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ANNOUNCEMENTS
Introducing "They Became My Family"
by Liz Barr

They Became My Family is a portrait gallery celebrating the diverse community of the ACTG. The ACTG’s Global Community Advisory Board (GCAB) and Community Scientific Subcommittee (CSS) are exemplars of community engagement in clinical research. Across the world, local CABs at the different ACTG sites provide opportunities for multidirectional communication between the ACTG and the communities it serves.
 
As part of my research on HIV treatment activism, I conducted interviews with ACTG community members to capture the ways they understand their participation in the network and to preserve this important legacy. These interviews provided rich information about ACTG community members’ motivations and desires for their involvement with the network.
 
Many community members leave the ACTG when their terms end or due to burnout, busy lives, or competing priorities. Sometimes members pass away. Without a mechanism to preserve community members’ voices, these valuable experiences risk being lost. They Became My Family is simultaneously an effort to honor individual activist legacies and document the rich diversity of our network.
 
You can find They Became My Family on the ACTG website under the Community tab or visit it here.
National Black HIV/AIDS Awareness Day
by Orbit Clanton (current GCAB co-chair, on the left) and Lionel Hillard (former GCAB co-chair, on the right)

February is Black History month in the United States, which serves as an annual celebration of achievements by African Americans, and a time for recognizing the central role of Blacks in U.S. history. In keeping with this theme, February 7th has been designated as National Black HIV/AIDS Awareness Day. Current data shows African Americans comprise 13% of the U.S. population, though they represent 43% of all people living with HIV in the United States.
 
What Is The ACTG Doing To Address This Disparity?
ORBIT: The progress of the ACTG in the treatment of HIV-1 infected individuals has resulted in dramatic reductions in AIDS mortality in the U.S. and other countries of the developed world.
 
Over the last 10 years within the ACTG, enrollment strategies that promote representation in HIV/AIDS clinical trials have continued to focus on including populations that resemble the demographics of the epidemic, including racial/ethnic minorities, women, and transgender individuals. To address this need, the ACTG created the Underrepresented Populations Committee (UPC) to promote and monitor participation of minorities in ACTG studies and ensure representation by investigators of color.
 
LIONEL: ACTG research in communities of color and underserved communities is vital to a comprehensive collection of data, as these communities have more barriers, like adhering to medications, biological differences, and tolerability. We must acknowledge the historical trauma that Black Americans experienced concerning clinical trials research, such as the Tuskegee Syphilis experiment, which lasted for more than four decades. In the early years of the HIV epidemic, the black community was often excluded from HIV clinical trial research, even though the medications that came out of those studies (once approved by the Food and Drug Administration), would need to be used by communities of color, including Black women, youth, and trans individuals.
 
ORBIT: Research has demonstrated that health disparities can be exacerbated by a number of factors, including socioeconomic status, race/ethnicity, and geography. And still, minorities continue to face barriers for HIV/AIDS clinical trial participation, even when research opportunities are available at our Clinical Research Sites. Enrollments vary by site but continued efforts to increase participants’ diversity in HIV studies are needed.
 
LIONEL: In order to reduce the racial disparities that still impede equitable inclusion in clinical trials, it is imperative that we educate communities of color and underrepresented populations (including the trans community) about the pros and cons of participating in HIV clinical trials, as well as the what, why, risk, purpose, and ultimately the scientific data outcomes that will be derived from participating in HIV clinical trials. Our community benefits from being engaged in these protocols. Moreover, it must be understood that all studies may not inherently benefit you directly, but the results may be a foundation for future research.
 
CONCLUDING THOUGHTS
 
LIONEL: On all levels of decision-making concerning HIV, from policies to implementation, we must be at the table. Decisions cannot be made about us, without us.
 
ORBIT: We must always remember no matter whatever roles, responsibilities, and positions that we obtain, we must be committed to the fundamental principles of doing our best to End the Epidemic. If we remove self-predication and self-interests from the picture, then we will triumph and end the disproportional inequities of community of colors participating in HIV clinical trials.  HIV Stops with Me.

PUBLICATIONS

This month’s newsletter highlights three important ACTG publications. Please check out the full list of ACTG publications on PubMed.

A5288: Diverse Drug Resistance Profiles among People Experiencing Virologic Failure on Second-line ART in Resource Limited Settings

A5288 assessed third-line antiretroviral treatment (ART) in individuals who were failing second-line ART. This publication aimed to define resistance profiles among individuals failing second-line ART in low- and middle-income countries (LMIC), as this information is vital to optimize individual patient management and to develop treatment guidelines for this group. Of the 653 individuals screened for A5288, more than three-quarters (78%) had resistance to one or more drugs. One-fifth (20%) of participants showed resistance to at least one drug in a drug class, 32% showed resistance to at least one drug in two drug classes, and 26% showed resistance to at least one drug in all three commonly available drug classes. Susceptibility to at least one second-line regimen was preserved in 59% of individuals, as was susceptibility to etravirine (78%) and darunavir/r (97%). Susceptibility to a second-line regimen was significantly higher among women, younger individuals, those with higher nadir CD4+T-cell count, and those who had received LPV/r, and was lower among prior nevirapine recipients.
 
Therefore, highly divergent HIV drug resistance profiles, ranging from no resistance to resistance to three drug classes, were seen among individuals failing second-line ART in LMIC.  These results underscore the need for ready access to resistance testing and newer antiretrovirals for optimal management of third-line ART in LMIC.
 
Wallis C., Hughes M., Ritz J., Viana R., Jesus C., Saravanan S., Van Schalkwyk M., Mngqibisa R., Salata R., Mugyenyi P., Hogg E., Hovind L., Wieclaw L., Gross R., Godfrey C., Collier A., Grinsztejn B., Mellors J. Diverse HIV-1 Drug Resistance Profiles at Screening for ACTG A5288: A Study of People Experiencing Virologic Failure on Second-line ART in Resource Limited Settings. Clin Infect Dis. 2019 Nov 14;. doi: 10.1093/cid/ciz1116. [Epub ahead of print] PubMedID: 31724034.
 
A5260s: Fungal Marker β-D-Glucan Increased After Antiretroviral Therapy, Associated with Fat Gains  

A5260s was a sub-study of A5257 in which ART-naïve individuals with HIV were randomized to receive atazanavir (ATV)/ritonavir (r), darunavir/r, or raltegravir. The objectives of A5260s were to compare cardiovascular markers, body composition, and immune activation between those initiating the three different regimens. This analysis in the A5260s study found that, among participants of A5257, beta-D-glucan (BDG, a marker of fungal translocation) increased over two years, irrespective of whether individuals were randomized to either of the two protease inhibitors or the integrase inhibitor. This finding may be as a result of ongoing intestinal damage that occurs despite successful ART. The study also found that BDG was associated with larger fat gains on therapy, supporting prior data from ACTG 5260s showing that a marker of intestinal injury was a strong predictor of fat gains on treatment. This research highlights the potential effect of gut dysfunction on metabolic comorbidities in HIV. 
 
Dirajlal-Fargo S., Moser C., Rodriguez K., El-Kamari V., Funderburg N., Bowman E., Brown T., Hunt P., Currier J., McComsey G. Changes in the Fungal Marker β-D-Glucan After Antiretroviral Therapy and Association With Adiposity. Open Forum Infect Dis. Vol 6. Iss 11. 2019 Nov 11;. doi: 10.1093/ofid/ofz434. eCollection 2019 Nov. PubMedID: 31737737
 
ACTG DACS 325: Screening and Enrollment by Sex in HIV Clinical Trials in the United States

While women represent about one-quarter of adults living with HIV in the United States, many HIV clinical trials enroll fewer than 25% women. ACTG DACS 325 sought to assess how people living with HIV are recruited into the network’s clinical trials and whether ACTG enrolled proportionally lower percentages of women compared to men from the United States (and if so, why). 
 
This analysis included all ACTG trials recruiting people living with HIV in the United States from 2003 (when the screening database started) through 2013. Data from 31 trials recruiting at 99 clinical research sites across the United States  resulted in information on almost 11,000 persons. About one fifth (19%) of those screened were women living with HIV. Among those assessed, 28% did not enroll, which was only slightly higher than the 27% observed among men. These results did not differ when considering race, ethnicity, or age. Researchers were not able to investigate gender identity as it was not added to the ACTG screening questions until 2017. The most common reasons for people not enrolling were not meeting trial requirements or persons opting-out, and these reasons did not differ by sex. Pregnancy, breastfeeding, and trial contraceptive requirements were rarely reported as reasons to not enroll, though researchers speculate that women for whom these requirements applied may have been excluded (or excluded themselves) from trial consideration prior to screening.
 
Because the data around some of the factors relevant to participant recruitment (for example, childcare access, transportation, or participant reimbursement) were not available in the database, researchers were not able to address their role in recruitment sex differences in this study. Investigators concluded that efforts to expand screening of women for trial eligibility is needed to improve rates of enrollment.
 
Smeaton LM, Kacanek D, Mykhalchenko K, Coughlin K, Klingman KL, Koletar SL, Barr E, Collier AC. Screening and Enrollment by Sex in HIV Clinical Trials in the United States. Clin Infect Dis. 2019 Sep 29;. doi: 10.1093/cid/ciz959. [Epub ahead of print] PubMed PMID: 31563942.
ACTG SITE SPOTLIGHT
Johns Hopkins University, School of Medicine
by Nadine Brown, Margaret Abaandou, and Ilene Wiggins

The Johns Hopkins University School of Medicine ACTG site is part of the BWI Clinical Trials Unit, consisting of three main sites: Johns Hopkins University (Baltimore, Maryland), Whitman Walker (Washington D.C), and Byramjee Jeejeebhoy Government Medical College CRS (India).
 
We currently have seven open protocols (A5128, A5380, A5359, A5332, including A5333s and A5361s, A5360) and seven upcoming protocols (A5357, A5368, A5371, A5372, A5375, A5379, A5391). We have been involved in a number of important studies over the years, including the groundbreaking ACTG 076 that set the standard of care for preventing perinatal HIV transmission.
 
We pride ourselves in providing a high standard of research integrity in our studies and in being able to retain participants in clinical trials by forming positive and impactful relationships with them. We also ensure excellent data collection and entry and are proud to consistently receive outstanding scores and feedback during monitoring visits.
 
Our wonderful pharmacy team helps dispense and prepare medication for every ACTG protocol, educates our participants about their medication, and provides a multitude of information to our multidisciplinary research team. Our community advisory board (CAB) serves as a link between our ACTG team and local community, meeting once a month to discuss upcoming protocols. 
 
Members of our multi-disciplinary team (two co-principal investigators, three nurses, three data staff and multiple investigators of record) have been part of the ACTG site for a wide range of time – from one week to 30 years! The dynamic in our office is uplifting and enjoyable as we strive to provide a flexible and positive atmosphere. We enjoy the positive impact we can make on our participants’ well-being, whether that is by encouraging participants to take their study medication, educating them about their chronic illness, or supporting them holistically. Our hope is that our study findings will ultimately contribute to standard-of-care treatments to manage HIV and HCV and improve the lives of our Baltimore, Washington, and India-based communities.

 
 
INVESTIGATOR HIGHLIGHT
Dr. Carlos del Rio and Dr. Carl Fichtenbaum 

Congratulations to Dr. Carlos del Rio for his recent election as the next Foreign Secretary of the National Academy of Medicine! Read more about Dr. del Rio and his new position here.


Dr. Carl Fichtenbaum (pictured on the right) recently sat down for an interview with Sarah Brown (pictured on the left) of the Failing Forward podcast. Failing Forward highlights successful people and how their failures ultimately launched them into success. You can listen to the full episode here to get to know Dr. Fichtenbaum, and learn how HIV/AIDS Research became a part of his life, and why he joined the ACTG.
COMMUNITY MEMBER SPOTLIGHT
Stanford Chimutimunzeve, Zimbabwe

Stanford Chimutimunzeve is passionate about the search for an HIV treatment free from side effects and HIV cure research.

Stanford has served a number of roles in the ACTG since joining in 2005, including serving as a co-chair of the Community Scientific Subcommittee, the community representative to the Inflammation Transformative Science Group, and the community representative on various protocols, including A5263 and A5356. He is also on the CAB for sex workers in Zimbabwe and has been actively involved in community mobilization for research education in his community. 

He notes that Zimbabwe has an HIV prevalence of around 13% among 15-49 year olds.

He describes some of the additional challenges his community faces: “We are experiencing high rates of new infections among young women. We’re also noticing an increase in the rate of STIs among the15-35 age group. Grandparents—especially grandmothers—have the burden of orphan care.”

Stanford says the most important treatment issues facing his community include understanding drug-drug interactions for people aging with HIV, initiating local viral hepatitis trials, addressing complications associated with HIV and long-term ART, paving the way for cure trials in research-limited settings, and ending TB in research-limited settings. 

For Stanford, one of his most important roles is as a mentor. “If I mentor lots of people, then my impact will be multiplied and my work will be remembered.” 
NEWS TO SHARE?

Do you have interesting ACTG-related news to share? Has your site done something exceptional? What’s the latest news about your study? Do you have job postings or any other ACTG-related information? We want to know! Please submit your news to ACTG Leadership & Operations Center Communications Specialist Karen Hoffman.
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actg.communications@fstrf.org


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