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This presentation was delivered as part of a symposium at the 2024 CPDD conference entitled, “Two-Eyed Seeing for Opioid Use Disorder Treatment and Recovery with American Indian and Alaska Native Communities,” moderated by Aimee Campbell and Carmen Rosa. In this section of the symposium, Dr. Patten discussed the development and testing of a novel, moderated, private Facebook group intervention to support AI/AN women in opioid use disorder recovery. The intervention was developed through feedback from key partners and beta tested and refined with AI/AN women in recovery.
Related protocols: CTN-0123
This is the primary outcomes article for Aim 1 of CTN-0123.
The ongoing opioid misuse epidemic has had a marked impact on American Indian/Alaska Native (AI/AN) communities. Culture- and gender-specific barriers to medically assisted recovery from opioid use disorder (OUD) have been identified, exacerbating its impact for AI/AN women. Wiidookaage’win is a community-based participatory research study that aims to develop a culturally tailored, moderated, private Facebook group intervention to support Minnesotan AI/AN women in medically assisted recovery from OUD. The current study, NIDA Clinical Trials Network study CTN-0123, assessed the preliminary feasibility and acceptability of the intervention in a beta-test to inform refinements before conducting a pilot randomized controlled trial (RCT).
The intervention was beta-tested for 30 days. Moderators were trained prior to delivering the intervention. Study assessments were conducted at baseline and post-intervention. The post-intervention assessments included substance use (self-report and urine drug screen), treatment acceptability, mental health, and spirituality outcomes. We examined intervention engagement patterns using Facebook metrics and qualitatively explored common topics that emerged in participant posts and comments.
Ten AI/AN women taking medication for OUD (MOUD) were recruited (age range 25–62 years). Participants had been in opioid recovery a mean of 15.2 months (SD = 16.1; range = 3–60). The study participation rate (accrued/eligible) was 91%. Nine participants completed the post-intervention survey assessment and eight completed a UDS. Acceptability was high based on the mean treatment satisfaction score (M = 4.8, SD = 0.2 out of a possible 5.0), Facebook group engagement, and positive qualitative feedback. All participants retained at post-intervention continued their MOUD treatment, and none had returned to opioid use.
Conclusions: The beta-test indicated that the Facebook platform and study procedures generally worked as intended and that the intervention was largely acceptable to study participants. The results of this study phase provided valuable insights to inform refinements prior to conducting a pilot RCT to further assess the feasibility, acceptability, and potential efficacy of the intervention.
Related protocols: CTN-0123
The purpose of this study, NIDA Clinical Trials Network protocol CTN-0123 was to develop a culturally-tailored American Indian/Alaska Native (AI/AN) women’s Facebook group supporting opioid recovery as an adjunct to medication. Participants were AI/AN women in Minnesota in opioid recovery, interested parties, and a Community Advisory Committee (CAC) of AI/AN women with lived experience, health care providers, and community members.
For the intervention, the study team developed evidence-based content focusing on stress/trauma and substance use, mindfulness, responding to triggers, and supportive community resources. Additional content centered on AI/AN culture was also selected.
Interviews were conducted by two women, then transcribed and coded using content analysis with NVivo software. Results were presented to CAC for further content refinement.
CAC members (n = 10) guided study methods, intervention development, and dissemination activities. 14 AI/AN women (mean age 36.4 years; mean 6.7 months opioid abstinence) and 12 interested parties (7 men, 5 women) were receptive to an AI/AN gender-specific Facebook group, preferring content with AI/AN people and/or text resonating with AI/AN culture (e.g., Native traditions, family, personal stories, historical trauma). Recommendations included (1) protect confidentiality, (2) retain positivity, (3) incorporate resources and exercises to build coping skills, and (4) moderators should be authentic and relatable to build trust.
Conclusions: This approach provides a model for developing culturally tailored, appealing and effective social media interventions to support AI/AN women in recovery from opioid use disorder.
Related protocols: CTN-0123
This is the Results Article for CTN-0084-A-2.
Multiple digital data sources can capture moment-to-moment information to advance a robust understanding of opioid use disorder (OUD) behavior, ultimately creating a digital phenotype for each patient. This information can lead to individualized interventions to improve treatment for OUD.
This aim of this study, CTN-0084-A-2, was to examine patient engagement with multiple digital phenotyping methods among patients receiving buprenorphine medication for OUD.
The study enrolled 65 patients receiving buprenorphine for OUD between June 2020 and January 2021 from 4 addiction medicine programs in an integrated health care delivery system in Northern California. Ecological momentary assessment (EMA), sensor data, and social media data were collected by smartphone, smartwatch, and social media platforms over a 12-week period. Primary engagement outcomes were meeting measures of minimum phone carry (=8 hours per day) and watch wear (=18 hours per day) criteria, EMA response rates, social media consent rate, and data sparsity. Descriptive analyses, bivariate, and trend tests were performed.
The participants’ average age was 37 years, 47% of them were female, and 71% of them were White. On average, participants met phone carrying criteria on 94% of study days, met watch wearing criteria on 74% of days, and wore the watch to sleep on 77% of days. The mean EMA response rate was 70%, declining from 83% to 56% from week 1 to week 12. Among participants with social media accounts, 88% of them consented to providing data; of them, 55% of Facebook, 54% of Instagram, and 57% of Twitter participants provided data. The amount of social media data available varied widely across participants. No differences by age, sex, race, or ethnicity were observed for any outcomes.
Conclusions: To our knowledge, this is the first study to capture these 3 digital data sources in this clinical population. Our findings demonstrate that patients receiving buprenorphine treatment for OUD had generally high engagement with multiple digital phenotyping data sources, but this was more limited for the social media data.
Related protocols: CTN-0084-A-2
This one-page research brief provides an overview and a summary of findings from CTN-0083, which compared the effectiveness of 3 web-based platforms (social media sites, dating apps, information sites) for promoting HIV self-testing among Latinx/Black/African American men who have sex with men (MSM).
Related protocols: CTN-0083
This is the primary outcomes article for CTN-0083.
Social media sites, dating apps, and information search sites have been used to reach individuals at high risk for HIV infection. However, it is not clear which platform is the most efficient in promoting home HIV self-testing, given that the users of various platforms may have different characteristics that impact their readiness for HIV testing.
This study, CTN-0083, “Using Social Media to Deliver HIV Self-Testing Kits and Link to Online PrEP Services,” aimed to compare the relative effectiveness of social media sites, dating apps, and information search sites in promoting HIV self-testing among minority men who have sex with men (MSM) at an increased risk of HIV infection. Test kit order rates were used as a proxy to evaluate promotion effectiveness. In addition, researchers assessed differences in characteristics between participants who ordered and did not order an HIV test kit.
Culturally appropriate advertisements were placed on popular sites of three different platforms: social media sites (Facebook, Instagram), dating apps (Grindr, Jack’D), and information search sites (Google, Bing). Advertisements targeted young (18-30 years old) and minority (Black or Latinx) MSM at risk of HIV exposure. Recruitment occurred in 2 waves, with each wave running advertisements on 1 platform of each type over the same period. Participants completed a baseline survey assessing sexual or injection use behavior, substance use including alcohol, psychological readiness to test, attitudes toward HIV testing and treatment, and HIV-related stigma. Participants received an electronic code to order a free home-based HIV self-test kit. Follow-up assessments were conducted to assess HIV self-test kit use and uptake of pre-exposure prophylaxis (PrEP) at 14 and 60 days post enrollment.
In total, 271 participants were enrolled, and 254 were included in the final analysis. Among these 254 participants, 177 (69.7%) ordered a home HIV self-test kit. Most of the self-test kits were ordered by participants enrolled from dating apps. Due to waves with low enrollment, between wave statistical comparisons were not feasible. Within wave comparison revealed that Jack’D showed higher order rates (3.29 kits/day) compared to Instagram (0.34 kits/day) and Bing (0 kits/day). There were no associations among self-test kit ordering and HIV-related stigma, perceptions about HIV testing and treatment, and mistrust of medical organizations.
Conclusions: These findings show that using popular dating apps might be an efficient way to promote HIV self-testing. Stigma, perceptions about HIV testing and treatment, or mistrust of medical organizations may not affect order rates of HIV test kits promoted on the internet.
Related protocols: CTN-0083
Across the U.S., the prevalence of opioid use disorder (OUD) and the rates of opioid overdoses have risen precipitously in recent years. Several effective medications for OUD (MOUD) exist and have been shown to be life-saving. A large volume of research has identified a confluence of factors that predict attrition and continued substance use during substance use disorder treatment. However, much of this literature has examined a small set of potential moderators or mediators of outcomes in MOUD treatment and may lead to over-simplified accounts of treatment non-adherence. Digital health methodologies offer great promise for capturing intensive, longitudinal ecologically-valid data from individuals in MOUD treatment to extend our understanding of factors that impact treatment engagement and outcomes.
This paper describes the protocol (including the study design and methodological considerations) from a novel study supported by the National Drug Abuse Treatment Clinical Trials Network at the National Institute on Drug Abuse (NIDA). This study (D-TECT, CTN-0084-A-2) primarily seeks to evaluate the feasibility of collecting ecological momentary assessment (EMA), smartphone and smartwatch sensor data, and social media data among patients in outpatient MOUD treatment. It secondarily seeks to examine the utility of EMA, digital sensing, and social media data (separately and compared to one another) in predicting MOUD treatment retention, opioid use events, and medication adherence [as captured in electronic health records (EHR) and EMA data]. To our knowledge, this is the first project to include all three sources of digitally derived data (EMA, digital sensing, and social media) in understanding the clinical trajectories of patients in MOUD treatment. These multiple data streams will allow us to understand the relative and combined utility of collecting digital data from these diverse data sources. The inclusion of EHR data allows us to focus on the utility of digital health data in predicting objectively measured clinical outcomes.
Discussion: Results may be useful in elucidating novel relations between digital data sources and OUD treatment outcomes. It may also inform approaches to enhancing outcomes measurement in clinical trials by allowing for the assessment of dynamic interactions between individuals’ daily lives and their MOUD treatment response.
Related protocols: CTN-0084-A-2
Presented by: Jacob Borodovsky, PhD, Research Scientist, Center for Technology and Behavioral Health, Biomedical Data Science, Dartmouth Geisel School of Medicine
Dr. Borodovsky presented:
- Recently published analyses which have identified national declines in adolescent “socializing without supervision” as a possible causal mechanism to explain national declines in adolescent substance use;
- A current working theory of causal links between adolescent use of technology subtypes (e.g., videogames, social media) and national trends in adolescent socializing, substance use, and mental health;
- Future plans to use data from the Adolescent Brain Cognitive Development Study to test hypothesized effects of digital technologies and identify environmental conditions that meaningfully alter the probability and severity of adolescent substance use and mental health.
The majority of those living with HIV are men who have sex with men (MSM), and young, minority MSM account for more new HIV infections than any other group. HIV transmission can be reduced through detection and early treatment initiation, or starting pre-exposure prophylaxis (PrEP), but rates of testing are lower than recommended among MSM and PrEP uptake has been slow. Although promoting HIV testing and PrEP uptake by placing advertisements on web-based platforms — such as social media websites and dating apps — is a promising approach for promoting HIV testing and PrEP, the relative effectiveness of HIV prevention advertising on common web-based platforms is underexamined.
This study, protocol CTN-0083, Social Media to Deliver HIV Self-Testing Kits and Link to Online PrEP Services, aims to evaluate the relative effectiveness of advertisements place on three types of web-based platforms (social media websites, dating apps, and informational websites) for promoting HIV self-testing and PrEP uptake.
Advertisements will be placed on social media websites (Facebook, Instagram, and Twitter), dating apps (Grindr, Jack’d, Hornet), and informational search websites (Google, Yahoo, Bing) to recruit approximately 400 young (18-30 years), minority (Black/Latino) MSM at elevated risk of HIV exposure. Recruitment will occur in three waves, with each wave running advertisements on one website from each platform. The number of participants per platform is not pre-specified, and recruitment in each wave will occur until approximately 133 HIV self-tests are ordered. Participants will complete a baseline survey assessing risk behavior, substance use, psychological readiness to test, and attitudes and then receive an electronic code to order a free home-based HIV self-test kit. Two follow-ups are planned to assess HIV self-test result and PrEP uptake.
Recruitment is in progress and is anticipated to be completed by Fall 2020.
Conclusions: Findings may improve our understanding of how the platform users’ receptivity to test for HIV differs across web-based platforms and thus may assist in facilitating web-based HIV prevention campaigns.
Related protocols: CTN-0083
The application of digital technologies to better assess, understand, and treat substance use disorders (SUDs) is a particularly promising and vibrant area of scientific research. The National Drug Abuse Treatment Clinical Trials Network (CTN), launched in 1999 by the U.S. National Institute on Drug Abuse, has supported a growing line of research that leverages digital technologies to glean new insights into SUDs and provide science-based therapeutic tools to a diverse array of persons with SUDs.
This article provides an overview of the breadth and impact of research conducted in the realm of digital health within the CTN. This work has included the CTN’s efforts to systematically embed digital screeners for SUDs into general medical settings to impact care models across the nation. This work has also included a pivotal multi-site clinical trial conducted on the CTN platform, whose data led to the very first “prescription digital therapeutic” authorized by the U.S. Food and Drug Administration (FDA) for the treatment of SUDs. Further CTN research includes the study of telehealth to increase capacity for science-based SUD treatment in rural and under-resourced communities. In addition, the CTN has supported an assessment of the feasibility of detecting cocaine-taking behavior via smartwatch sensing. And, the CTN has supported the conduct of clinical trials entirely online (including the recruitment of national and hard-to-reach/under-served participant samples online, with remote intervention delivery and data collection). Further, the CTN is supporting innovative work focused on the use of digital health technologies and data analytics to identify digital biomarkers and understand the clinical trajectories of individuals receiving medications for opioid use disorder (OUD).
This paper concludes by outlining the many potential future opportunities to leverage the unique national CTN research network to scale-up the science on digital health to examine optimal strategies to increase the reach of science-based SUD service delivery models both within and outside of healthcare.
Related protocols: CTN-0044, CTN-0059, CTN-0073-Ot, CTN-0076, CTN-0083, CTN-0084-A-2, CTN-0090, CTN-0095, CTN-0101, CTN-0102
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
The growing use of newer communication and internet technologies, even among low income and transient populations, require research staff to update their outreach strategies to ensure high follow-up and participant retention rates. This paper presents the views of research assistants on the use of cell phones and the internet to track participants in a multi-site randomized trial of substance use disorder treatment. Pre-interview questionnaires exploring tracking and other study-related activities were collected from 21 research staff across the 10 sites participating in the National Drug Abuse Treatment Clinical Trials Network study CTN-0044, about an online intervention for substance use disorders (Therapeutic Education System). Data were then used to construct a semi-structured interview guide which, in turn, was used to interview 12 of the same staff members. The questionnaires and interview data were entered in Atlas.ti and analyzed for emergent themes related to the use of technology for participant tracking purposes.
Study staff reported that most participants had cell phones, despite having unstable physical addresses and landlines. The incoming call feature of most cell phones was useful for participants and research staff alike, and texting proved to have additional benefits. However, reliance on participants’ cell phones also proved problematic at times. Even homeless participants were found to have access to the internet through public libraries and could respond to study staff e-mails. Some study sites opened generic social media accounts, through which study staff sent private messages to participants. However, the Institutional Review Board (IRB) approval process for tracking participants using social media at some sites was prohibitively lengthy. Internet searches through Google, national paid databases, obituaries, and judiciary websites were also helpful tool.
Conclusions: Research staff perceive that cell phones, internet searches, and social networking sites were effective tools to achieve high follow-up rates in drug abuse research and should be used in addition to established study procedures. Studies should incorporate cell phone, texting, and social network website information on locator forms; obtain IRB approval for contacting participants using social networking websites; and include web searches, texting, and the use of social media in staff training as standard operating procedures.
Related protocols: CTN-0044
The use of social media has grown exponentially over the past decade. Social media is a potential mechanism to disseminate science-based information with the ability to reach patients, organizations, cities, states, and federal entities simultaneously. The Ohio Valley Node (OVN) of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) began using Facebook and Twitter in the fall of 2011 to disseminate science-based information regarding substance use disorders (SUD). Data from calendar year 2012 was captured and metrics were developed to evaluate the utility of using social media as a dissemination tool. Information was posted to Facebook 73% of days with a mean number of 1.4 posts per day (SD=1.6, range=0-11) and to Twitter 75% of days with a mean number of 1.2 posts per day (SD=1.5, range=0-12). For Facebook posts, the total mean reach of Facebook posts was 32 people (SD=11, range=0-85) and the mean total impressions was 118 people (SD=39, range=5-293). By the end of 2012, 95 people or pages liked the OVN Facebook page and the OVN liked 341 Facebook pages. By the end of 2012, the OVN twitter account had 504 followers and the OVN was following 1,063 Twitter accounts. Additional data will be presented describing target audience reach (persons or organizations interested in SUD) and content of posts, as well as social networking metrics. In summary, social media is a low-cost tool to disseminate information and additional research is needed to measure the impact of this form of dissemination.
In 2012, the CTN Web Seminar Series introduced research staff to the use of social media in trials and the tools available in the market. Building on that training, this 60-minute webinar, produced by the National Drug Abuse Treatment Clinical Trials Network (CTN) Clinical Coordinating Center for CTN members and the public, focuses on applying that knowledge and incorporating guidelines for use in clinical trials.
Objectives for this webinar include:
- Understanding organizational and IRB guidelines regarding the use of social media in the conduct of research.
- Learning how to use social media tools to recruit, engage, and follow-up with research participants.
- Reviewing what elements to consider when drafting a social media strategy for your research project.
- The target audience is research staff interested in using social media in the conduct of clinical trials.
Presented by Erin L. Winstanley, PhD (University of Cincinnati, OV Node) and Gloria M. Miele, PhD (Columbia University, GNY Node)
Additional Resources:
This workshop, led by Carmen Rosa of NIDA’s Center for the Clinical Trials Network, featured three presentations focused on the use of various types of new media in the design and conduct of clinical trials. Over 82% of adults now use internet or email, including 53% of those age 65 and older. Additionally, 67% of online adults use social networking sites. Mobile devices such as smartphones, tablets, netbooks, and laptops are now a primary source of Internet connectivity, and 79% of cell phone owners say they use text messaging. As use of these tools continues to grow, exploring ways to put them to use in clinical trials seems increasingly relevant.
The first presentation, by Erin Winstanley, “Using New Media Tools in the Design and Conduct of Clinical Trials,” provided an overview of the concept of “new media” and ways it can be applied to research, including advertising of studies, recruiting/tracking participants, communicating with participants, and disseminating research findings. An introduction to Facebook and Twitter is provided, as well as a look at the use of blogs, Pinterest, and LinkedIn.
Gloria Miele presented on “Social Media Communication Strategy,” giving participants a look at ways to think about and draft policies regarding the use of social media in your study or workplace. A variety of legal considerations, as well as examples of using social media to recruit study participants is also provided. Sample IRB guidance is included, along with IRB Best Practices for using new media. The presentation ends with a case study based on CTN-0044 (“Web Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders”), which used social media platforms like Facebook, as well as email and texting, to contact and follow-up with participants.
The third presentation, by Lynn Simpson, was a demonstration of the variety of uses for “REDCap, Research Electronic Data Capture, A Data Management and Survey Tool.” REDCap is a web-based application designed to give researchers and clinicians the capacity to create and manage databases and surveys in order to support data capture for research.
Related protocols: CTN-0044