examine its feasibility, acceptability, and impact. Over the course of 1 year, health department staff collaborated with the academic research team to develop Fast Track protocols and workflows, create a cloud-based database to interview and track patients, and train disease intervention specialists to deliver the new program. The initial field-based program (Fast Track 1.0) was piloted March to December 2019. A modified telephone-based program (Fast Track 2.0) was developed in response to COVID-19 pandemic constraints and was piloted August 2020 to March 2021. These 2 pilots demonstrate the feasibility and acceptability of integrating comprehensive sexual health services into HIV PS programs. Disease intervention specialists were successfully trained to conduct comprehensive sexual health visits, and clients reported that the availability of comprehensive sexual health services made them more willing to engage with PS. Key lessons for scale-up include managing collaboration with a licensed provider, navigating technical and technological issues, and challenges in client engagement and retention. The success of this integrated strategy suggests that telehealth visits may be a critical gateway to care engagement for PS clients. This model is an innovative strategy for increasing engagement with HIV testing, prevention, and treatment for underserved populations.

Expanding Medicaid to Reduce Human Immunodeficiency Virus Transmission in Houston, Texas: Insights From a Modeling Study.

Medicaid expansion has been nationally shown to improve engagement in the human immunodeficiency virus (HIV) treatment and prevention continua, which are vital steps to stopping the HIV epidemic. New HIV infections in the United States are disproportionately concentrated among young Black men who have sex with men (YBMSM). Houston, TX, is the most populous city in the Southern United States with a racially/ethnically diverse population that is located in 1 of 11 US states that have not yet expanded Medicaid coverage as of 2021. An agent-based model that incorporated the sexual networks of YBMSM was used to simulate improved antiretroviral treatment and pre-exposure prophylaxis (PrEP) engagement through Medicaid expansion in Houston, TX. Analyses considered the HIV incidence (number of new infections and as a rate metric) among YBMSM over the next 10 years under Medicaid expansion as the primary outcome. Additional scenarios, involving viral suppression and PrEP uptake above the projected levels achieved under Medicaid expansion, were also simulated. The baseline model projected an HIV incidence rate of 4.96 per 100 person years (py) and about 368 new annual HIV infections in the 10th year. Improved HIV treatment and prevention continua engagement under Medicaid expansion resulted in a 14.9% decline in the number of annual new HIV infections in the 10th year. Increasing viral suppression by an additional 15% and PrEP uptake by 30% resulted in a 44.0% decline in new HIV infections in the 10th year, and a 27.1% decline in cumulative infections across the 10 years of the simulated intervention. Simulation results indicate that Medicaid expansion has the potential to reduce HIV incidence among YBMSM in Houston. Achieving HIV elimination objectives, however, might require additional effective measures to increase antiretroviral treatment and PrEP uptake beyond the projected improvements under expanded Medicaid.

Patient and Physician Preferences Regarding Long-Acting Pre-Exposure Prophylaxis and Antiretroviral Therapy: A Mixed-Methods Study in Southern California, USA.

Antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are key strategies in ending the HIV epidemic. However, poor adherence to daily ART and PrEP increases the risk of HIV transmission and acquisition. Long-acting ART and PrEP formulations attempt to improve adherence through providing long-lasting forms of the medication delivered through different routes of administration: oral (potentially monthly), injection (1-6 months), and subdermal implant (up to annually). This study explored patient and physician preferences for long-acting ART and PrEP as well as adherence support strategies. Adult patients (n = 42) with experience taking ART or PrEP participated in individual interviews or focus groups. Physicians (n = 13) currently prescribing ART and/or PrEP completed an online questionnaire. Rapid qualitative analysis systematically synthesized qualitative data, and descriptive statistics examined survey responses. Patients supported improved adherence as a top potential advantage of long-acting ART and PrEP, and reduced internal stigma as a strong benefit specific to long-acting ART. Annual coverage offered through subdermal implants had strong appeal; however, oral was the preferred modality for long-acting ART and PrEP. Patients preferred injectable ART and PrEP if concurrently receiving hormone therapy injections. Side effects, medication cost, and treatment accessibility were potential barriers. Patients preferred calendar tracking and text messages/phone reminders for adherence supports. Physicians reported that they would reduce clinic visits and HIV testing for all patients on long-acting PrEP, except men who have sex with men who would continue to complete HIV testing every 3 months. Physicians were mixed on whether they believed long-acting ART and PrEP would improve patient adherence. Overall, findings demonstrate the potential benefits of long-acting ART and PrEP, while highlighting the need to obtain additional information to address treatment concerns.