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Background <p>Implementation strategies are dynamic and multi-faceted, and may require adaptations to fit implementation contexts, especially in lower-and-middle income countries. We report the adaptations for an ongoing late-stage implementation science trial (R01HL147811) that integrates hypertension management into HIV care in Lagos, Nigeria – a country with a high dual-disease burden – through the Task Strengthening Strategy for Hypertension (TASSH) intervention and Practice Facilitation implementation strategy.</p> Methods <p>FRAME (Framework for Reporting Adaptations and Modifications—Enhanced) modules were used to record adaptations to the intervention (i.e., TASSH) respectively, enhance participant recruitment and retention rates, and increase frequency of trainings. Data collection sources included (not limited to) patient records, nurses’ logs, and minutes of implementation review meetings. Data across these sources was coded retrospectively by trained research staff and triangulated during virtual meeting discussions. Once consensus was reached, data was mapped onto the relevant framework modules using Microsoft Excel.</p> Results <p>We modified FRAME to include an additional component on ‘what was originally planned’ for the context of the adaptations. There were twelve adaptations identified during the implementation of the study. The adaptations characterized by using the frameworks included reordering recruitment start dates of study cohorts, providing patients incentives to attend follow-up visits, adding feeder sites to the study sites, and increasing the frequency of training to account for the high nurse turnover in the primary healthcare centers. Overall, 25% of the adaptations involved expanding the structure of the intervention and implementation strategies, and 33% involved adding new elements to the strategies. All adaptations occurred in the implementation phase of the trial.</p> Conclusion <p>Based on our experiences, the characterization of the adaptations using FRAME demonstrates their combined applicability to an ongoing trial that can be tailored to fit the local context.</p> Trial registration <p>ClinicalTrials.gov ( NCT04704336). Registered on 11 January 2021.</p>

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Adaptations to an implementation study for integrating hypertension management into HIV care in Lagos, Nigeria: application of the FRAME

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月10日

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  • Chioma Hope Nwankwo,
  • Oluwayemi Dorcas Odejobi,
  • Oluwatosin Olaseni Odubela,
  • Shivani Mishra,
  • Deborah Onakomaiya,
  • Nafesa Kanneh,
  • Ucheoma Nwasozuru,
  • Aina Olufemi Odusola,
  • Weixi Chen,
  • Aderonke Bayonle,
  • Ifeoma Idigbe,
  • David Oladele,
  • Bamidele Olusegun Tayo,
  • Jiyuan Hu,
  • Zaidat Musa,
  • Angela A. Aifah,
  • Gbenga Ogedegbe,
  • Juliet Iwelunmor,
  • Oliver Ezechi

摘要

Background

Implementation strategies are dynamic and multi-faceted, and may require adaptations to fit implementation contexts, especially in lower-and-middle income countries. We report the adaptations for an ongoing late-stage implementation science trial (R01HL147811) that integrates hypertension management into HIV care in Lagos, Nigeria – a country with a high dual-disease burden – through the Task Strengthening Strategy for Hypertension (TASSH) intervention and Practice Facilitation implementation strategy.

Methods

FRAME (Framework for Reporting Adaptations and Modifications—Enhanced) modules were used to record adaptations to the intervention (i.e., TASSH) respectively, enhance participant recruitment and retention rates, and increase frequency of trainings. Data collection sources included (not limited to) patient records, nurses’ logs, and minutes of implementation review meetings. Data across these sources was coded retrospectively by trained research staff and triangulated during virtual meeting discussions. Once consensus was reached, data was mapped onto the relevant framework modules using Microsoft Excel.

Results

We modified FRAME to include an additional component on ‘what was originally planned’ for the context of the adaptations. There were twelve adaptations identified during the implementation of the study. The adaptations characterized by using the frameworks included reordering recruitment start dates of study cohorts, providing patients incentives to attend follow-up visits, adding feeder sites to the study sites, and increasing the frequency of training to account for the high nurse turnover in the primary healthcare centers. Overall, 25% of the adaptations involved expanding the structure of the intervention and implementation strategies, and 33% involved adding new elements to the strategies. All adaptations occurred in the implementation phase of the trial.

Conclusion

Based on our experiences, the characterization of the adaptations using FRAME demonstrates their combined applicability to an ongoing trial that can be tailored to fit the local context.

Trial registration

ClinicalTrials.gov ( NCT04704336). Registered on 11 January 2021.