Delivering integrated strategies from a mobile unit to address the intertwining epidemics of HIV and addiction in people who inject drugs: the HPTN 094 randomized controlled trial protocol (the INTEGRA Study).

BACKGROUND: Persons with opioid use disorders who inject drugs (PWID) in the United States (US) face multiple and intertwining health risks. These include interference with consistent access, linkage, and retention to health care including medication for opioid use disorder (MOUD), HIV prevention using pre-exposure prophylaxis (PrEP), and testing and treatment for sexually transmitted infections (STIs). Most services, when available, including those that address substance misuse, HIV prevention, and STIs, are often provided in multiple locations that may be difficult to access, which further challenges sustained health for PWID. HPTN 094 (INTEGRA) is a study designed to test the efficacy of an integrated, "whole-person" strategy that provides integrated HIV prevention including antiretroviral therapy (ART), PrEP, MOUD, and STI testing and treatment from a mobile health delivery unit ("mobile unit") with peer navigation compared to peer navigation alone to access these services at brick and mortar locations. METHODS: HPTN 094 (INTEGRA) is a two-arm, randomized controlled trial in 5 US cities where approximately 400 PWID without HIV are assigned either to an experimental condition that delivers 26 weeks of "one-stop" integrated health services combined with peer navigation and delivered in a mobile unit or to an active control condition using peer navigation only for 26 weeks to the same set of services delivered in community settings. The primary outcomes include being alive and retained in MOUD and PrEP at 26 weeks post-randomization. Secondary outcomes measure the durability of intervention effects at 52 weeks following randomization. DISCUSSION: This trial responds to a need for evidence on using a "whole-person" strategy for delivering integrated HIV prevention and substance use treatment, while testing the use of a mobile unit that meets out-of-treatment PWID wherever they might be and links them to care systems and/or harm reduction services. Findings will be important in guiding policy for engaging PWID in HIV prevention or care, substance use treatment, and STI testing and treatment by addressing the intertwined epidemics of addiction and HIV among those who have many physical and geographic barriers to access care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04804072 . Registered on 18 March 2021.

COVID-19 preparedness at health facilities and community service points serving people living with HIV in Sierra Leone.

After a decade of civil war and the 2014-2016 West African Ebola outbreak, Sierra Leone now faces the COVID-19 pandemic with a fragile health system. As was demonstrated during Ebola, preparedness is key to limiting a health crisis' spread and impact on health systems and ensuring continued care for vulnerable populations including people living with HIV (PLHIV). To assess COVID-19 preparedness and inform interventions to ensure continuity of HIV services at health facilities (HFs) and community service points (CSPs), we conducted site readiness assessments in Freetown, the epicenter of COVID-19 in Sierra Leone. Data were collected at nine high-volume HIV HFs and seven CSPs in April 2020, a month after COVID-19 was declared a pandemic. CSPs comprised three community drop-in centers providing HIV counseling and testing services as well as HIV prevention services (e.g., condoms and lubricants) for key and priority populations and four community-based support groups serving PLHIV. At the time of assessment, CSPs did not provide antiretroviral therapy (ART) but were considered potential sites for expansion of differentiated service delivery (DSD)-a client-centered approach to HIV care-in the context of COVID-19. Overall, 5/9 HFs had trained staff on use of personal protective equipment (PPE) and prevention of COVID-19 transmission. Most had access to masks (5/9) and gloves (7/9) for management of suspected/confirmed COVID-19 cases, and 4/9 HFs had triage procedures for isolation of suspected cases. Conversely, few CSPs had access to masks (2/7) or gloves (2/7) and no staff were trained on PPE use or COVID-19 transmission. 7/9 HFs had adequate ART stock for multi-month dispensing though few had procedures for (3/9) or had trained staff in providing DSD (2/9). Among CSPs where measures were applicable, 2/4 had procedures for DSD, 1/3 had staff trained on DSD and none had adequate ART stock. Identification of gaps in COVID-19 preparedness is a critical step in providing support for infection control and modified service delivery. Findings from this assessment highlight gaps in COVID-19 preparedness measures at sites supporting PLHIV in Sierra Leone and indicate CSPs may require intensive supervision and training to ensure HIV services are uninterrupted while minimizing COVID-19 risk, especially if used as sites to scale up DSD.

Missed Opportunities for Engagement in the Prevention Continuum in a Predominantly Black and Latino Community in New York City.

Even though over the last 25 years, the Centers for Disease Control and Prevention recommendations for HIV screening have expanded to encompass population-wide screening in all healthcare settings, and despite the availability of pre-exposure prophylaxis (PrEP), a large proportion of individuals at risk of infection are not linked to prevention care. We evaluated missed opportunities for HIV screening and linkage to PrEP from 2006 through 2017 at an urban academic medical center serving a predominantly minority community. A missed opportunity for HIV screening was a provider visit that did not include HIV testing and occurred within the 12 months before the first positive HIV test. A missed opportunity for prevention was a visit after 2012 that included a negative HIV test, no evaluation for PrEP, and was followed by a positive HIV test. Univariate analysis was performed to assess characteristics of individuals with missed opportunities for screening and prevention services. Between 2006 and 2017, 721 patients were newly diagnosed with HIV. Two hundred forty-seven diagnoses were made in the early period (2006-2010), 236 in the middle period (2010-2013), and 238 in the late period (2014-2017). Overall 60% of patients had at least one missed opportunity, 36% for HIV screening, and 42% for PrEP. There was no improvement in the rates of individuals with a missed opportunity for HIV screening over time. Ending the HIV epidemic will require concerted efforts to bolster access to testing and ensure that all individuals are offered screening, counseling, and linkage to prevention and care services.

A forgotten population: older adults with newly diagnosed HIV.

Limited data are available regarding adults age ≥50 at initial HIV diagnosis. Improved understanding of this group is critical in designing interventions to facilitate earlier diagnosis and linkage to HIV care. We characterize individuals newly diagnosed with HIV, particularly those ≥50 years old, and examine the relationship between age and late diagnosis defined as concurrent HIV and AIDS diagnoses. This is a retrospective study of individuals newly diagnosed with HIV from 2006-2011 at an academic medical center in New York City. Multivariable logistic regression was performed to evaluate the effect of age, gender, race/ethnicity, risk factor, and prior medical visits on late diagnosis. Adults age ≥50 comprised 21.3% of all newly diagnosed individuals. Among these older adults, 70.0% were diagnosed as inpatients and 68.9% concurrent with AIDS, compared to 41.7% and 38.9% of younger adults, respectively. On adjusted analyses, age ≥50 (OR 3.13, 95% CI 1.63, 5.98) and injection drug use (OR 4.4, 95% CI 1.31, 14.75) were positively associated with late diagnosis, whereas female gender was negatively associated with late diagnosis (OR 0.52, 95% CI 0.28, 0.98). Our data suggest that HIV testing efforts targeting older adults are essential to address the unmet needs of this population, including implementation of HIV screening guidelines in primary care settings.