Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Oct 1:10:20552076241288757.
doi: 10.1177/20552076241288757. eCollection 2024 Jan-Dec.

eConsent administered by Community Health Workers in a study using the Trials within Cohorts (TwiCs) design-Experiences from the Community-Based chronic Care Lesotho (ComBaCaL) project

Felix Gerber  1   2   3 , Thesar Tahirsylaj  1   2 , Thabo Ishmael Lejone  1   2 , Tristan Lee  1   2 , Giuliana Sanchez-Samaniego  1   2 , Fabian Raeber  1   2 , Sesale Masike  4 , Ravi Gupta  4 , Manthabiseng Molulela  4 , Makhebe Khomolishoele  4 , Mota Mota  4 , Matumaole Bane  4 , Mamoronts'ane Pauline Sematle  4 , Retselisitsoe Makabateng  4 , Jason Immanuel Browne  5 , Jonas Wittwer  5 , Dave Brian Basler  1 , Kevin Kindler  1   5 , Niklaus Daniel Labhardt  1   2 , Alain Amstutz  1   2   6   7
Affiliations

eConsent administered by Community Health Workers in a study using the Trials within Cohorts (TwiCs) design-Experiences from the Community-Based chronic Care Lesotho (ComBaCaL) project

Felix Gerber et al. Digit Health. .

Abstract

Improving access to essential health services requires the development of innovative health service delivery models and their scientific assessment in often large-scale pragmatic trials. In many low- and middle-income countries, lay Community Health Workers (CHWs) play an important role in delivering essential health services. As trusted members of their communities with basic medical training, they may also contribute to health data collection. Digital clinical decision support applications may facilitate the involvement of CHWs in service delivery and data collection. Electronic consent (eConsent) can streamline the consent process that is required if the collected data is used for the scientific purposes. Here, we describe the experiences of using eConsent in the Community-Based chronic Care Lesotho (ComBaCaL) cohort study and multiple nested pragmatic cluster-randomized trials assessing CHW-led care delivery models for type 2 diabetes and arterial hypertension using the Trials within Cohorts (TwiCs) design. More than a hundred CHWs, acting both as service providers and data collectors in remote villages of Lesotho utilize an eConsent application that is linked to a tailored clinical decision support and data collection application. The eConsent application presents simplified consent information and generates personalized consent forms that are signed electronically on a tablet and then uploaded to the database of the clinical decision support application. This significantly streamlines the consent process and allows for quality consent documentation through timely central monitoring, facilitating the CHW-led management of a large-scale population-based cohort in a remote low-resource area with continuous enrollment-currently at more than 16,000 participants.

Keywords: Community Health Worker; Electronic consent; Lesotho; Trials within Cohorts; clinical decision support system.

PubMed Disclaimer

Conflict of interest statement

The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.

References

    1. Loudon K, Treweek S, Sullivan F, et al. The PRECIS-2 tool: designing trials that are fit for purpose. Br Med J 2015; 350: h2147. - PubMed
    1. World Health Organization Regional Office for the Eastern Mediterranean. Community Health Workers: a strategy to ensure access to primary health care services. [cited 2023 Aug 28], https://apps.who.int/iris/bitstream/handle/10665/249563/EMROPUB_2016_EN_....
    1. World Health Organization. WHO guideline: recommendations on digital interventions for health system strengthening. Geneva: World Health Organization, 2019. [cited 2023 Jun 5]. https://apps.who.int/iris/handle/10665/311941. - PubMed
    1. Greuel M, Sy F, Bärnighausen T, et al. Community health worker use of smart devices for health promotion: scoping review. JMIR mHealth uHealth 2023; 11: e42023. - PMC - PubMed
    1. Hohl SD, Thompson B, Krok-Schoen JL, et al. Characterizing community health workers on research teams: results from the centers for population health and health disparities. Am J Public Health 2016; 106: 664–670. - PMC - PubMed

LinkOut - more resources