Impact of a tuberculosis treatment adherence intervention versus usual care on treatment completion rates: results of a pragmatic cluster randomized controlled trial

Abstract

Background With the global shortage of skilled health workers estimated at 7.2 million, outpatient tuberculosis (TB) care is commonly task-shifted to lay health workers (LHWs) in many low- and middle-income countries where the shortages are greatest. While shown to improve access to care and some health outcomes including TB treatment outcomes, lack of training and supervision limit the effectiveness of LHW programs. Our objective was to refine and evaluate an intervention designed to address common causes of non-adherence to TB treatment and LHW knowledge and skills training needs. Methods We employed a pragmatic cluster randomized controlled trial. Participants included 103 health centres (HCs) providing TB care in four districts in Malawi, randomized 1:1 stratified by district and HC funding (Ministry of Health, non-Ministry funded). At intervention HCs, a TB treatment adherence intervention was implemented using educational outreach, a point-of-care reminder tool, and a peer support network. Clusters in the control arm provided usual care. The primary outcome was the proportion of patients with successful TB treatment (i.e., cure or treatment completion). We used a generalized linear mixed model, with district as a fixed effect and HC as a random effect, to compare proportions of patients with treatment success, among the trial arms, with adjustment for baseline differences. Results We randomized 51 HCs to the intervention group and 52 HCs to the control group. Four intervention and six control HCs accrued no eligible patients, and 371 of 1169 patients had missing outcome, HC, or demographic data, which left 74 HCs and 798 patients for analysis. Randomization group was not related to missing outcome, however, district, age, and TB type were significantly related and included in the primary analysis model. Among the 1153 patients with HC and demographic data, 297/605 (49%) and 348/548 (64%) in the intervention and control arms, respectively, had treatment success. The intervention had no significant effect on treatment success (adjusted odds ratio 1.35 [95% confidence interval 0.93–1.98]). Conclusion We found no significant effect of the intervention on TB treatment outcomes with high variability in implementation quality, highlighting important challenges to both scale-up and sustainability. Trial registration ClinicalTrials.gov NCT02533089. Registered August 20, 2015.

Evaluations of training and education interventions for improved infectious disease management in low-income and middle-income countries: a systematic literature review

“… 74–77 One study described an intervention that aimed to improve the knowledge and skills of lay health workers to improve TB care provided to patients and subsequently improve treatment adherence. 78 …”

Process evaluation of an implementation strategy to support uptake of a tuberculosis treatment adherence intervention to improve TB care and outcomes in Malawi

“…19 Effectiveness of the intervention in improving TB treatment success rates was assessed within the context of a pragmatic cluster randomised trial in four districts in the south east zone of Malawi, with 51 HCs randomised to the intervention arm and is reported in detail elsewhere. 20 The process evaluation employed a mixed-methods design informed by the Reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework, 21 22 and our experience with the pilot study. In keeping with our pragmatic design, data sources for the process evaluation were selected to limit contact with participants in order to reduce the potential for process evaluation data collection to act as a booster to implementation.…”

“…There was no significant effect of the intervention on TB treatment success, adjusted OR 1.35 (95% CI 0.93 to 1.98), with high variation in implementation quality a potential contributing factor. 20 LHW interview participants and quarterly PT meeting notes, revealed a variety of benefits of the intervention to LHWs including: increased knowledge, improved skills in patient-provider interactions and counselling, better collaboration among providers, and improved patient care. While some PTs reported use of the phone stipend to discuss challenges or problem solve with their peers during initial cascade training and reported this support as essential to their success, few reported continued use of the peer support network beyond the first quarter of 'Since I started receiving medication here I have never faced any insult, they welcome me well and they also make sure that I am taking my drugs accordingly'…”

“…16 17 Given these findings and stakeholder interest in exploring potential scale-up, we refined the intervention and implementation strategy based on feedback and our implementation experience in the pilot study and evaluated the refined intervention using a mixed-methods design. Effectiveness of the intervention in improving TB treatment completion rates was evaluated in a cluster randomised controlled trial, reported in detail elsewhere, 20 with findings of the process evaluation reported here.…”