The IHAT-GUT Iron Supplementation Trial in Rural Gambia: Barriers, Facilitators, and Benefits

Introduction: In most sub-Saharan African countries iron deficiency anaemia remains highly prevalent in children and this has not changed in the last 25 years. Supplementation with iron hydroxide adipate tartrate (IHAT) was being investigated in anaemic children in a phase two clinical trial (termed IHAT-GUT), conducted at the Medical Research Council Unit the Gambia at the London School of Hygiene and Tropical Medicine (LSHTM) (abbreviated as MRCG hereof). This qualitative study aimed to explore the personal perceptions of the trial staff in relation to conducting a clinical trial in such settings in order to highlight the health system specific needs and strengths in the rural, resource-poor setting of the Upper River Region in the Gambia. Methods: Individual interviews (n = 17) were conducted with local trial staff of the IHAT-GUT trial. Data were analysed using inductive thematic analysis. Results: Potential barriers and facilitators to conducting this clinical trial were identified at the patient, staff, and trial management levels. Several challenges, such as the rural location and cultural context, were identified but noted as not being long-term inhibitors. Participants believed the facilitators and benefits outnumbered the barriers, and included the impact on education and healthcare, the ambitious and knowledgeable locally recruited staff, and the local partnership. Conclusions: While facilitators and barriers were identified to conducting this clinical trial in a rural, resource-poor setting, the overall impact was perceived as beneficial, and this study is a useful example of community involvement and partnership for further health improvement programs. To effectively implement a nutrition intervention, the local health systems and context must be carefully considered through qualitative research beforehand.

Download Full-text

The IHAT-GUT iron supplementation trial in rural Gambia: barriers, facilitators, and benefits

10.1101/2020.09.30.20199992 ◽

2020 ◽

Author(s):

Isabella Stelle ◽

Lorraine K McDonagh ◽

Mohammed Ilias Hossain ◽

Anastasia Z Kalea ◽

Dora I.A. Pereira

Keyword(s):

Clinical Trial ◽

The Gambia ◽

Resource Poor Setting ◽

Health Improvement ◽

Local Health ◽

River Region ◽

Resource Poor ◽

Trial Staff ◽

Improvement Programs ◽

The Impact

Introduction In most sub-Saharan African countries iron deficiency anaemia remains highly prevalent in children and this has not changed in the last 25 years. Supplementation with iron hydroxide adipate tartrate (IHAT) was being investigated in anaemic children in a phase two clinical-trial (termed IHAT-GUT), conducted at the MRC Unit The Gambia at LSHTM (MRCG). This qualitative study aimed to explore the personal perceptions of the trial staff in relation to conducting a clinical trial in such settings in order to highlight the health system specific needs and strengths in the rural, resource-poor setting of the Upper River Region in The Gambia. Methods Individual interviews (n=17) were conducted with local trial staff of the IHAT-GUT trial. Data were analysed using inductive thematic analysis. Results Potential barriers and facilitators to conducting this clinical trial were identified at the patient, staff, and trial-management levels. Several challenges, such as the rural location and cultural context, were identified but noted as not being long-term inhibitors. Participants believed the facilitators and benefits outnumbered the barriers, and included the impact on education and healthcare, the ambitious and knowledgeable locally recruited staff and the local partnership. Conclusion While facilitators and barriers were identified to conducting this clinical trial in a rural, resource poor setting, the overall impact was perceived as beneficial, and this study is a useful example of community involvement and partnership for further health improvement programs. To effectively implement a nutrition intervention, the local health systems and context must be carefully considered through qualitative research beforehand.

Download Full-text

G254(P) The impact of an obstetric birth and neonatal emergency life support education project on staff competences, organisational capacity and patient outcomes in a resource – poor setting

Archives of Disease in Childhood ◽

10.1136/archdischild-2015-308599.247 ◽

2015 ◽

Vol 100 (Suppl 3) ◽

pp. A109.2-A109

Author(s):

JO Menakaya

Keyword(s):

Patient Outcomes ◽

Life Support ◽

Resource Poor Setting ◽

Education Project ◽

Organisational Capacity ◽

Resource Poor ◽

The Impact

Download Full-text

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

JMIR Research Protocols ◽

10.2196/20904 ◽

2020 ◽

Vol 9 (11) ◽

pp. e20904

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. Trial Registration ClinicalTrials.gov NCT03576313; https://clinicaltrials.gov/ct2/show/NCT03576313 International Registered Report Identifier (IRRID) DERR1-10.2196/20904

Download Full-text

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

Download Full-text

Serology reflects a decline in the prevalence of trachoma in two regions of The Gambia

10.1101/149237 ◽

2017 ◽

Author(s):

Stephanie J Migchelsen ◽

Nuno Sepúlveda ◽

Diana L Martin ◽

Gretchen Cooley ◽

Sarah Gwyn ◽

...

Keyword(s):

Public Health Problem ◽

Population Based ◽

Cross Sectional Study ◽

The Gambia ◽

Cross Sectional ◽

Sexually Transmitted ◽

River Region ◽

Significant Difference ◽

Ct Antigens ◽

The Impact

ABSTRACTTrachoma is caused by Chlamydia trachomatis (Ct). It is targeted for global elimination as a public health problem. In 2014, a population-based cross-sectional study was performed in two previously trachoma-endemic areas of The Gambia. Participants of all ages from Lower River Region (LRR) (N = 1028) and Upper River Region (URR) (N = 840) underwent examination for trachoma and had blood collected for detection of antibodies against the Ct antigen Pgp3, by ELISA. Overall, 30 (1.6%) individuals had active trachoma; the prevalence in children aged 1–9 years was 3.4% (25/742) with no statistically significant difference in prevalence between the regions. There was a significant difference in overall seroprevalence by region: 26.2% in LRR and 17.1% in URR (p<0.0001). In children 1-9 years old, seroprevalence was 4.4% in LRR and 3.9% in URR. Reversible catalytic models using information on age-specific seroprevalence demonstrated a decrease in the transmission of Ct infection in both regions, possibly reflecting the impact of improved access to water, health and sanitation as well as mass drug administration campaigns. Serological testing for antibodies to Ct antigens is potentially useful for trachoma programmes, but consideration should be given to the coendemicity of sexually transmitted Ct infections.

Download Full-text

The impact of COVID-19 on the clinical trial

PLoS ONE ◽

10.1371/journal.pone.0251410 ◽

2021 ◽

Vol 16 (5) ◽

pp. e0251410

Author(s):

Zhimin Chen ◽

Liran Chen ◽

Huafang Chen

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Remote Monitoring ◽

Structured Interviews ◽

Trial Staff ◽

The Impact ◽

Express Delivery

The objective of this study was to explore the impact of the coronavirus disease 2019 epidemic on ongoing and upcoming drug clinical trials. Qualitative semi-structured interviews were conducted with clinical trial staff and clinical trial subjects were surveyed by questionnaire in this study. The results of interviews and questionnaire showed that coronavirus disease 2019 pandemic has led to many changes in the implementation of drug clinical trials, including: a variety of meetings being held online webinars using various platforms, telemedicine and follow-up by video, A large number of deviations from protocol and losses of follow-up, delivery of clinical trial drugs by express, additional workload caused by screening for coronavirus, and anxiety of subjects. These results suggest that the coronavirus disease 2019 outbreak has hindered the progress and damaged the quality of clinical trials. The online meeting, remote follow-up, express delivery of drugs and remote monitoring in the epidemic environment can ensure the progress of clinical trials to a certain extent, but they cannot fully guarantee the quality as before.

Download Full-text

The impact of an inclusive education intervention on learning outcomes for girls with disabilities within a resource-poor setting

African Journal of Disability ◽

10.4102/ajod.v9i0.555 ◽

2020 ◽

Vol 9 ◽

Author(s):

Mark Carew ◽

Marcella Deluca ◽

Nora Groce ◽

Sammy Fwaga ◽

Maria Kett

Keyword(s):

Educational Attainment ◽

Inclusive Education ◽

Intervention Group ◽

Resource Poor Setting ◽

Control Group ◽

Education Intervention ◽

Persons With Disabilities ◽

National Implementation ◽

Resource Poor ◽

The Impact

Background: Despite a global commitment to the right to education for persons with disabilities, little is known about how to achieve inclusive education in practice, particularly in low- and middle-income countries (LMICs), where the majority of the world’s people with disabilities reside. Moreover, although exclusion from education is magnified by intersecting gender and socioeconomic inequalities, there is especially little knowledge regarding what approaches to inclusive education are effective amongst girls with disabilities living in resource-poor settings.Objectives: The objective of this article was to assess the impact of an inclusive education intervention led by a non-governmental organisation (NGO) on the educational attainment of girls with disabilities in the resource-poor Lakes region of Kenya.Method: A quasi-experimental design was employed, where the literacy and numeracy educational attainment of the intervention and control groups was compared over two time points a year apart (Time 1 and Time 2; total matched N = 353). During this period, activities pertaining to six core components of a holistic inclusive education model were implemented.Results: Relative to the control group, girls with disabilities in the intervention group reported a greater increase in literacy and numeracy attainment, adjusted for grade and level of functional difficulty.Conclusion: Findings suggest that the intervention was successful in engendering additional improvements in the educational attainment of girls with disabilities from the resource-poor Lakes region of Kenya. Results highlight both the applicability of NGO-led interventions in settings, where national implementation of inclusive education is constrained, and the potential of taking such interventions to scale.

Download Full-text