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Abstract: This web seminar series had three components: Introduction to Retention in the NDAT CTN. Presented by Dikla Blumberg, PhD (NDAT CTN Clinical Coordinating Center): Recruitment and retention are vital aspects of clinical research trials and can factor into the success of a study. Therefore, it is important that researchers understand and identify barriers to meeting recruitment and retention targets and the consequences experienced with poor retention. Additionally, it is helpful to examine historical data available on study retention trends to inform implementation efforts on future studies. Accordingly, this presentation briefly addresses these areas by providing an overview on the topic of study retention, retention within the context of the CTN, and discusses the importance of incorporating strategies and tools for study success. Download slides (pdf)

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The “CHEERS” Principle of Participant Retention: More Than Just Techniques. Presented by Frankie Kropp, MS (OV Node) and Mitra Lewis, MS (NDAT CTN CCC): Good participant retention involves more than just specific techniques; retention depends on the study staff’s overall philosophy of managing and accommodating study participants. One helpful way to think about participant retention is to insert the “CHEERS” principle into study retention efforts– Customer service, Help overcome barriers, Environment, Excellence, Relationship/Respect, and Search. This 20-minute webinar will provide an overview of the CHEERS principle, including specific examples of what sites can do to maximize participant retention. Download slides (pdf)

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Utilizing a Robust and Comprehensive Locator Form as a Retention Tool. Presented by Phoebe Gauthier, MA, MPH (NE Node) and Dagmar Salazar, MS (NDAT CTN CCC). Participant recruitment and retention are critical aspects of conducting quality clinical research projects. The National Drug Abuse Treatment Clinical Trials Network (NDAT CTN), which evaluates behavioral, pharmacological, and integrated treatment interventions for substance use disorders, routinely enrolls participants who may be challenging to locate during the treatment and follow-up phase of a trial. This 20-minute presentation will review one tool for increasing retention—an adapted locator form. This locator form is designed to better facilitate locating participants, especially those with unstable living conditions or with limited contact information. Additionally, this presentation will discuss the form elements beyond conventional locator forms and methods for collecting the information to help increase participant retention. Download slides (pdf)  

Abstract:

In the United States, approximately one-third of HIV-infected persons either delay seeking care or do not seek care until their disease has progressed to require acute treatment. These patients may cycle through emergency rooms and hospital inpatient wards. The majority of these individuals are from communities of color that have traditionally been medically underserved; many of them are also either active or former substance users. Beginning in 2012, NIDA Clinical Trials Network’s Project HOPE, a multi-site randomized clinical trial designed to evaluate three strategies for linking and retaining HIV-infected substance users, recruited 801 participants from 11 hospital settings across the U.S. This poster describes the study rationale and inclusion criteria for Project HOPE, as well as the baseline drug use and demographic characteristics for the project, which describe a marginalized population with multiple social and environmental problems.

Related protocols: CTN-0049

Abstract:

Clinical trials have been slow to incorporate e-technology (digital and electronic technology that utilizes mobile devices of the Internet) into the design and execution of studies. In the meantime, individuals and corporations/organizations are relying more on electronic platforms and most have incorporating such technology into their daily lives. This paper, written by five members of the NIDA Clinical Trials Network, provides a general overview of the use of e-technologies in clinical trials research, specifically within the last decade, marked by rapid growth of mobile and Internet-based tools. Benefits of and challenges to the use of e-technologies in data collection, recruitment and retention, delivery of interventions, and dissemination are provided, as well as a description of the current status of regulatory oversight of e-technologies in clinical trials research. As an example of ways in which e-technologies can be used for intervention delivery, a summary of e-technologies for the treatment of substance use disorders is presented, including the Therapeutic Education System studied in protocol CTN-0044 of the NIDA Clinical Trials Network, making trials more efficient while also reducing costs. However, researchers should be cautious when adopting these tools given the many challenges in uses new technologies, as well as threats to participant privacy/confidentiality.

Conclusions: Challenges of using e-technologies in each stage of a clinical trial can be overcome with careful planning, useful partnerships, and forethought. The role of web- and smartphone-based applications is expanding, and the increasing use of those platforms by scientists and the public alike make them tools that cannot be ignored.

Related protocols: CTN-0044

Abstract:

The first ten years of the National Institute on Drug Abuse’s Clinical Trials Network (CTN) yielded a wealth of data on the effectiveness of a number of behavioral, pharmacologic, and combined approaches in community based settings. This article summarizes some of the methodological contributions and lessons learned from the behavioral trials conducted during its first ten years, including the capacity and enormous potential of this national research infrastructure. The CTN made contributions to the methodology of effectiveness research; new insights from secondary analyses; the extent to which approaches with strong evidence bases, such as contingency management, extend their effectiveness to real world clinical settings; new data on “standard treatment” as actually practiced in community programs; the extent to which retention remains a major issue in the field; important data on the safety of specific behavioral therapies for addiction; and heightened the importance of continued sustained attention to bridging the gap between treatment and research.

Conclusions: Areas of focus for the CTN’s future include defining common outcome measures to be used in treatment outcome studies for illicit drugs; incorporating performance indicators and measures of clinical significance; conducting comparative outcome studies; contributing to the understanding of effective treatments of comorbidity; reaching underserved populations; building implementation science; understanding long-term outcomes of current treatments and sustaining treatment effects; and conducting future trials more efficiently.