A Randomized Controlled Pilot Study of Just4Us, a Counseling and Navigation Intervention to Promote Oral HIV Prophylaxis Uptake Among PrEP-Eligible Cisgender Women.

HIV pre-exposure prophylaxis (PrEP) uptake among cisgender women in the United States is low. Just4Us, a theory-based counseling and navigation intervention, was evaluated in a pilot randomized controlled trial among PrEP-eligible women (n = 83). The comparison arm was a brief information session. Women completed surveys at baseline, post-intervention, and at three months. In this sample, 79% were Black, and 26% were Latina. This report presents results on preliminary efficacy. At 3 months follow-up, 45% made an appointment to see a provider about PrEP; only 13% received a PrEP prescription. There were no differences in PrEP initiation by study arm (9% Info vs. 11% Just4Us). PrEP knowledge was significantly higher in the Just4Us group at post-intervention. Analysis revealed high PrEP interest with many personal and structural barriers along the PrEP continuum. Just4Us is a promising PrEP uptake intervention for cisgender women. Further research is needed to tailor intervention strategies to multilevel barriers.Clinicaltrials.gov registration NCT03699722: A Women-Focused PrEP Intervention (Just4Us).

RESUMEN: La aceptación de la profilaxis previa a la exposición (PrEP) al VIH entre las mujeres cisgénero en los Estados Unidos es baja. Just4Us, una intervención de asesoramiento y navegación basada en la teoría, se evaluó en un ensayo piloto controlado aleatorizado con mujeres aptas para la PrEP (n = 83). El brazo de comparación fue una breve sesión de información. Las mujeres completaron encuestas al inicio, después de la intervención ya los 3 meses. En la muestra, el 79% eran negros y el 26% eran latinas. Este informe presenta resultados sobre la eficacia preliminar. A los 3 meses de seguimiento, el 45% hizo una cita para ver a un proveedor acerca de la PrEP; solo el 13% recibió una receta de PrEP. No hubo diferencias en el inicio de la PrEP por brazo de estudio (9% Info frente a 11% Just4Us). El conocimiento fue significativamente mayor en el grupo Just4Us después de la intervención. El análisis reveló un alto interés por la PrEP con muchas barreras personales y estructurales a lo largo del continuo de la PrEP. Just4Us es una prometedora intervención de adopción de PrEP para mujeres cisgénero. Se necesita más investigación para adaptar las estrategias de intervención a las barreras multinivel.

Using a patient portal as a recruitment tool to diversify the pool of participants in COVID-19 vaccine clinical trials.

The coronavirus disease 2019 (COVID-19) pandemic has disproportionately affected racial/ethnic minorities in the United States, who are underrepresented in clinical trials. We assessed the feasibility of using the University of Pennsylvania Health System electronic health record patient portal to diversify the pool of participants in COVID-19 vaccine clinical trials. The patient portal was used to send invitations to eligible individuals living in zip codes with high rates of racial/ethnic minorities. The 5614 invited consisted of 96.7% black, 1.3% Hispanic/Latinx, and 1.5% white. The overall response rate was 5.4%, with lower response rates among Black (3.8%) and Hispanic/Latinx (9.6%) as compared to white individuals (91.6%). Among respondents, black individuals had lower rates of interest in participating (26.7%), as compared to white (65.8%) and Hispanic/Latinx (71.4%) individuals. Of 115 respondents who expressed interest, 9 enrolled in the clinical trial, which included 6 black, 3 white, and 1 Hispanic/Latinx. During phone outreach to nonresponders and decliners, common reasons for declining included mistrust of the COVID-19 vaccine, underlying health conditions, and logistical barriers to trial participation. Because of low rates of patient portal account activation and use, compounded with vaccine hesitancy, this method yielded a small number of interested individuals.

SARS-CoV-2 infections elicit higher levels of original antigenic sin antibodies compared with SARS-CoV-2 mRNA vaccinations.

It is important to determine if severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and SARS-CoV-2 mRNA vaccinations elicit different types of antibodies. Here, we characterize the magnitude and specificity of SARS-CoV-2 spike-reactive antibodies from 10 acutely infected health care workers with no prior SARS-CoV-2 exposure history and 23 participants who received SARS-CoV-2 mRNA vaccines. We found that infection and primary mRNA vaccination elicit S1- and S2-reactive antibodies, while secondary vaccination boosts mostly S1 antibodies. Using absorption assays, we found that SARS-CoV-2 infections elicit a large proportion of original antigenic sin-like antibodies that bind efficiently to the spike of common seasonal human coronaviruses but poorly to the spike of SARS-CoV-2. In converse, vaccination modestly boosts antibodies reactive to the spike of common seasonal human coronaviruses, and these antibodies cross-react more efficiently to the spike of SARS-CoV-2. Our data indicate that SARS-CoV-2 infections and mRNA vaccinations elicit fundamentally different antibody responses.

Health care worker seromonitoring reveals complex relationships between common coronavirus antibodies and COVID-19 symptom duration.

Some studies suggest that recent common coronavirus (CCV) infections are associated with reduced COVID-19 severity upon SARS-CoV-2 infection. We completed serological assays using samples collected from health care workers to identify antibody types associated with SARS-CoV-2 protection and COVID-19 symptom duration. Rare SARS-CoV-2 cross-reactive antibodies elicited by past CCV infections were not associated with protection; however, the duration of symptoms following SARS-CoV-2 infections was significantly reduced in individuals with higher common betacoronavirus (ßCoV) antibody titers. Since antibody titers decline over time after CCV infections, individuals in our cohort with higher ßCoV antibody titers were more likely recently infected with common ßCoVs compared with individuals with lower antibody titers. Therefore, our data suggest that recent ßCoV infections potentially limit the duration of symptoms following SARS-CoV-2 infections through mechanisms that do not involve cross-reactive antibodies. Our data are consistent with the emerging hypothesis that cellular immune responses elicited by recent common ßCoV infections transiently reduce symptom duration following SARS-CoV-2 infections.

Sero-monitoring of health care workers reveals complex relationships between common coronavirus antibodies and SARS-CoV-2 severity.

Recent common coronavirus (CCV) infections are associated with reduced COVID-19 severity upon SARS-CoV-2 infection, however the immunological mechanisms involved are unknown. We completed serological assays using samples collected from health care workers to identify antibody types associated with SARS-CoV-2 protection and COVID-19 severity. Rare SARS-CoV-2 cross-reactive antibodies elicited by past CCV infections were not associated with protection; however, the duration of symptoms following SARS-CoV-2 infections was significantly reduced in individuals with higher common betacoronavirus (ßCoV) antibody titers. Since antibody titers decline over time after CCV infections, individuals in our cohort with higher ßCoV antibody titers were more likely recently infected with common ßCoVs compared to individuals with lower antibody titers. Therefore, our data suggest that recent ßCoV infections potentially limit the severity of SARS-CoV-2 infections through mechanisms that do not involve cross-reactive antibodies. Our data are consistent with the emerging hypothesis that cellular immune responses elicited by recent common ßCoV infections transiently reduce disease severity following SARS-CoV-2 infections.

HIV Infection and Depression Among Opiate Users in a US Epicenter of the Opioid Epidemic.

Using a mobile research facility, we enrolled 141 opioid users from a neighborhood of Philadelphia, an urban epicenter of the opioid epidemic. Nearly all (95.6%) met DSM-5 criteria for severe opioid use disorder. The prevalence of HIV infection (8.5%) was more than seven times that found in the general population of the city. Eight of the HIV-positive participants (67.0%) reported receiving antiretroviral treatment but almost all of them had unsuppressed virus (87.5%). The majority of participants (57.4%) reported symptoms consistent with major depressive disorder. Severe economic distress (60.3%) and homelessness were common (57%). Polysubstance use was nearly universal, 72.1% had experienced multiple overdoses and prior medication for opioid use disorder (MOUD) treatment episodes (79.9%), but few currently engaged in addiction care. The prevalence, multiplicity and severity of chronic health and socioeconomic problems highlight consequences of the current opioid epidemic and underscore the urgent need to develop integrated models of treatment.

RESUMEN: Utilizando un Centro de Investigación Móvil, inscribimos a 141 usuarios de opioides del vecindario de Filadelfia, un epicentro urbano de la epidemia de opioides. Casi todos (95,6%) cumplieron con los criterios del DSM-5 para el trastorno del uso severo del consumo de opioides. La prevalencia de la infección de VIH (8,5%) fue másﹶ de 7 veces superior a las encontrada en la población general de la ciudad. Ocho de los participantes con VIH positivo (67,0%) reportaron haber recibido tratamiento antirretroviral pero casi todos tuvieron virus no suprimido (87,5%). La mayoría de los participantes (57,4%) informaron síntomas compatibles con el Desorden Depresivo Mayor. La angustia severa por lo económico (60,3%) y las personas sin hogar fueron comunes (57%). El uso de múltiples sustancias fue casi universal, el 721% había experimentado múltiples sobredosis y previos medicamentos para el tratamiento del trastorno por consumo de opioides (MOUD) (79,9%), pero muy pocos estaban comprometidos con la atención a las adicciones. La prevalencia, la multiplicidad y la seriedad de los problemas de salud crónica y los problemas socioeconómicos destacan las consecuencias de la actual epidemia de opioides y subrayan la urgente necesidad de desarrollar nuevos modelos de tratamiento integrados.

Just4Us: Development of a Counselor-Navigator and Text Message Intervention to Promote PrEP Uptake Among Cisgender Women at Elevated Risk for HIV.

ABSTRACT: In the United States, pre-exposure prophylaxis (PrEP) uptake among eligible cisgender women has been slow, despite the availability of oral PrEP since 2012. Although women make up nearly 20% of those living with HIV, there are currently few PrEP uptake interventions for cisgender women at elevated risk for acquiring HIV. Here we describe the process used to design and pre-pilot test Just4Us, a theory-based behavioral intervention to promote PrEP initiation and adherence among PrEP-eligible cisgender women. This work was part of a multiphase study conducted in New York City and Philadelphia, two locations with HIV rates higher than the national average. The counselor-navigator component of the intervention was designed to be delivered in a 60- to 90-min in-person session in the community, followed by several phone calls to support linkage to care. An automated text messaging program was also designed for adherence support. Just4Us addressed personal and structural barriers to PrEP uptake using an empowerment framework by building on women's insights and resources to overcome barriers along the PrEP cascade. Usability pre-pilot testing results were favorable and provided valuable feedback used to refine the intervention.

Prior Sexually Transmitted Infection and Human Immunodeficiency Virus Risk Perception in a Diverse At-Risk Population of Men Who Have Sex with Men and Transgender Individuals.

Prior sexually transmitted infections (STIs) are associated with higher rates of subsequent human immunodeficiency virus (HIV) infection, but the influence of prior STIs on perceived vulnerability to HIV remains unclear. We aimed to assess this relationship, hypothesizing that a prior STI diagnosis is associated with higher self-assessed vulnerability to HIV. We performed a cross-sectional study of men and transgender individuals who have sex with men screening for HIV prevention trials in Philadelphia. An unadjusted regression analysis found no significant association between prior STI and HIV risk perception (p = 0.71) or HIV anxiety (p = 0.32). Multivariate logistic regression models that controlled for predetermined potential cofounders known to impact HIV risk-such as condom use, preexposure prophylaxis use, and demographics-also failed to show statistically significant associations between prior STI and HIV risk perception (p = 0.87) or HIV anxiety (p = 0.10). Furthermore, there was no effect modification by HIV preventive behaviors on the relationship between prior STI and HIV vulnerability. These data suggest that a gap exists between how clinicians may attribute individual HIV risk and how individuals view their own vulnerability at a given moment in time. Future research should focus on the dynamic relationship between perceived HIV vulnerability, STI diagnosis, and adoption of preventive behavior to determine better, individualized targets for HIV prevention interventions.

Mental Health, Social Influences, and HIV Pre-exposure Prophylaxis (PrEP) Utilization Among Men and Transgender Individuals Screening for HIV Prevention Trials.

The effects of mental health comorbidities and social support on the HIV pre-exposure prophylaxis (PrEP) care continuum are unknown. We conducted a cross-sectional study of men and transgender individuals, ≥ 18 years-old, with ≥ 2 male or transgender partners, or recent condomless anal intercourse. Surveys assessed demographics, mental health treatment, depressive symptomatology, social support, and PrEP-related social contacts. Logistic regression assessed associations between these factors and PrEP uptake and persistence. Participants (n = 247) were 89% cis-male and 46% African-American. Median age was 27 (IQR:23-33). Thirty-seven percent had ever used PrEP, of whom 18% discontinued use. High depressive symptomology was identified in 11% and 9% were receiving mental health treatment. There were no significant associations between depressive symptoms or mental health treatment on the odds of PrEP uptake or discontinuation. Each additional PrEP contact conferred a greater odds of uptake (aOR:1.24, 95% CI: 1.09-1.42). Network-level targets may produce fruitful interventions to increase PrEP uptake.

Beliefs Associated with Intention to Use PrEP Among Cisgender U.S. Women at Elevated HIV Risk.

Women comprise 19% of those newly diagnosed with HIV in the U.S. There is a wide gap between recommended use of pre-exposure prophylaxis (PrEP) and actual uptake among women who are eligible for PrEP. In order to identify women's beliefs and intentions about starting PrEP, a survey, informed by the reasoned action approach, was administered to 160 cisgender PrEP-eligible women, age 18-55, in Philadelphia and New York City. The mean age was 40.2 years (SD = 11.78), 44% had completed high school, 75% were unemployed, and 85% experienced financial instability in the past 3 months. Multivariate linear regression analyses identified sets of behavioral and normative beliefs associated with intention to start PrEP in the next 3 months. Behavioral beliefs reflected views about PrEP benefits such as preventing HIV, and normative beliefs reflected perceptions of support or lack thereof from others including partners, friends, mother, and children. These findings can be used to inform interventions to foster greater PrEP uptake among women.

Racial Inequities in HIV Prevalence and Composition of Risk Networks Among People Who Inject Drugs in HIV Prevention Trial Network 037.

BACKGROUND: HIV prevention interventions in the United States have failed to eliminate racial inequities. Here, we evaluate factors associated with racial inequities in HIV prevalence among people who inject drugs using HIV Prevention Trial Network 037 data. METHODS: We measured racial homophily (ie, all members share the same race), being in an HIV+ network (network with ≥1 HIV+ member), and drug and sex risk behaviors. A 2-level logistic regression with a random intercept evaluated the association between being in an HIV+ network and race adjusting for individual-level and network-level factors. RESULTS: Data from 232 index participants and 464 network members were included in the analysis. Racial homophily was high among blacks (79%) and whites (70%); 27% of all-black, 14% of all-white, and 23% of racially mixed networks included HIV+ members. Sex risk was similar across networks, but needle sharing was significantly lower in all-black (23%) compared with all-white (48%) and racially mixed (46%) networks. All-black [adjusted odds ratio (AOR), 3.6; 95% confidence interval (CI), 1.4 to 9.5] and racially mixed (AOR, 2.0; 95% CI: 1.1 to 3.7) networks were more likely to include HIV+ network members; other factors associated with being in HIV+ network included homelessness (AOR, 2.0; 95% CI, 1.2 to 3.2), recent incarceration (AOR, 0.4; 95% CI, 0.2 to 0.7), and cocaine injection (AOR, 1.7; 95% CI, 1.0 to 2.7). Risk behaviors were not associated with being in an HIV+ network. CONCLUSION: Despite having lower drug risk behavior, all-black networks disproportionately included HIV+ members. HIV prevention interventions for people who inject drugs need to go beyond individual risk and consider the composition of risk networks.

Going social: Success in online recruitment of men who have sex with men for prevention HIV vaccine research.

OBJECTIVE: To compare the use of four different social media sites to recruit men who have sex with men (MSM) and transgender women to a phase 2b HIV prevention vaccine trial, HVTN 505. DESIGN: Retrospective, observational study. METHODS: The University of Pennsylvania HIV Vaccine Trials Unit (Penn HVTU) employed street outreach and online recruitment methods to recruit participants for HVTN 505 using a combination of national recruitment images/messages with Philadelphia-specific language and imagery. We compared the efficiency (number of enrolled participants per number of completed phone screens) and effectiveness (number of enrolled participants per time interval employed) of each strategy, as well as the demographics and risk behaviors of the populations. RESULTS: Online recruitment strategies populated 37% (71/191) of trial participants at our site. Among the four social media strategies employed, 45.1% (32/71) were enrolled through Facebook, 16.9% (12/71) through Craigslist, 15.5% (11/71) through a web-based marketing company (WBMC), and 22.5% (16/71) via GRINDR. The number of participants enrolled per month of strategy and the months the strategy was employed were Facebook - 32(33months), Craigslist - 12(33months), WBMC - 11(6months), and GRINDR - 16(0.56months). In-person and online recruitment strategies yielded participants of similar demographics and levels of risk behavior. CONCLUSION: Use of several social media recruitment modalities produced large numbers of MSM engaging in high risk behavior and willing to participate in an HIV prevention vaccine trial. In comparison to other social media and online strategies, recruitment via GRINDR was the most effective.

Individual and community factors associated with geographic clusters of poor HIV care retention and poor viral suppression.

BACKGROUND: Previous analyses identified specific geographic areas in Philadelphia (hotspots) associated with negative outcomes along the HIV care continuum. We examined individual and community factors associated with residing in these hotspots. METHODS: Retrospective cohort of 1404 persons newly diagnosed with HIV in 2008-2009 followed for 24 months after linkage to care. Multivariable regression examined associations between individual (age, sex, race/ethnicity, HIV transmission risk, and insurance status) and community (economic deprivation, distance to care, access to public transit, and access to pharmacy services) factors and the outcomes: residence in a hotspot associated with poor retention-in-care and residence in a hotspot associated with poor viral suppression. RESULTS: In total, 24.4% and 13.7% of persons resided in hotspots associated with poor retention and poor viral suppression, respectively. For persons residing in poor retention hotspots, 28.3% were retained in care compared with 40.4% of those residing outside hotspots (P < 0.05). Similarly, for persons residing in poor viral suppression hotspots, 51.4% achieved viral suppression compared with 75.3% of those outside hotspots (P < 0.0.05). Factors significantly associated with residence in poor retention hotspots included female sex, lower economic deprivation, greater access to public transit, shorter distance to medical care, and longer distance to pharmacies. Factors significantly associated with residence in poor viral suppression hotspots included female sex, higher economic deprivation, and shorter distance to pharmacies. CONCLUSIONS: Individual and community-level associations with geographic hotspots may inform both content and delivery strategies for interventions designed to improve retention-in-care and viral suppression.

Racial disparities in HIV prevalence and risk behaviors among injection drug users and members of their risk networks.

In the United States, racial differences in the prevalence and incidence of HIV infection and AIDS diagnoses are dramatic. These differences are large, have been recognized for nearly 20 years, and are as yet not well investigated. These disparities show no signs of diminishing and, in fact, are widening, particularly among drug users and women. Most observers of the racial disparities in prevalence and incidence of HIV infections and AIDS diagnoses in the United States have concluded that these disparities exist because prevention messages, supplies, and/or interventions do not effectively reach those at greatest risk of infection. In essence, such interpretations suggest that Blacks and Latinos continue to practice more risk behaviors than Whites. There are much data to suggest that this is, in fact, not true. Evidence from 232 'index' injection drug users and 465 of their drug and sexual network members participating in HIV Prevention Trials Network 037 is presented. These data describe lower use and/or access to drug treatment and needle exchange programs by Black injectors. In addition, data indicate the coexistence of increased prevalence of HIV in the networks of uninfected Black drug users and fewer associated risk behaviors in the networks of Black and Latino indices compared with networks of White indices. Understanding racial disparities in HIV is a critical challenge; yet, risk behaviors alone do not explain observed disparities in infection rates.

Active Drug-Using Women Use Female-Initiated Barrier Methods to Reduce HIV/STI Risk: Results from a Randomized Trial.

UNLABELLED: Background. We tested an original, woman-focused intervention, based on body empowerment, and female-initiated barrier methods, including the female condom (FC) and cervical barriers. Methods. Eligible women were >= 18 years of age, HIV seronegative, and active drug users, reporting 30% or greater unprotected sex acts. Both controls (C) and intervention (I) participants received enhanced HIV/STI harm reduction counseling. I participants underwent 5 additional weekly group sessions. We compared change in frequency of unprotected vaginal intercourse across arms at 12 months. Results. Among 198 enrolled women, over 95% completed followup. Two-thirds were African-American; most of them used crack, had a primary partner, and reported sex exchange. In paired t-tests from baseline to followup, the frequency of unprotected vaginal sex dropped significantly for I (primary P < 0.00, nonprimary P < 0.002) and C (primary P < 0.008, nonprimary P < 0.000) arms with all partners. The difference in change across arms was of borderline significance for primary partner (P = 0.075); no difference was seen for nonprimary partner (P = 0.8). Use of male condom and FC increased with both partner types over time, but more consistently among I women. CONCLUSION: The "value-added" impact of the intervention was observed mainly with primary partners. Body knowledge with routine FC counseling should be incorporated into interventions for drug-using women.

Correlates of trichomonas prevalence among street-recruited, drug-using women enrolled in a randomized trial.

OBJECTIVES: Substance-using women need prevention technologies and programs to reduce risk of HIV/sexually transmitted infection (STI). We examined STI prevalence and identified risk correlates for female drug users. METHODS: We used interviewer-administered and computer-assisted surveys, and tested specimens for four, treatable STIs (trichomonas, early syphilis, gonorrhea, chlamydia) on 198 HIV-seronegative, street-recruited, substance-using women enrolled in a randomized trial to reduce HIV/STI risk. RESULTS: Most women were crack users (88%), reported sex exchange (80%) and were not in drug user treatment (74%). Two-thirds were African-American and nearly all were unemployed. Protection during sex was infrequent. African-American women reported fewer unprotected sex acts and fewer sexual partners, but greater crack use and more sex-for exchange, than whites or Hispanics. Trichomonas prevalence (36.9%) exceeded that for chlamydia (3.5%), syphilis (1.5%), and gonorrhea (0%). In multivariate logistic regression, having a primary and casual partner more than doubled (AOR 2.86) the risk of having trichomonas and being African-American raised the risk by more than 8 times (AOR 8.45). CONCLUSIONS: African-American, drug-using women, and women with multiple partner types, are in urgent need of effective STI/HIV prevention interventions.

Sociodemographic and behavioral characteristics associated with timeliness and retention in a 6-month follow-up study of high-risk injection drug users.

Timeliness and retention in a 6-month follow-up study were analyzed by subjects' baseline characteristics in a seroincidence study of 263 injection drug users at high risk of human immunodeficiency virus infection. Subjects were recruited from September 1997 to June 1998 in community settings in Philadelphia, Pennsylvania. Of these subjects, 93% were completers: 11% before the targeted date, 38% at the targeted date, 32% within 1 month of delay, and 12% beyond 1 month. Late completers were more likely than other completers to be younger and to live farther away from the study center, less likely to have stayed in a shelter or a welfare residence during the past year, more likely to have a lower income, and more likely to have shared rinse water, cotton, or cooker. By contrast, loss to follow-up was not associated with these variables. Subjects lost to follow-up were more likely than those retained to have a high school diploma and to have moved during the past year; their source of needles was less likely to be a needle exchange program and more likely to be a shooting gallery. None of the drug-related behaviors that increase the risk of human immunodeficiency virus infection was associated with timeliness or retention, suggesting that the study might be minimally biased.