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Press Releases and Announcements
This month, the ACTG announced the publication of study A5349 in the New England Journal of Medicine. Read more HERE.

Findings from a substudy of REPRIEVE (A5332/A5322s) were published in the Journal of the American Medical Association Network Open (JAMA Network Open). Read more HERE.

The ACTG also honored the 40th anniversary of the initial publication of reports of what came to be known as HIV/AIDS in CDC's Morbidity and Mortality Weekly Report on June 5, 1981. Read more HERE.

The ACTG announced the addition of two monoclonal antibodies to the ACTIV-2 outpatient treatment study for COVID-19 (A5401). Read more HERE


The ACTG announced that Camostat will not advance to phase 3 in the ACTIV-2 outpatient treatment study for COVID-19 (A5401). Read more HERE.

Study A5386, a phase 1 HIV cure study evaluating two promising therapies was launched this month. Read more HERE
Publications
Uncovering the relationship between neurocognitive impairment and frailty

Cognitive impairment and frailty are more common among older people living with HIV. Both cognitive impairment and frailty have been associated with increased risk of mortality and poor health outcomes including disability and reduced quality of life. While cognitive impairment and frailty often overlap with one another, it has not been well-established whether cognitive impairment precedes frailty or the other way around in older people living with HIV. This study (a substudy of A5322) examined factors associated with the development of or improvement in cognitive impairment and frailty among older people living with HIV enrolled in ACTG A5322/HAILO, including the association of each syndrome with the other. The study found that cognitive impairment was associated with increased risk of frailty, but frailty was not associated with development of cognitive impairment. These findings suggest that when older people living with HIV have cognitive impairment, providers should monitor for the development of frailty and conduct interventions to prevent it from emerging. In addition, treating modifiable risk factors associated with cognitive impairment and frailty may ultimately benefit both conditions and improve quality and length of life for older adults aging with HIV.

Masters MC, Perez J, Wu K, Ellis R, Goodkin K, Koletar SL, Andrade A, Yang J, Brown TT, Palella FJ, Sacktor N, Tassiopoulos K, Erlandson KM. Baseline neurocognitive impairment (NCI) is associated with incident frailty but baseline frailty does not predict incident NCI in older persons with HIV. Clin Infect Dis. 2021 Feb 13:ciab122. doi: 10.1093/cid/ciab122. Epub ahead of print. PMID: 33580258.

Estimating the proportion of individuals who don’t get TB despite close contact

One of the most interesting and intriguing aspect of tuberculosis (TB) epidemiology is that some people continue to test negative for TB despite having prolonged, close contact with someone with TB. This observation raises the question of whether some individuals resist getting TB – a phenomenon commonly called “resister phenotype” – and, if so, what insights may be gleaned from them to inform prevention strategies, including vaccines. Research on this topic has been challenging because currently available tests for TB and for measuring exposure are imperfect. In this analysis from the ACTG/IMPAACT PHOENIx Feasibility Study (A5300/I2003), researchers had a unique opportunity to use data from 16 sites in eight high- and medium-TB burden countries to estimate the proportion of household contacts of patients with multidrug-resistant TB who might be resistant to getting TB. The study explored how the proportion would change using different definitions for TB infection and TB exposure to define the resister phenotype, based on test cutoffs, repeat testing, and degree of exposure. The study found that 10 to 21% of contacts could be classified as resistant to TB infection, regardless of the definition used. That means that even using the strictest definitions for lack of infection and restricting the analysis to contacts who had high exposure to their family member with infectious TB, one in 10 showed no signs of TB. Better understanding of the resister phenotype, including studies that explore its biologic underpinnings, can support the development of new therapeutics and even vaccines. These findings provide important insights that will enable a more uniform approach to defining the resister phenotype in order to unlock potential clues for more effective ways of preventing TB.

Baliashvili D, Gandhi NR, Kim S, Hughes M, Mave V, Mendoza-Ticona A, Gonzales P, Kim N, Selvamuthu P, Badal-Faesen S, Upton C, Naini L, Smith E, Gupta A, Churchyard G, Swindells S, Hesseling A, Shah NS. Resistance to Mycobacterium tuberculosis infection among household contacts: a multinational study. Clin Infect Dis. 2021 Mar 27:ciab269. doi: 10.1093/cid/ciab269. Epub ahead of print. PMID: 33772550.
ACTG Minority HIV Investigator Mentoring Program (MHIMP) and International HIV Investigaot Mentoring Program (IHIMP)
During the ACTG Annual Network Meeting, the awardees for the 2021-2023 MHIMP and IHIMP were announced. Read more about the awardees below!
New MHIMP Awardee
George Yendewa, M.D., M.P.H., T.M., Case Western CRS



George Yendewa, M.D., M.P.H., T.M. is an Assistant Professor of Medicine in the Division of Infectious Diseases and HIV Medicine at Case Western Reserve University School of Medicine in Cleveland, Ohio. A native of Sierra Leone, Dr. Yendewa earned his M.D. from the First Faculty of Medicine at Charles University in Prague, Czech Republic. He subsequently earned an M.P.H. in Tropical Medicine from Tulane University School of Tropical Medicine, conducted his residency in internal medicine at New York Medical College/Brookdale University Hospital, and completed a combined clinical and research fellowship in infectious diseases and HIV medicine at Case Western Reserve University. He is currently pursuing his Doctor of Public Health degree in implementation science from Johns Hopkins Bloomberg School of Public Health. 
 
To date, Dr. Yendewa’s research has centered on the molecular epidemiology of HIV infection, HIV drug resistance, clinical consequences of HIV co-infection with endemic and emerging viruses (HBV, HCV, HLTV 1/2, and SARS-CoV-2), and the socio-cultural and economic determinants of HIV acquisition and outcomes in West Africa (Sierra Leone and Liberia) and the United States. He currently serves as the Case CRS PI for two Hepatitis TSG protocols and A5404. He is also the Case CRS PI for the CFAR Network of Integrated Clinical Systems consortium, which uses CFAR databases from eight clinical sites in the United States to assess HIV clinical outcomes and conduct comparative effectiveness research. He was elected to serve on the ACTG Hepatitis TSG committee in 2021. Dr. Yendewa’s research has been supported by the Roe Green Center for Travel Medicine and Global Health Award (2017-2020), the Vicky Tifft International Health Award (2019-2020), and the Faculty Development Award at Case Western Reserve University. 
 
Dr. Yendewa's career goals are to become an independent clinician-investigator, HIV trialist, and implementation scientist, with a special focus on HIV and viral hepatitis co-infection in underserved populations domestically and internationally. The objectives of the ACTG Minority HIV Investigator MP Award are well suited to providing Dr. Yendewa the requisite training and mentorship needed to achieve these goals. Outside his professional pursuits, Dr. Yendewa enjoys watching football (he is a lifelong and passionate Arsenal FC fan), long-distance running, travelling, and attending live-music concerts.
New IHIMP Awardee
Pamela Mukwekwerere, MD, Milton Park CRS



Pamela Grace Mukwekwerere, M.D. is a physician and clinical research site coordinator at the Milton Park CRS (University of Zimbabwe – Clinical Trials Research Centre) with eight years of experience in clinical research operations. She has been part of high-impact studies with the ACTG since 2013, including A5225 (“A Phase I/II Dose-Finding Study of High-Dose Fluconazole Treatment in AIDS-Associated Cryptococcal Meningitis”) and A5279 (“A Phase III Clinical Trial of Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Adults with Latent Tuberculosis Infection”), which showed that a 1-month rifapentine/isoniazid regimen prevents TB in people living with HIV as well as standard 9-month isoniazid alone. This experience has built up Dr. Mukwekwerere’s interest to be actively involved in getting to zero new HIV cases by the year 2030.

Dr. Mukwekwerere was recently elected to serve as a member of the Protocol Development and Implementation Subcommittee and the Field Representatives Working Group. She has demonstrated passion in conducting investigator-initiated research that is relevant and helpful to her community. Dr. Mukwekwerere recently conducted a self-funded research study evaluating the effects of the COVID-19 pandemic and lockdown on young people in three Zimbabwean cities. The preliminary results of this study were presented as a poster at the HIV Adolescence 2020 conference.

Becoming the 2021-2023 International HIV Investigator Mentoring Program awardee will provide Dr. Mukwekwerere with an opportunity to learn and interact with role models and collaborators. She is looking forward to contributing to the ACTG behavioral science agenda by identifying gaps and opportunities to integrate behavioral science interventions into ongoing and future trials.
SPOTLIGHTS
INVESTIGATOR SPOTLIGHT

 This month's Investigator Spotlight will shine on the the 2019-2021 awardees, Drs. Hemil Gonzalez and Ponego Ponatshego.  

2019-2021 MHIMP Awardee: Hemil Gonzalez, MD, Northwestern University CRS

 

Hemil Gonzalez, M.D. was born and raised in the Dominican Republic. His experiences there sparked his interest in infectious diseases, particularly in neurological infections. Dr. Gonzalez moved to Chicago, IL to complete his residency in internal medicine at Cook County Hospital and his fellowship at Rush University. He also completed a research fellowship in HIV neuropathogenesis at Rush University. His research has largely focused on the effects of antiretrovirals on glial cells, particularly astrocytes.
 
“The Minority HIV Investigator Mentoring Program has been a fantastic opportunity to share with other experts in the field while developing my research skills. I feel strategically positioned to understand what is presently most relevant in the field and what the future directions will be,” says Dr. Gonzalez.
 
He says that having the support of the ACTG and dedicated time to devote to research have been instrumental in his development over the last two years. During the 2019-2021 award period, Dr. Gonzalez published an original article on the application of a point-of-care diagnostic test for neurosypilis, a review on neurosyphilis, and a review on the current knowledge on the effects of cART on astrocytes. Within the ACTG, he has been part of the Underrepresented Populations Committee and the Neurology Collaborative Science Group.
 
Despite the impact of the current COVID-19 pandemic on the ability to perform research, Dr. Gonzalez felt that the Underrepresented Populations Committee was a great resource to help formulate approaches to community outreach and volunteer activities to help spread information and/or participate in vaccine distribution and inoculation. He is very proud of his active participation, both as a clinician in the hospital setting and a volunteer in the community, during this challenging time. “Committees such as the Underrepresented Populations Committee serve as a fantastic model of how this type of work can be formulated and applied in real time,” he said. Outside of his professional life, Dr. Gonzalez’s interests include practicing and teaching martial arts (kendo) and more recently, training for the Chicago Triathlon.


2019-2021 IHIMP Awardee: Ponego Ponatshego, MD, Molepolole CRS

Ponego Ponatshego, M.D. is a research clinician working with Botswana Harvard AIDS Institute Partnership based in Gaborone, Botswana. He is involved in several clinical trials for the ACTG as a study physician and the IMPAACT as a study physician and study coordinator. Dr. Ponatshego has also been involved in the AMBITION trials for the treatment of HIV-associated cyrptococcal meningitis under the European and Developing Countries Clinical Trials Partnership. Currently, he is also the lead doctor for an implementation science project aimed at integrating HIV and hypertension care services in Botswana.

Dr. Ponatshego’s research focuses on the consequences of aging in HIV in resource-limited settings and the rise of non-communicable diseases and other complications as people on treatment live longer and ‘healthier.’ As the ACTG 2019-2021 IHIMP awardee, he is continuing to conduct an ongoing research project on frailty prevalence among an HIV cohort in Botswana, in which he is investigating possible associations between frailty and albuminuria (having too much albumin in urine – a sign of kidney disease). The project has enrolled 990 participants to date from a projected enrollment target of 1148 participants (the COVID-19 pandemic has slowed enrollment and required the study team to make adaptations to retain both personnel and participants). Within the ACTG, he has been part of the Underrepresented Populations Committee, the Site Management and Clinical Care Committee, and the Comorbidities Transformative Science Group.

Outside of his clinical work, Dr. Ponatshego was recently accepted to a Master’s of Science in Global Health program at the Liverpool School of Tropical Medicine, to begin in September 2021.


SITE SPOTLIGHT

Washington University Therapeutics CRS, St. Louis, MO



The Washington University Therapeutics CRS (WT) has been an ACTG site since 1987 and has participated in every trial they have been eligible for, --more than 78 ACTG studies to date! In the early days of the CRS, the site had a particular strength in opportunistic infection studies, especially fungal infections, as they saw a lot of people with Cryptococcus and Histoplasma. WT has also been very active in HIV treatment studies since the beginning. The site has had a longstanding collaboration with both neurology and metabolic complications. More recently, WT has established active programs that facilitate its participation in cure studies, including collaborations with radiology, gastroenterology, hematology, and surgery to obtain tissue samples such as lymph node, gut, bone marrow, lumbar puncture, and pheresis to contribute further to these studies.

Over the past year, WT turned its attention almost entirely to COVID-19, making sure to keep up with their long-term participants in clinical trials like REPRIEVE, HPTN 083, and the ACTG observational cohort studies. The site is thrilled to have been able to participate in the COVID-19 response by enrolling participants in the Janssen vaccines studies, as well as A5401 and ACTIV-1. In addition, WT has conducted active translational work on the humoral immune response after natural infection and vaccination, demonstrating an active memory response that appears to be long lasting.

WT has been particularly fortunate to have an incredibly dedicated staff, many of whom have been with the site for more than 20 years, including three of the original staff, hired in 1987: Study Coordinator Mike Klebert, Pharmacist Mike Royal, and Data Manager Warren Seyfried (who retired in June 2021). The WT staff has been extremely dedicated to the ACTG, participating on numerous committees and in leadership positions. Given that much of the staff has worked together for so long, they’ve gotten to know each other on a personal level, including their talents and foibles, from Mike Royal’s baking to Mike Klebert’s whistling. The staff has gotten to work with amazing investigators, including Bill Powderly, M.D., Judy Aberg, M.D., Carl Fichtenbaum, M.D., Pablo Tebas, M.D., and Turner Overton, M.D.

WT has been fortunate to be a part of novel treatments for HIV, HCV, Sars-CoV-2, and other diseases that have made a real difference in people’s lives. The site has a tremendous CAB, including participants who have been involved in numerous studies – some who were part of the earliest ACTG treatment trials still want to participate today! The site’s artwork has all been either created or donated by patients and their families. This long-term involvement with study participants and the ability to see the meaningful changes in people’s health and well-being caused by our site’s efforts makes this work feel both significant and consequential for the WT staff.
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