Projecting the impact of equity-based preexposure prophylaxis implementation on racial disparities in HIV incidence among MSM.
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ABSTRACT: Background
It is unknown what levels of preexposure prophylaxis (PrEP) use are needed to reduce racial disparities in HIV incidence among men who have sex with men (MSM). Using an agent-based model, we quantified the impact of achieving PrEP coverage targets grounded in equity on racial disparities in HIV incidence among MSM in an urban setting in the Southeastern United States.Methods
An agent-based model was adapted to simulate HIV transmission in a network of Black/African American and White MSM aged 18-39 years in the Atlanta-Sandy Springs-Roswell metropolitan area over 10 years (2015-2024). Scenarios simulated coverage levels consistent with targets based on the ratio of the number of individuals using PrEP to the number of individuals newly diagnosed in a calendar year (i.e., the 'PrEP-to-need ratio'), ranging from 1 to 10. Incidence rate ratios and differences were calculated as measures of disparities.Results
Without PrEP, the model predicted a rate ratio of 3.82 and a rate difference of 4.50 comparing HIV incidence in Black/African American and White MSM, respectively. Decreases in the rate ratio of at least 50% and in the rate difference of at least 75% were observed in all scenarios in which the PrEP-to-need ratio among Black/African American MSM was 10, regardless of the value among White MSM.Conclusion
Significant increases in PrEP use are needed among Black/African American MSM to reduce racial disparities in HIV incidence. PrEP expansion must be coupled with structural interventions to address vulnerability to HIV infection among Black/African American MSM.
SUBMITTER: Goedel WC
PROVIDER: S-EPMC7368810 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:PURPOSE:Preexposure prophylaxis (PrEP) in the form of daily emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) is effective for preventing HIV infection. Implementation has been limited by an inability to systematically evaluate uptake and use. All-Payer Claims Databases (APCDs) provide an opportunity to evaluate population-level PrEP implementation. METHODS:We used 2012-2017 data from Rhode Island's APCD and developed an algorithm to identify individuals prescribed FTC/TDF for PrEP. We describe PrEP implementation by patient demographics and provider type and mapped PrEP implementation across ZIP codes. We compared APCD data to electronic medical record data and comprehensive pharmaceutical claims data (AIDSVu.org). RESULTS:The Rhode Island APCD represented approximately 87% of the state's population. PrEP use increased 31-fold from 2012 to 2017. Users were predominantly privately insured, male, and concentrated in Providence County (76.6%). Infectious diseases providers had 3.2 times the odds of being a PrEP prescriber compared to primary care providers. Compared to other pharmaceutical and electronic medical record data, the APCD underestimated the number of PrEP users in Rhode Island but improved in capturing users over time. CONCLUSIONS:APCDs are a useful data source for characterizing PrEP use across a state. There is a need to increase PrEP prescribing among primary care providers, especially in areas with underserved populations.
| S-EPMC7252205 | biostudies-literature
Project description:HIV-testing algorithms for preexposure prophylaxis (PrEP) should be optimized to minimize the risk of drug resistance, the time off PrEP required to evaluate false-positive screening results, and costs and to expedite the start of therapy for those confirmed to be infected. HIV rapid tests (RTs) for anti-HIV antibodies provide results in less than 1 h and can be conducted by nonlicensed staff at the point of care. In many regions, Western blot (WB) testing is required to confirm reactive RT results. WB testing, however, causes delays in diagnosis and adds expense. The iPrEx study evaluated the safety and efficacy of daily oral emtricitabine-tenofovir disoproxil fumarate among HIV-seronegative men and transgender women who have sex with men: HIV infection was assessed with two RTs plus WB confirmation, followed by HIV-1 plasma viral load testing. During the iPrEx study, there were 51,260 HIV status evaluations among 2,499 volunteers using RTs: 142 (0.28%) had concordant positive results (100% were eventually confirmed) and 19 (0.04%) had discordant results among 14 participants; 11 were eventually determined to be HIV infected. A streamlined approach using only one RT to screen and a second RT to confirm (without WB) would have had nearly the same accuracy. Discrepant RT results are best evaluated with nucleic acid testing, which would also increase sensitivity.
| S-EPMC4290918 | biostudies-literature
Project description:BACKGROUND:Pre-exposure prophylaxis (PrEP) uptake has been slow among African American men who have sex with men (AAMSM) in the United States. We used an agent-based model (ABM) to simulate race-specific PrEP coverage to estimate their impact on racial disparities in HIV incidence among MSM in Atlanta, GA. METHODS:An ABM was constructed to simulate HIV transmission in a dynamic network of 10,000 MSM over 10 years, beginning in 2015. We modeled a base scenario with estimated PrEP coverage of 2.5% among AAMSM and 5.0% among white MSM (WMSM). We then compared HIV incidence over 10 years and calculated a disparity ratio of AAMSM to WMSM incidence rates across varying PrEP scale-up scenarios, with equal and unequal coverage among AAMSM and WMSM. RESULTS:Assuming current coverage remains constant, the model predicts HIV incidence rates of 2.95 and 1.76 per 100 person-years among AAMSM and WMSM, respectively, with a disparity ratio of 1.68. If PrEP coverage was to increase 6-fold without addressing inequities in PrEP uptake, the model predicts incidences of 2.65 and 1.34, corresponding to a mean decrease of 10.4% and 24.0% in HIV incidence, respectively. This stronger benefit for WMSM increased the disparity ratio to 1.98. Equal PrEP coverage among AAMSM and WMSM resulted in lower incidence rates overall with lower disparity ratios. CONCLUSIONS:Lower uptake among AAMSM relative to WMSM may limit the population-level impact of PrEP use among AAMSM, which may ultimately culminate in wider racial disparities in HIV incidence among MSM.
| S-EPMC6342014 | biostudies-literature
Project description:BACKGROUND:Tenofovir disoproxil fumarate/emtricitabine preexposure prophylaxis (PrEP) is effective against HIV acquisition when taken as prescribed. Strategies that identify and intervene with those challenged by adherence to daily medication are needed. SETTING:PATH-PrEP was an open-label single-arm interventional cohort study conducted at 2 community-based clinical sites in Los Angeles, CA. METHODS:We enrolled self-identified men who have sex with men and transgender women ?18 years of age at an elevated risk of HIV acquisition. Participants received a postexposure prophylaxis (PEP)-based or PrEP-based HIV prevention package for at least 48 weeks. Plasma tenofovir levels from each PrEP visit assessed as below the limit of quantitation (<10 ng/mL) triggered increased adherence support. RESULTS:Three hundred one participants enrolled. Forty-eight-week retention in the PrEP cohort was 75.1%. Biomarker evidence of PrEP adherence consistent with ?4 doses per week at weeks 4, 12, 24, 36, and 48 was found in 83.1%, 83.4%, 75.7%, 71.6%, and 65.5% of participants, respectively; younger and African American participants were less likely to have protective drug levels. Most of those with suboptimal adherence had adherence improvement after brief intervention. One seroconversion occurred in a participant who discontinued PrEP. Nearly half (46.4%) of participants were diagnosed with at least 1 incident sexually transmitted infection during 48 weeks of study follow-up. CONCLUSIONS AND RELEVANCE:PrEP was acceptable and well tolerated in a diverse population of men who have sex with men in Los Angeles. A brief intervention triggered from biomarkers of poor adherence was associated with improved adherence. Drug level monitoring has the potential to allow targeting of additional adherence support to those struggling with daily tablet adherence.
| S-EPMC5681370 | biostudies-literature
Project description:The review describes the evidence for HIV preexposure prophylaxis (PrEP) with daily combined tenofovir disoproxil fumarate and emtricitabine for adolescents and young adults. Current recommendations are described, as are the unique medical, socioeconomic, and legal considerations regarding the use of PrEP for youth.PrEP with daily oral tenofovir disoproxil fumarate-emtricitabine has been shown to help prevent new HIV infection among adults at substantial risk. Evidence suggests a protective benefit of PrEP for youth at risk for HIV, although low adherence is emerging as a barrier to effective use.Effective use of antiretrovirals for PrEP represents a seminal development in HIV prevention efforts. Improving access and adherence to PrEP for youth has the potential to substantially reduce the incidence of HIV in this population.
| S-EPMC5762125 | biostudies-other
Project description:Antiretroviral preexposure prophylaxis (PrEP), using tenofovir disoproxil fumarate (TDF) and combination emtricitabine/tenofovir disoproxil fumarate (FTC+TDF), is efficacious for prevention of human immunodeficiency virus (HIV) acquisition. PrEP could reduce periconception HIV risk, but the effect on pregnancy outcomes is not well defined.To assess pregnancy incidence and outcomes among women using PrEP during the periconception period.Randomized trial among 1785 HIV-serodiscordant heterosexual couples (the Partners PrEP Study) in which the female partner was HIV uninfected that demonstrated that PrEP was efficacious for HIV prevention, conducted between July 2008 and June 2013 at 9 sites in Kenya and Uganda.Daily oral TDF (n?=?598), combination FTC+TDF (n?=?566), or placebo (n?=?621) through July 2011, when PrEP demonstrated efficacy for HIV prevention. Thereafter, participants continued receiving active PrEP without placebo. Pregnancy testing occurred monthly and study medication was discontinued when pregnancy was detected.Pregnancy incidence, birth outcomes (live births, pregnancy loss, preterm birth, congenital anomalies), and infant growth.A total of 431 pregnancies occurred. Pregnancy incidence was 10.0 per 100 person-years among women assigned placebo, 11.9 among those assigned TDF (incidence difference, 1.9; 95% CI, -1.1 to 4.9 [P?=?.22 vs placebo]), and 8.8 among those assigned FTC+TDF (incidence difference, -1.3; 95% CI, -4.1 to 1.5 [P?=?.39 vs placebo]). Before discontinuation of the placebo treatment group in July 2011, the occurrence of pregnancy loss (96 of 288 pregnancies) was 42.5% for women receiving FTC+TDF compared with 32.3% for those receiving placebo (difference for FTC+TDF vs placebo, 10.2%; 95% CI, -5.3% to 25.7%; P?=?.16) and was 27.7% for those receiving TDF alone (difference vs placebo, -4.6%; 95% CI, -18.1% to 8.9%; P?=?.46). After July 2011, the frequency of pregnancy loss (52 of 143 pregnancies) was 37.5% for FTC+TDF and 36.7% for TDF alone (difference, 0.8%; 95% CI, -16.8% to 18.5%; P?=?.92). Occurrence of preterm birth, congenital anomalies, and growth throughout the first year of life did not differ significantly for infants born to women who received PrEP vs placebo.Among HIV-serodiscordant heterosexual African couples, differences in pregnancy incidence, birth outcomes, and infant growth were not statistically different for women receiving PrEP with TDF alone or combination FTC+TDF compared with placebo at conception. Given that PrEP was discontinued when pregnancy was detected and that CIs for the birth outcomes were wide, definitive statements about the safety of PrEP in the periconception period cannot be made. These results should be discussed with HIV-uninfected women receiving PrEP who are considering becoming pregnant.clinicaltrials.gov Identifier: NCT00557245.
| S-EPMC4362516 | biostudies-literature
Project description:Preexposure prophylaxis with antiretroviral drugs has been effective in the prevention of human immunodeficiency virus (HIV) infection in some trials but not in others.In this randomized, double-blind, placebo-controlled trial, we assigned 2120 HIV-negative women in Kenya, South Africa, and Tanzania to receive either a combination of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or placebo once daily. The primary objective was to assess the effectiveness of TDF-FTC in preventing HIV acquisition and to evaluate safety.HIV infections occurred in 33 women in the TDF-FTC group (incidence rate, 4.7 per 100 person-years) and in 35 in the placebo group (incidence rate, 5.0 per 100 person-years), for an estimated hazard ratio in the TDF-FTC group of 0.94 (95% confidence interval, 0.59 to 1.52; P=0.81). The proportions of women with nausea, vomiting, or elevated alanine aminotransferase levels were significantly higher in the TDF-FTC group (P=0.04, P<0.001, and P=0.03, respectively). Rates of drug discontinuation because of hepatic or renal abnormalities were higher in the TDF-FTC group (4.7%) than in the placebo group (3.0%, P=0.051). Less than 40% of the HIV-uninfected women in the TDF-FTC group had evidence of recent pill use at visits that were matched to the HIV-infection window for women with seroconversion. The study was stopped early, on April 18, 2011, because of lack of efficacy.Prophylaxis with TDF-FTC did not significantly reduce the rate of HIV infection and was associated with increased rates of side effects, as compared with placebo. Despite substantial counseling efforts, drug adherence appeared to be low. (Supported by the U.S. Agency for International Development and others; FEM-PrEP ClinicalTrials.gov number, NCT00625404.).
| S-EPMC3687217 | biostudies-literature
Project description:ImportanceEmerging evidence suggests that risk of bacterial sexually transmitted infections (STIs) increases among gay and bisexual men following initiation of HIV preexposure prophylaxis (PrEP).ObjectiveTo describe STI incidence and behavioral risk factors among a cohort of predominantly gay and bisexual men who use PrEP, and to explore changes in STI incidence following PrEP commencement.Design, setting, and participantsThe Pre-exposure Prophylaxis Expanded (PrEPX) Study, a multisite, open-label intervention study, was nested within the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) clinic network. A total of 4275 participants were enrolled (July 26, 2016-April 1, 2018) in Victoria, Australia. Of these, 2981 enrolled at 5 ACCESS clinics (3 primary care, 1 sexual health, and 1 community-based HIV rapid testing service), had at least 1 follow-up visit, and were monitored until April 30, 2018.ExposuresUpon enrollment, participants received daily oral tenofovir disoproxil fumurate and emtricitabine for HIV PrEP, quarterly HIV and STI testing, and clinical monitoring.Main outcomes and measuresThe primary outcome was incidence of chlamydia, gonorrhea, or syphilis. Incidence rates and hazard ratios describing behavioral risk factors of STI diagnosis were calculated. Incidence rate ratios (IRRs), adjusted for change in testing frequency, described changes in STI incidence from 1-year preenrollment to study follow-up among participants with preenrollment testing data (n = 1378).ResultsAmong the 2981 individuals (median age, 34 years [interquartile range, 28-42]), 98.5% identified as gay or bisexual males, 29% used PrEP prior to enrollment, 89 (3%) withdrew and were censored at date of withdrawal, leaving 2892 (97.0%) enrolled at final follow-up. During a mean follow-up of 1.1 years (3185.0 person-years), 2928 STIs were diagnosed among 1427 (48%) participants (1434 chlamydia, 1242 gonorrhea, 252 syphilis). STI incidence was 91.9 per 100 person-years, with 736 participants (25%) accounting for 2237 (76%) of all STIs. Among 2058 participants with complete data for multivariable analysis, younger age, greater partner number, and group sex were associated with greater STI risk, but condom use was not. Among 1378 participants with preenrollment testing data, STI incidence increased from 69.5 per 100 person-years prior to enrollment to 98.4 per 100 person-years during follow-up (IRR, 1.41 [95% CI, 1.29-1.56]). After adjusting for testing frequency, the increase in incidence from 1 year preenrollment to follow-up was significant for any STI (adjusted IRR, 1.12 [95% CI, 1.02-1.23]) and for chlamydia (adjusted IRR, 1.17 [95% CI, 1.04-1.33]).Conclusions and relevanceAmong gay and bisexual men using PrEP, STIs were highly concentrated among a subset, and receipt of PrEP after study enrollment was associated with an increased incidence of STIs compared with preenrollment. These findings highlight the importance of frequent STI testing among gay and bisexual men using PrEP.
| S-EPMC6459111 | biostudies-literature
Project description:ImportanceLong-term follow-up is needed to evaluate gaps in HIV preexposure prophylaxis (PrEP) care delivery and to identify individuals at risk for falling out of care.ObjectiveTo characterize the PrEP continuum of care, including prescription, initiation, discontinuation, and reinitiation, and evaluate incident HIV infections.Design, setting, and participantsThis retrospective cohort study used data from the electronic health records (EHR) at Kaiser Permanente Northern California to identify individuals aged 18 years and older who received PrEP care between July 2012 and March 2019. Individuals were followed up from date of linkage (defined as a PrEP referral or PrEP-coded encounter) until March 2019, HIV diagnosis, discontinuation of health plan membership, or death. Data were analyzed from December 2019 to January 2021.ExposuresSociodemographic factors included age, sex, race and ethnicity, and neighborhood deprivation index, and clinical characteristics were extracted from the EHR.Main outcomes and measuresThe primary outcomes were attrition at each step of the PrEP continuum of care and incident HIV infections.ResultsAmong 13 906 individuals linked to PrEP care, the median (interquartile range [IQR]) age was 33 (27-43) years, 6771 individuals (48.7%) were White, and 13 227 (95.1%) were men. Total follow-up was 26 210 person-years (median [IQR], 1.6 [0.7-2.8] years). Of individuals linked to PrEP care, 88.1% (95% CI, 86.1%-89.9%) were prescribed PrEP and of these, 98.2% (95% CI, 97.2%-98.8%) initiated PrEP. After PrEP initiation, 52.2% (95% CI, 48.9%-55.7%) discontinued PrEP at least once during the study period, and 60.2% (95% CI, 52.2%-68.3%) of these individuals subsequently reinitiated. Compared with individuals aged 18 to 25 years, older individuals were more likely to receive a PrEP prescription (eg, age >45 years: hazard ratio [HR], 1.21 [95% CI, 1.14-1.29]) and initiate PrEP (eg, age >45 years: HR, 1.09 [95% CI, 1.02-1.16]) and less likely to discontinue (eg, age >45 years: HR, 0.46 [95% CI, 0.42-0.52]). Compared with White patients, African American and Latinx individuals were less likely to receive a PrEP prescription (African American: HR, 0.74 [95% CI, 0.69-0.81]; Latinx: HR, 0.88 [95% CI, 0.84-0.93]) and initiate PrEP (African American: HR, 0.87 [95% CI, 0.80-0.95]; Latinx: HR, 0.90 [95% CI, 0.86-0.95]) and more likely to discontinue (African American: HR, 1.36 [95% CI, 1.17-1.57]; Latinx: 1.33 [95% CI, 1.22-1.46]). Similarly, women, individuals with lower neighborhood-level socioeconomic status (SES), and persons with a substance use disorder (SUD) were less likely to be prescribed (women: HR, 0.56 [95% CI, 0.50-0.62]; lowest SES: HR, 0.72 [95% CI, 0.68-0.76]; SUD: HR, 0.88 [95% CI, 0.82-0.94]) and initiate PrEP (women: HR, 0.71 [95% CI, 0.64-0.80]; lower SES: HR, 0.93 [95% CI, 0.87-.0.99]; SUD: HR, 0.88 [95% CI, 0.81-0.95]) and more likely to discontinue (women: HR, 1.99 [95% CI, 1.67-2.38]); lower SES: HR, 1.40 [95% CI, 1.26-1.57]; SUD: HR, 1.23 [95% CI, 1.09-1.39]). HIV incidence was highest among individuals who discontinued PrEP and did not reinitiate PrEP (1.28 [95% CI, 0.93-1.76] infections per 100 person-years).Conclusions and relevanceThese findings suggest that gaps in the PrEP care continuum were concentrated in populations disproportionately impacted by HIV, including African American individuals, Latinx individuals, young adults (aged 18-25 years), and individuals with SUD. Comprehensive strategies to improve PrEP continuum outcomes are needed to maximize PrEP impact and equity.
| S-EPMC8391097 | biostudies-literature
Project description:BACKGROUND:Publicly funded HIV-testing sites can identify HIV preexposure prophylaxis (PrEP) candidates and provide PrEP linkage. SETTING:Harris Health System's HIV clinic, HIV-testing program, and HIV-prevention program (HPP) in Houston, TX, a high HIV-incidence city. METHODS:A prospective assessment of individuals aged 18 years and older recruited from walk-in HIV testing from December 2013 to April 2015 included risk assessment, HIV testing, and self-administered survey, with follow-up surveys at 6 and 12 months and medical record review. RESULTS:The mean age of our sample (n = 300) was 38.3 ± 11.7 years. Men constituted 63.1% of the sample and 53.7% were black non-Hispanic, 26.3% Hispanic, and 14.7% white non-Hispanic. Most were uninsured (63.5%). Only 27% always used condoms, although 67% perceived personal HIV risk. Of 300 participants, 64 (21.3%) linked to PrEP care and 49 (16.3%) took PrEP. In multivariable analysis, compared with heterosexual men, women [adjusted OR (aOR) 4.1, 95% CI: 1.5 to 11.1] and MSM (aOR 10.2, 95% CI: 3.4 to 31.0) were more likely to attend HPP and to take PrEP (aOR 3.0, 95% CI: 1.6 to 15.1 and 3.0, 95% CI: 1.1 to 8.3, respectively). Serodiscordance and PrEP interest correlated with program attendance (aOR 14.0, 95% CI: 6.1 to 32.3 and aOR 6.7, 95% CI: 1.8 to 25.4) and taking PrEP (aOR 13.1, 95% CI: 5.2 to 32.8 and 14.4, 95% CI: 1.8 to 166.9), respectively. CONCLUSIONS:Preexposure prophylaxis interest, being female or MSM, and serodiscordance correlated with PrEP linkage. Safety-net health systems can facilitate PrEP access in marginalized populations, but the PrEP initiation rates remain low.
| S-EPMC5949071 | biostudies-literature