Community Resource Initiative has been at the forefront of HIV/AIDS clinical research since the beginning.
Led by Research Director Dr. Amy Colson, our dedicated research team runs clinical trials that play a crucial role in the discovery of safer, simpler, and more effective treatments for HIV and other infectious diseases.
Since 1989, Community Resource Initiative (formerly AccessHealth MA) has participated in pivotal clinical trials and designed numerous studies that have led to the FDA approval of almost all of the HIV/AIDS treatment medication available today- changing countless lives for the better. Learn more about our history here
None of this is possible without our research participants.
Our trials enable research participants to be more active in their own healthcare, to gain access to new treatments before they become widely available, and to help others by contributing to ground-breaking medical knowledge. Learn more about how to participate in a trial at Community Resource Initiative.
Ongoing and Recent Clinical Trials
DEFINE
Closed
The DEFINE clinical research study measures changes in weight and body composition after switching HIV treatment to a single tablet regimen, Symtuza, which is FDA approved for adults living with HIV-1.
Define Clinical Trial
Islatravir in Combination with Lenacapavir
Ongoing (no longer enrolling)
Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV.
A Phase 2 Randomized, Open-Label, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV.
Islatravir In Combination with Doravirine
Ongoing (no longer enrolling)
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir. Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Biktarvy.
Learn more about this trialLong-acting medications for HIV represent the next frontier for optimizing treatment
Community Resource Initiative was proud to be the only site in New England selected to participate in the ATLAS trials to test the recently FDA-approved treatment of Cabenuva. Cabenuva is now approved for administration for either every four or eight weeks.
Clinical Trials Frequently Asked Questions
Clinical trial is the scientific term for a test or study of a drug or medical device in order to see if it is safe and effective for people to use.
Clinical research trials are the most effective way to determine which treatment strategies work best to help people live more productive, comfortable, and healthy lives. Clinical research trials also offer participants the opportunity to gain access to new treatments before they would otherwise be available.
People participate in clinical trials for many different reasons. Some of those reasons include wanting to:
- gain access to new drugs or treatments that may not be available yet
- improve the science and help researchers better understand how to treat diseases
- work closely with a team of medical professionals who will closely monitor their health during the study and communicate regularly with their primary care provider
The major goal of a clinical research trial is to study a drug or treatment in order to understand how it will affect the population of people who will be taking the drug(s) should it become approved. Because treatments may work differently in different groups of people, it is important to ensure the study population mirrors the diverse range of people who will eventually be taking the new drug. This is one of the reasons Community Resource Initiative seeks to ensure diverse clinical trial enrollment.
Learn more about our enrolling clinical trials
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At Community Resource Initiative, the health of participants in clinical trials is closely tracked by expert physicians and study coordinators.
There are many safeguards in place to protect the rights and safety of those who volunteer for a clinical trial. These protections include:
- The informed consent process. Potential participants review and sign a document that describes all the possible risks and benefits involved in the study (see additional information below).
- The IRB. Every step of the research process is carefully reviewed and approved by an independent ethics board (known as the Institutional Review Board, or IRB) charged with protecting human participants.
- Data Safety Monitoring Boards. Experts on the Data Safety Monitoring Board review study data as it is produced. If the data indicates a strong risk — or conversely a strong advantage — of a particular treatment they respond as necessary. For example, if the committee sees a treatment is harmful, they will stop the study immediately.
- FDA inspections. The FDA, the federal agency in charge of clinical research, will inspect records and research sites periodically to make sure volunteers are protected and studies are being conducted properly.
Before participating in a clinical trial, a member of the research team will carefully explain every aspect of the trial, including its purpose, duration, requirements, risks, and benefits. Following this explanation, you will be asked if you have any questions and given an informed consent document to sign. It is important that you understand and are comfortable with all the information in the informed consent document. You should feel free to ask as many questions as you want before signing. This document is not a contract; even after you sign, you are free to withdraw from the study at any time without facing penalties.
Dr. Amy E. Colson leads a compassionate, dedicated research team at Community Resource Initiative with decades of experience on HIV/AIDS and other infectious diseases.
Community Resource Initiative is an independent, community-based research organization. Our research is conducted at our office in Boston.
Community Resource Initiative conducts a wide variety of clinical trials which focus on the treatment of HIV and other infectious diseases. For a complete listing of our current trials, click here.
- Pharmaceutical companies pay a portion of the costs of running some of our clinical research trials.
- Community Resource Initiative also designs and conducts its own clinical trials (called investigator-initiated or physician-led trials) for which the organization raises its own funds from foundations and private donors.
- In addition, Community Resource Initiative participates in studies funded by government organizations, such as the National Institutes of Health (NIH). Study sponsors are always listed in the clinical trial Web summary.
Learn more about how you can help support Community Resource Initiative’s life-saving research here
Research studies designed and led by the Community Resource Initiative research team are often meant to answer questions relevant to the health of our particular clients.
Clinicaltrials.gov: http://clinicaltrials.gov/ct2/info/understand
The Body: http://www.thebody.com/index/treat/clintri.html
The team at Community Resource Initiative is committed to making sure that everyone in the community knows about and can get the life-saving medications that give us all hope.
Clinical research conducted at Community Resource Initiative has given me a new lease on life, and I’m not alone. I have been living with HIV for 18 years and was co-infected with hepatitis C too. CRI’s outreach and education programs provided me with critical information and access to better, safer treatments that allow me to enjoy a healthier life.
Jose, CRI Community Advisory Board Member
Meet the Research Team
Roberta Bauer
Regulatory Specialist, Data Manager
Karen A. McLaughlin, CCRC
Research Senior Manager
David Huckle
BRIDGE Team Health Insurance Enrollment Specialist and Research Associate