Cluster-Randomized Clinical Trial Examining the Impact of Platelet Function Testing on Practice

Background With a decline in malaria burden, innovative interventions and tools are required to reduce malaria transmission further. Mass drug administration (MDA) of artemisinin-based combination therapy (ACT) has been identified as a potential tool to further reduce malaria transmission, where coverage of vector control interventions is already high. However, the impact is limited in time. Combining an ACT with an endectocide treatment that is able to reduce vector survival, such as ivermectin (IVM), could increase the impact of MDA and offer a new tool to reduce malaria transmission. Objective The study objective is to evaluate the impact of MDA with IVM plus dihydroartemisinin-piperaquine (DP) on malaria transmission in an area with high coverage of malaria control interventions. Methods The study is a cluster randomized trial in the Upper River Region of The Gambia and included 32 villages (16 control and 16 intervention). A buffer zone of ~2 km was created around all intervention clusters. MDA with IVM plus DP was implemented in all intervention villages and the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program plans. Results The MDA campaigns were carried out from August to October 2018 for the first year and from July to September 2019 for the second year. Statistical analysis will commence once the database is completed, cleaned, and locked. Conclusions This is the first cluster randomized clinical trial of MDA with IVM plus DP. The results will provide evidence on the impact of MDA with IVM plus DP on malaria transmission. Trial Registration ClinicalTrials.gov NCT03576313; https://clinicaltrials.gov/ct2/show/NCT03576313 International Registered Report Identifier (IRRID) DERR1-10.2196/20904

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Mass Drug Administration With High-Dose Ivermectin and Dihydroartemisinin-Piperaquine for Malaria Elimination in an Area of Low Transmission With High Coverage of Malaria Control Interventions: Protocol for the MASSIV Cluster Randomized Clinical Trial (Preprint)

10.2196/preprints.20904 ◽

2020 ◽

Author(s):

Edgard Diniba Dabira ◽

Harouna M Soumare ◽

Steven W Lindsay ◽

Bakary Conteh ◽

Fatima Ceesay ◽

...

Keyword(s):

Clinical Trial ◽

Malaria Transmission ◽

Randomized Clinical Trial ◽

Drug Administration ◽

Malaria Control ◽

Mass Drug Administration ◽

High Coverage ◽

River Region ◽

Cluster Randomized ◽

The Impact

BACKGROUND With a decline in malaria burden, innovative interventions and tools are required to reduce malaria transmission further. Mass drug administration (MDA) of artemisinin-based combination therapy (ACT) has been identified as a potential tool to further reduce malaria transmission, where coverage of vector control interventions is already high. However, the impact is limited in time. Combining an ACT with an endectocide treatment that is able to reduce vector survival, such as ivermectin (IVM), could increase the impact of MDA and offer a new tool to reduce malaria transmission. OBJECTIVE The study objective is to evaluate the impact of MDA with IVM plus dihydroartemisinin-piperaquine (DP) on malaria transmission in an area with high coverage of malaria control interventions. METHODS The study is a cluster randomized trial in the Upper River Region of The Gambia and included 32 villages (16 control and 16 intervention). A buffer zone of ~2 km was created around all intervention clusters. MDA with IVM plus DP was implemented in all intervention villages and the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program plans. RESULTS The MDA campaigns were carried out from August to October 2018 for the first year and from July to September 2019 for the second year. Statistical analysis will commence once the database is completed, cleaned, and locked. CONCLUSIONS This is the first cluster randomized clinical trial of MDA with IVM plus DP. The results will provide evidence on the impact of MDA with IVM plus DP on malaria transmission. CLINICALTRIAL ClinicalTrials.gov NCT03576313; https://clinicaltrials.gov/ct2/show/NCT03576313 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/20904

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Does Medication Sampling Improve Compliance with Brief Advice? Results from a Pragmatic Randomized Clinical Trial

The Journal of Smoking Cessation ◽

10.1155/2021/6638872 ◽

2021 ◽

Vol 2021 ◽

pp. 1-4

Author(s):

Nathaniel J. Silvestri ◽

Jennifer Dahne ◽

Amy E. Wahlquist ◽

Benjamin Toll ◽

Matthew J. Carpenter

Keyword(s):

Primary Care ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Standard Care ◽

Secondary Data ◽

Tobacco Treatment ◽

Improve Compliance ◽

Cluster Randomized ◽

Brief Advice ◽

The Impact

Introduction. The 5As model is a standard component of most guidelines for tobacco treatment. Unfortunately, provider adherence to this model is modest. Aims. Providing physicians with adjunctive tools to adhere to 5As guidelines may serve as a catalyst for brief advice delivery. Methods. This was a secondary data analysis of a cluster randomized clinical trial assessing the uptake and impact of free nicotine replacement therapy (NRT) sampling versus standard care in primary care. Patients reported receipt of separate elements of the 5As model, assessed one month following a baseline visit. Analyses compared patients who recalled receipt of brief advice among those who received NRT vs. standard care. Additional analyses examined demographic predictors of receiving brief advice. Results/Findings. Medication sampling did not improve compliance with ask, advise, or assess. Receipt of “assistance” was significantly higher among NRT recipients (70%) ( p ≤ 0.0001 ). The NRT sampling group was more likely to have received all components ( p = 0.004 ). As age increased, being asked ( p = 0.006 ), advised ( p = 0.05 ), and assessed ( p = 0.003 ) decreased. Non-Whites reported higher rates of assessment ( p = 0.02 ). Conclusions. Provision of NRT sampling increased provider compliance with some elements of the brief advice model, thus enhancing the impact of cessation advice within primary care. Trial Registration. This trial is registered with ClinicalTrials.gov NCT02096029.

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