Health Care Provider Decisions to Initiate Oral HIV Preexposure Prophylaxis in New York City Public Sexual Health Clinics.

BACKGROUND: Oral HIV preexposure prophylaxis (PrEP) is safe and effective but underutilized. Health care providers' beliefs about PrEP and attitudes toward people who could benefit may affect PrEP access. METHODS: This mixed-methods study (2016-2018) was conducted in 8 New York City public sexual health clinics that implemented a PrEP program. Data included 32 in-depth qualitative interviews with clinicians, quantitatively coded to reflect their PrEP beliefs; a provider questionnaire; and 6 months of medical record visit data for these providers. Among patients with a PrEP indication, we examined the odds of a patient being initiated on PrEP associated with providers' PrEP beliefs and demographic characteristics, and patient characteristics. RESULTS: Providers reported strong support for offering PrEP to eligible patients. The majority denied concerns about possible development of drug-resistant viral strains, giving PrEP to people who might not benefit, and PrEP toxicity. Nevertheless, about one-third agreed with each of these concerns, and 55% thought PrEP use might limit condom use. Of 2176 patients with a PrEP indication, 20% were initiated. Providers with more restrictive PrEP beliefs did not have lower odds of initiating patients on PrEP. Women as well as Black and Latinx patients were less likely to be initiated on PrEP. CONCLUSIONS: Contrary to our hypotheses, providers' negative PrEP beliefs did not seem to reduce initiation of PrEP for eligible patients. This may be attributable to clear clinical protocols, strong staff support, and training on implementing PrEP in this setting. Racial and gender disparities in PrEP uptake urgently require attention.

Reasons for PrEP Discontinuation After Navigation at Sexual Health Clinics: Interactions Among Systemic Barriers, Behavioral Relevance, and Medication Concerns.

BACKGROUND: Pre-exposure prophylaxis (PrEP) for HIV prevention requires engagement throughout the PrEP care continuum. Using data from a PrEP navigation program, we examine reasons for PrEP discontinuation. SETTING: Participants were recruited from New York City Health Department Sexual Health Clinics with PrEP navigation programs. METHODS: Participants completed a survey and up to 3 interviews about PrEP navigation and use. This analysis includes 94 PrEP initiators that were PrEP-naive before their clinic visit, started PrEP during the study, and completed at least 2 interviews. Interview transcripts were reviewed to assess reasons for PrEP discontinuation. RESULTS: Approximately half of PrEP initiators discontinued PrEP during the study period (n = 44; 47%). Most participants (71%) noted systemic issues (insurance or financial problems, clinic or pharmacy logistics, and scheduling barriers) as reasons for discontinuation. One-third cited medication concerns (side effects, potential long-term side effects, and medication beliefs; 32%) and behavioral factors (low relevance of PrEP because of sexual behavior change; 34%) as contributing reasons. Over half (53.5%) highlighted systemic issues alone, while an additional 19% attributed discontinuation to systemic issues in combination with other factors. Of those who discontinued, approximately one-third (30%) restarted PrEP during the follow-up period, citing resolution of systemic issues or behavior change that increased PrEP relevance. CONCLUSIONS: PrEP continuation is dependent on interacting factors and often presents complex hurdles for patients to navigate. To promote sustained engagement in PrEP care, financial, clinic, and pharmacy barriers must be addressed and counseling and navigation should acknowledge factors beyond sexual risk that influence PrEP use.

Durable Viral Suppression Among People with HIV and Problem Substance Use in the Era of Universal Antiretroviral Treatment.

This study explored factors associated with durable viral suppression (DVS) among two groups of people living with HIV (PLWH) and problem substance use in the context of universal antiretroviral treatment initiation. Participants (N = 99) were recruited between 2014-2017 from public sexual health clinics [SHC] and a hospital detoxification unit [detox]). DVS (NYC HIV surveillance registry) was defined as two consecutive viral load tests ≤ 200 copies/mL, ≤ 90 days apart, with all other viral loads suppressed over 12 or 18 months. Detox participants were significantly older, with more unstable housing/employment, substance use severity, and longer-term HIV vs. SHC participants. Older age, opioid and stimulant use disorder were significantly associated with lower odds of DVS, while fulltime employment and stable housing were significantly associated with higher odds of DVS at 12-month follow-up. Patterns held at 18-month follow-up. Co-located substance use and HIV services, funding for supportive housing, and collaborative patient-provider relationships could improve DVS among populations with the syndemic of problem substance use, poverty, and long-term HIV.

Initiating antiretroviral treatment for newly diagnosed HIV patients in sexual health clinics greatly improves timeliness of viral suppression.

OBJECTIVE: The 'JumpstART' program in New York City (NYC) public Sexual Health Clinics (SHC) provides patients newly diagnosed with human immunodeficiency virus (HIV) with antiretroviral medication (ART) (1-month supply) on day of diagnosis and active linkage to HIV care (LTC). We examined viral suppression (VS) among patients who did and did not receive JumpstART services. DESIGN: Retrospective cohort. METHODS: Among newly diagnosed SHC patients (23 November 2016-30 September 2018) who were matched to the NYC HIV surveillance registry to obtain HIV laboratory test results through 30 June 2019, we compared 230 JumpstART and 73 non-JumpstART patients regarding timely LTC (≤30 days), probability of VS (viral load < 200 copies/ml) by 3 months post-diagnosis, and time to and factors associated with achieving VS within the follow-up period. RESULTS: Of 303 patients, 76% (230/303) were JumpstART and the remaining were non-JumpstART patients; 36 (11%) had acute HIV infections. LTC ≤30 days was observed for 63% of JumpstART and 73% of non-JumpstART patients. By 3 months post-diagnosis, 83% of JumpstART versus 45% of non-JumpstART patients achieved VS (log-rank, P < .0001). Median times to VS among virally suppressed JumpstART and non-JumpstART patients were 31 (interquartile range [IQR]: 24-51) and 95 days (IQR: 52-153), respectively. For groups with and without timely LTC, JumpstART was associated with viral suppression within 3 months post-diagnosis, after adjusting for age and baseline viral load. CONCLUSIONS: Prompt ART initiation among SHC patients, some with acute HIV infections, resulted in markedly shortened intervals to VS. Immediate ART provision and active LTC can be key contributors to improved HIV treatment outcomes and the treatment-as-prevention paradigm, with potential for downstream, population-level benefit.

Development of a standardized method to evaluate the protective efficiency of cosmetic packaging against microbial contamination.

Doubts surrounding the potential adverse effects of antimicrobial preservatives have modified the demand of consumers, who increasingly insist on the production of low-level and even preservative-free cosmetics. Protection of the product against microbial contamination is therefore focused on the packaging. This has prompted the emergence of a highly diverse array of so-called "protective", "overprotective", and "barrier" packaging. However, these designations are not normalized and the choice of the right packaging adapted to each cosmetic product is still essentially empirical, hazardous, and time consuming. The Cosmetic Valleys cluster has launched a commission to define a complete and experimentally-validated method to classify the level of protection of cosmetic packaging against microbial contamination. As reported herein, this required the development a specific bacteriostatic medium that can be used for 7 days and an in vitro procedure that reproduces in-use contamination and consumer practices. Based on tests performed on over 800 packages of different origin and performance characteristics, we propose a classification, divided into six grades, to differentiate the protective efficiency of cosmetic packaging. This work can be considered as a first step towards a regulatory text.

HIV Treatment Knowledge in the Context of "Treatment as Prevention" (TasP).

According to 2012 universal ART guidelines, as part of "treatment as prevention" (TasP), all people living with HIV (PLWH) should immediately initiate antiretroviral therapy post-diagnosis to facilitate viral suppression. PLWH who are virally suppressed have no risk of sexually transmitting HIV. This study used descriptive analysis of quantitative data (N = 99) and thematic analysis of qualitative interviews (n = 36) to compare participants recruited from a hospital-based detoxification (detox) unit, largely diagnosed with HIV pre-2012 (n = 63) vs. those recruited from public, urban sexual health clinics (SHCs), mainly diagnosed in 2012 or later (n = 36). Detox participants were significantly more knowledgeable than SHC participants about HIV treatment, except regarding TasP. SHC participants' desire for rapid linkage to care and ART initiation was in line with 2012 universal ART guidelines and TasP messaging regarding viral suppression. More targeted messaging to PLWH pre-2012 could ensure that all PLWH benefit from scientific advances in HIV treatment.

The HIV Pre-exposure Prophylaxis (PrEP) Cascade at NYC Sexual Health Clinics: Navigation Is the Key to Uptake.

BACKGROUND: Clinics providing sexual health care pose unique opportunities to implement HIV pre-exposure prophylaxis (PrEP) programs. The PrEP program at New York City's Sexual Health Clinics provides intensive on-site navigation for linkage to PrEP care. We assessed uptake of this intervention. METHODS: We categorized men who have sex with men (MSM) without HIV hierarchically as having had (1) HIV post-exposure prophylaxis (PEP) use (past year); or (2) selected sexually transmitted infections (STI) (past year); or (3) HIV-diagnosed sex/needle-sharing partners (past 6 months); or (4) expressed interest in PrEP (day of clinic visit). We constructed PrEP cascades and used multivariable regression to examine acceptance of PrEP navigation, referral to a PrEP provider, linkage (<60 days), and PrEP prescription. RESULTS: One thousand three hundred one of 2106 PrEP (62%) patients accepted navigation. Of those, 55% (718/1301) were black or Hispanic MSM. STI and PEP patients had lowest navigation acceptance levels (35%-46%). Of navigated patients, 56% (628/1114) accepted referrals, 46% (288/628) linked to PrEP providers, and 82% (235/288) were prescribed PrEP; overall, 11% of those offered navigation (235/2106) received prescriptions. Navigated MSM with PEP history [adjusted prevalence ratio (aPR) 1.34, 95% confidence interval (CI): 1.16 to 1.56)], previous STI (aPR 1.28, 95% CI: 1.12 to 1.45), or HIV-diagnosed partners (aPR 1.18, 95% CI: 1.01 to 1.37) were more likely than those with PrEP interest to accept referrals. Probability of linkage varied by insurance status; prescription did not vary by patient factors. CONCLUSIONS: Although MSM in key priority groups (eg, previous STI) showed low navigation uptake, those who accepted navigation were likely to be referred for PrEP, suggesting a need for expanded up-front engagement.

Antiretroviral medication treatment for all HIV-infected individuals: a protocol using innovative multilevel methodologies to evaluate New York City's universal ART policy among problem substance users.

BACKGROUND: The intersection of HIV-related health outcomes and problem substance use has been well documented. New York City continues to be a focal point of the U.S. HIV epidemic. In 2011, the NYC Department of Health and Mental Hygiene (NYC DOHMH) issued a recommendation that all HIV infected individuals should be offered antiretroviral therapy (ART) regardless of CD4 cell count or other indicators of disease progression. This policy is based in the concept of "treatment as prevention," in which providing ART to people living with HIV (PLWH) greatly reduces the likelihood of HIV transmission, while also improving individual health. The "ART for ALL" (AFA) study was designed to inform modifications to and identify gaps in the implementation of universal ART, and specifically to help guide allocation of resources to obtain local policy goals for increasing viral suppression among PLWH who have problem substance use. METHODS/DESIGN: The AFA Study is informed by two complementary frameworks: Glasgow and colleagues' RE-AIM model, a multi-level framework developed to guide the evaluation of implementation of new policies, and Bronfrenbrenner's ecological systems model, which conceptualizes the bi-directional interplay between people and their environment. Using multi-level data and mixed methods, the primary aims of the AFA Study are to assess rates of viral load suppression, using the NYC HIV Surveillance Registry, within 12 months of HIV diagnosis with (a) yearly cohorts of high-risk-to-transmit, difficult-to-treat, substance using patients recruited from NYC Sexually Transmitted Disease clinics and a large detoxification unit and (b) yearly cohorts of all newly HIV diagnosed people in NYC. Further goals include (c) recruiting cross-sectional samples of HIV/AIDS service providers to assess ART initiation with problem substance users and d) examining geographic factors that influence rates of viral load suppression. An Implementation Collaborative Board meets regularly to guide study procedures and interpret results. DISCUSSION: The AFA Study has the unique strength of accessing and analyzing data at multiple levels using mixed methodology, taking advantage of NYC DOHMH biomedical surveillance data. If successful, others may benefit from lessons learned to inform local and state policies to improve the health of PLWH and further reduce HIV transmission.

Targeting the use of pooled HIV RNA screening to reduce cost in health department STD clinics: New York City, 2009-2011.

OBJECTIVE: Staff at public New York City sexually transmitted disease (STD) clinics screen patients for acute HIV infection (AHI) using pooled nucleic acid amplification tests. AHI screening is expensive but important for populations at high risk of acquiring HIV. We analyzed if targeting AHI screening in STD clinics could reduce program costs while maintaining AHI case detection. METHODS: From January 2009 through May 2010, we screened all patients with negative rapid HIV tests for AHI. Using risk information on cases detected during this universal screening period, we developed criteria for targeted AHI screening and compared case yields and testing costs during 12 months of universal screening (June 2009 through May 2010) vs. 12 months of targeted screening (June 2010 through May 2011). RESULTS: During the defined period of universal screening, we identified 40 AHI cases, and during targeted screening, we identified 35 AHI cases. Because of targeting efforts, the number needed to test to find one AHI case dropped from 1,631 to 254. With targeted screening, it cost an average of $4,535 per case detected and 39.3 cases were detected per 10,000 specimens; using universal screening, $29,088 was spent per case detected and 6.1 cases were detected per 10,000 specimens processed. CONCLUSION: Targeted screening identified similar numbers of AHI cases as when screening all clinic patients seeking HIV testing, but at one-seventh the cost.