INTRODUCTIONEnding the HIV epidemic in the U.S. holds rapid antiretroviral therapy as a key strategy to improve the health of those with HIV and to decrease transmission. In 2015, Getting to Zero San ...Francisco, a multisector consortium, expanded rapid antiretroviral therapy citywide. METHODSA Getting to Zero San Francisco Rapid ART Program Initiative for HIV Diagnoses Committee (academic, community, service delivery, health department partners) designed the program, protocol, dissemination plan, and monitoring strategy. Newly diagnosed patients were linked to an HIV medical home or Rapid ART Program Initiative for HIV Diagnoses initiation hub to best deliver rapid antiretroviral therapy across a diverse patient mix, with a goal of ≤5 working days from diagnosis to care and ≤1 day from care to antiretroviral therapy. Stakeholders were trained on rapid antiretroviral therapy via Getting to Zero San Francisco meetings, in-services, public health detailing, and peer-to-peer recruiting, prioritizing HIV clinics serving patients of color, Latinx ethnicity, youth, and the uninsured or publicly insured. Rapid ART Program Initiative for HIV Diagnoses-specific metrics were derived from surveillance data; stratified by sex/gender, age, race/ethnicity, and housing status; and presented at public meetings. Data were analyzed between January and April 2021. RESULTSFrom 2014 to 2018, median time from diagnosis to care decreased 71% (7 to 2 days), care to antiretroviral therapy decreased from 19 to 0 days, and diagnosis to virologic suppression decreased 51% (94 to 46 days). Improvements occurred regardless of age, race/ethnicity, sex/gender, exposure, or housing status. CONCLUSIONSDuring a citywide initiative to optimize antiretroviral therapy initiation, time from HIV diagnosis to care, antiretroviral therapy, and virologic suppression decreased across all affected groups to varying degrees. The Rapid ART Program Initiative for HIV Diagnoses Committee continues to address challenges to retention and expand implementation.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
BACKGROUND:Given the strong relation between sexually transmitted diseases (STDs) and the spread of HIV infection, recent outbreaks of syphilis in the United States could lead to increased rates of ...new HIV infection. STD clinics serving persons at risk for syphilis would be logical sites to monitor rates of acute HIV infection. The detection of acute HIV infection, however, is not routine and requires the use of HIV RNA testing in combination with HIV antibody testing.
METHODS:To determine the rate of acute HIV infection, we performed HIV RNA testing on pooled HIV antibody-negative specimens from persons seeking care at San Francisco City Clinic (SFCC) and from men seeking care at 3 STD clinics in Los Angeles. We compared prevalence of acute HIV infection among those groups.
RESULTS:From October 2003 to July 2004, we tested 3075 specimens from persons at the SFCC, of which 105 (3%) were HIV antibody-positive and 11 were HIV RNA-positive/HIV antibody-negative, resulting in a prevalence of acute HIV infection of 36 per 10,000 (95% confidence interval CI26 to 50 per 10,000) and increasing by 10.5% the diagnostic yield of HIV RNA testing compared with standard testing. From February 2004 to April 2004, 1712 specimens were tested from men at 3 Los Angeles STD clinics, of which 14 (0.82%) were HIV-positive by enzyme immunoassay testing and 1 was HIV RNA-positive/HIV antibody-negative, resulting in a prevalence of 6 per 10,000 (95% CI3 to 13 per 10,000) and increasing the diagnostic yield for HIV infection by 7.1%.
CONCLUSIONS:In our study, the addition of HIV RNA screening to routine HIV antibody testing in STD clinics identified a substantial increased proportion of HIV-infected persons at high risk for further HIV transmission, who would have been missed by routine HIV counseling and testing protocols. Further evaluation of the addition of HIV RNA screening to routine HIV antibody testing is warranted.
Many resource-constrained countries now train non-physician clinicians in HIV/AIDS care, a strategy known as 'task-shifting.' There is as yet no evidence-based international standard for training ...these cadres. In 2007, the Mozambican Ministry of Health (MOH) conducted a nationwide evaluation of the quality of care delivered by non-physician clinicians (técnicos de medicina, or TMs), after a two-week in-service training course emphasizing antiretroviral therapy (ART).
Forty-four randomly selected TMs were directly observed by expert clinicians as they cared for HIV-infected patients in their usual worksites. Observed clinical performance was compared to national norms as taught in the course.
In 127 directly observed patient encounters, TMs assigned the correct WHO clinical stage in 37.6%, and correctly managed co-trimoxazole prophylaxis in 71.6% and ART in 75.5% (adjusted estimates). Correct management of all 5 main aspects of patient care (staging, co-trimoxazole, ART, opportunistic infections, and adverse drug reactions) was observed in 10.6% of encounters.The observed clinical errors were heterogeneous. Common errors included assignment of clinical stage before completing the relevant patient evaluation, and initiation or continuation of co-trimoxazole or ART without indications or when contraindicated.
In Mozambique, the in-service ART training was suspended. MOH subsequently revised the TMs' scope of work in HIV/AIDS care, defined new clinical guidelines, and initiated a nationwide re-training and clinical mentoring program for these health professionals. Further research is required to define clinically effective methods of health-worker training to support HIV/AIDS care in Mozambique and similarly resource-constrained environments.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
OBJECTIVE:Little is known about long-term viral suppression rates for patients who start antiretroviral therapy (ART) soon after diagnosis. We describe virologic outcomes from the San Francisco-based ...Ward 86 Rapid ART Program for Individuals with an HIV Diagnosis (RAPID) ART program.
DESIGN:Retrospective review of clinic-based cohort.
METHODS:In 2013, Ward 86 adopted immediate ART at the first visit after HIV diagnosis. Patients were referred from testing sites, offered same or next-day intakes, and received multidisciplinary evaluation, support, and insurance enrollment/optimization. Patients were provided ART starter packs and close follow-up. Demographics and labs were extracted from medical records. Subsequent viral loads were obtained from public health surveillance data. Kaplan–Meier curves summarized distribution of times to first viral suppression; viral suppression rates at last viral load recorded were calculated.
RESULTS:Of 225 patients referred to RAPID ART from 2013 to 2017, 216 (96%) were started on immediate-ARTmedian age 30; 7.9% women; 11.6% African-American, 26.9% Hispanic, 36.6% white; 51.4% with substance use; 48.1% with mental health diagnoses; 30.6% unstably housed; baseline median CD4 cell count 441 cells/μl median viral load 37 011. By 1 year after intake, 95.8% achieved viral suppression to less than 200 cells/μl at least once. Over a median follow-up time of 1.09 years (0–3.92), 14.7% of patients had viral rebound, but most (78%) resuppressed. Viral suppression rates were 92.1% at last recorded viral load.
CONCLUSION:In an urban clinic with high rates of mental illness, substance use and housing instability, immediate ART provided through a RAPID program resulted in viral suppression at last viral load measurement for more than 90% of patients over a median of 1.09 years. RAPID ART for vulnerable populations is acceptable, feasible, and successful with multidisciplinary care and municipal support.
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.
BACKGROUND:Pre-exposure prophylaxis (PrEP) for prevention of HIV infection has demonstrated efficacy in randomized controlled trials and in demonstration projects. For PrEP implementation to result ...in significant reductions in HIV incidence for men who have sex with men in the United States, sufficient access to PrEP care and continued engagement outside of demonstration projects is required.
METHODS:We report the results of a follow-up survey of 173 former participants from the Miami and San Francisco sites of the US PrEP Demo Project, administered 4–6 months after study completion.
RESULTS:Survey respondents continued to frequently access medical care and had a high incidence of sexually transmitted infections after completion of the Demo Project, indicating ongoing sexual risk behavior. Interest in continuing PrEP was high with 70.8% indicating that they were “very interested” in continuing PrEP. Among respondents, 39.9% reported continuation of PrEP after completion of the Demo Project, largely through their primary care providers and frequently at low or no cost. Variability in access and engagement was seen, with participants from the San Francisco site, those with medical insurance, and those with a primary care provider at the end of the Demo Project more likely to successfully obtain PrEP medication. Two respondents reported HIV seroconversion in the period between study completion and the follow-up survey.
CONCLUSIONS:Additional effort to increase equitable access to PrEP outside of demonstration projects is needed to realize the potential impact of this evidence-based prevention intervention.
Abstract
We found that the odds of return clinic visits for persistent non-gonococcal urethritis (NGU) were significantly lower (odds ratio: .4; 95% confidence interval: .3–.6; P < .0001) after ...implementing (1) testing for Mycoplasma genitalium during initial evaluations for NGU and (2) switching from azithromycin to doxycycline as first-line NGU treatment.
Early virologic suppression (VS) after human immunodeficiency virus (HIV) infection improves individual health outcomes and decreases onward transmission. In San Francisco, immediate antiretroviral ...therapy (ART) at HIV diagnosis was piloted in 2013-2014 and expanded citywide in 2015 in a rapid start initiative to link all new diagnoses to care within 5 days and start ART at the first care visit.
HIV providers and linkage navigators were trained on a rapid start protocol with sites caring for vulnerable populations prioritized. Dates of HIV diagnosis, first care visit, ART initiation, and VS were abstracted from the San Francisco Department of Public Health HIV surveillance registry.
During 2013-2017, among 1354 new HIV diagnoses in San Francisco, median days from diagnosis to first VS decreased from 145 to 76 (48%; P < .0001) and from first care visit to ART initiation decreased from 28 to 1 (96%; P < .0001). By 2017, 28% of new diagnoses had a rapid start, which was independently associated with Latinx ethnicity (AOR, 1.73; 95% CI, 1.15-2.60) and recent year of diagnosis (2017; AOR, 16.84; 95% CI, 8.03-35.33). Persons with a rapid ART start were more likely to be virologically suppressed within 12 months of diagnosis than those with a non-rapid start (RR, 1.17; 95% CI, 1.10-1.24).
During a multisector initiative to optimize ART initiation, median time from diagnosis to VS decreased by nearly half. Immediate ART at care initiation was achieved across many, but not all, populations, and was associated with improved suppression rates.
It is unknown if extremely early initiation of antiretroviral therapy (ART) may lead to long-term ART-free HIV remission or cure. As a result, we studied 2 individuals recruited from a pre-exposure ...prophylaxis (PrEP) program who started prophylactic ART an estimated 10 days (Participant A; 54-year-old male) and 12 days (Participant B; 31-year-old male) after infection with peak plasma HIV RNA of 220 copies/mL and 3,343 copies/mL, respectively. Extensive testing of blood and tissue for HIV persistence was performed, and PrEP Participant A underwent analytical treatment interruption (ATI) following 32 weeks of continuous ART.
Colorectal and lymph node tissues, bone marrow, cerebral spinal fluid (CSF), plasma, and very large numbers of peripheral blood mononuclear cells (PBMCs) were obtained longitudinally from both participants and were studied for HIV persistence in several laboratories using molecular and culture-based detection methods, including a murine viral outgrowth assay (mVOA). Both participants initiated PrEP with tenofovir/emtricitabine during very early Fiebig stage I (detectable plasma HIV-1 RNA, antibody negative) followed by 4-drug ART intensification. Following peak viral loads, both participants experienced full suppression of HIV-1 plasma viremia. Over the following 2 years, no further HIV could be detected in blood or tissue from PrEP Participant A despite extensive sampling from ileum, rectum, lymph nodes, bone marrow, CSF, circulating CD4+ T cell subsets, and plasma. No HIV was detected from tissues obtained from PrEP Participant B, but low-level HIV RNA or DNA was intermittently detected from various CD4+ T cell subsets. Over 500 million CD4+ T cells were assayed from both participants in a humanized mouse outgrowth assay. Three of 8 mice infused with CD4+ T cells from PrEP Participant B developed viremia (50 million input cells/surviving mouse), but only 1 of 10 mice infused with CD4+ T cells from PrEP Participant A (53 million input cells/mouse) experienced very low level viremia (201 copies/mL); sequence confirmation was unsuccessful. PrEP Participant A stopped ART and remained aviremic for 7.4 months, rebounding with HIV RNA of 36 copies/mL that rose to 59,805 copies/mL 6 days later. ART was restarted promptly. Rebound plasma HIV sequences were identical to those obtained during acute infection by single-genome sequencing. Mathematical modeling predicted that the latent reservoir size was approximately 200 cells prior to ATI and that only around 1% of individuals with a similar HIV burden may achieve lifelong ART-free remission. Furthermore, we observed that lymphocytes expressing the tumor marker CD30 increased in frequency weeks to months prior to detectable HIV-1 RNA in plasma. This study was limited by the small sample size, which was a result of the rarity of individuals presenting during hyperacute infection.
We report HIV relapse despite initiation of ART at one of the earliest stages of acute HIV infection possible. Near complete or complete loss of detectable HIV in blood and tissues did not lead to indefinite ART-free HIV remission. However, the small numbers of latently infected cells in individuals treated during hyperacute infection may be associated with prolonged ART-free remission.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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