Malaria Clinical Trial
Official title:
Exploring the Impact of Scaling up Mass Testing, Treatment and Tracking on Malaria Prevalence Among Children in the Pakro Sub District of Ghana
NCT number | NCT04167566 |
Other study ID # | NoguchiMIMR |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2017 |
Est. completion date | July 30, 2019 |
Verified date | November 2019 |
Source | Noguchi Memorial Institute for Medical Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Malaria poses a serious burden in sub-Sahara Africa. Efforts are ongoing to scale up interventions that work. These include the use of Long Lasting Insecticidal Nets (LLIN), Intermittent Preventive Treatment in children (IPTc), and test, treat and track (TTT). There is the need, however, for mass testing, treatment and tracking (MTTT) of the whole population to reduce the parasite load before implementing the aforementioned interventions. Though, Seasonal Malaria Chemoprophylaxis (SMC) is adopted for selected localities in Ghana, the impact of such interventions could be enhanced, if associated with MTTT in order to reduce the parasite load at baseline. MTTT of children in Ghana has demonstrated a parasite load reduction from 25% to 1%. However, unanswered questions include - could this be scaled up? What proportion of the community could be covered over a given time? What would it take to accomplish large scale MTTT? In designing interventions that aim at reducing the burden of malaria in children under five, for example, MTTT has largely been left out. Adults who are not often targeted by such interventions remain reservoirs that fuel transmission. This study explores the scale-up of interventions that work using existing community volunteer teams to lower cost. These volunteers will play a surveillance role by conducting home-based management of malaria. To avoid challenges posed by stockouts, short message service (SMS) will be used to monitor the level of stocks for malaria medicine and Rapid Diagnostic Tests (RDTs). It is hypothesized that there are more asymptomatic malaria cases (those who carry the parasite but are not ill) than symptomatic cases reported by hospital records in the Pakro sub district and that, carrying out MTTT in combination with home-based management of malaria in specific communities could greatly reduce the burden. Through this study, the bottlenecks that hinder scaling-up of MTTT will be documented in order to facilitate the process.
Status | Completed |
Enrollment | 5000 |
Est. completion date | July 30, 2019 |
Est. primary completion date | July 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Months to 15 Years |
Eligibility |
Inclusion Criteria: 1. Overall inclusion criteria for MTTT: - Be aged 2 months or older - Be resident in the study area - Have completed and signed the consent for adults or assent form for children 12-17 years. 2. Inclusion Criteria for children in the cohort study: - Be age range 6 months to 14 years - Be resident in the study area for the period of the study. - Be willing to participate - Parent or guardian have completed and signed consent form Exclusion Criteria: - If an individual intents to stay less than one year in the study site - Be absent at some time because he/she is schooling in a boarding school - Has a life threatening illness (excluding malaria). |
Country | Name | City | State |
---|---|---|---|
Ghana | Noguchi Memorial Institute for Medical Research | Accra | Greater |
Lead Sponsor | Collaborator |
---|---|
Noguchi Memorial Institute for Medical Research | World Health Organization |
Ghana,
Ahorlu CK, Koram KA, Seake-Kwawu A, Weiss MG. Two-year evaluation of Intermittent Preventive Treatment for Children (IPTc) combined with timely home treatment for malaria control in Ghana. Malar J. 2011 May 15;10:127. doi: 10.1186/1475-2875-10-127. — View Citation
Ahorlu CK, Koram KA, Seakey AK, Weiss MG. Effectiveness of combined intermittent preventive treatment for children and timely home treatment for malaria control. Malar J. 2009 Dec 11;8:292. doi: 10.1186/1475-2875-8-292. — View Citation
Appawu MA, Baffoe-Wilmot A, Afari EA, Nkrumah FK, Petrarca V. Species composition and inversion polymorphism of the Anopheles gambiae complex in some sites of Ghana, west Africa. Acta Trop. 1994 Feb;56(1):15-23. — View Citation
Bousema T, Okell L, Felger I, Drakeley C. Asymptomatic malaria infections: detectability, transmissibility and public health relevance. Nat Rev Microbiol. 2014 Dec;12(12):833-40. doi: 10.1038/nrmicro3364. Epub 2014 Oct 20. Review. — View Citation
Bull PC, Lowe BS, Kortok M, Molyneux CS, Newbold CI, Marsh K. Parasite antigens on the infected red cell surface are targets for naturally acquired immunity to malaria. Nat Med. 1998 Mar;4(3):358-60. — View Citation
Dicko A, Sagara I, Sissoko MS, Guindo O, Diallo AI, Kone M, Toure OB, Sacko M, Doumbo OK. Impact of intermittent preventive treatment with sulphadoxine-pyrimethamine targeting the transmission season on the incidence of clinical malaria in children in Mali. Malar J. 2008 Jul 8;7:123. doi: 10.1186/1475-2875-7-123. — View Citation
DISTRICT HEALTH DIRECTORATE, 2014. District Annual Report 2014, Akwapim South, Aburi, Ghana.
DISTRICT HEALTH DIRECTORATE, 2015. District Annual Report 2015, Akwapim South, Aburi, Ghana
Farnert A, Snounou G, Rooth I, Bjorkman A. Daily dynamics of Plasmodium falciparum subpopulations in asymptomatic children in a holoendemic area. Am J Trop Med Hyg. 1997 May;56(5):538-47. — View Citation
GHANA STATISITCAL SERVICE, 2010. Population and Housing Sensus. District Analytic Report: Akwapim South District.
GNMCP 2006. Ghana National Malaria Control Programme: Ghana Health Service Report 2006 Accra.
ISRAEL, G. D. 1992. Determining sample size, University of Florida Cooperative Extension Service, Institute of Food and Agriculture Sciences, EDIS.
Koram K, Quaye L, Abuaku B. Efficacy of amodiaquine/artesunate combination therapy for uncomplicated malaria in children under five years in ghana. Ghana Med J. 2008 Jun;42(2):55-60. — View Citation
Kweku M, Webster J, Adjuik M, Abudey S, Greenwood B, Chandramohan D. Options for the delivery of intermittent preventive treatment for malaria to children: a community randomised trial. PLoS One. 2009 Sep 30;4(9):e7256. doi: 10.1371/journal.pone.0007256. — View Citation
Ndong IC, Okyere D, Enos JY, Amambua-Ngwa A, Merle CSC, Nyarko A, Koram KA, Ahorlu CS. Challenges and perceptions of implementing mass testing, treatment and tracking in malaria control: a qualitative study in Pakro sub-district of Ghana. BMC Public Healt — View Citation
Ndong IC, van Reenen M, Boakye DA, Mbacham WF, Grobler AF. Trends in malaria admissions at the Mbakong Health Centre of the North West Region of Cameroon: a retrospective study. Malar J. 2014 Aug 22;13:328. doi: 10.1186/1475-2875-13-328. — View Citation
Newell K, Kiggundu V, Ouma J, Baghendage E, Kiwanuka N, Gray R, Serwadda D, Hobbs CV, Healy SA, Quinn TC, Reynolds SJ. Longitudinal household surveillance for malaria in Rakai, Uganda. Malar J. 2016 Feb 9;15:77. doi: 10.1186/s12936-016-1128-6. — View Citation
Ofosu-Okyere A, Mackinnon MJ, Sowa MP, Koram KA, Nkrumah F, Osei YD, Hill WG, Wilson MD, Arnot DE. Novel Plasmodium falciparum clones and rising clone multiplicities are associated with the increase in malaria morbidity in Ghanaian children during the transition into the high transmission season. Parasitology. 2001 Aug;123(Pt 2):113-23. — View Citation
OTUPIRI, E., YAR, D. & HINDIN, J. 2012. Prevalence of Parasitaemia, Anaemia and treatment outcomes of Malaria among School Children in a Rural Community in Ghana. Journal of Science and Technology (Ghana), 32, 1-10.
Rao VB, Schellenberg D, Ghani AC. Overcoming health systems barriers to successful malaria treatment. Trends Parasitol. 2013 Apr;29(4):164-80. doi: 10.1016/j.pt.2013.01.005. Epub 2013 Feb 14. Review. — View Citation
Sarpong N, Owusu-Dabo E, Kreuels B, Fobil JN, Segbaya S, Amoyaw F, Hahn A, Kruppa T, May J. Prevalence of malaria parasitaemia in school children from two districts of Ghana earmarked for indoor residual spraying: a cross-sectional study. Malar J. 2015 Jun 25;14:260. doi: 10.1186/s12936-015-0772-6. — View Citation
Sinclair D, Zani B, Donegan S, Olliaro P, Garner P. Artemisinin-based combination therapy for treating uncomplicated malaria. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007483. doi: 10.1002/14651858.CD007483.pub2. Review. — View Citation
WORLD HEALTH ORGANISATION (2012).
WORLD HEALTH ORGANISATION Roll Back Malaria Report. Geneva: WHO; 2003. http://www.rollbackmalaria.org/microsites/wmd2011/amr_toc.html. Accessed 15 November. 2016
WORLD HEALTH ORGANISATION. World Malaria Report 2009. Geneva: WHO; 2009 http://www.who.int/malaria/world_malaria_report_2014/en. Accessed 3 December. 2016
WORLD HEALTH ORGANISATION. World Malaria Report 2010. Geneva: WHO; 2010. http://www.who.int/malaria/world_malaria_report_2010/en. Accessed 1 December 2016
WORLD HEALTH ORGANISATION. World Malaria Report 2011. Geneva: WHO; 2013 http://www.who.int/malaria/publications/world_malaria_report_2013/en. Accessed 2 December 2016
WORLD HEALTH ORGANISATION. World Malaria Report 2014. Geneva: WHO; 2014 http://www.who.int/malaria/publications/world_malaria_report_2014/en. Accessed 1 December, 2016
* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rate of asymptomatic malaria parasitaemia among afebrile children aged 6 months to 15 years and adults in the Pakro sub district will be known. | The change in the rate of asymptomatic parasistaemia at evaluation compared to baseline. This will be determined by testing for the presence of malaria parasite in healthy participants without a history of fever in the last 48 hours before an intervention. This will be done using rapid diagnostic test. The temperature will be taken before the the test to ensure that the patients are not febrile. Questionnaires will be used to collect data on the prevalence of febrile illnesses. | Once every 4 months, over a period of 24 months | |
Primary | The proportion hospital admissions due to malaria that are averted as a result of MTTT implementation will be determined. | The effect of MTTT on hospital admissions in the intervention communities will be evaluated by comparing the proportion of confirmed malaria cases during the MTTT intervention period to the proportion of confirmed malaria cases period before implementation of the MTTT intervention at the Pakro Health Centre. Data on malaria test results will be collected from hospital registers. The proportion will be defined as (number of confirmed malaria cases/number of participants tested for malaria) *100. Questionnaires, focus group discussions and In-depth interviews will be used to gather complementary information to obtain a holistic picture of the effect of the interventions in the community. | 24 months | |
Primary | The list of challenges that needs to be addressed to enable scale-up of MTTT interventions feasible in Ghana. | This outcome will provide a list of challenges faced by the investigators during the implementation of MTTT. It will also state how many challenges were addressed and at what level. A detailed description will be made of how each challenge was addressed at the level of the community, administration and stakeholders. Data will be collected from field notes taken during monthly monitoring visits, field reports, interviews and focus group discussion. | 24 months | |
Secondary | The cost benefit analysis of the scaling up MTTT intervention in the area will be known. | This outcome describes the benefit in terms of number of cases of malaria prevented or amount of income saved by the participants or resources saved by the health system as a result of implementing MTTT | 24 Months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04601714 -
Baseline Cohort Malaria Morbidity Study
|
||
Withdrawn |
NCT04020653 -
A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
|
Phase 2 | |
Terminated |
NCT04368910 -
Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria
|
Phase 3 | |
Completed |
NCT03641339 -
Defining Skin Immunity of a Bite of Key Insect Vectors in Humans
|
N/A | |
Completed |
NCT02544048 -
Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
|
||
Completed |
NCT00527163 -
Role of Nitric Oxide in Malaria
|
||
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Active, not recruiting |
NCT04704674 -
Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia
|
||
Completed |
NCT03276962 -
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
|
Phase 2 | |
Completed |
NCT04966871 -
Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults
|
Phase 1 | |
Completed |
NCT00289185 -
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
|
Phase 2 | |
Recruiting |
NCT03937817 -
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
|
||
Active, not recruiting |
NCT06153862 -
Africa Ready Malaria Screening
|
N/A | |
Completed |
NCT04545905 -
Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso
|
||
Recruiting |
NCT06278181 -
Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
|
||
Completed |
NCT02909712 -
Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania
|
Phase 2 | |
Withdrawn |
NCT02793388 -
A Trial on Supervised Primaquine Use in Ethiopia
|
Phase 4 | |
Withdrawn |
NCT02793414 -
Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
|
||
Completed |
NCT02793622 -
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
|
Phase 3 | |
Completed |
NCT02536222 -
Accelerating the Reduction of Malaria Transmission in Kanel, Ranérou and Linguère Districts
|
Phase 4 |