HIV Prevention and Treatment Services Lab

Children’s National Hospital’s HIV Prevention and Treatment Services (HPTS) Program has a long history of contributing to the improvements in health outcomes among mothers, infants, adolescents and young adults living with HIV or affected by the epidemic. Natella Rakhmanina, MD, PhD, leads a strong interdisciplinary and highly collaborative clinical program that integrates clinical, epidemiological, behavioral, implementation and translational research for HIV treatment and prevention. With support from Ryan White federal funding, the clinic provides large array of clinical and support services, including patient navigation, antiretroviral oral and injectable HIV treatment and pre-exposure prophylaxis (PrEP), individualized case management, mental health services, national support, psychosocial support and peer support. HPTS has strong ties with the regional metropolitan DC community including suburban Maryland and Virginia and works with many community-based partners with mutual referrals for clinical services and research. Outside of the metropolitan area, HPTS staff are also leaders in the global health arena with Kathy Ferrer, MD, and Natella Rakhmanina, MD, PhD, as Children's National Global Health Initiative faculty members.

Epidemiological and clinical research at HPTS is represented by multiple studies including clinical trial of novel antiretroviral drugs and innovative prevention and treatment approaches. Many of these studies have gained national recognition and have been cited in HHS HIV management guidelines, led to FDA approval of new drug formulations for treating HIV in children and adolescents, and introduced innovative approaches to HIV service delivery.

For over a decade, Children’s National has been a sole designated pediatric/adolescent site within the DC Cohort, a longitudinal study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). As a cohort study that has been following about 12,000 HIV-positive patients receiving care at 15 treatment clinics in D.C., the goal of the project is to improve the quality of care and treatment of HIV-positive patients being cared for in D.C. Within this study, HPTS led the publication of three manuscripts and collaborated on more than 25 joint publications. As a part of the cohort, HPTS participated in an innovative efficacy and implementation study for the use of a mHealth application, PositiveLinks, for patients that are disengaged in care or have challenges with medication adherence.

Other studies within our program are also focused on PrEP such as one led by Andrew Barnett, PhD, on enhancing PrEP and clinic-based HIV prevention care among young men who have sex with men (YMSM). Dr. Barnett is the principal investigator of a NIMH-funded patient-oriented mentored research career development award (K23MH136831), “Using Implementation Science to Enhance HIV Prevention among Young Men who have Sex with Men.” The objective of the project is to identify and pilot implementation strategies to facilitate delivery of CDC-recommended evidence-based practices (motivational interviewing and personalized health education) in PrEP care with YMSM to increase retention and use of PrEP and other HIV prevention methods. Additionally, we are collaborating with Eastern Virgina Medical School and Medstar Washington Hospital Center on an end-user research project looking into women’s preference on a long-acting, multiple prevention technology (MPT) implant for birth control and HIV PrEP.

The HPTS program has participated in the national and international clinical trials conducted by multiple pharmaceutical industry partners, such as Gilead, Bristol Myers Squib (BMS), Merk, ViiV, and contributed to development and approval of the novel pediatric and adolescent antiretroviral drug formulations. Most recently, Children’s National patients participated in a Gilead Sciences Inc. sponsored Phase 2/3 studies evaluating the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide and bictegravir/emtricitabine/tenofovir alafenamide. CNH is also one of the two US sites for the SHIELD Study, funded by the Pediatric European Network for Treatment of AIDS (PENTA)/ViiV, assessing the safety and efficacy of fostemsavir administered as part of the antiretroviral regimen in children and adolescents between 6-18 years of age who are failing their current ART. Most recently, we launched GlaxoSmithKline funded DRAGON study which is a Phase 1/2 study of switching to a fixed dose combination treatment of dolutegravir/rilpivirine among virologically suppressed children 6-12 years of age, and a Gilead Sciences Inc. sponsored Phase 2/3 study evaluating the pharmacokinetics, safety and antiviral activity of bictegravir/lenacapavir.

HPTS program initiates many innovative site-generated studies to understand the diverse social, behavioral, laboratory and clinical characteristics of patients receiving testing and care at the clinic. Some of our recent cross-cutting research publications are listed below, with an extensive found in our HPTS Bibliography.