NCT06885658

Brief Summary

This study aims to evaluate the effectiveness of a visual storytelling intervention in improving antibiotic adherence among adults with urinary tract infections (UTIs). Participants will be randomly assigned to either the intervention group, where they will receive a visual sticker on their antibiotic packaing, explaining the importance of completing their antibiotic course, or the control group, which will receive routine care. The study will measure how well participants follow their prescribed antibiotic regimens and assess their knowledge and attitudes toward antibiotic use. The goal is to determine if visual storytelling can enhance adherence, reduce antibiotic resistance, and improve health outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
358

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2026

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

21 days

First QC Date

February 28, 2025

Last Update Submit

April 21, 2026

Conditions

Keywords

Visual storytellingAntibiotic AdherenceUTI recurrence

Outcome Measures

Primary Outcomes (1)

  • Antibiotic adherence

    The primary outcome measure of this study is antibiotic adherence, which will be assessed by tracking the number of prescribed antibiotic pills taken by the participants at the end of their treatment course (typically 3-7 days). Adherence will be calculated in two ways: Proportional Adherence: The percentage of the prescribed pills that the patient takes will be calculated, expressed as a proportion (number of pills taken/total prescribed). Categorical Adherence: Patients will be categorized as "adhered" (if they took ≥90% of the prescribed antibiotics) or "not adhered" (if they took \<90% of the prescribed antibiotics).

    Based on the antibiotic treatment course (3-7 days)

Secondary Outcomes (3)

  • UTI Recurrence

    UTI recurrence will be assessed at 3 months, and 6 months following the initial antibiotic treatment.

  • Knowledge

    Knowledge will be assessed at baseline (before the intervention) and at first follow up (3-7 days) 3 months, and 6 months follow-up after the intervention.

  • Attitude

    Attitude will be assessed at baseline (before the intervention) and at first follow up (3-7 days) 3 months, and 6 months follow-up after the intervention.

Study Arms (2)

Intervention Arm: Visual Storytelling using stickers

EXPERIMENTAL

In this arm, participants will receive a visual storytelling intervention designed to improve antibiotic adherence. The intervention involves a stickers (affixed to the antibiotic packages) containing simple, visually appealing illustrations that explain how antibiotics work and the consequences of not completing the full course. The story contrasts the positive outcomes of adhering to the treatment with the risks of non-adherence, including the development of antibiotic resistance. Key messages will highlight the importance of completing the prescribed antibiotic course. The intervention is intended to engage patients emotionally and cognitively, enhancing their understanding of antibiotic use and encouraging adherence to the prescribed treatment regimen.

Behavioral: Visual Storytelling Intervention for Antibiotic Adherence

Control Group: Standard Care for Antibiotic Adherence

NO INTERVENTION

The control group will receive the usual standard care for antibiotic adherence, which typically includes verbal or written instructions provided by the healthcare provider about the correct usage of prescribed antibiotics for treating urinary tract infections (UTI). This group will not receive any additional interventions, such as the visual storytelling intervention. The standard care aims to represent the typical approach to UTI treatment, allowing for a comparison of the effectiveness of the visual storytelling intervention against routine practice in improving antibiotic adherence. Participants in this group will also complete the same baseline and follow-up assessments related to knowledge and attitudes about antibiotics and adherence.

Interventions

The intervention involves the use of a visual storytelling approach designed to improve antibiotic adherence in patients diagnosed with urinary tract infections (UTIs). The intervention consists of a sticker featuring simple, visually appealing illustrations and a narrative highlighting the importance of completing the full course of prescribed antibiotics. The story contrasts the positive outcomes of adhering to the treatment with the negative consequences of stopping early, such as increased bacterial resistance. Key messages are reinforced through bold text and visual cues. This intervention aims to engage patients emotionally and cognitively, promoting behavior change by making the concept of antibiotic adherence more relatable and memorable.

Intervention Arm: Visual Storytelling using stickers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older.
  • Physician-confirmed diagnosis of uncomplicated urinary tract infection (UTI).
  • Prescribed oral antibiotics (tablet/capsule) for UTI treatment.
  • Willingness to participate in the study and provide informed consent.
  • Ability to complete follow-up assessments and adhere to the study protocol.

You may not qualify if:

  • Diagnosed with complicated UTI (e.g., pyelonephritis, sepsis, or structural abnormalities).
  • Multiple comorbidities that require polypharmacy.
  • Cognitive impairment or mental disorders that would interfere with study participation.
  • Pregnant or breastfeeding women.
  • Participation in another clinical trial that could interfere with this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tertiary care hospitals (n = 6)

Peshawar, Khyber Pakhtunkhwa, Pakistan

Location

Related Publications (1)

  • Hussain I, Rasool MF, Ullah J, Khan I, Kadirhaz M, Xu M, Tang C, Dong Y, Zhao W, Khan FU, Chang J, Fang Y. Effectiveness of nudge-based visual storytelling in antibiotic adherence in uncomplicated urinary tract infection in Pakistan: protocol for a randomized controlled trial. Trials. 2025 Dec 17;27(1):63. doi: 10.1186/s13063-025-09328-1.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
In this study, the participants and site staff delivering the intervention will not be masked, due to the nature of the behavioral intervention (visual storytelling sticker), which participants will be actively engaged with. However, the physician who diagnoses the UTI and confirms UTI recurrence will be blinded to the intervention allocation to avoid bias in outcome assessment. Additionally, the data analysts (outcome assessor) will be blinded to group assignments. The dataset will be labeled neutrally (e.g., "Group A" and "Group B") to ensure unbiased analysis of the primary and secondary outcomes.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study uses a parallel two-arm randomized controlled trial (RCT) design. Participants will be randomly assigned in a 1:1 ratio to either: Intervention group: Receives a visual storytelling intervention designed to improve antibiotic adherence in patients with urinary tract infections (UTIs). Control group: Receives standard care, which includes routine verbal or written instructions about antibiotic use. The intervention involves the delivery of a sticker affixed on the antibiotic packaging containing visual stories that emphasize the importance of completing the full antibiotic course and the consequences of non-adherence, including antibiotic resistance. The study aims to compare the effectiveness of this intervention with standard care in improving adherence to prescribed antibiotics
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2025

First Posted

March 20, 2025

Study Start

July 1, 2025

Primary Completion

July 22, 2025

Study Completion

January 21, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations