Schistosomiasis Clinical Trial
Official title:
Using Community-Based Volunteers to Reach Non-Enrolled School-Aged Children Through Community-Directed Treatment of Schistosomiasis in School-Aged Children in Rural Northern Ghana
Schistosomiasis and soil-transmitted helminhtiasis occur throughout the developing world and are most prevalent in the poorest communitites. These worms have been linked to several nutritional and intellectual deficiencies in many endemic populations worldwide. Helminth control, though crucial has been neglected for varied reasons. Currently, interests towards the control of neglected diseases including schistosomiasis and soil-transmitted helminths has been revived through many interventions including repeated chemotherapy to help improve public health outcomes and prevent long term morbidity. This will contribute to achieving several of the Millennium Development Goals at a favourable cost. A community-directed treatment of human schistosomiasis and STH in school-aged children in rural notrhern Ghana using praziquantel and albendazole is proposed. It is planned to test the hypothesis that community-based volunteers are non-inferior and more cost effective than rural school teachers at reaching school-aged children.
The primary objectives of the study are:
To compare coverage rate of community based volunteers and rural school teachers in the
distribution of praziquantel and albendazole to scholl-aged children To determine the cost
effectiveness of using community based volunteers to distribute praziquantel and albendazole
to school-aged children in rural Ghana.
Study methods:
A list of all school-aged children (6-15 years) in the study area will be generated from the
Navrongo Demographic Surveillance System database and registers produced and given to all
school teachers and community based volunteers who will be responsible for the distribution
of the antihelminithics. The school teachers and community based volunteers will provide the
drugs to both enrolled and non-enrolled school-aged children. Percentage coverage of
school-aged children will be the outcome measure and compated between the school teachers
and the community based volunteers. Stool and urine samples will be collected from a
representative sample (916) of the children for laboratory analysis before the
administration of the drugs for baseline data. Sample collection and laboratory analysis
will be repeated 6 and 12 months after the first round of chemotherapy.
;
Observational Model: Case Control, Time Perspective: Longitudinal
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04115072 -
Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT05999825 -
Sm-p80 Schistosomiasis Challenge Study
|
Phase 2 | |
| Completed |
NCT00276224 -
Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia
|
N/A | |
| Completed |
NCT00215267 -
The Effect of Praziquantel Treatment on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria, Uganda
|
N/A | |
| Completed |
NCT03845140 -
L-PZQ ODT in Schistosoma Infected Children
|
Phase 3 | |
| Completed |
NCT01512277 -
Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis
|
Phase 1 | |
| Active, not recruiting |
NCT03910972 -
Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults
|
Phase 1/Phase 2 | |
| Completed |
NCT05085470 -
Repeated Controlled Human Schistosoma Mansoni Infection
|
N/A | |
| Completed |
NCT02755324 -
Single-sex Controlled Human Schistosomiasis Infection: Safety and Dose Finding
|
N/A | |
| Recruiting |
NCT05868005 -
Delivering a Multi-disease Screening Tool to Migrant Populations
|
N/A | |
| Active, not recruiting |
NCT01869465 -
Evaluation of Strategies for Improved Uptake of Preventive Treatment for Intestinal Schistosomiasis
|
N/A | |
| Completed |
NCT01553552 -
Schistosomiasis Effect on Response to Vaccines, Anaemia and Nutritional Status of Children of Northern Senegal
|
N/A | |
| Recruiting |
NCT04589390 -
Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension
|
Phase 2 | |
| Completed |
NCT02868385 -
Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)
|
Phase 3 | |
| Recruiting |
NCT05762393 -
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar
|
Phase 1 | |
| Not yet recruiting |
NCT06182176 -
Effectiveness and Cost-effectiveness of Integrated Model for Malaria and Helminth Control
|
N/A | |
| Active, not recruiting |
NCT05292391 -
Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults
|
Phase 1 | |
| Completed |
NCT03110757 -
A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel)(R) With or Without AP 10-701 for Intestinal Schistosomiasis in Healthy Exposed Adults
|
Phase 1 | |
| Completed |
NCT01154049 -
Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis
|
Phase 1 | |
| Active, not recruiting |
NCT05354258 -
Feasibility and Safety of Combining Anti-malarial With Deworming Drugs in African Children
|
N/A |