REMEDI study: Improving malaria diagnosis and treatment in Nigeria

• Register: ISRCTN
• Last refreshed on: 11 February 2019
• Main ID: ISRCTN12605216
• Date of registration: 18/10/2013
• Prospective Registration: Yes
• Primary sponsor: University of California, San Francisco (USA)
• Public title: REMEDI study: Improving malaria diagnosis and treatment in Nigeria
• Scientific title: The REMEDI study ? Rapid Examination of Malaria and Evaluation of Diagnostic Information
• Date of first enrolment: 21/10/2013
• Target sample size: 1500
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN12605216
• Study type: Interventional
• Study design: Single site double-blind parallel-group study with two behavioral randomizations (Diagnostic)
• Phase: Not Applicable

Countries of recruitment

Nigeria

Contacts

• Name: Jenny Liu

Key inclusion & exclusion criteria

Inclusion criteria:
1. Adult aged over 17 years and having purchased malaria drugs for either him/herself or an accompanying minor at an enrolled study site
2. Customers must be willing to be assigned to any of the study intervention groups
3. Participating drugs shops must sell at least one type of antimalarial drug

Exclusion criteria:
1. Pregnant women who are seeking malaria treatment for herself are excluded because the recommended treatment for malaria is a different drug regimen than one than the study can provide
2. Any individual seeking treatment for illnesses other than malaria
3. Any adult who is purchasing malaria for a minor and the minor is not present at the time of enrollment
4. Because the study involves a follow-up survey conducted via phone, participants who cannot provide at least one phone number at which they can be reached are excluded
5. Drug shops that do not sell antimalarial drugs are excluded


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Diagnosis and appropriate treatment of malaria
Infections and Infestations
Unspecified malaria

Intervention(s)

The study will involve 1500 participants who will be followed-up 4 days after initial enrollment and testing to assess self-reported adherence (the recommended malaria treatment regimen is 3 days). There are two randomized components.

1. Randomization #1: Participants will be randomized to be either given the malaria rapid diagnostic test for free or for a small fee.
2. Randomization #2: One day after enrollment into the study, a text message reminder will sent to the mobile phone number provided by the participant. For participants who agreed to be tested with the malaria rapid diagnostic test at the time of enrollment, their phone numbers will be randomized to either receive no message vs. a text message with general information of the rapid diagnostic test availability in Nigeria vs. a text message with specific information of the rapid diagnostic test availability from drug shop vendors.

Primary Outcome(s)

Malaria rapid diagnostic test result measured at baseline

Secondary Outcome(s)

Assessed 4 days after enrollment and testing and will include:
1. Self-reported treatment with anti-malarial medication
2. Self-reported treatment with non-antimalarial medications
3. Perceptions of drug shop vendors ability to perform rapid diagnostic tests
4. Perceptions of rapid diagnostic tests in general
5. Cost effectiveness
6. Perceptions of the text message reminders

Secondary ID(s)

A121186

Source(s) of Monetary Support

ExxonMobil Foundation (USA) (PO046342)

Ethics review

Status:
Approval date:
Contact:

1. National Health Research Ethics Committee of Nigeria (NHREC), Federal Ministry of Health, Abuja, 21 September 2013, ref: NHRED/01/01/2007-21/09/2013 2. Committee on Human Research, University of California, San Francisco, 17 September 2013, IRB# 12-09472, ref# 072086

Results

• Results available: Yes
• Date Completed: 15/12/2013