Table 4 Lessons learned and recommendations of future trials
Issue | Description | Recommendation |
|---|---|---|
Maximising subject recruitment | Out of individuals who were eligible (126) many (23) declined to take part in the study. Anecdotally, this was often because they wanted to receive treatment ‘as normal’. Much of this may be out of the desire to reduce the number of times to attend clinic or perceptions that they were getting something less efficacious or safe. Individuals were required to attend at weeks 0/2/4/8/12 and have a telephone consult at week 16 | Simplified patient information sheet (PIS) with a plain English summary Minimise additional follow-up appointments, so care is as close to the standard of care as possible Making sure that all recruiting clinicians are well trained and motivated to recruit and there are dedicated recruitment nurses in clinics Qualitative interviews of perceptions of LTBI treatment and of taking part in clinical trials Flexible times to attend clinics outside of normal working hours |
Loss to follow-up (LFU) | 6 people were LFU and did not complete the trial. Several were at the end of treatment and so may well have completed treatment but did not want to attend their last appointment. | Larger incentive at end of treatment Qualitative interviews for those LFU |
Adherence checks | The isoniazid metabolite urine test frequently came back as negative because participants in the weekly dosing arm had taken the tablets more than 24/48 h before being tested. Participants often took the medication at a time convenient for them e.g. when they were not working or at weekends. | Electronic measures of adherence may be more useful, especially when using a weekly regimen e.g. MEMS cap. |
Inclusion criteria | Initially, inclusion criteria specified a positive IGRA test and did not include TST. The protocol was subsequently amended to include both. Individuals under-served populations with social risk factors for poor adherence were excluded | As broad as possible to include anyone eligible to have LTBI treatment in usual clinical practice. Include under-served populations to generate adherence data regarding their adherence. |