Strategies for Successful Clinical Trial Recruitment of People Living with HIV in Low- and Middle-Income Countries: Lessons Learned and Implementation Implications from the Nigeria Renal Risk Reduction (R3) Trial

Ahonkhai, Aima A.; Wudil, Usman J.; Dankishiya, Faisal S; Ingles, Donna J.; Musa, Baba Maiyaki; Hamza, Muhammad; Sani, Mahmoud U; Nalado, Aisha M.; Abdu, Aliyu; Abdussalam, Kabiru; Pierce, Leslie; Wester, Carolyn; Aliyu, Muktar H.

doi:10.1007/s11904-021-00566-x

Cited by 6 publications

(8 citation statements)

References 34 publications

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“…As we adapted recruitment strategies during the study, we realized, as others have, the importance of considering implementation strategies and associated outcomes while planning a study. 14 In fact, though we did not intend to do so from the outset, we used several of the implementation strategies named by Powell et al, including changing service sites, developing and implementing tools for quality monitoring, and promoting adaptability. 23 Using an implementation science framework and associated list of implementation strategies from the beginning of the study would have improved our ability to identify and evaluate the impact of adaptations to recruitment strategies.…”

Section: Discussionmentioning

confidence: 99%

“…Our findings regarding successful recruitment strategies and the importance of data-driven adaptations to these strategies are consistent with recent recruitment literature. [14][15][16][17] In particular, iterative adaptation to a priori recruitment and enrollment strategies based on timely evaluation of available data was key to our study's ability to meet enrollment targets. 17 Using existing data capture systems like REDCap 10 can streamline the ease with which data from these recruitment strategies can be analyzed.…”

Section: Discussionmentioning

confidence: 99%

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Real-time evaluation and adaptation to facilitate rapid recruitment in a large cohort

Honushefsky¹,

Wagner²,

Sheridan³

et al. 2023

Preprint

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Objectives Recruiting large, diverse cohorts efficiently can speed the translation of findings into care across a range of scientific disciplines and medical specialties. Yet, efficient recruitment can be hampered by factors such as financial barriers, logistical concerns, and lack of resources for patients and clinicians. Here we use a case study of a large, prospective trial of a multicancer early detection test to describe how the study team tracked enrollment, protocol fidelity, and participant experience and iteratively adapted procedures. Methods While conducting a large, prospective trial of a multicancer early detection blood test at Geisinger, an integrated health system in central Pennsylvania, we monitored recruitment progress, fidelity to protocol procedures, and participants satisfaction. Tracking mechanisms such as paper records, electronic health records, research databases, dashboards, and electronic files were utilized to measure each outcome. We then reviewed study procedures and timelines to list the implementation strategies that were used to address barriers to recruitment, protocol fidelity and participant satisfaction. Results We enrolled 10,006 women ages 65 to 75 over 22 months. Adaptations to recruitment and enrollment methods that contributed to achieving the enrollment goal included adopting group consenting, improving visit convenience, increasing electronic capture and tracking of data and source documents, staffing optimization via leveraging resources external to the study team when appropriate, and integrating the disclosure of study results into routine clinical care without adding unfunded work for physicians. We maintained high protocol fidelity and positive participant experience as exhibited by a very low protocol deviation rate and a low number of participant complaints. Conclusion Recruiting rapidly for large studies, and thereby facilitating clinical translation, requires a nimble, creative approach that marshals available resources and changes course according to data. Planning a rigorous assessment of a studys implementation outcomes prior to study recruitment can further ground study adaptations and facilitate translation into practice. This can be accomplished by proactively and continuously assessing and revising implementation strategies.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Real-time evaluation and adaptation to facilitate rapid recruitment in a large cohort

Honushefsky¹,

Wagner²,

Sheridan³

et al. 2023

Preprint

View full text Add to dashboard Cite

show abstract

“…Our ndings regarding successful recruitment strategies and the importance of real-time data-driven adaptations to these strategies are consistent with recent recruitment literature. [14][15][16][17] The results demonstrate the importance of this iterative adaptation to a priori recruitment and enrollment strategies based on timely evaluation of available data as key to our study's ability to meet enrollment targets. 17 Using existing data capture systems like REDCap 10 can streamline the ease with which data from these recruitment strategies can be analyzed.…”

Section: Discussionmentioning

confidence: 99%

Real-time evaluation and adaptation to facilitate rapid recruitment in a large cohort

Honushefsky,

Wagner,

Sheridan

et al. 2023

Preprint

View full text Add to dashboard Cite

Background Recruiting large, diverse cohorts efficiently can speed the translation of findings into care across a range of scientific disciplines and medical specialties. Yet, recruitment can be hampered by factors such as financial barriers, logistical concerns, and lack of resources for patients and clinicians. Here we use a case study of a large, prospective trial of a multi-cancer early detection test to describe how the study team tracked enrollment, protocol fidelity, and participant experience and iteratively adapted procedures.Methods While conducting a large, prospective trial of a multi-cancer early detection blood test at Geisinger, an integrated health system in central Pennsylvania, we monitored recruitment progress, fidelity to protocol, and participants’ satisfaction. Tracking mechanisms such as paper records, electronic health records, research databases, dashboards, and electronic files were utilized to measure each outcome. We then reviewed study procedures and timelines to list the implementation strategies that were used to address barriers to recruitment, protocol fidelity and participant satisfaction.Results Adaptations to methods that contributed to achieving the enrollment goal included adopting group consenting, improving visit convenience, increasing electronic capture and tracking of data and source documents, staffing optimization via leveraging resources external to the study team when appropriate, and integrating the disclosure of study results into routine clinical care without adding unfunded work for physicians. We maintained high protocol fidelity and positive participant experience as exhibited by a very low rate of protocol deviations and participant complaints.Conclusion Recruiting rapidly for large studies – and thereby facilitating clinical translation – requires a nimble, creative approach that marshals available resources and changes course according to data. Planning a rigorous assessment of a study’s implementation outcomes prior to study recruitment can further ground study adaptations and facilitate translation into practice. This can be accomplished by proactively and continuously assessing and revising implementation strategies.

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“…There is limited data available from LMICs about factors resulting in screen failure. A similar audit coming out of a LMIC showed the screen failure rate at an impressive 5% [ 12 , 13 ].…”

Section: Discussionmentioning

confidence: 99%

Audit of screen failure in 15 randomised studies from a low and middle-income country

Parekh¹,

Patil²,

Nawale³

et al. 2022

ecancer

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Background: Growth and development in patient management occurs via randomised studies. Screen failure is a significant hurdle while conducting randomised studies. There is limited data available from low and middle-income countries about factors resulting in screen failure. Hence, this audit was performed to identify the proportion of patients who screen failed and to elucidate reasons for the same. Methods:This was an audit of 15 randomised studies performed by medical oncology solid tumour unit II of Tata Memorial Centre. The screening logs of these studies were acquired. From the screening logs, data regarding the number of patients who had screen failed & reason for the same were obtained. Descriptive statistics were performed.Results: A total of 7,481 patients were screened for 15 randomised clinical studies. Out of these, 3,666 (49.0%) patients were enrolled into trials and 3,815 (51.0%) screen failed. The most common reason for screen failure was 'not meeting inclusion criteria' (54.9%) followed by declining to take treatment (22.2%). Other factors that affect enrolment were 'not willing to stay in the locality of the trial site' (6.2%), being recruited in other studies (3.7%), poor performance status (PS) (3.4%), non-compliance (2.2%), meeting exclusion criteria (0.9%) and 'other' (6.5%). Conclusion:The commonest causes of screen failure in lower and middle-income countries are non-meeting of inclusion criteria followed by declining to take treatment, not willing to stay in locality of trial site, recruited into other studies, poor PS, non-compliance, meeting exclusion criteria & 'other'. This information would help analysing and hence planning of newer strategies to decrease the rate of screen failure.

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Strategies for Successful Clinical Trial Recruitment of People Living with HIV in Low- and Middle-Income Countries: Lessons Learned and Implementation Implications from the Nigeria Renal Risk Reduction (R3) Trial

Cited by 6 publications

References 34 publications

Real-time evaluation and adaptation to facilitate rapid recruitment in a large cohort

Real-time evaluation and adaptation to facilitate rapid recruitment in a large cohort

Real-time evaluation and adaptation to facilitate rapid recruitment in a large cohort

Audit of screen failure in 15 randomised studies from a low and middle-income country

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