Sexual and Reproductive Justice and Health Equity for LGBTQ+ Women.

LGBTQ+ women have long been overlooked in sexual and reproductive health research. However, recent research has established that LGBTQ+ women have unique and specific needs that need to be addressed in order to improve effectiveness of sexual health education and practice with this historically and presently underserved population. Informed by a reproductive justice framework coupled with liberation psychology theory, this review discusses the current state of sexual and reproductive health and technologies among LGBTQ+ women. In particular, we focus on a range of HIV prevention and reproductive technologies and their use and promotion, including the internal condom, abortion, oral contraceptives, dapivirine ring, HIV pre-exposure prophylaxis, intrauterine device, and other less studied options, such as the contraceptive sponge. Grounded in an intersectional framing, this review acknowledges the intersecting systems of oppression that affect multiply marginalized women inequitably and disproportionately. A sociohistorical, critical lens is applied to acknowledge the well-documented racist origins of reproductive health technologies and ongoing coercive practices that have led to medical mistrust among marginalized and stigmatized communities, particularly racialized LGBTQ+ women, women with disabilities, and women who are poor or incarcerated. Moreover, we discuss the urgent need to center LGBTQ+ women in research and clinical care, community-engaged health promotion efforts, affirming non-heteronormative sexual health education, and health policies that prioritize autonomy and dismantle structural barriers for this population. We conclude with recommendations and future directions in this area to remedy entrenched disparities in health.

A Qualitative Study of Barriers and Facilitators of PrEP Uptake Among Women in Substance Use Treatment and Syringe Service Programs.

PrEP is an HIV prevention option that could benefit substance-involved women, a high-risk population with low PrEP uptake. Little is known about their interest in PrEP. This qualitative study used in-depth interviews to examine PrEP willingness, barriers, and facilitators among 16 women in outpatient psychosocial substance use treatment, methadone, and/or harm reduction/syringe programs in NYC. All expressed willingness to use PrEP, but only during periods of perceived risk. Women perceived themselves to be at high risk for HIV when engaging in active substance use and/or transactional sex. They perceived themselves to be at low risk and therefore unmotivated to take PrEP when abstinent from these activities. Paradoxically, a major barrier to using PrEP was anticipated interference from substance use and transactional sex, the very same activities that create a perception of risk. Facilitators of PrEP use included perceptions of it as effortless (as opposed to barrier methods during sex) and effective, safe, and accessible. Other barriers included fear of stigma and doubts about adhering daily. Recommendations for best PrEP implementation practices for substance-involved women included tailored and venue-specific PrEP information and messaging, PrEP discussion with trusted medical providers, and on-site PrEP prescription in substance use treatment and harm reduction programs.

RESUMEN: PrEP es una opción de prevención de VIH que puede beneficiar a las mujeres que consumen sustancias, una población de alto riesgo con baja aceptación de la PrEP, pero poco se sabe de su interés en la PrEP. Este estudio cualitativo utilizó entrevistas para examinar el interés en tomar la PrEP y las barreras y los facilitadores del uso de la PrEP entre 16 mujeres en tratamiento por el uso de sustancias en clínicas ambulatorias, clínicas metadonas, o programas de reducción de daños en la ciudad de Nueva York, Estados Unidos. Todas las participantes expresaron su disposición a usar PrEP, pero solo durante períodos de riesgo percibido (por ejemplo, tiempos de uso de sustancias activas y/o sexo transaccional). Paradójicamente, una barrera importante para el uso de PrEP fue la interferencia anticipada por el uso de sustancias y el sexo transaccional, las mismas actividades que crean una percepción de riesgo. Los facilitadores incluyeron percepciones de PrEP como sin esfuerzo durante las relaciones sexuales, efectiva, segura, y accesible. Otras barreras incluyeron el miedo del estigma y dudas sobre la adherencia diaria. Las recomendaciones para las mejores prácticas de implementar la PrEP para mujeres que consumen sustancias incluyeron información y mensajes de PrEP personalizados y específicos del lugar, discusión de PrEP con proveedores médicos confiables, y prescripción de PrEP en el sitio en programas de tratamiento y reducción de daños por uso de sustancias.

Field Testing the "Avoid the Needle" Intervention for Persons at Risk for Transitioning to Injecting Drug Use in Tallinn, Estonia and New York City, USA.

This study aimed to field tested the "Avoid the Needle" (AtN) intervention to reduce transitions from non-injecting to injecting drug use in two different epidemiological settings. Respondent driven sampling was used to recruit current non-injecting drug users (NIDUs) in Tallinn, Estonia in 2018-19 and in New York City (NYC) in 2019-20. Both persons who had never injected and persons who had previously injected but not in the last 6 months were eligible; a structured interview was administered, a blood sample collected, and the intervention administered by trained interventionists. We recruited 19 non-injectors from Tallinn and 140 from NYC. Participants in Tallinn were younger and had begun using drugs at earlier ages than participants in NYC. The primary drugs used in Tallinn were amphetamine, fentanyl, and opioid analgesics, while in NYC they were heroin, cocaine, speedball, and fentanyl. Six-month follow-up data were obtained from 95% of participants in Tallinn. The study was interrupted by COVID-19 lockdown in NYC, but follow-up data were obtained from 59% of participants. There were minimal transitions to injecting: 1/18 in Tallinn and 0/83 in NYC. There were significant declines in the frequencies of using readily injectable drugs (fentanyl, amphetamine, heroin, cocaine) from baseline to follow-up in both sites (Cochran-Armitage tests for trend, χ2 = 21.3, p < 0.001 for New York City; and χ2 = 3.9, p = 0.048 for Tallinn). Reducing transitions into injecting is a potentially very important method for reducing HIV transmission and other harms of drug use. Further investigation and implementation of AtN type interventions is warranted.

Strategies of Managing Repeated Measures: Using Synthetic Random Forest to Predict HIV Viral Suppression Status Among Hospitalized Persons with HIV.

The HIV/AIDS epidemic remains a major public health concern since the 1980s; untreated HIV infection has numerous consequences on quality of life. To optimize patients' health outcomes and to reduce HIV transmission, this study focused on vulnerable populations of people living with HIV (PLWH) and compared different predictive strategies for viral suppression using longitudinal or repeated measures. The four methods of predicting viral suppression are (1) including the repeated measures of each feature as predictors, (2) utilizing only the initial (baseline) value of the feature as predictor, (3) using the last observed value as the predictors and (4) using a growth curve estimated from the features to create individual-specific prediction of growth curves as features. This study suggested the individual-specific prediction of the growth curve performed the best in terms of lowest error rate on an independent set of test data.

Characterizing Ryan White Part A-funded support service utilization patterns and their association with viral suppression among people with HIV in New York City.

Use of HIV-related support services has been demonstrated to improve outcomes for people living with HIV. Further exploring patterns of use could help identify how and in what settings additional HIV care and treatment adherence support could be provided. We aimed to identify support service utilization patterns and examine their association with viral load suppression (VLS). Our sample comprised 6,581 people with HIV who received Ryan White Part A support services for basic needs (food and nutrition, legal, harm reduction, housing services) in New York City from 1/2013 to 12/2016, but had not received services specifically targeting HIV care and treatment adherence. Five support service utilization classes were identified using latent class analysis, the majority of which were characterized by the predominant use of concrete services (e.g., food assistance). Compared with the low-intensity, sporadic concrete service use class, clients in all other classes had lower odds of VLS in a 365-day follow-up period, but this disadvantage disappeared with adjustment for confounding variables indicative of need. Our findings underscore the impact of need-related barriers on VLS and suggest that long-term service utilization beyond the one year period of this study may be required to diminish their negative effect on HIV outcomes.

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.

Bundling Rapid Human Immunodeficiency Virus and Hepatitis C Virus Testing to Increase Receipt of Test Results: A Randomized Trial.

BACKGROUND: The overlapping human immunodeficiency virus (HIV) and hepatitis C virus (HCV) epidemics disproportionately affect people with substance use disorders. However, many people who use substances remain unaware of their infection(s). OBJECTIVE: The objective of this study was to examine the efficacy of an on-site bundled rapid HIV and HCV testing strategy in increasing receipt of both HIV and HCV test results. RESEARCH DESIGN: Two-armed randomized controlled trial in substance use disorder treatment programs (SUDTP) in New York City. Participants in the treatment arm were offered bundled rapid HIV and HCV tests with immediate results on-site. Participants in the control arm were offered the standard of care, that is, referrals to on-site or off-site laboratory-based HIV and HCV testing with delayed results. PARTICIPANTS: A total of 162 clients with unknown or negative HIV and HCV status. MEASURES: The primary outcome was the percentage of participants with self-reported receipt of HIV and HCV test results at 1-month postrandomization. RESULTS: Over half of participants were Hispanic (51.2%), with 25.3% being non-Hispanic black and 17.9% non-Hispanic white. Two thirds were male, and 54.9% reported injection as method of drug use. One hundred thirty-four participants (82.7%) completed the 1-month assessment. Participants in the treatment arm were more likely to report having received both test results than those in the control arm (69% vs. 19%, P<0.001). Seven participants in the treatment arm received a preliminary new HCV diagnosis, versus 1 in the control arm (P=0.029). CONCLUSION: Offering bundled rapid HIV and HCV testing with immediate results on-site in SUDTPs may increase awareness of HIV and HCV infection among people with substance use disorders.

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.

DSM-5 substance use disorder symptom clusters and HIV antiretroviral therapy (ART) adherence.

This study examines self-reported 30-day antiretroviral therapy (ART) adherence among 101 people living with HIV and substance use disorders (SUD) in New York City in terms of Diagnostic and Statistical Manual - 5th Edition (DSM-5) SUD symptom clusters: impaired control, social impairment, risky use and pharmacological criteria. Overall, 60.4% met DSM-5 criteria for stimulant, 55.5% for alcohol, 34.7% for cannabis and 25.7% for opioid SUD. Of the 76 participants with a current ART prescription, 75.3% reported at least 90% 30-day adherence. Participants with vs. without alcohol SUD were significantly less likely to report ART adherence (64.3% vs. 88.2%, p = .017). Endorsement of social impairment significantly differed among adherent vs. non-adherent participants with alcohol SUDs (74.1% vs. 100%, p = .038) and with opioid SUDs (94.1% vs. 50.0%, p = .040). Understanding specific SUD symptom clusters may assist providers and patients in developing strategies to improve ART adherence.

Implementing an Updated "Break the Cycle" Intervention to Reduce Initiating Persons into Injecting Drug Use in an Eastern European and a US "opioid epidemic" Setting.

We tested the hypothesis that an updated "Break the Cycle" (BtC) intervention, based in social cognitive theory and motivational interviewing, would reduce the likelihood that current persons who inject drugs (PWID) would assist persons who do not inject drugs (non-PWID) with first injections in Tallinn, Estonia and Staten Island, New York City. 402 PWID were recruited, a baseline interview covering demographics, drug use, and assisting non-PWID with first drug injections was administered, followed by BtC intervention. 296 follow-up interviews were conducted 6 months post-intervention. Percentages assisting with first injections declined from 4.7 to 1.3% (73% reduction) in Tallinn (p < 0.02), and from 15 to 6% (60% reduction) in Staten Island (p < 0.05). Persons assisted with first injections declined from 11 to 3 in Tallinn (p = 0.02) and from 32 to 13 in Staten Island. (p = 0.024). Further implementation research on BtC interventions is urgently needed where injecting drug use is driving HIV/HCV epidemics and areas experiencing opioid epidemics.

"It's Never Just About the HIV:" HIV Primary Care Providers' Perception of Substance Use in the Era of "Universal" Antiretroviral Medication Treatment.

Antiretroviral therapy (ART) is recommended for all people living with HIV (PLWH), regardless of disease status. Substance use disorders (SUD) are common barriers to successful HIV treatment; however, few studies have comprehensively explored how HIV primary care providers take SUDs into account in the context of universal ART implementation. This study uses thematic analysis of qualitative interviews to explore providers' (N = 25) substance use assessment and factors associated with ART initiation. 64% of providers had 15 or more years of HIV treatment experience. Almost all providers agreed with the guidelines for universal ART initiation despite the presence of SUD. Still, identification and management of SUD is challenged by inconsistent assessment, providers' misperceptions about SUD and patients' willingness to discuss it, and lack of accessible treatment resources when SUD is identified. Greater guidance in systematic SUD assessment and management, combined with integrated addiction services, could enhance universal ART implementation among PLWH/SUD.

Participation in HIV Behavioral Research: Unanticipated Benefits and Burdens.

HIV behavioral research has provided an invaluable knowledge base for effective approaches to behavioral challenges along the HIV care cascade. Little attention has been paid to tracking unanticipated effects of research participation, whether negative or positive. We used qualitative methods to elicit impressions of unanticipated effects of participation in behavioral research. An instrument was developed and piloted to assess positive (emotional gains, practical gains, HIV prevention knowledge and skills gains) and negative (emotional stress, discomfort with research) unanticipated effects. Participants (N = 25) from five projects, including men who have sex with men, adults who use substances, and youth, reported multiple positive unanticipated effects (sexual and drug risk reduction, goal setting, improvements in self-esteem and mood, relationship gains, health care behavior gains, knowledge and introspection gains) and rare unanticipated negative effects. Developing a systematic tool of unanticipated positive and negative effects of participation in behavioral research is a crucial next step.

A qualitative study of persons who inject drugs but who have never helped others with first injections: how their views on helping contrast with the views of persons who have helped with first injections, and implications for interventions.

BACKGROUND: Transitioning from non-injection to injection drug use dramatically escalates health risks. Evidence suggests that people who inject drugs (PWID) help in a majority of others' first injections, yet these helpers represent only a minority of experienced PWID. Recent research has provided insight into this helping process, as reported by helpers. PWID who have never helped, although the majority of PWID, have not previously been the focus of study. To address this gap, we give primary voice to non-helpers' perspectives on the helping process, while also comparing their views with persons in our sample who have helped with first injections. Finally, we consider how non-helpers' perspectives can inform harm reduction interventions to reduce, or make safer, initiation into injecting drug use. METHODS: We conducted audio-recorded, qualitative interviews with 23 current opioid injectors on Staten Island, NY, where the opioid epidemic is pronounced. Seventeen had never helped with first injections and 6 had. Interviews were transcribed verbatim, and three coders used a consensus-developed codebook to code all interviews. Framework analysis was used to identify overarching themes. RESULTS: We identified three key themes in non-helpers' discourse around not helping: altruistic motivations to prevent immediate and delayed harms to individuals injecting for the first time; inhibition due to negative assessments of their own injecting skills; and absolutist ethical convictions against helping. Non-helpers differed from helpers on each theme. CONCLUSIONS: Because most PWID have never helped with first injections, their perspectives on helping warrant consideration and can inform harm reduction interventions to reduce, or make safer, transitions to injection drug use. Their perspectives can be used to broaden the factors PWID consider around questions of promoting injection and helping with others' first injections, including considerations of the moral issues involved in choosing to help or not to help.

Decline in Herpes Simplex Virus Type 2 Among Non-Injecting Heroin and Cocaine Users in New York City, 2005 to 2014: Prospects for Avoiding a Resurgence of Human Immunodeficiency Virus.

BACKGROUND: Herpes simplex virus type 2 (HSV-2) infection increases both susceptibility to and transmissibility of human immunodeficiency virus (HIV), and HSV-2 and HIV are often strongly associated in HIV epidemics. We assessed trends in HSV-2 prevalence among non-injecting drug users (NIDUs) when HIV prevalence declined from 16% to 8% among NIDUs in New York City. METHODS: Subjects were current non-injecting users of heroin and/or cocaine and who had never injected illicit drugs. Three thousand one hundred fifty-seven NIDU subjects were recruited between 2005 and 2014 among persons entering Mount Sinai Beth Israel substance use treatment programs. Structured interviews, HIV, and HSV-2 testing were administered. Change over time was assessed by comparing 2005 to 2010 with 2011 to 2014 periods. Herpes simplex virus type 2 incidence was estimated among persons who participated in multiple years. RESULTS: Herpes simplex virus type 2 prevalence was strongly associated with HIV prevalence (odds ratio, 3.9; 95% confidence interval, 2.9-5.1) from 2005 to 2014. Herpes simplex virus type 2 prevalence declined from 60% to 56% (P = 0.01). The percentage of NIDUs with neither HSV-2 nor HIV infection increased from 37% to 43%, (P < 0.001); the percentage with HSV-2/HIV coinfection declined from 13% to 6% (P < 0.001). Estimated HSV-2 incidence was 1 to 2/100 person-years at risk. CONCLUSIONS: There were parallel declines in HIV and HSV-2 among NIDUs in New York City from 2005 to 2014. The increase in the percentage of NIDUs with neither HSV-2 nor HIV infection, the decrease in the percentage with HSV-2/HIV coinfection, and the low to moderate HSV-2 incidence suggest some population-level protection against resurgence of HIV. Prevention efforts should be strengthened to end the combined HIV/HSV-2 epidemic among NIDUs in New York City.

Racial/Ethnic Disparities at the End of an HIV Epidemic: Persons Who Inject Drugs in New York City, 2011-2015.

OBJECTIVES: To examine whether racial/ethnic disparities persist at the "end of the HIV epidemic" (prevalence of untreated HIV infection < 5%; HIV incidence < 0.5 per 100 person-years) among persons who inject drugs (PWID) in New York City. METHODS: We recruited 2404 PWID entering New York City substance use treatment in 2001 to 2005 and 2011 to 2015. We conducted a structured interview, and testing for HIV and herpes simplex virus 2 (HSV-2; a biomarker for high sexual risk). We estimated incidence by using newly diagnosed cases of HIV. Disparity analyses compared HIV, untreated HIV, HIV-HSV-2 coinfection, HIV monoinfection, and estimated HIV incidence among Whites, African Americans, and Latinos. RESULTS: By 2011 to 2015, Whites, African Americans, and Latino/as met both criteria of our operational "end-of-the-epidemic" definition. All comparisons that included HIV-HSV-2-coinfected persons had statistically significant higher rates of HIV among racial/ethnic minorities. No comparisons limited to HIV monoinfected persons were significant. CONCLUSIONS: "End-of-the-epidemic" criteria were met among White, African American, and Latino/a PWID in New York City, but elimination of disparities may require a greater focus on PWID with high sexual risk.

Sociodemographic and Substance Use Disorder Determinants of HIV Sexual Risk Behavior in Men and Women in Outpatient Drug Treatment in the NIDA National Drug Abuse Treatment Clinical Trials Network.

BACKGROUND: Sexual risk behavior is now the primary vector of HIV transmission among substance users in the United States with gender as a crucial moderator of risk behavior. OBJECTIVES: The purpose of this study was to examine gender differences in factors (age, race/ethnicity, education) that predict main-partner unprotected sexual occasions (USO) using the unique platform of two parallel NIDA National Drug Abuse Treatment Clinical Trials Network gender-specific safer sex intervention trials. METHODS: Baseline assessments of male (N = 430) and female (N = 377) participants included demographic characteristics; past 3-month sexual activity; and a diagnostic assessment for alcohol, cocaine/stimulant, and opioid use disorders. Using mixed effects generalized linear modeling of the main outcome USO, two-way interactions of gender with age, race/ethnicity, and education were evaluated and adjusted by alcohol, cocaine/stimulant, or opioid use disorder. RESULTS: When adjusted for alcohol use disorder, the interaction of education and gender was significant. For men, a high school or greater education was significantly associated with more USO compared to men with less than high school. For women, greater than high school education was significantly associated with less USO compared to women with a high school education. None of the other interactions were significant when adjusted for cocaine/stimulant or opioid use disorder. Conclusions/Importance: This study demonstrates gender differences in the relationship of education, alcohol use disorder, and main-partner USO in individuals in substance abuse treatment. This underscores the importance of considering demographic and substance use factors in HIV sexual risk behavior and in crafting prevention messages for this population.

Strength in the midst of pain: Abuse as a predictor of sexual relationship power among substance-abusing Black women.

The aim of this research was to explore the association of abuse experiences (child sexual abuse and adult physical/sexual violence) to sexual relationship power among Black substance-abusing women. The study was a secondary analysis of baseline data collected from 124 Black women in 12 drug treatment programs across the United States who initially participated in an HIV risk reduction trial conducted within the National Drug Abuse Treatment Clinical Trials Network of the National Institute on Drug Abuse (NIDA). The findings revealed that adult sexual abuse, but not childhood sexual or adult physical abuse, was associated with lower relationship control and decision-making dominance as measured by the Sexual Relationship Power Scale. The findings suggest that designing and implementing sexual risk reduction interventions that address adult sexual violence may enhance the relationship power of Black substance-abusing women and in turn may promote safer sex practices.

Consistent Estimates of Very Low HIV Incidence Among People Who Inject Drugs: New York City, 2005-2014.

OBJECTIVES: To compare methods for estimating low HIV incidence among persons who inject drugs. METHODS: We examined 4 methods in New York City, 2005 to 2014: (1) HIV seroconversions among repeat participants, (2) increase of HIV prevalence by additional years of injection among new injectors, (3) the New York State and Centers for Disease Control and Prevention stratified extrapolation algorithm, and (4) newly diagnosed HIV cases reported to the New York City Department of Health and Mental Hygiene. RESULTS: The 4 estimates were consistent: (1) repeat participants: 0.37 per 100 person-years (PY; 95% confidence interval [CI] = 0.05/100 PY, 1.33/100 PY); (2) regression of prevalence by years injecting: 0.61 per 100 PY (95% CI = 0.36/100 PY, 0.87/100 PY); (3) stratified extrapolation algorithm: 0.32 per 100 PY (95% CI = 0.18/100 PY, 0.46/100 PY); and (4) newly diagnosed cases of HIV: 0.14 per 100 PY (95% CI = 0.11/100 PY, 0.16/100 PY). CONCLUSIONS: All methods appear to capture the same phenomenon of very low and decreasing HIV transmission among persons who inject drugs. Public Health Implications. If resources are available, the use of multiple methods would provide better information for public health purposes.

Providing ART to HIV Seropositive Persons Who Use Drugs: Progress in New York City, Prospects for "Ending the Epidemic".

New York City has experienced the largest HIV epidemic among persons who use psychoactive drugs. We examined progress in placing HIV seropositive persons who inject drugs (PWID) and HIV seropositive non-injecting drug users (NIDU) onto antiretroviral treatment (ART) in New York City over the last 15 years. We recruited 3511 PWID and 3543 NIDU from persons voluntarily entering drug detoxification and methadone maintenance treatment programs in New York City from 2001 to 2014. HIV prevalence declined significantly among both PWID and NIDU. The percentage who reported receiving ART increased significantly, from approximately 50 % (2001-2005) to approximately 75 % (2012-2014). There were no racial/ethnic disparities in the percentages of HIV seropositive persons who were on ART. Continued improvement in ART uptake and TasP and maintenance of other prevention and care services should lead to an "End of the AIDS Epidemic" for persons who use heroin and cocaine in New York City.

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.