Understanding Psychosocial Determinants of PrEP Uptake Among Cisgender Women Experiencing Heightened HIV Risk: Implications for Multi-Level Communication Intervention.

Pre-exposure prophylaxis (PrEP) is a highly effective daily pill that decreases the likelihood of HIV acquisition by up to 92% among individuals at risk for HIV. PrEP can be discretely used, autonomously controlled, and in place at the time of risk exposure, making it an especially promising method for HIV prevention for cisgender women (CGW). But, PrEP is underutilized by CGW relative to the demonstrable need. We apply the Integrative Model of Behavioral Prediction to identify the critical psychosocial factors that shape CGW's intentions to use PrEP and their relevant underlying beliefs. We surveyed (N = 294) community- and clinic-recruited PrEP eligible CGW to understand the relative importance of attitudes, norms, and efficacy in shaping PrEP intentions. We utilized structural equation modeling to identify the relevant paths. We inspected the summary statistics in relation to three message three selection criteria. We identified beliefs that demonstrated (1) an association with intention, (2) substantial room to move the population, (3) practicality as a target for change through communication intervention. Results show that PrEP awareness was low. When women learned about PrEP, they voiced positive intentions to use it. There were significant and positive direct effects of SE (0.316***), attitudes (0.201**), and subjective norms (0.249***) on intention to initiate PrEP. We illustrate the strategic identification of beliefs within the relevant paths using the 3 belief selection criteria. We also discuss implications for social and structural communication interventions to support women's HIV prevention.

Incidence of Venous Thromboembolism in Transgender Women Receiving Oral Estradiol.

INTRODUCTION: One of the most serious known adverse effects of feminizing cross-sex hormone therapy (CSHT) is venous thromboembolism (VTE); however, no study has assessed the incidence of VTE from the hormone therapies used in the United States because previous publications on this topic have originated in Europe. CSHT in the United States typically includes estradiol with the antiandrogen spironolactone, whereas in Europe estradiol is prescribed with the progestin cyproterone acetate. AIM: To estimate the incidence of VTE from the standard feminizing CSHTs used in the United States. METHODS: A retrospective chart review of transgender women who had been prescribed oral estradiol at a District of Columbia community health center was performed. MAIN OUTCOME MEASURE: The primary outcomes of interest were deep vein thrombosis or pulmonary emboli. RESULTS: From January 1, 2008 through March 31, 2016, 676 transgender women received oral estradiol-based CSHT for a total of 1,286 years of hormone treatment and a mean of 1.9 years of CSHT per patient. Only one individual, or 0.15% of the population, sustained a VTE, for an incidence of 7.8 events per 10,000 person-years. CONCLUSION: There was a low incidence of VTE in this population of transgender women receiving oral estradiol.

Age-related factors associated with intention to initiate pre-exposure prophylaxis among cisgender women in Washington D.C.

Background: Pre-exposure prophylaxis (PrEP) utilization among cisgender women (subsequently 'women') is low across age groups, relative to their risk of HIV acquisition. We hypothesize that age-related differences in psychosocial factors also influence women's intention to initiate oral PrEP in Washington, D.C. Methods: A secondary analysis of a cross-sectional survey data was performed to evaluate factors influencing intention to initiate oral PrEP among women seen at a family planning and a sexual health clinic. A bivariate analysis was performed to identify differences by age group in demographic characteristics, indications for PrEP, and attitudes toward PrEP; we then performed additional bivariate analysis to assess these variables in relation to PrEP intention. Results: Across age groups, perceived risk of HIV acquisition was not significantly different and was not associated with intention to initiate PrEP. Awareness of and attitude toward PrEP, injunctive norms, descriptive norms, and self-efficacy were not different across age, however there were significant age-associated differences in relation to PrEP intention. Specifically, among 18-24-year-olds, intention to start PrEP was associated with support from provider (p = 0.03), main sexual partner (p < 0.01), and peers (p < 0.01). For women 25-34 years old, having multiple sexual partners (p = 0.03) and support from casual sexual partners (p = 0.03) was also important. Among women 35-44 years old, prior awareness of PrEP (p = 0.02) and their children's support of PrEP uptake (p < 0.01) were associated with intention to initiate PrEP. Among 45-55 year-old women intention to initiate PrEP was positively associated with engaging in casual sex (p = 0.03) and negatively associated with stigma (p < 0.01). Conclusion: Overall, there were more similarities than differences in factors influencing intention to initiate PrEP across age groups. Observed differences offer an opportunity to tailor PrEP delivery and HIV prevention interventions to increase awareness and uptake for cisgender women.

Research showing how women's age affects their decision to start pre-exposure prophylaxis to prevent HIV in Washington, DC We know that many women need pre-exposure prophylaxis (PrEP) to prevent HIV infection in Washington, DC, yet the number of women who use PrEP is lower than expected. The study was done to determine whether a woman's age affects her decision to start PrEP. This is important because providers need to know the factors affecting a woman's decision to start PrEP in order to increase PrEP use in at-risk patients. We re-analyzed a set of data that was generated from surveys given to women in a women's health clinic. The surveys asked women about their background, including risk factors for HIV infection, and their awareness of and attitudes toward PrEP. We also asked women questions that were meant to determine their belief in their own ability to make decisions as well as the degree to which other people in their life affect their own decisions. We wanted to know whether age affects the degree to which these characteristics affect women's decision to start PrEP. Overall, there were more similarities than differences between age groups when looking at how different factors affect the decision to start PrEP. Across age groups, there were no differences in how women view their risk of HIV infection. We found that 18-24-year-olds were more likely to start PrEP when they felt support from their provider, main sexual partner, and peers. 25-34-year-olds were more likely to start PrEP when they felt this same source of support and had had multiple sexual partners. 35-44-year-olds were more likely to start PREP when they already had awareness of PrEP or had their children's support of their PrEP use. 45-55-year-olds were more likely to start PrEP when they had engaged in casual sex and were less likely to start PrEP if they expected negative judgement for it. Even though there were significant similarities between age groups, the differences that we found offer an opportunity to tailor PrEP awareness and interventions to promote PrEP use among women.

Out-of-pocket costs and HIV pre-exposure prophylaxis persistence in a US multicity demonstration project.

OBJECTIVE: To evaluate whether out-of-pocket (OOP) costs reduced HIV pre-exposure prophylaxis (PrEP) persistence. DATA SOURCE: Participants from five urban community health centers (CHCs) in four US cities enrolled in a PrEP demonstration project from September 2014 to August 2017. STUDY DESIGN: Patients initiating PrEP were followed quarterly until they withdrew from PrEP care or the study ended. Self-reported OOP medication and clinic visit costs were assessed by semiannual questionnaires. Persistence was defined as the time from study enrollment to the last visit after which two subsequent 3-month visits were missed. Multivariable Cox proportional hazard regression was used to assess the effect of demographics, insurance, and OOP costs on PrEP persistence. PRINCIPAL FINDINGS: Among 918 participants with OOP cost data, the average quarterly OOP cost was $34 (median: $5, IQR: $0-$25). Participants who were men, White, employed, completed college, and had commercial insurance had higher OOP costs. Higher OOP costs were not associated with lower PrEP persistence by Cox proportional hazards regression (adjusted hazard ratio = 1.00 per $50 increase, 95% CI = 0.97, 1.02). CONCLUSION: Among patients receiving care from these urban CHCs, OOP costs were low and did not undermine PrEP persistence.

Quarterly screening optimizes detection of sexually transmitted infections when prescribing HIV preexposure prophylaxis.

OBJECTIVE: The optimal screening frequency of sexually transmitted infections (STIs) for MSM and transgender women (TGW) on HIV pre-exposure prophylaxis (PrEP) is unclear, with present guidelines recommending screening every 3-6 months. We aimed to determine the number of STIs for which treatment would have been delayed without quarterly screening. DESIGN: The US PrEP Demonstration Project was a prospective, open-label cohort study that evaluated PrEP delivery in STI clinics in San Francisco and Miami, and a community health center in Washington, DC. In all, 557 HIV-uninfected MSM and TGW were offered up to 48 weeks of PrEP and screened quarterly for STIs. METHODS: The proportion of gonorrhea, chlamydia, and syphilis infections for which treatment would have been delayed had screening been conducted every 6 versus every 3 months was determined by taking the number of asymptomatic STIs at weeks 12 and 36 divided by the total number of infections during the study follow-up period for each STI. RESULTS: Among the participants, 50.9% had an STI during follow-up. If screening had been conducted only semiannually or based on symptoms, identification of 34.3% of gonorrhea, 40.0% of chlamydia, and 20.4% of syphilis infections would have been delayed by up to 3 months. The vast majority of participants (89.2%) with asymptomatic STIs reported condomless anal sex and had a mean of 8.1 partners between quarterly visits. CONCLUSIONS: Quarterly STI screening among MSM on PrEP could prevent a substantial number of partners from being exposed to asymptomatic STIs, and decrease transmission.

Brief Report: Short-Term Adherence Marker to PrEP Predicts Future Nonretention in a Large PrEP Demo Project: Implications for Point-of-Care Adherence Testing.

BACKGROUND: Objective adherence metrics for tenofovir (TFV) disoproxil fumarate/emtricitabine (FTC)-based pre-exposure prophylaxis (PrEP) were critical for interpretation of efficacy in PrEP clinical trials, and there is increasing interest in using drug levels to tailor interventions for reengagement and adherence. Point-of-care immunoassays for TFV, which examine short-term adherence, are in development. However, the ability of poor short-term and long-term adherence to predict future PrEP nonretention is unknown. SETTING: Secondary data analysis of a large, prospective multi-site U.S. PrEP demonstration project. METHODS: An adjusted Cox-proportional hazards model examined the relationship of dried blood spot (DBS) levels of FTC-triphosphate (FTC-TP) or TFV-diphosphate (TFV-DP), measures of short-term and long-term PrEP adherence, respectively, with future study nonretention. RESULTS: Overall, 294 individuals (median age 33 years) contributed drug levels within the U.S. PrEP demonstration project. By the end of study, 27% were lost to follow-up, 25% had at least one undetectable FTC-TP level indicating poor short-term adherence, and 29% had a drug level indicating suboptimal long-term adherence (TFV-DP <700 fmol/punch). The strongest factor associated with future study nonretention using a binary drug-level cut-off was an undetectable DBS FTC-TP level (adjusted hazard ratio 6.3; 95% confidence interval 3.8 to 10.2). The suboptimal long-term adherence based on low DBS TFV-DP levels was also associated with nonretention (adjusted hazard ratio 4.3; 95% confidence interval: 2.4 to 7.6). CONCLUSIONS: Both short- and long-term metrics of PrEP adherence are strongly associated with future loss to follow-up in a U.S. demonstration project study. Short-term metrics of adherence, once available at the point-of-care, could be used to direct real-time tailored retention and adherence interventions.

Changes in Kidney Function Associated With Daily Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Preexposure Prophylaxis Use in the United States Demonstration Project.

BACKGROUND: HIV preexposure prophylaxis (PrEP) using daily oral tenofovir-disoproxil-fumarate/emtricitabine (TDF/FTC) is effective for preventing HIV acquisition, but concerns remain about its potential kidney toxicity. This study examined kidney function in individuals using PrEP in real-world clinical settings. SETTING: Demonstration project in 2 sexually transmitted infection clinics and a community health center. METHODS: We evaluated kidney function among men who have sex with men and transgender women taking tenofovir-disoproxil-fumarate/emtricitabine PrEP for up to 48 weeks. Serum creatinine and urine dipstick for protein were obtained at 12-week intervals. Kidney function was estimated using creatinine clearance (CrCl) (Cockcroft-Gault) and estimated glomerular filtration rate (eGFR) (CKD-EPI). RESULTS: From October 2012 to January 2014, we enrolled 557 participants (median age 33). Mean creatinine increased from baseline to week 12 by 0.03 mg/dL (4.6%) (P < 0.0001); mean CrCl decreased by 4.8 mL/min (3.0%) (P < 0.0001). These changes remained stable through week 48 (P = 0.81, P = 0.71 respectively). There were 75/478 (15.7%) participants who developed worsening proteinuria at week 12 compared with baseline (P < 0.0001), and this percent remained stable through week 48 (P = 0.73). Twenty-five participants (5.1%) developed new-onset eGFR <70 mL/min/1.73 m; independent predictors of this outcome were age ≥40 years (OR 3.79, 95% CI: 1.43 to 10.03) and baseline eGFR <90 mL/min/1.73 m (OR 9.59, 3.69-24.94). CONCLUSIONS: In a demonstration setting, daily tenofovir-disoproxil-fumarate/emtricitabine PrEP leads to reduced CrCl and eGFR; however, these eGFR changes are based on very small changes in serum creatinine and seem to be nonprogressive after the first 12 weeks. Future studies are needed to understand the prognostic significance of these small changes.

Preexposure Prophylaxis for HIV Infection Integrated With Municipal- and Community-Based Sexual Health Services.

IMPORTANCE: Several randomized clinical trials have demonstrated the efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) acquisition. Little is known about adherence to the regimen, sexual practices, and overall effectiveness when PrEP is implemented in clinics that treat sexually transmitted infections (STIs) and community-based clinics serving men who have sex with men (MSM). OBJECTIVE: To assess PrEP adherence, sexual behaviors, and the incidence of STIs and HIV infection in a cohort of MSM and transgender women initiating PrEP in the United States. DESIGN, SETTING, AND PARTICIPANTS: Demonstration project conducted from October 1, 2012, through February 10, 2015 (last date of follow-up), among 557 MSM and transgender women in 2 STI clinics in San Francisco, California, and Miami, Florida, and a community health center in Washington, DC. Data were analyzed from December 18, 2014, through August 8, 2015. INTERVENTIONS: A combination of daily, oral tenofovir disoproxil fumarate and emtricitabine was provided free of charge for 48 weeks. All participants received HIV testing, brief client-centered counseling, and clinical monitoring. MAIN OUTCOMES AND MEASURES: Concentrations of tenofovir diphosphate in dried blood spot samples, self-reported numbers of anal sex partners and episodes of condomless receptive anal sex, and incidence of STI and HIV acquisition. RESULTS: Overall, 557 participants initiated PrEP, and 437 of these (78.5%) were retained through 48 weeks. Based on the findings from the 294 participants who underwent measurement of tenofovir diphosphate levels, 80.0% to 85.6% had protective levels (consistent with ≥4 doses/wk) at follow-up visits. African American participants (56.8% of visits; P = .003) and those from the Miami site (65.1% of visits; P < .001) were less likely to have protective levels, whereas those with stable housing (86.8%; P = .02) and those reporting at least 2 condomless anal sex partners in the past 3 months (88.6%; P = .01) were more likely to have protective levels. The mean number of anal sex partners declined during follow-up from 10.9 to 9.3, whereas the proportion engaging in condomless receptive anal sex remained stable at 65.5% to 65.6%. Overall STI incidence was high (90 per 100 person-years) but did not increase over time. Two individuals became HIV infected during follow-up (HIV incidence, 0.43 [95% CI, 0.05-1.54] infections per 100 person-years); both had tenofovir diphosphate levels consistent with fewer than 2 doses/wk at seroconversion. CONCLUSIONS AND RELEVANCE: The incidence of HIV acquisition was extremely low despite a high incidence of STIs in a large US PrEP demonstration project. Adherence was higher among those participants who reported more risk behaviors. Interventions that address racial and geographic disparities and housing instability may increase the impact of PrEP.

High interest in preexposure prophylaxis among men who have sex with men at risk for HIV infection: baseline data from the US PrEP demonstration project.

BACKGROUND: Preexposure prophylaxis (PrEP) is the first biomedical intervention with proven efficacy to reduce HIV acquisition in men who have sex with men (MSM) and transgender women. Little is known about levels of interest and characteristics of individuals who elect to take PrEP in real-world clinical settings. METHODS: The US PrEP Demonstration Project is a prospective open-label cohort study assessing PrEP delivery in municipal sexually transmitted disease clinics in San Francisco and Miami and a community health center in Washington, DC. HIV-uninfected MSM and transgender women seeking sexual health services at participating clinics were assessed for eligibility and offered up to 48 weeks of emtricitabine/tenofovir for PrEP. Predictors of enrollment were assessed using a multivariable Poisson regression model, and characteristics of enrolled participants are described. RESULTS: Of 1069 clients assessed for participation, 921 were potentially eligible and 557 (60.5%) enrolled. In multivariable analyses, participants from Miami (adjusted Relative Risk [aRR]: 1.53; 95% confidence interval [CI]: 1.33 to 1.75) or DC (aRR: 1.33; 95% CI: 1.2 to 1.47), those who were self-referred (aRR: 1.48; 95% CI: 1.32 to 1.66), those with previous PrEP awareness (aRR: 1.56; 95% CI: 1.05 to 2.33), and those reporting >1 episode of anal sex with an HIV-infected partner in the last 12 months (aRR: 1.20; 95% CI: 1.09 to 1.33) were more likely to enroll. Almost all (98%) enrolled participants were MSM, and at baseline, 63.5% reported condomless receptive anal sex in the previous 3 months. CONCLUSIONS: Interest in PrEP is high among a diverse population of MSM at risk for HIV infection when offered in sexually transmitted disease and community health clinics.