Safety and Immunogenicity of an AMA-1 Malaria Vaccine in Malian Adults: Results of a Phase 1 Randomized Controlled Trial

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017

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Assessing the Effectiveness and Acceptability of a Personalized Mobile Phone App in Improving Adherence to Oral Hygiene Advice in Orthodontic Patients: Protocol for a Feasibility Study and a Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/18021 ◽

2021 ◽

Vol 10 (1) ◽

pp. e18021

Author(s):

Mohammad Owaise Sharif ◽

Jonathon Timothy Newton ◽

Susan J Cunningham

Keyword(s):

Health Care ◽

Randomized Controlled Trial ◽

Behavior Change ◽

Mobile Phone ◽

Mobile Phones ◽

Orthodontic Treatment ◽

Controlled Trial ◽

Phase 1 ◽

Adherence To Treatment ◽

Randomized Controlled

Background Orthodontic treatment is a common health care intervention; treatment duration can be lengthy (2-3 years on average), and adherence to treatment advice is therefore essential for successful outcomes. It has been reported that up to 43% of patients fail to complete treatment, and there are currently no useful predictors of noncompletion. Given that the National Health Service England annual expenditure on primary-care orthodontic treatment is in excess of £200 million (US $267 million), noncompletion of treatment represents a significant inefficient use of public resources. Improving adherence to treatment is therefore essential. This necessitates behavior change, and interventions that improve adherence and are designed to elicit behavioral change must address an individual’s capability, opportunity, and motivation. Mobile phones are potentially an invaluable tool in this regard, as they are readily available and can be used in a number of ways to address an individual’s capability, opportunity, and motivation. Objective This study will assess the effectiveness and acceptability of a personalized mobile phone app in improving adherence to orthodontic treatment advice by way of a randomized controlled trial. Methods This study will be conducted in 2 phases at the Eastman Dental Hospital, University College London Hospitals Foundation Trust. Phase 1 is feasibility testing of the My Braces app. Participants will be asked to complete the user version of the Mobile Application Rating Scale. The app will be amended following analysis of the responses, if appropriate. Phase 2 is a randomized controlled trial to test the effectiveness and acceptability of the My Braces app. Results This study was approved by the London – Bloomsbury Research Ethics Committee on November 5, 2019 (reference 19/LO/1555). No patients have been recruited to date. The anticipated start date for recruitment to phase 1 is October 2020. Conclusions Given the availability, affordability, and versatility of mobile phones, it is proposed that they will aid in improving adherence to treatment advice and hence improve treatment completion rates. If effective, the applicability of this methodology to developing behavior change/modification interventions and improving adherence to treatment across health care provides an exciting opportunity. Trial Registration ClinicalTrials.gov NCT04184739; https://clinicaltrials.gov/ct2/show/NCT04184739 International Registered Report Identifier (IRRID) PRR1-10.2196/18021

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Safety and immunogenicity of a new Sabin inactivated poliovirus vaccine candidate produced on the PER.C6® cell-line: a phase 1 randomized controlled trial in adults

Human Vaccines & Immunotherapeutics ◽

10.1080/21645515.2020.1812315 ◽

2020 ◽

pp. 1-8

Author(s):

Isabel Leroux-Roels ◽

Geert Leroux-Roels ◽

Georgi Shukarev ◽

Hanneke Schuitemaker ◽

Conor Cahill ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cell Line ◽

Vaccine Candidate ◽

Controlled Trial ◽

Phase 1 ◽

Randomized Controlled

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Socio-Ecological Natural Experiment with Randomized Controlled Trial to Promote Active Commuting to Work: Process Evaluation, Behavioral Impacts, and Changes in the Use and Quality of Walking and Cycling Paths

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph16091661 ◽

2019 ◽

Vol 16 (9) ◽

pp. 1661 ◽

Cited By ~ 1

Author(s):

Minna Aittasalo ◽

Johanna Tiilikainen ◽

Kari Tokola ◽

Jaana Suni ◽

Harri Sievänen ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Natural Experiment ◽

Controlled Trial ◽

Phase 1 ◽

Active Commuting ◽

Phase 2 ◽

Behavioral Strategies ◽

Beneficial Effects ◽

Randomized Controlled ◽

Journey To Work

Active commuting to work (ACW) has beneficial effects on health, traffic, and climate. However, more robust evidence is needed on how to promote ACW. This paper reports the findings of a multilevel natural experiment with a randomized controlled trial in 16 Finnish workplaces. In Phase 1, 11 workplaces (1823 employees) from Area 1 were exposed to environmental improvements in walking and cycling paths. In Phase 2, five more workplaces (826 employees) were recruited from Area 2 and all workplaces were randomized into experimental group (EXP) promoting ACW with social and behavioral strategies and comparison group (COM) participating only in data collection. Process and impact evaluation with questionnaires, travel diaries, accelerometers, traffic calculations, and auditing were conducted. Statistics included Wilcoxon Signed Ranks Test, Mann-Whitney U-test, and after-before differences with 95% confidence intervals (95% CI). After Phase 1, positive change was seen in the self-reported number of days, which the employees intended to cycle part of their journey to work in the following week (p = 0.001). After Phase 2, intervention effect was observed in the proportion of employees, who reported willingness to increase walking (8.7%; 95% CI 1.8 to 15.6) and cycling (5.5%; 2.2 to 8.8) and opportunity to cycle part of their journey to work (5.9%; 2.1 to 9.7). To conclude, the intervention facilitated employees’ motivation for ACW, which is the first step towards behavior change.

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A Phase 1, Dose-escalation, Double-blind, Block-randomized, Controlled Trial of Safety and Efficacy of Neosaxitoxin Alone and in Combination with 0.2% Bupivacaine, with and without Epinephrine, for Cutaneous Anesthesia

Anesthesiology ◽

10.1097/aln.0000000000000831 ◽

2015 ◽

Vol 123 (4) ◽

pp. 873-885 ◽

Cited By ~ 33

Author(s):

Kimberly Lobo ◽

Carolina Donado ◽

Laura Cornelissen ◽

Joseph Kim ◽

Rebeca Ortiz ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Local Anesthesia ◽

Active Sites ◽

Peak Plasma ◽

Controlled Trial ◽

Phase 1 ◽

Double Blind ◽

Safety And Efficacy ◽

Randomized Controlled

Abstract Background: Neosaxitoxin (NeoSTX) is a site-1 sodium channel blocker that produces prolonged local anesthesia in animals and humans. Under a Food and Drug Administration–approved phase 1 Investigational New Drug trial, the authors evaluated safety and efficacy of NeoSTX alone and combined with 0.2% bupivacaine (Bup) with and without epinephrine. Methods: The authors conducted a double-blind, randomized, controlled trial involving healthy male volunteers aged 18 to 35 yr receiving two 10-ml subcutaneous injections. Control sites received Bup. In part 1, active sites received (1) 5 to 40 μg NeoSTX+Saline (NeoSTX-Saline), (2) 5 to 40 μg NeoSTX+Bup (NeoSTX-Bup), or (3) placebo (Saline). In part 2, active sites received 10 or 30 μg NeoSTX+Bup+Epinephrine (NeoSTX-Bup-Epi) or placebo. Primary outcome measures were safety and adverse events associated with NeoSTX. Secondary outcomes included clinical biochemistry, NeoSTX pharmacokinetics, and cutaneous hypoesthesia. Results: A total of 84 subjects were randomized and completed the two-part trial with no serious adverse events or clinically significant physiologic impairments. Perioral numbness and tingling increased with NeoSTX dose for NeoSTX-Saline and NeoSTX-Bup. All symptoms resolved without intervention. NeoSTX-Bup-Epi dramatically reduced symptoms compared with other NeoSTX combinations (tingling: 0 vs. 70%, P = 0.004; numbness: 0 vs. 60%, P = 0.013) at the same dose. Mean peak plasma NeoSTX concentration for NeoSTX-Bup-Epi was reduced at least two-fold compared with NeoSTX-Saline and NeoSTX-Bup (67 ± 14, 134 ± 63, and 164 ± 81 pg/ml, respectively; P = 0.016). NeoSTX-Bup showed prolonged cutaneous block duration compared with Bup, NeoSTX-Saline, or placebo, at all doses. Median time to near-complete recovery for 10 μg NeoSTX-Bup-Epi was almost five-fold longer compared with Bup (50 vs. 10 h, P = 0.007). Conclusion: NeoSTX combinations have a tolerable side effect profile and appear promising for prolonged local anesthesia.

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