Table 2 Framework of treatment fidelity strategies

Study design

Ensure the same treatment dose within conditions and equivalent dose across conditions.

1. The structured GBEP is designed to be completed within 3 h with an allowance of 15-min deviation.

2. The intervention manual will ensure all facilitators conduct the intervention in a consistent manner.

3. Observation on 3 sessions of the intervention conducted by the involved facilitators prior to the actual study will be done by the researchers to assess the consistency and appropriateness in conducting the intervention. Feedback will be given to the facilitators by the observers after the observation. The facilitators will also discuss the issues faced during the intervention with the researchers.

4. All facilitators are acquired to adhere to the time allocated for each activity throughout the intervention.

Plan for implementation setbacks.

Have an extra 4 qualified and trained facilitators in case of unavailability of the involved facilitators.

Provider training

Standardize training.

All the qualified and involved facilitators together with the 4 back-up facilitators will be trained together to ensure consistency in conducting the intervention. Observation on 3 sessions of the intervention conducted by the involved facilitators prior to the actual study will be able to ensure the actual performance of the involved facilitators.

Ensure provider skill acquisition.

A scoring scale to assess the qualification and consistency of the facilitators in conducting the intervention will be practised.

Minimize “drift” in provider skills.

During the actual study, the researchers will still observe the intervention conducted by the facilitators to ensure the consistency of the intervention. Should the researchers observe below 90% of consistency as compared to the training sessions, the reasons that caused the inconsistency will be investigated and reported.

Accommodate provider differences.

All facilitators are pharmacists who work in the Pharmaceutical Services Division, Sarawak State Health Department. Hence, the facilitators have a similar pattern of knowledge background and are considered expert related to the study.

Treatment delivery

Control for provider differences.

The facilitators have similar background and have the same training at the same time.

Reduce differences within treatment.

A scripted intervention manual is available in the form of Microsoft PowerPoint slides and used by the facilitators.

Ensure adherence to the treatment protocol.

During the actual study, the researchers will still observe the intervention conducted by the facilitators and will be video-recorded to ensure the consistency of the intervention. Should the researchers observe below 90% of consistency as compared to the training sessions, the reasons that caused the inconsistency will be investigated and reported.

Minimize contamination between conditions.

This is a randomized controlled trial with blinding on the researchers, facilitators and participants to treatment allocation prior to the intervention.

Treatment receipt

Ensure participant comprehension.

1. Participant understanding on the message will be evaluated with the scales developed to measure the impact of the intervention on the psychosocial variables of the participants. A comparison between the intervention group and the control group will show whether the improvement in the psychosocial variables is due to chance or is because of the intervention.

2. A qualitative interview after the intervention will enable the researchers to know how the intervention impacts their medication-taking behaviour.

Ensure participant ability to use cognitive skills.

1. The facilitators work with the participants until they can demonstrate correct medication-taking skills.

2. Hypothetical situations that the participants may face in real life will be addressed during group discussion and sharing on their reasons for non-adherence and the method that they will adopt to overcome the problem.

Ensure participant ability to perform behavioural skills.

The facilitators work with the participants until they can demonstrate correct medication-taking skills.

Enactment of treatment skills

Ensure participant use of cognitive skills.

The use of a medication chart prepared by the participants will show how well they comprehend the medication-taking skills.

Ensure participant use of behavioural skills

Medication adherence will be measured after 1, 3 and 6 months of the intervention to ensure that the messages conveyed through the intervention are translated into action and such action is maintained.