Decentralized clinical trials (DCTs) are often hindered by challenges in remotely capturing biomarkers. To address this gap, we developed MyTrials, a mobile application integrated with REDCap, designed to facilitate the remote capture of biomarkers via Bluetooth-enabled remote patient monitoring (RPM) devices. The purpose of the present study was to evaluate the feasibility and acceptability of MyTrials among participants within a DCT design.

In this four-arm randomized trial, 47 participants were allocated to receive zero, one, two, or three RPM devices. Participants were asked to use their devices once per week for a total of four weeks to remotely provide biomarkers via MyTrials. Feasibility was assessed using objective metrics of successful biomarker submission (i.e., valid device data accompanied by a video confirming participant identity) alongside the participant-reported Feasibility of Intervention Measure (FIM). Acceptability was evaluated via the Acceptability of Intervention Measure (AIM) and the System Usability Scale (SUS).

Among participants assigned at least one device, the successful biomarker submission rate was 74% across all study weeks. FIM and AIM scores exceeded prespecified feasibility benchmarks across all conditions except the zero-device condition. SUS scores consistently indicated high usability across all conditions (range: 77.29–94.29).

The MyTrials platform is a feasible and acceptable solution for remote biomarker capture in DCTs. These findings support the potential of MyTrials to advance remote data collection in clinical research.

IMARA-South Africa (SA) is an HIV/STI prevention program for adolescent girls and young women (AGYW) and their female caregivers (FC). We examined six implementation outcomes of IMARA-SA (acceptability, appropriateness, feasibility, reach, adoption, and sustainability) from the perspectives of study staff, investigators, and collaborators.

We used a sequential explanatory mixed-methods design. We administered surveys, hosted three focus group discussions with study staff/facilitators (n = 5), clinic staff (n = 3), and community advisory board members (n = 5), and conducted seven key informant interviews with investigators and study staff. We used descriptive statistics and rapid qualitative analyses, merging quantitative and qualitative data by implementation outcome to achieve triangulation.

On 27 surveys analyzed, mean scores were highest for acceptability (2.8/3, SD = 0.6), appropriateness (2.7/3, SD = 0.5), and reach (2.7/3, SD = 0.5), followed by feasibility (2.1/3, SD = 0.5), adoption (3.8/5, SD = 0.3), and sustainability (5.9/7, SD = 0.8). All perceived the AGYW and FC to love the program, which fit well with South African culture and addressed AGYW’s needs. The delivery site was deemed highly appropriate for reaching vulnerable populations. The lowest scoring items concerned time constraints (2.2/3, SD = 0.9), safety concerns (1.4/3, SD = 0.7), complexity (2.9/5, SD = 1.3), and cost (2.8/5, SD = 0.9). Qualitative participants attributed complexity and cost challenges to the research procedures, not the intervention. Participants proposed potential avenues for future implementation (e.g., schools, clinics) and interest in engaging males.

IMARA-SA is implementable. Findings reveal challenges with navigating trade-offs between implementation outcomes and surveys distinguishing between intervention and research activities. Findings can inform future delivery of IMARA-SA and similar programs regionally.

The conduct of Clinical and Translational Research (CTR) requires the engagement of highly effective collaborative teams. Clinical and Translational Science Award hubs have employed team-building strategies to improve team processes and interpersonal relationships in CTR teams. As previously reported, the University of Wisconsin Institute for Clinical and Translational Research (UW-ICTR) team science core operationalized and implemented one such strategy: Collaboration Planning. Here, we report on optimization of that intervention and assessment of three outcomes: (1) Changes in clarity and confidence around team processes; (2) Value and usefulness; and (3) Plans for future behavior change.

Collaboration Planning 2.0 improves upon our initial implementation by (1) optimizing the worksheet for flow, accessibility, and deeper discussion; (2) expanding the evaluation process; and (3) creating a facilitator training to support broad dissemination. We tested this iteration in 11 UW-ICTR pilot teams using pre- and post-session self-assessment surveys.

Data indicated an increase in participants’ clarity and confidence around all measured team processes except authorship. Ninety-one percent of participants found the intervention both valuable and useful. Participants indicated plans for future behavior change, including increased attention to team processes. To date, more than 400 individuals have completed the Collaboration Planning Facilitator Training, indicating a deep need in the community for tools for effective team-focused interventions.

These results provide evidence that Collaboration Planning is an effective, accessible, low-barrier intervention for improving team processes and interpersonal relationships in CTR teams. Future work includes expanded evaluation, greater personalization of the intervention, and self-administered facilitation.