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A randomized, active-controlled, double-blind clinical study to investigate the safety and efficacy of oral Islatravir, a once-monthly pill as pre-exposure prophylaxis (PrEP) in cisgender women at high risk for HIV-1 infection. Closed to enrollment. In active study follow-up.
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Generating knowledge, catalyzing solutions
ICAP is at the forefront of research generating new knowledge to improve access to and quality of health services, strengthen delivery mechanisms, and evaluate public health interventions. Leveraging years of experience and a committed cadre of accomplished experts, ICAP designs, implements, monitors, and evaluates a range of innovative implementation science, epidemiological, and clinical research studies. To ensure sustainability of this pragmatic research, ICAP provides training and mentorship in the countries where it works.
Feature Research Story
In summer 2021, a state-of-the-art mobile clinic began making rounds in the streets of Harlem and the Bronx, drawing attention with its bright graphics. But beneath the colorful exterior is a serious proposition – to address the intertwined public health crises of opioid addiction, HIV, and hepatitis C among people who inject drugs.
Drug overdose is the leading cause of accidental death in the United States, with nearly 108,000 fatalities in 2021, the highest number of overdose deaths recorded in any 12-month period. Factors such as lack of access to health care, poverty, mental health disorders, use of multiple illicit substances, stigma and discrimination combine to increase the risk of HIV transmission and acquisition and other health issues among people who inject drugs.
The mobile clinic is at the center of ICAP’s participation in the nationwide INTEGRA study (HPTN 094), which aims to determine whether using mobile health units to deliver integrated health services for people with opioid use disorder can improve addiction, HIV, hepatitis C and substance use outcomes compared to standard of care. At locations frequented by people who inject drugs, ICAP study team members engaged with individuals, provided them with information regarding the study, enrolled participants and followed up with them throughout their study participation.
Participants in the study are randomized to receive integrated care on the “van” – as the study team calls it – or to receive the services of a health care navigator who will assist the participant in finding care in the community.
“The integrated care model means they will be able to receive their buprenorphine [a medication to treat opioid use disorder] prescription from the van,” said Rashaunna Redd, NP, site clinician for ICAP’s Bronx Prevention Center, which conducts the study. “And they will also be tested for HIV, STIs, and hepatitis, and screened for routine primary care problems such as diabetes and blood pressure issues.”
After six months, all participants transition to care in the community. Follow-up after the study extends to 12 months.
“Our goal is to make it as close to one stop as a possible. Although we recognize that some people will have serious medical conditions that require them to see specialists – and we will help them with that,” said Ellen Morrison, MD, site lead at ICAP’s Bronx Prevention Center.
Since the study began, initial findings revealed a high prevalence of mental health disorders such as anxiety, depression, and post-traumatic stress disorder among participants.
“This finding is particularly important because recreational drug use may be used as a form of self-medication,” said Alan Padilla, BA, community educator at ICAP’s Bronx Prevention Center. “Our team is actively promoting the need to address these underlying factors to fully provide addiction services.”
As the van proclaims in bright lettering, ICAP is driving health forward. Mobile health units, along with this study, are providing the engine necessary to reach that mission.
Funder: U.S. National Institute of Allergy and Infectious Diseases (NIAID) with funding from the U.S. National Institute on Drug Abuse (NIDA)
Project: HIV Prevention Trials Network (HPTN); INTEGRA study (HPTN 094)
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As COVID-19 swept the globe, its ruthless trajectory exacerbated the challenges and inequities already faced by the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) community, including employment and housing discrimination, inequitable health care, and more. To gain insight into the burden and impact of COVID-19 on this community, and assess vaccine uptake, ICAP conducted a study that reached more than 1,000 LGBTQ+ New Yorkers aged 18 to 68 years.
While LGBTQ+ individuals in NYC reported a similar burden of COVID-19 and vaccine uptake compared to the general population of the city, the study revealed this community is more likely to experience increased financial and emotional challenges due to the pandemic, particularly among the most stigmatized, such as gender minorities and among those with multiple minority identities. For example, 81 percent of LGBTQ+ individuals reported experiencing financial hardship as a result of the pandemic. This important evidence base will inform strategies to reach unvaccinated individuals and assist policymakers in developing further programs to support those most negatively impacted by the pandemic.
Funder: Rockefeller Foundation
Project: Experiences of LGBTQ+ Populations in New York City During the COVID-19 Pandemic (The LEXICON Study)
In New York City, older adults had seven times the mortality rate from COVID-19 compared to all other ages, but there was little known about the mental health and social ramifications of the pandemic on this population – especially those who were still living at home and not in nursing homes.
To gain a better understanding of the effects of the pandemic on this vulnerable group, ICAP launched the SARS-CoV-2 Impact on Lives and Views of Elderly Residents (SILVER) study, aimed at understanding the physical, emotional, and economic effects of the COVID-19 pandemic on older adults living at home. A total of 676 participants 70 years and older were enrolled – overall, 18 percent of older adults screened for depression and 17 percent for anxiety, with a greater percent of Latinx older adults reporting loneliness than other races and ethnicities. Almost one-third of older New Yorkers reported financial challenges and almost one in ten reported not having enough to eat.
With new funding, ICAP launched a second SILVER study seeking to learn more about the impact of the pandemic on participants’ ongoing health and wellbeing. The second round of data collection expanded topic areas, pursuing further details about participants’ access to resources such as telehealth, housing, internet, social support, and use of city services. Attitudes toward the COVID-19 vaccine, booster doses, and the influenza vaccine were also evaluated. In addition to following up with the first SILVER study participants, the second study included new participants, specifically Asian New Yorkers, to better represent the diversity of New York City. The ultimate goal of the study was to provide policymakers in New York City and other communities with more accurate information on how to best serve and assist older adults during times of crisis.
Funder: New York Community Trust
Project: SARS-CoV-2 Impact on Lives and Views of Elderly Residents (SILVER) Study
