Transparency and adolescent HIV prevention and care research
Addressing HIV prevention and care research for adolescents and young adults is a critical priority in our national HIV response. Adolescents and young adults are a key population in the epidemic in need of specialized services because of the unique challenges of providing prevention and care in the context of the cognitive, intellectual and emotional development of youth. Within iTech, we are keenly aware not just of the opportunity that we have to develop innovative approaches to serve young people at risk for or living with HIV, but also of our responsibility to do this work with transparency.
Why is transparency important in the work of the iTech?
There are several reasons that transparency is so important to us. First, being open about our work allows for youth and other interested people to provide input regarding the planned studies early in the process, rather than after a study has been conducted and the results presented. Just like with other rigorous research, explaining up front what our studies aim to do and how and when we will decide if our interventions work keeps us accountable to our scientific approach. Further, we have a firm commitment to ensuring that iTech resources (both financial and participant time) are being used to further work that has the possibility of making an impact on the epidemic and the communities we serve with this work. Sharing research materials with other researchers allows our work to be evaluated in detail in an unbiased way, reduces the need for others to develop similar tools (like questionnaires and programmatic materials) from scratch, and increases the chance that different studies can measure outcomes and exposures in similar ways – allowing us to combine results of many studies that used common measures.
How does iTech promote transparency?
iTech fulfills our commitment to transparency in several ways. These include making different levels of information available to anyone who is interested, reaching out to engage young people in our process, using public tools to tell people exactly how we have planned trials, publishing academic papers to provide details about specific studies, publishing study forms and questions, and making full protocols available to researchers or other interested parties, if requested.
- Multiple levels of information available: For many people having a paragraph or two of information about a study will be all the information they need. Our ITech web website includes short summaries of each protocol, introduces the people on the study team and provides information about where the study will be conducted. You can find the short summaries on the iTech website located here.
- Reaching out to young people: We have developed several mechanisms to involve young people who are interested in HIV prevention in our process of planning and conducting protocols. Each of the ITech sites has as active Youth Advisory Board (YAB) that learns about the protocols and helps us think about how to implement them most effectively. In addition, a Youth Advisory Council (YAC) made up of members from each of the YABs meets monthly via videoconferencing to discuss the overall research agenda of iTech and how to ensure the voices of youth are being considered in all aspects of iTech execution.
- Using public tools to describe our planned trials: Before we start enrolling research subjects in any protocol, each study is required to be registered on ClinicalTrials.gov. This submission includes specific details about participant eligibility criteria, the intervention and how we plan to test and evaluate it. This ensures that we have thought through and been open about our research plans before we start enrolling participants. It also creates a record of how we plan to evaluate whether or not our intervention’s work, and for whom. It also allows researchers who may be considering similar interventions to know exactly how we plan to conduct our trial, and reach out to us and ask about our experiences, even before we have published the results. Once results from the studies are available, they will also be posted on ClinicalTrials.gov.
- Publishing academic papers: For those who want more detail (than available on the iTech website or on ClinicalTrials.gov) about exactly how each of the trials is planned to be conducted, we will also publish a full length academic paper describing the protocol and its components in detail. Further, we are committed to publishing these papers in a journal which makes free and open access available to all interested parties, even those who may not have academic subscriptions to allow viewing journal materials. The publication times for journals vary, but in general, we will make every effort to have academic publications reviewed and accepted before we start the main efficacy aim of the interventions. In many cases, it may also be possible for us to provide pre-publication versions of manuscripts which are accepted but not yet published, if researchers have a specific interest in seeing that manuscript before its final publication. After trials are complete, we will use multiple methods to make the results of studies available to both the research community and the public at large. This includes, presentations at academic conferences and community forums, and the publication of papers describing the results of the studies in peer-reviewed journals. We will make links available from the iTech website to all public presentations and manuscripts.
- Publishing study forms and questions: The forms and questionnaires used in iTech studies can not only be helpful to other researchers working with similar populations or on similar topics but they also help illustrate exactly how we are collecting main study exposures and determining outcomes. To that end, we will take steps to make our study data collection materials available. One way to accomplish that is to provide study materials as online appendices to the publication of research protocols. In this way, those materials will be available through the same website where the protocol is published, and will be freely downloadable to researchers. In other cases, researchers might have specific interest in materials that are not posted online. In that case, we encourage interested parties to contact the iTech through the Get In Touch form to request specific materials that might help support their own research, or their understanding of ours.
- Making protocols available on request: In some cases, it may be important for researchers or other interested parties to see the full protocols for our studies. These are typically documents that are more technical in nature, and are developed specifically for operational implementation and for review by human subjects’ bodies which work to ensure that studies are protecting the interests of research participants. Because of the more technical nature of these documents, if a researcher or other interested party is interested in seeing more detail, we encourage them to contact the iTech through the Get In Touch form to discuss what their specific needs are, and to determine in consultation with a iTech staff member how we can best provide information and materials to support their needs.
We recognize that our research programs represent a substantial investment of public funds. We take seriously our obligations to both conduct high quality research, and to do so in a way that is transparent to all interested parties. If you have questions about our protocols or need additional information about any of the studies that we are conducting, the easiest way to learn more is to first read the study descriptions on the iTech website. If you want more information, please reach out to us and we can start a discussion about your interest, and how we can best provide materials that allows you to better understand the work iTech is doing in our portfolio of research projects to support HIV prevention and care for adolescents and young adults.
-Lisa and Patrick (iTech PIs)