The cross-network Bill of Rights and Responsibilities for HIV Research document provides a short list of the rights and responsibilities for participants in a clinical trial. The purpose of this document is to help research participants act on their own behalf and in partnership with study staff. Rights and responsibilities listed in the document are in no particular rank order. This document was developed by the Community Partners Bill of Rights and Responsibilities Working Group for use by sites, at their discretion, along with informed consent forms. Feel free to share this resource with collaborators both within and outside the HIV/AIDS Clinical Trials Networks.
Community Partners developed a Community Engagement Resources document highlighting some of the resources available to support community engagement in HIV research.
This guidance document highlights a number of different practices that can facilitate gender-inclusiveness in study protocol design, data collection, and data reporting across the networks, and provides needed context and direction to support these efforts.
H=H, the podcast that centers on the human in HIV, presents content on the human side of HIV research, education, affirming Black, Indigenous, and other People of Color (BIPOC), and sexual gender minority communities desproprotionally impacted by the HIV.
Episode 5: Transgender Women's Health Research
Episode 4: The Health of Transgender People
Episode 3: A Conversation with Carl Dieffenbach, Director of the Division of AIDS
Episode 2: World AIDS Day
Episode 1: The H is for Human
February 7: National Black HIV/AIDS Awareness Day
2020 statement from the Legacy Project and Women's HIV Research Collaborative
March 20: National Native HIV/AIDS Awareness Day
Understanding a protocol is important for community members interested in engaging in clinical research. One of the challenges for community and CAB members participating in protocol development is learning how to critically review a protocol from a community perspective. This document was designed and updated to help individuals understand the most important components of a protocol and how to critically (and quickly) read a protocol and provides suggestions to help focus on the most critical areas of the protocol to help save time.
The Legacy Project Working Group has produced an information sheet that includes the recent developments on Long-Acting Antiretroviral Injectables (LAIs) in different formats for use in social media outlets or to print.
Long-Acting Antiretroviral Injectables Brochure (horizontal format)
Long-Acting Antiretroviral Injectables Brochure (vertical format)
Long-Acting Antiretroviral Injectables for Treatment (flyer)
Long-Acting Antiretroviral Injectables for Prevention (flyer)
Language can empower, but it can also perpetuate stigma, and as studies continue to bear out, stigma exacerbates the HIV epidemic. While many factors that contribute to stigma are entrenched and systemic, NIAID officials have the immediate power and opportunity to improve language and lead by example. This guide includes language suggestions for communicating about HIV and related topics.
The world of clinical trials research is highly regulated, with an array of documents guiding the conduct of clinical trials research. Policy documents and procedural guidelines, such as Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP), cover most aspects of clinical research but none of these documents discuss standards for engaging community in the research process.
Community representatives working with the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH increasingly felt that this type of guidance was essential and in 2009 sought to develop recommendations as a way to address good community practice. These recommendations were updated in 2014, and again in 2020, to help research staff and community representatives expand and deepen existing partnerships, and forge new ones, with the ultimate goal of facilitating effective community engagement in all aspects of clinical trials research.
Recommendations for Community Engagement in HIV/AIDS Research Version 3.0
Recommendations for Community Engagement in HIV/AIDS Research Version 3.0 Portuguese Translation
Recommendations for Community Engagement in HIV/AIDS Research Version 3.0 Spanish Translation
The RSR is a tool to enhance the representation of study populations in clinical research. It consists of a twelve-item questionnaire that examines individual studies for their representation of study populations in terms of age, ethnicity, gender, injection drug use, pregnancy, race, and sex assigned at birth. The HANC Legacy Project recommends that research teams use the RSR proactively in the development of each study protocol.
As part of the mandate from DAIDS to work with other disease groups, Community Partners (CP) and the TB Community Research Advisors Group (CRAG) are collaborating and working together on a joint TB/HIV project. The Community Research Advisors Group is an international, community-driven advisory body that works to ensure the meaningful representation and engagement of affected communities in research conducted by the U.S. Centers for Disease Control and Prevention's Tuberculosis Trials Consortium. This group of research-literate activists supports a robust, comprehensive and innovative TBTC research agenda that is responsive to community needs as well as scientific priorities.
One goal of the CP/CRAG partnership is to help educate TB community members and researchers about HIV and to help educate HIV community members and researchers about TB and how the two diseases are connected.
Open Letter: Retiring stigmatizing and criminalizing language from the global TB discourse
Activist Guide to Clinical Trial Protocols
TB-HIV Fact Sheet
TB-HIV Infection Control Parameters
USCA 2015 CP/CRAG Collaboration Slides
Project Brief: How to reduce HIV risk among adolescent girls and young women in sub-Saharan Africa? Implementation science around the DREAMS partnership
PHOENix Study Participant Talking Points
PHOENix Study Site Staff Talking Points
CDC- Slide Set — Guidelines for Preventing the Transmission of M. tuberculosis in Health-Care Settings, 2005
Critical Path to New TB Drug Regimens
Good Participatory Practices for TB Drug Trials
Stop TB Partnership
TB Community Research Advisory Group (CRAG)
TB Quick Facts
TB/HIV Activist Toolkit slide set
The Tuberculosis Clinical Diagnostics Research Consortium (CDRC)
WHO- Treatment of tuberculosis: guidelines for national programmes