Hello! We would like to cordially invite you to join our new DC CTU Newsletter! Through this new publication, we look forward to updating you on exciting news for Washington, DC's HIV research communities. If you are unfamiliar with the structure, the Division of AIDS (DAIDS) within the National Institute of Allergy and Infectious Diseases has united two high-performing Clinical Research Sites (CRS) to form the new DC Clinical Trials Unit. By uniting the Whitman-Walker Health (WWH) CRS and the George Washington University (GW) CRS in our research efforts, the CTU aims to bring cutting-edge studies to a region with one of the highest rates of HIV in the United States. The DC CTU builds on the collaborative research successes of the DC Center for AIDS Research and the DC Cohort, while allowing WWH and GW to maintain their unique identities and practices. Following the recent creation of the DC CTU, we invite you to stay tuned for upcoming trials, community member highlights, clinician highlights, and other exciting news. 

DAIDS has funded a new global structure to streamline resources to advance four areas of HIV science: prevention, vaccine development, new adult therapeutics, and therapeutics for mothers and children. Each of these four aims ultimately intend to reduce the incidence of HIV, develop next-generation therapies, develop a cure, and address HIV-associated comorbidities. 

Here in the DC metropolitan area, WWH focuses on treatment and cure studies, while GW focuses on biomedical and behavioral prevention strategies. DC CTU efforts are informed by deep community conversations and collaborations across institutions and populations.

NIH Research Priorities

Here are some studies currently underway:

Current Studies: WWH

1. A5380 (Purge-C): this study treats participants, with or without HIV, who are experiencing recent or acute diagnosis of hepatitis C. The study aims to test if a shorter course of treatment might be effective in curing HCV than the current 6 month regimen.
2. A5391 (The Do IT Study): This clinical trial evaluates a medication switch for people living with HIV who experience excessive weight gain from the “INSTI” treatment combination to another approach using doravirine.
3. A5379 (BEe-HIVe): This clinical trial tests various hepatitis B vaccines in people living with HIV to find efficacious dosing. 
4. A5321 (AHRC): This cohort study follows people living with HIV who have been on antiretroviral treatment for years to assess the differences and changes in HIV reservoirs, or the HIV-infected cells that manage to hide from otherwise successful antiretroviral treatment regimens.

Current Studies: GW

1. HVTN 136/HPTN 092 and HVTN 140/HPTN 101: These studies are conducted in collaboration with the HIV Vaccine Trials Network (HVTN). They are Phase I early stage studies to assess the safety of broadly neutralizing monoclonal antibodies as PrEP. HVTN 140/HPTN 101 is open for recruitment! To learn more, email gwuphc@gwu.edu.
2. HPTN 094 (INTEGRA): This study examines mobile integrated care strategies for people with opioid use disorder who inject drugs and either have or are at risk of HIV. HPTN 094 is open for recruitment! To learn more, email gwuphc@gwu.edu.
3. HPTN 083: This is a Phase III study that investigates the safety and efficacy of long acting injectable cabotegravir as HIV pre-exposure prophylaxis (PrEP) among cis-gender men who have sex with men and transgender women. 
4. The GW HPTN CRS also is a site for the Coronavirus Prevention Network (COVPN) and participated as a site for the Moderna Phase III COVID-19 vaccine trials among other COVID related prevention studies.

The People's Highlights

Participants, study staff, and community are what make the DC CTU special! In the coming newsletter issues, we will highlight participants, staff, and community members. Today we will start with community engagement. We'd love to hear from you! Share any suggestions on content you'd like to see from us here.

The Whitman-Walker Health ACTG community advisory board (CAB) consists of long term survivors and people who have been involved with ACTG trials at Whitman-Walker for years. On a monthly basis, the same 8-10 study participants gather virtually with clinicians and research specialists to discuss their trial experiences, offer feedback on protocol iterations and dissect new study materials. The aim is to strengthen community input and accountability in ACTG trials. 

The GW Prevention Research CAB meets quarterly or as needed for specific tasks. Beginning in 2007, this CAB includes a diverse group who are interested in HIV prevention. This includes people who represent organizations, those with or at risk for HIV, and concerned members of the DC metropolitan area community. Meetings focus on new studies, implementation questions or challenges, and study findings. Extra meetings are held as needed for specific topics, for example, to consider whether a given new study should be pursued, review questionnaires or protocols, or in the case of retention challenges. The GW Prevention Research CAB expanded in 2020 to include COVID-19 as so many populations affected by HIV are also highly impacted by COVID-19. We continue to partner with numerous organizations and individuals. At this time, most meetings are still virtual. If you would like to become a member, please email cmorris297@gwu.edu and you will be informed about future meetings.

The DC CTU joint CAB embraces both the WWH ACTG CRS and the GW HPTN CRS in semi-annual meetings to bring the prevention and treatment study communities together. Most recently, the CAB presented a symposium with scientists, patients, and participants regarding injectable antiretroviral treatment and prevention. It was an outstanding session and educational for all. If you are interested in future DC CTU Joint CAB events please email cmorris297@gwu.edu.

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