A Systematic Review of Implementation Research on Determinants and Strategies of Effective HIV Interventions for Men Who Have Sex with Men in the United States.

Men who have sex with men (MSM) are disproportionately affected by HIV, accounting for two-thirds of HIV cases in the United States despite representing ∼5% of the adult population. Delivery and use of existing and highly effective HIV prevention and treatment strategies remain suboptimal among MSM. To summarize the state of the science, we systematically review implementation determinants and strategies of HIV-related health interventions using implementation science frameworks. Research on implementation barriers has focused predominantly on characteristics of individual recipients (e.g., ethnicity, age, drug use) and less so on deliverers (e.g., nurses, physicians), with little focus on system-level factors. Similarly, most strategies target recipients to influence their uptake and adherence, rather than improving and supporting implementation systems. HIV implementation research is burgeoning; future research is needed to broaden the examination of barriers at the provider and system levels, as well as expand knowledge on how to match strategies to barriers-particularly to address stigma. Collaboration and coordination among federal, state, and local public health agencies; community-based organizations; health care providers; and scientists are important for successful implementation of HIV-related health innovations.

Filling in the Gaps: Updates on Doxycycline Prophylaxis for Bacterial Sexually Transmitted Infections.

Over the past two decades, cases of sexually transmitted infections (STIs) due to syphilis, gonorrhea, and chlamydia have been rising in the United States, disproportionately among gay, bisexual, and other men who have sex with men (MSM), as well as racial and ethnic minorities of all genders. In this review, we address updates about the evidence on doxycycline post-exposure prophylaxis (doxy-PEP) for prevention of bacterial STIs, including efficacy, safety, antimicrobial resistance (AMR), acceptability, modeling population impact, and evolving guidelines for use. Equitable implementation of doxy-PEP will require evaluation of who is offered and initiates it, understanding patterns of use and longer-term STI incidence and AMR, provider training, and tailored community education.

Trajectories of Oral PrEP Adherence Among Young Kenyan Women: Implications for Promoting Effective PrEP Use.

Using data from a 2-year study of young women at high HIV risk in Thika and Kisumu, Kenya, we identified group-based trajectories of PrEP adherence based on electronic pillcap-monitoring and assessed potentially associated demographic and socio-behavioral factors. Among 348 women, we selected a three-trajectory adherence model: low and declining (N = 211, 61%), moderate but declining (N = 119, 34%) and steady high adherers (N = 18, 5%). We also identified a two-trajectory HIV risk model based on self-perceived risk in the past week: high and increasing (N = 28, 8%) and steady low (N = 320, 92%) risk. The Kisumu site was associated with the moderate but declining and steady high adherence trajectories, while increasing VOICE risk score was associated with the low and declining adherence trajectory. We found no association between the adherence and risk trajectories. Our findings suggest adherence support may need tailoring by setting. Early, sustained support may also help those at highest risk of non-adherence.

RESUMEN: Utilizando datos de un estudio de dos años de duración en mujeres jóvenes con alto riesgo de VIH en Thika y Kisumu, Kenia, identificamos trayectorias grupales de adherencia a la PrEP basadas en el monitoreo electrónico de pillcap y evaluamos los factores demográficos, sociales y de comportamiento potencialmente asociados con la adherencia. En un grupo de 348 mujeres, seleccionamos un modelo de adherencia de tres trayectorias: baja y decreciente (N = 211, 61%), moderada pero decreciente (N = 119, 34%) y altas constantes (N = 18, 5%). También identificamos un modelo de riesgo de VIH de dos trayectorias basado en el riesgo autopercibido en la última semana: riesgo alto y creciente (N = 28, 8%) y riesgo bajo constante (N = 320, 92%). El sitio de Kisumu estuvo asociado con las trayectorias de adherencia alta moderadas pero decrecientes y constantes, mientras que el aumento de la puntuación de riesgo de VOICE se asoció con la trayectoria de adherencia baja y decreciente. No se encontró asociación entre la adherencia y las trayectorias de riesgo. Nuestros hallazgos sugieren que el apoyo a la adherencia podría individualizarse de acuerdo con el entorno. El apoyo temprano y sostenido a la adherencia también puede ayudar a las personas con mayor riesgo de no adherencia.

PrEP Use and Adherence among Transgender Persons in Chicago, IL (SHIPP Study, 2014-2018, USA).

Few studies investigating daily oral preexposure prophylaxis (PrEP) focus on transgender persons. The Sustainable Health Center Implementation PrEP Pilot (SHIPP) Study included a large observational cohort of transgender persons with implications for PrEP in the United States. We examined data from SHIPP's observational cohort and its Medication Adherence Substudy (MAS) to understand adherence among transgender participants in Chicago, IL. We assessed adherence by the proportion of days covered (PDC) for PrEP medication prescriptions, self-reported interview data, and concentrations of intracellular tenofovir diphosphate (TFV-DP) in dried blood spot (DBS) samples. Between 2014 and 2018, there were 510 transgender participants, 349 (68.4%) transgender women and 152 (29.8%) transgender men. Forty-five of these participants were enrolled in the MAS, 31 (68.9%) transgender women and 9 (20.0%) transgender men. By the 3-month follow up, 100% of MAS participants who completed an interview reported taking 4 or more doses of PrEP in the previous week. At 6, 9, and 12 months, taking 4 or more doses in the past week was reported by 81.0%, 94.1%, and 83.3% of participants, respectively. Results from TFV-DP DBS indicated that fewer participants reached the same level of adherence (4 or more doses/week) at clinical visits compared to self-report and even fewer participants reached this level of adherence based on the calculated PDC. Among participants who remained on PrEP throughout the study, DBS adherence levels declined after the first three months. There remains a critical need to develop strategies to address barriers and interventions that support PrEP adherence among transgender people.

Support for evidence-informed opioid policies and interventions: The role of racial attitudes, political affiliation, and opioid stigma.

Political affiliation, racial attitudes, and opioid stigma influence public support for public health responses to address opioid use disorders (OUD). Prior studies suggest public perceptions of the opioid epidemic are less racialized and less politically polarized than were public perceptions of the crack cocaine epidemic. Analyzing a cross-sectional, nationally representative sample (n = 1161 U.S. adults) from the October 2020 AmeriSpeak survey, we explored how political affiliation, racial attitudes (as captured in the Color-Blind Racial Attitudes Scale [CoBRAS]), and OUD stigma were associated with respondents' expressed views regarding four critical domains. Respondents with unfavorable attitudes towards Black Americans were less likely to support expanding Medicaid funding, increasing government spending to provide services for people living with OUD, and distributing naloxone for overdose prevention. Democratic Party affiliation was associated with greater support for all three of the above measures, and increased support for mandatory treatment, which may be seen as a substitute for more punitive interventions. Black respondents were also less likely to support expanding Medicaid funding, increasing government spending to provide services for people living with OUD, and of distributing naloxone. Our finding suggest that negative attitudes towards African-Americans and political differences remain important factors of public opinion on responding to the OUD epidemic, even after controlling for opioid stigma. Our findings also suggest that culturally-competent dialogue within politically conservative and Black communities may be important to engage public support for evidence-informed treatment and prevention.

Correlations of HIV Preexposure Prophylaxis Indications and Uptake, Chicago, Illinois, 2015-2018.

Objectives. To examine gaps in identification of preexposure prophylaxis (PrEP) candidates, uptake, and use of PrEP by populations most likely to seroconvert.Methods. At a federally qualified health center in Chicago, Illinois, we used electronic medical records, prescription data, and our best approximation of Centers for Disease Control and Prevention PrEP guidelines to determine how many patients were indicated for PrEP relative to HIV diagnoses (indication:HIV), how many were on PrEP relative to indications (PrEP:indication), and how many were on PrEP relative to HIV diagnoses (PrEP:HIV). We compared these ratios across age, gender and orientation, race/ethnicity, and insurance.Results. Overall, there were 32 indications per incident diagnosis and 16 patients on PrEP per incident diagnosis. In adjusted models, Whites had higher indication:HIV and PrEP:HIV ratios compared with Blacks, men who have sex with men had higher indication:HIV and PrEP:HIV ratios compared with transwomen but lower PrEP:indication ratios, and uninsured patients had higher indication:HIV but lower PrEP:indication and PrEP:HIV ratios compared with those with insurance.Conclusions. PrEP use, relative to HIV diagnoses, differs by important patient characteristics. While improved guidelines will address some of the disparity, better approaches for determining PrEP candidates and more normalized patient-provider communication are needed to ensure better PrEP access to all individuals at high risk for HIV.

Patterns of Oral PrEP Adherence and HIV Risk Among Eastern African Women in HIV Serodiscordant Partnerships.

Understanding how women use PrEP is important for developing successful implementation programs. We hypothesized there are distinct patterns of adherence, related to HIV risk and other factors. We identified patterns of PrEP adherence and HIV risk behavior over the first 6 months of PrEP use, using data from 233 HIV-uninfected women in high-risk serodiscordant couples in a demonstration project in Kenya & Uganda. We modeled PrEP adherence, assessed by daily electronic monitoring, and HIV risk behavior using group-based trajectory models. We tested baseline covariates and risk behavior group as predictors of adherence patterns. There were four distinct adherence patterns: high steady adherence (55% of population), moderate steady (29%), late declining (8%), and early declining (9%). No baseline characteristics significantly differed between adherence patterns. Adherence patterns differed in average weekly doses (6.7 vs 5.4 vs 4.1 vs 1.5, respectively). Two risk behavior groups were identified: steady HIV risk (78% of population) and declining (22%). Compared to women with declining HIV risk behavior, women with steady risk behavior were more likely to have high steady adherence (61% vs 35%) and less likely to have early (6% vs 17%) or late (4% vs 19%) declining adherence. Women's use of PrEP was associated with concurrent HIV risk behavior; higher risk was associated with higher, sustained adherence.

Prevalence, Magnitude, and Correlates of HIV-1 Genital Shedding in Women on Antiretroviral Therapy.

Background: Genital human immunodeficiency virus (HIV) RNA shedding can continue despite HIV being undetectable in blood, and can be associated with transmission. Methods: We included African women on antiretroviral therapy (ART). Linear and generalized linear mixed models were used to compare the magnitude and prevalence of genital shedding, respectively, by time since ART initiation. Multivariable logistic regression with generalized estimating equations was used to assess predictors of genital shedding among women with undetectable plasma viral load (VL). Results: Among 1114 women, 5.8% of visits with undetectable plasma VL and 23.6% of visits with detectable VL had genital shedding. The proportion of visits with genital shedding decreased with time since ART initiation but the magnitude of shedding remained unchanged when plasma VL was undetectable (P = .032). Prevalence of shedding did not vary by time since ART initiation when plasma VL was detectable (P = .195), though the magnitude of shedding significantly increased (P = .04). Predictors of genital shedding were HIV disease stage, antiretroviral regimen, and genital ulcers or cervical tenderness. Discussion: In addition to ART, reducing immune activation through prevention and treatment of HIV-related conditions and genital tract infections may decrease the risk of HIV-1 shedding and potential transmission.

HIV-1-Neutralizing IgA Detected in Genital Secretions of Highly HIV-1-Exposed Seronegative Women on Oral Preexposure Prophylaxis.

Although nonhuman primate studies have shown that simian immunodeficiency virus/simian-human immunodeficiency virus (SIV/SHIV) exposure during preexposure prophylaxis (PrEP) with oral tenofovir can induce SIV immunity without productive infection, this has not been documented in humans. We evaluated cervicovaginal IgA in Partners PrEP Study participants using a subtype C primary isolate and found that women on PrEP had IgA with higher average human immunodeficiency virus type 1 (HIV-1)-neutralizing magnitude than women on placebo (33% versus 7%; P = 0.008). Using a cutoff of ≥90% HIV-1 neutralization, 19% of women on-PrEP had HIV-1-neutralizing IgA compared to 0% of women on placebo (P = 0.09). We also estimated HIV-1 exposure and found that the proportion of women with HIV-1-neutralizing IgA was associated with the level of HIV-1 exposure (P = 0.04). Taken together, our data suggest that PrEP and high levels of exposure to HIV may each enhance mucosal HIV-1-specific humoral immune responses in sexually exposed but HIV-1-uninfected individuals. IMPORTANCE: Although there is not yet an effective HIV-1 vaccine, PrEP for at-risk HIV-1-uninfected individuals is a highly efficacious intervention to prevent HIV-1 acquisition and is currently being recommended by the CDC and WHO for all individuals at high risk of HIV-1 acquisition. We previously demonstrated that PrEP use does not enhance peripheral blood HIV-1-specific T-cell responses in HIV-exposed individuals. Here, we evaluate for cervicovaginal HIV-neutralizing IgA responses in genital mucosal secretions of HIV-exposed women, which is likely a more relevant site than peripheral blood for observation of potentially protective immune events occurring in response to sexual HIV-1 exposure for various periods. Furthermore, we assess for host response in the context of longitudinal quantification of HIV-1 exposure. We report that HIV-neutralizing IgA is significantly correlated with higher HIV-1 exposure and, furthermore, that there are more women with HIV-1-neutralizing IgA in the on-PrEP group than in the placebo group.

Post-traumatic stress is associated with verbal learning, memory, and psychomotor speed in HIV-infected and HIV-uninfected women.

The prevalence of post-traumatic stress disorder (PTSD) is higher among HIV-infected (HIV+) women compared with HIV-uninfected (HIV-) women, and deficits in episodic memory are a common feature of both PTSD and HIV infection. We investigated the association between a probable PTSD diagnosis using the PTSD Checklist-Civilian (PCL-C) version and verbal learning and memory using the Hopkins Verbal Learning Test in 1004 HIV+ and 496 at-risk HIV- women. HIV infection was not associated with a probable PTSD diagnosis (17% HIV+, 16% HIV-; p = 0.49) but was associated with lower verbal learning (p < 0.01) and memory scores (p < 0.01). Irrespective of HIV status, a probable PTSD diagnosis was associated with poorer performance in verbal learning (p < 0.01) and memory (p < 0.01) and psychomotor speed (p < 0.001). The particular pattern of cognitive correlates of probable PTSD varied depending on exposure to sexual abuse and/or violence, with exposure to either being associated with a greater number of cognitive domains and a worse cognitive profile. A statistical interaction between HIV serostatus and PTSD was observed on the fine motor skills domain (p = 0.03). Among women with probable PTSD, HIV- women performed worse than HIV+ women on fine motor skills (p = 0.01), but among women without probable PTSD, there was no significant difference in performance between the groups (p = 0.59). These findings underscore the importance of considering mental health factors as correlates to cognitive deficits in women with HIV.

Sexual minority status and violence among HIV infected and at-risk women.

IMPORTANCE: Sexual minority women with and at-risk for human immunodeficiency virus (HIV) may face increased risks of violence. OBJECTIVE: To understand the relationship between sexual minority status and violence; and how high-risk sex and substance use mediate that relationship among women with and at-risk for HIV. DESIGN & PARTICIPANTS: Longitudinal study of 1,235 HIV infected and 508 uninfected women of the Women's Interagency HIV Study (WIHS) cohort, from New York City, NY, Chicago, IL, Washington D.C., and San Francisco, CA, 1994-2012. MAIN MEASURES: Primary exposures are sexual identity (heterosexual, bisexual, lesbian/gay) and sexual behavior (male, female, or male & female partners). Primary outcomes are sexual abuse, intimate partner violence (IPV) and physical violence; high-risk sex and substance use were examined as mediators. KEY RESULTS: Bisexual women were at increased odds for sexual abuse [aOR 1.56 (1.00, 2.44)], IPV [aOR 1.50 (1.08, 2.09)], and physical violence [aOR 1.77 (1.33, 2.37)] compared to heterosexual women. In a separate analysis, women who reported sex with men and women (WSMW) had increased odds for sexual abuse [aOR 1.65 (0.99, 2.77], IPV [aOR 1.50 (1.09, 2.06)] and physical violence [aOR 2.24 (1.69, 2.98)] compared to women having sex only with men (WSM). Using indirect effects, multiple sex partners, cocaine and marijuana were significant mediators for most forms of abuse. Transactional sex was only a mediator for bisexual women. Women who reported sex only with women (WSW) had lower odds of sexual abuse [aOR 0.23 (0.06, 0.89)] and physical violence [aOR 0.42 (0.21, 0.85)] compared to WSM. CONCLUSIONS: Women who identify as bisexual or report both male and female sex partners are most vulnerable to violence; multiple recent sex partners, transactional sex and some types of substance use mediate this relationship. Acknowledging sexual identity and behavior, while addressing substance use and high-risk sex in clinical and psychosocial settings, may help reduce violence exposure among women with and at-risk for HIV.

Sexual minority women and depressive symptoms throughout adulthood.

OBJECTIVES: We examined the associations between depressive symptoms and sexual identity and behavior among women with or at risk for HIV. METHODS: We analyzed longitudinal data from 1811 participants in the Women's Interagency HIV Study (WIHS) from 1994 to 2013 in Brooklyn and the Bronx, New York; Chicago, Illinois; Washington, DC; and Los Angeles and San Francisco, California, by comparing depressive symptoms by baseline sexual identity and ongoing sexual behavior. We controlled for age, socioeconomic status, violence history, and substance use. RESULTS: In separate analyses, bisexual women and women who reported having sex with both men and women during follow-up had higher unadjusted odds of depressive symptoms compared with heterosexuals and women who reported only having male sexual partners (adjusted odd ratio [AOR] = 1.36; 95% confidence interval [CI] = 1.10, 1.69 and AOR = 1.21; 95% CI = 1.06, 1.37, respectively). Age was a significant effect modifier in multivariable analysis; sexual minority women had increased odds of depressive symptoms in early adulthood, but they did not have these odds at midlife. Odds of depressive symptoms were lower among some sexual minority women at older ages. CONCLUSIONS: Patterns of depressive symptoms over the life course of sexual minority women with or at risk for HIV might differ from heterosexual women and from patterns observed in the general aging population.

Factors Associated with HIV Pre-Exposure Prophylaxis Use Among Transmasculine People Who Have Sex with Cisgender Men, at a Federally Qualified Health Center in Chicago, Illinois.

Transmasculine individuals who have sex with cisgender men (TMSM) remain an understudied population regarding pre-exposure prophylaxis (PrEP). We used electronic medical record data to assess PrEP eligibility and initiation in TMSM in a large LGBTQ+ focused federally qualified health center in Chicago, Illinois. We examined a sample of 430 TMSM from January 1, 2015 to December 31, 2019, and used logistic regression to model PrEP eligibility and initiation. Overall, 37% of participants were eligible for and 18% initiated PrEP. Eligibility was not associated with initiation. National PrEP guidance should be tailored to include transmasculine people.

Increasing providers' PrEP prescription for Black cisgender women: A qualitative study to improve provider knowledge and competency via PrEP training.

BACKGROUND: Awareness and uptake of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) remains low among Black/African American cisgender women, partly due to low self-reported PrEP knowledge and comfort among primary care providers. Ensuring providers are trained on PrEP is crucial, as increased PrEP knowledge is associated with higher rates of PrEP prescription. OBJECTIVE: We aimed to develop a PrEP training for providers to improve their self-efficacy in discussing and prescribing PrEP for Black women, with the ultimate goal of increasing PrEP awareness and utilization among Black women. DESIGN: In this qualitative study, we conducted focus groups with medical providers at three federally qualified health centers in the Southern and Midwestern United States to identify themes informing the development of a provider PrEP training. METHODS: Providers were asked for input on content/design of PrEP training. Transcripts underwent rapid qualitative analysis using the Stanford Lightning Report Method. Themes were identified and presented under the domains of the Consolidated Framework for Implementation Research. RESULTS: Ten providers completed four focus groups. Themes included the individual characteristics of providers (low comfort initiating PrEP discussions, particularly among White providers) and the outer setting of client attitudes (perceptions of potential provider bias/racism, varying levels of concern about HIV acquisition). Opportunities were identified to maximize the benefit of training design (e.g., developing case scenarios to enhance providers' cultural competency with Black women and PrEP knowledge). CONCLUSION: This comprehensive PrEP training features both didactic material and interactive role-plays to equip providers with the clinical knowledge for prescribing PrEP while building their competency discussing PrEP with Black women. This training is particularly important for providers who have racial or gender discordance with Black women and express lower comfort discussing PrEP with these clients. Provider training could lead to minimizing racial- and gender-based inequities in PrEP use.

Increasing the use of pre-exposure prophylaxis (PrEP) among Black women: a study to improve provider knowledge through PrEP trainingWhy was the study done? Use of pre-exposure prophylaxis (PrEP), a medication that can prevent the transmission of human immunodeficiency virus (HIV), is low among Black/African American women. Part of the reason why is because primary care providers (PCPs) report lower knowledge about PrEP and lower comfort talking about PrEP with clients. Making sure PCPs are trained on PrEP could help increase PrEP use among Black women. What did the researchers do? The research team held focus groups, during which they asked medical providers at federally qualified health centers (FQHCs) in the Southern and Midwestern United States questions about their experiences with discussing PrEP and what information should be included in a training about PrEP for providers to make sure the training would be helpful for them. What did the researchers find? A total of ten providers completed four focus groups. Important points mentioned in the focus groups included low comfort among providers when bringing up PrEP to clients, especially among White providers, as well as different levels of concern about HIV and feelings of potential provider bias/racism among clients. These points helped the researchers design a PrEP training that addresses providers' needs (such as creating case scenarios that help providers practice discussing PrEP with Black women and answering common questions about PrEP). What do the findings mean? A PrEP training for providers should have both information about prescribing PrEP and interactive role-plays to build providers' PrEP knowledge while improving their confidence and skill in talking about PrEP with Black women. This training is particularly important for providers who are a different race or gender than Black women and express lower rates of comfort discussing PrEP with these clients. Provider training could eventually lead to higher PrEP use among Black women.

Temporary changes in STI & HIV testing & diagnoses across different phases of the COVID-19 pandemic, Chicago IL.

Introduction: While the U.S. has seen a sustained rise in STI cases over the past decade, the impact of the COVID-19 on STIs and HIV is unclear. Methods: To examine the short- and medium-term impacts of COVID-19 and HIV and STI testing and diagnosis, we compared pre-pandemic trends to three periods of the pandemic: early- pandemic, March-May 2020; mid-pandemic June 2020-May 2021; and late-pandemic, June 2021-May 2022. We compared average number of monthly tests and diagnoses, overall and by gender, as well as the monthly change (slope) in testing and diagnoses. Results: We find that after decreases in average monthly STI and HIV testing and diagnoses during the early- and mid-pandemic, cases were largely back to pre-pandemic levels by the late-pandemic, with some variation by gender. Conclusion: Changes in testing and diagnoses varied by phase of the pandemic. Some key populations may require additional outreach efforts to attain pre-pandemic testing levels.

Changes in HIV Prevention and Sexual Experiences During the COVID-19 Pandemic: A Mixed-Methods Study.

BACKGROUND: STI and HIV services and infection rates were affected during the COVID-19 pandemic, because of changes in access to health care and individual behavior. Understanding how individuals made decisions around prevention and sexual activities during different phases of the pandemic is useful to addressing the rising rates of STIs and HIV. SETTING: Federally-qualified health center focused on sexual and gender minority health, Chicago IL, 2021. METHODS: Patients with a history of PrEP use who were contacted by the PrEP retention team as part of standard care were invited to complete an online survey. A subset of survey participants were then contacted to complete one-on-one interviews. Participants were asked about two distinct periods: November 2020 to January 2021 and February to June 2021. RESULTS: From the 356 survey participants (mostly young, insured, and experienced with PrEP), more than half maintained their number of sex partners during the early pandemic and most also maintained PrEP use; during the later pandemic; most reported more or the same number of sex partners and almost all maintained PrEP use. From interviews, we identified diverse and changing experiences regarding sexual practices throughout the pandemic; whereas many participants changed PrEP use in accordance with sexual practices, many others maintained PrEP use as a habit. COVID-19 prevention was also a factor in sexual activities, particularly prevaccination. CONCLUSION: Many PrEP users try to align their HIV prevention with their sexual exposures and establish PrEP as a long-term habit. Removing financial and access barriers is important to improve PrEP use and STI testing.

The Relationship between Substance Use Stigma and COVID-19 Vaccine Hesitancy.

Two parallel public health epidemics affecting the United States include the COVID-19 pandemic and a rise in substance use disorders (SUDs). Limited research has examined the potential relationship between these two epidemics. Our objective was therefore to perform an exploratory study in order to examine the association between public stigma toward people with a past history of opioid, methamphetamine, cocaine, and alcohol use disorder and COVID-19 vaccine hesitancy. A national sample of U.S. adults (N = 6515) completed a survey which assessed the degree of negative perceptions toward individuals with a past history of substance use disorders (referred to as substance use stigma) and COVID-19 vaccine hesitancy, along with variables such as racial prejudice, source of health news, and other demographics. We evaluated four multivariable logistic regression models to predict COVID-19 vaccine hesitancy, utilizing substance use stigma toward opioids, methamphetamine, cocaine, and alcohol use as independent variables. We found that COVID-19 vaccine hesitancy was positively associated with substance use stigma toward opioid (AOR = 1.34, p < 0.05), methamphetamine (AOR = 1.40, p < 0.01), and cocaine (AOR = 1.28, p < 0.05) use, but not alcohol use (AOR = 1.06, n.s.). Predictive models that incorporate substance use stigma may therefore improve our ability to identify individuals that may benefit from vaccine hesitancy interventions. Future research to understand the underlying reasons behind the association between substance use stigma and COVID-19 vaccine hesitancy may help us to construct combined interventions which address belief systems that promote both substance use stigma and vaccine hesitancy.

POWER Up-Improving pre-exposure prophylaxis (PrEP) uptake among Black cisgender women in the Southern United States: Protocol for a stepped-wedge cluster randomized trial (SW-CRT).

BACKGROUND: HIV disproportionately affects Black/African American cisgender women (hereafter women) in the United States. Despite its proven effectiveness, pre-exposure prophylaxis (PrEP) for HIV prevention remains vastly under-prescribed to women based on their need. Increasing PrEP uptake and persistence among women is crucial to reducing HIV transmission; however, there have been few studies designed specifically for women. This article describes the study protocol used to assess the feasibility, acceptability, and effectiveness of implementation strategies to improve PrEP uptake and persistence among Black women in the Midwest and South. METHODS: PrEP Optimization among Women to Enhance Retention and Uptake (POWER Up) is an evidence-based, woman-focused set of five implementation science strategies that addresses barriers of PrEP utilization at the provider, patient, and clinic levels. POWER Up includes 1) routine PrEP education for patients, 2) standardized provider training, 3) electronic medical record (EMR) optimization, 4) PrEP navigation, and 5) PrEP clinical champions. These strategies will be adapted to specific clinics for implementation, tested via a stepped-wedge trial, and, if effective, packaged for further dissemination. DISCUSSION: We will utilize a stepped-wedge cluster randomized trial (SW-CRT) to measure change in PrEP utilization across diverse geographic areas. Preparation for adapting and implementing the bundle of strategies is needed to determine how to tailor them to specific clinics. Implementation challenges will include adapting strategies with the available resources at each site, maintaining stakeholder involvement and staff buy-in, adjusting the study protocol and planned procedures as needed, and ensuring minimal crossover. Additionally, strengths and limitations of each strategy must be examined before, during, and after the adaptation and implementation processes. Finally, the implementation outcomes of the strategies must be evaluated to determine the real-world success of the strategies. This study is an important step toward addressing the inequity in PrEP service delivery and increasing PrEP utilization among Black women in the U.S.

PrEP Persistence Support and Monitoring in Areas of High HIV Burden in the Midwestern United States.

Monitoring pre-exposure prophylaxis (PrEP) metrics can guide service delivery yet does not occur routinely. We developed a survey to understand current practices for monitoring PrEP at PrEP-providing organizations in Illinois and Missouri. The survey was distributed from September through November 2020; 26 organizations participated. Most respondents indicated ongoing efforts to screen for PrEP eligibility (66.7%), link to care (87.5%), and retain clients in care (70.8%); 70.8% reported collecting data on PrEP initiation, 41.7% on retention in care, and 37.5% on missed visits. Barriers to monitoring PrEP metrics included lack of IT support (69.6%), manual processes (69.6%), and lack of staff resources (65.2%). Most respondents offered clients support for PrEP retention and adherence and wanted to expand interventions for PrEP persistence, yet fewer monitored corresponding metrics. To enhance PrEP implementation, organizations should improve monitoring and evaluation of PrEP metrics along the entire continuum and respond with appropriate services to support clients.