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To evaluate the feasibility and impact of an audio-enhanced electronic informed consent tool on comprehension, autonomy, and participant recruitment in clinical trials within resource-limited settings

To evaluate the feasibility and impact of an audio-enhanced electronic informed consent tool on comprehension, autonomy, and participant recruitment in clinical trials within resource-limited settings

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202510918803652
Enrollment
140
Registered
2025-10-22
Start date
2025-11-10
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Audio enhanced electronic informed consent
Standard Paper Based Informed Consent

Sponsors

London School of Hygiene and Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants of the SERVAL clinical trial Willingness and ability to participate and interact with the audio-enhanced consent tool or the traditional paper-based consent. Willingness to consent to participate in this evaluation of the paper vs e-consent.

Exclusion criteria

Exclusion criteria: We will exclude participants that are not willing to consent either with the electronic or paper informed consent prototypes.

Design outcomes

Primary

MeasureTime frame
The primary outcomes are comprehension of the informed consent information immediately after the informed consent is delivered; and, recall of the information after one month of participating in the informed consent process.—

Secondary

MeasureTime frame
Secondary outcomes are accuracy of the consent data and time taken to complete the informed consent process.—

Countries

Gambia

Contacts

Public ContactGibbi Sey

Clinical Trial Manger

Gibbi.Sey@lshtm.ac.uk+2203510102

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026