Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial Aim 2
Phase: NA
Conditions: Malaria, Febrile Illness
Sponsor: Duke University

TESTsmART Aim 2 – Nigeria Protocol 
Version 0.1 
 
08 October 2019 
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
 
 
 
 
A randomized experiment of malaria diagnostic testing and 
conditional subsidies to target ACTs in the retail sector: the 
TESTsmART trial AIM 2 
 
DMID Protocol Number: 
 
 
Sponsored by: 
National Institute of Allergy and Infectious Diseases (NIAID) 
 
 
 
Principal Investigators: 
Wendy Prudhomme O’Meara 
Theodoor Visser 
Jeremiah Laktabai 
 
 
 
Draft or Version Number: v 0.1 
 
Day Month Year 
08 October 2019 
 
NCT04428385 
 
 
 

TESTsmART Aim 2 – Nigeria Protocol 
Version 0.1 
 
08 October 2019 
 ____________________________________________________________________________________________ 
 
 
 ____________________________________________________________________________________________ 
i 
Statement of Compliance 
The study will be carried out in accordance with Good Clinical Practice (GCP) as required by the 
following: 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies 
(45 CFR Part 46; 21 CFR Part 50, 21 CFR Part 56, and 21 CFR Part 312) 
• 
ICH E6; 62 Federal Register 25691 (1997)  
• 
NIH Clinical Terms of Award 
 
All key personnel (all individuals responsible for the design and conduct of this study) have 
completed Human Subjects Protection Training. 
 
 
 

TESTsmART Aim 2 – Nigeria Protocol 
Version 0.1 
 
08 October 2019 
 ____________________________________________________________________________________________ 
 
 
 ____________________________________________________________________________________________ 
ii 
NATIONAL HEALTH RESEARCH ETHICS COMMITTEE, NIGERIA 
(NHREC) 
SCIENTIFIC AND ETHICAL REVIEW COMMITTEE (SERC)   
RESEARCH PROPOSAL FORM 
 
 
  
 
 
Project No.___________________      (To be given by SERC) 
 
Title:                                    A randomized experiment of malaria diagnostic testing and conditional 
subsidies to target ACTs in the retail sector: the TESTsmART trial AIM 2 
 
Person(s) undertaking the project-Study Team 
                        Name 
     Qualification 
Designation 
Institution 
Wendy Prudhomme O’Meara 
PhD 
Principal Investigator 
Duke University 
Theodoor Visser 
MA, MBA 
Principal Investigator 
CHAI 
Aaron Woolsey 
PhD 
Principal Investigator 
CHAI 
Liz Turner 
PhD 
Co-Investigator 
Duke University 
Lakshmi Balachandran  
MPA 
CHAI Team 
CHAI 
Tayo Olaleye 
PhD 
CHAI Team 
CHAI 
Luke Baertlein 
MPH 
CHAI Team 
CHAI 
Olukunle Akinwusi 
MSc 
CHAI Team 
CHAI 
Chuka Ndukauba 
MD, MBA 
CHAI Team 
CHAI 
Oluwatosin Ogunsola 
BSc 
CHAI Team 
CHAI 
Ryan Simmons 
MA 
Duke Biostatistician 
Duke University 
Study period: 5 years 
Date of commencement: October 2018 
Date of completion: September 2023 
Description of study sites: Study sites are the Patent and Proprietary Medicine Vendors (PPMVs) in the private retail 
sector 
 
 
 
 

TESTsmART Aim 2 – Nigeria Protocol 
Version 0.1 
 
08 October 2019 
 ____________________________________________________________________________________________ 
 
 
 ____________________________________________________________________________________________ 
iii 
Co-Principal Investigators 
 
Name 
Wendy Prudhomme O’Meara 
Institution 
Duke University School of Medicine 
Address 
 
E-mail 
wendypomeara@gmail.com 
 
Name 
Theodoor Visser 
Institution 
Clinton Health Access Initiative 
Address 
383 Dorchester Avenue, Boston, MA, USA, 02127 
E-mail 
tvisser@clintonhealthaccess.org 
 
Name 
Aaron Woolsey 
Institution 
Clinton Health Access Initiative 
Address 
 
E-mail 
awoolsey@clintonhealthaccess.org 
 
Name 
Owens Wiwa 
Institution 
Clinton Health Access Initiative 
Address 
7 Ganges Street, Maitama, Abuja - Nigeria 
E-mail 
owiwa@clintonhealthaccess.org 
 
 
 
 
 
 
 

TESTsmART Aim 2 – Nigeria Protocol 
Version 0.1 
 
08 October 2019 
 ____________________________________________________________________________________________ 
 
 
 ____________________________________________________________________________________________ 
iv 
SIGNATURE PAGE 
The signature below constitutes the approval of this protocol and the attachments, and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable US federal regulations and ICH guidelines. 
 
Site Investigator:* 
 
Signed: 
 
Date: 
 
 
Name 
Title 
 
 
 

 
 ____________________________________________________________________________________________ 
1 
Contents 
Statement of Compliance ............................................................................................................. i 
Signature Page ........................................................................................................................... ii 
List of Abbreviations ................................................................................................................... vi 
Protocol Summary .................................................................................................................. …1 
 
1 
Background Information and Scientific Rationale................................................................ 6 
1.1 
Background Information .......................................................................................... 6 
1.2 
Scientific Rationale  ................................................................................................ 8 
1.3 
Potential Risks and Benefits ................................................................................... 9 
1.3.1 
Potential Risks ............................................................................................ 9 
1.3.2 
Known Potential Benefits............................................................................. 9 
2 
Objectives ........................................................................................................................ 10 
3 
Study Design .................................................................................................................... 11 
4 
Study Population .............................................................................................................. 13 
4.1 
Selection of the Study Population ......................................................................... 13 
4.2 
Inclusion/Exclusion Criteria ................................................................................... 13 
5 
STUDY PROCEDURES/EVALUATIONS ......................................................................... 14 
5.1 
Study Procedures ................................................................................................. 14 
5.2 
Laboratory Evaluations ......................................................................................... 14 
6 
Statistical Considerations ................................................................................................. 15 
6.1 
Study Outcome Measures .................................................................................... 15 
6.2 
Sample Size Considerations ................................................................................. 16 
6.3 
Participant Enrollment and Follow-Up ................................................................... 17 
6.4 
Analysis Plan ........................................................................................................ 18 
7 
SUBJECT CONFIDENTIALITY ........................................................................................ 20 
7.1 Future Use of Stored Specimens ................................................................................ 20 
8 
Informed Consent Process ............................................................................................... 21 
8.1 
Informed Consent/Assent Process (in Case of a Minor or Others Unable to 
Consent for Themselves) ...................................................................................... 21 
9 
Literature References ....................................................................................................... 22 
 
 
SUPPLEMENTS/APPENDICES 
 
 
 
 
 
 
 
 

 
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2 
List of Abbreviation 
 
ACT 
AE 
AM 
Artemisinin Combination Therapy 
Adverse Event 
Antimalarial 
CFR 
Code of Federal Regulations 
CIOMS 
Council for International Organizations of Medical Sciences 
CRF 
CHW 
DFID 
Case Report Form 
Community Health Worker 
Department for International Development, UK 
DMID 
Division of Microbiology and Infectious Diseases, NIAID, NIH, 
DHHS 
DSMB 
Data and Safety Monitoring Board 
FWA 
Federal-Wide Assurance 
GCP 
GEE 
Good Clinical Practice 
Generalized Estimating Equation 
ICF 
Informed Consent Form 
ICH 
ID 
International Conference on Harmonisation 
Identification 
IEC 
Independent or Institutional Ethics Committee 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
JAMA 
Journal of the American Medical Association 
MOP 
Manual of Procedures 
N/n 
Number (typically refers to subjects) 
NEJM 
New England Journal of Medicine 
NIAID 
National Institute of Allergy and Infectious Diseases, NIH, 
DHHS 
NIH 
National Institutes of Health 
OCRA 
Office of Clinical Research Affairs, DMID, NIAID, NIH, DHHS 
OHRP 
Office for Human Research Protections 
ORA 
Office of Regulatory Affairs, DMID, NIAID, NIH, DHHS 
PI 
Principal Investigator 
PPMV 
Patent and Proprietary Medicine Vendors 
RA 
Research Assistant 
RD 
Risk Difference 
RDT 
Rapid Diagnostic Test 
RR 
Risk Ratio 
SAE 
Serious Adverse Event 
SMC 
Safety Monitoring Committee 
SOP 
Standard Operating Procedure 
USAID 
United States Agency for International Development 
WHO 
World Health Organization 
 
 

 
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3 
Protocol Summary 
Title: 
A randomized experiment of malaria diagnostic testing and conditional 
subsidies to target ACTs in the retail sector: the TESTsmART trial AIM 2 
 
Population: 
48 registered Patent and Proprietary Medicine Vendors (PPMVs) in 
Lagos State, Nigeria, 8160 participants seeking care from these PPMVs 
 
Number of Sites: 
48 
 
Study Duration: 
18 months 
 
Subject Duration: 
30 minutes 
 
 
Objectives: 
 
The objective of this study is to test the effect of provider-directed and patient-directed 
incentives on improving the management of suspected malaria fevers that receive care in the 
retail sector. Provider-directed incentives include small payments for taking the time to conduct 
malaria-RDT testing for participants with malaria-like illness. Patient-directed incentives are 
inexpensive RDT testing coupled with a conditional ACT discount. The ACT discount is only 
applied if the RDT is positive for malaria. Outcomes will be measured by exit interviews on 
random days each month at each participating outlet.  
 
Primary: 
• 
The primary outcome will be the proportion of all ACTs that are sold to individuals with a 
positive malaria diagnostic test. For this outcome, a positive test is anyone who has a 
malaria-RDT performed at the outlet and receives a positive result or is referred from a 
health facility or a diagnostic lab with a documented positive test result. 
 
Secondary: 
• 
The major secondary outcome is the proportion of suspected malaria cases that are tested 
with an RDT at the outlet. This outcome will allow us to determine whether the conditional 
subsidy can drive demand for testing.  
• 
Other secondary outcomes will measure 1) adherence to the RDT result among all those 
tested at the outlet, 2) proportion of all suspected malaria cases that are managed 
appropriately (tested for malaria, and use ACT following a positive test or do not purchase 
an ACT after a negative test), and 3) ACT use by untested clients.  
 

 
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4 
For questions regarding this protocol, contact Dr Chuka Ndukauba at the Clinton Health Access 
Initiative (CHAI). 
Individuals:  
Chuka Ndukauba 
Senior Research Associate, Clinton Health Access Initiative 
7B Ganges Street, Off Alvan Ikoku Road, Maitama, Abuja 
Phone: 09 291 2658; 0901 663 6686 
cndukauba@clintonhealthaccess.org 
 
Chizoba Fashanu 
Deputy Program Director, Clinton Health Access Initiative 
7B Ganges Street, Off Alvan Ikoku Road, Maitama, Abuja 
Phone: 09 291 2658; 0703 133 1546 
cfashanu@clintonhealthaccess.org 
 
Owens Wiwa 
Country Director, Clinton Health Access Initiative 
7B Ganges Street, Off Alvan Ikoku Road, Maitama, Abuja 
Phone: 09 291 2658; 0805 603 6151 
owiwa@clintonhealthaccess.org 
DMID Representative: 
 
Walt Jones, RN, MPH 
 
Clinical Project Manager NIH/NIAID/DMID/PIPB 
 
5601 Fisher’s Lane, Room 8A37, Rockville, MD 20892 
 
PHONE: 240-627-3283 
 
joneswalter@niaid.nih.gov 
Principal Investigator:  Site investigator responsible for conducting the study: 
Wendy Prudhomme O’Meara, PhD 
Associate Professor of Medicine and Global Health, Duke University 
Box 90519, Trent Hall, Durham, NC  27708 
PHONE: +254 728 306 521  
wpo@duke.edu 
 
Subcontract Principal Investigators: 
Theodoor Visser 
Senior Manager, Malaria Commodity Access, Clinton Health Access Initiative 
383 Dorchester Ave., Ste 400, Boston, MA 02127 
FAX: 617 774 0220 
PHONE: 706 296 4141 
tvisser@clintonhealthaccess.org 
 

 
 ____________________________________________________________________________________________ 
5 
Institutions:  
 
Duke University  
 
Box 90519, Room 219, Trent Hall Durham, NC  27708 
 
Jamie Mills, Lead Grants and Contracts Administrator, DGHI 
 
FAX: 1 919 681 7748 
 
PHONE: 1 919 684 1755 
   
jamie.mills@duke.edu 
 
 
Clinton Health Access Initiative (CHAI) 
 
383 Dorchester Ave., Ste 400, Boston, MA 02127 
 
Molly Baker, Finance and Operations Manager, Access Programs, CHAI 
FAX: 617 774 0220 
PHONE: 617 774 0110 
mbaker@clintonHealthAccess.org 
 
 
Moi University 
 
PO Box 4606-30100 MEC Building, Nandi Road, Eldoret, Kenya 
 
Robert Rono, Head of Research and Sponsored Projects Office 
 
FAX: +254 532 061 992 
 
robertrono@iukenya.org 

 
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6 
1 
BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE  
1.1 
Background Information  
Artemisinin combination therapies (ACTs) – the WHO-recommended first line therapy for 
uncomplicated malaria – have played a significant role in reducing global malaria mortality [1], 
but their overuse is rampant. In 2016, an estimated 216 million cases of malaria occurred 
worldwide, yet more than 400 million treatment courses of ACT were consumed1 [2]. 
Approximately 75% of global ACT demand is subsidized with international public funds from 
sources such as The Global Fund, DFID, and USAID2 [3]. Overconsumption of ACTs is an 
unnecessary drain on scarce public health resources and threatens the future sustainability of 
publicly-funded subsidies. In addition, it puts both present and future patients at risk; 
inappropriate treatment of a non-malaria illness with an antimalarial increases case fatality rates 
[4, 5] and contributes to population-wide drug pressure that accelerates the spread of drug 
resistance [6-8].  
 
Global over-consumption of ACTs is largely driven by its increased over-the-counter 
distribution in private retail outlets as a result of publicly-funded subsidies directed to the private 
sector [9]. In 2015, 44% of all donor-funded ACTs consumed world-wide were distributed 
through the private retail sector [9] where studies have shown that between 65-91% of ACTs 
dispensed for malaria are actually purchased by people without malaria [10-13]. Targeting 
ACTs to only those who receive a confirmatory diagnosis could dramatically reduce 
inappropriate ACT consumption, in alignment with WHO policy that stipulates that all febrile 
patients be tested before administering antimalarials.  
 
Although more than half of families in sub-Saharan Africa seek care for febrile illness 
through the retail sector [14, 15], it has remained largely outside of efforts to improve rational, or 
diagnosis-directed, use of antimalarials. Private medicine retail outlets are made up of for-profit 
outlets that specialize in medicines, such as pharmacies and drug stores. These outlets are 
generally poorly regulated, often operate outside of formal channels, and have weak, 
sometimes antagonistic relationships with the formal health care sector. The lack of 
accountability and incentive structure undermines adherence to national case management 
guidelines and contributes to poor ACT stewardship in the retail sector.  
 
Point-of-care malaria rapid diagnostic tests (RDTs), which have excellent sensitivity and 
specificity and are simple enough to be used by trained persons with limited formal training [16], 
could expand the reach of diagnostics into the retail sector and help improve the rational use of 
antimalarials. However, in the context of subsidized ACTs and a for-profit business model, it 
may not be in the economic interest of clients to test when the treatment is less expensive than 
                                               
1 This includes both 311 million courses of subsidized, WHO-prequalified ACTs as well as an estimated figure of 
more than 100 million courses of other brands not subsidized or tracked by the WHO. Quality-assured or pre-qualified 
ACTs are pre-approved ACT brands that meet WHO quality standards. Only quality-assured ACTs are subsidized. 
2 USAID – United States Agency for International Development; DFID – Department for International Development, 
UK 

 
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7 
the RDT. Clients may prefer to forgo the RDT in favor of the treatment if they strongly suspect 
they have malaria, particularly if testing may increase their out-of-pocket costs. Similarly, use of 
a test may also mean loss of a sale for the retailer if the test is negative, particularly if there is 
an expectation that the provider will refer all clients who test negative for further evaluation at a 
formal health facility, as has been suggested by policy-makers. Therefore, in the presence of 
highly subsidized ACTs, incentives for testing are not aligned with provider or client interests in 
the private retail sector. As a result, the private retail sector remains the largest contributor 
to inappropriate use of ACTs. 
Currently, recipients of Global Fund grants may use funds to subsidize RDTs in the private 
sector, including in private retail outlets. However, outside of a few countries (i.e., Cambodia, 
Ghana, Myanmar), the use of RDTs in the retail sector is uncommon as is evidenced by the 
very low testing rates (<10%) in the private sector in sub-Saharan Africa [2, 17]. Several studies 
have explored the potential role of RDTs in improving case management in the retail sector with 
mixed and often poor results. In most of these studies, retail providers received case 
management training, followed by supportive supervision visits by researchers. In a few studies, 
the wholesale RDT price was partially or fully subsidized but retail providers were permitted to 
set their own price to the consumer and offer testing at their discretion [18, 19]. More often, 
outlets were required to provide testing free of charge or at a low fixed price. Instructions to the 
outlets regarding when an RDT should be performed and an ACT should be dispensed were 
quite rigid [20] [21-23]. Providers were not explicitly incentivized to conduct RDTs. All of these 
studies shared two features – 1) ACTs were heavily subsidized for all customers and 2) there 
was no relationship between the RDT result and the ACT subsidy. This range of implementation 
strategies resulted in a wide range of testing uptake; between 7 - 100% of suspected malaria 
cases were tested [24]. Adherence to a negative malaria test was inconsistent (between 1-40% 
of those with a negative test purchased an ACT) and often a significant portion of those testing 
positive, up to 70%, did not take an ACT [24]. 
 
In order to align both the provider and customer incentives towards testing and 
targeting, the provider must be willing to perform the test and sell the appropriate 
medicine and, at the same time, the customer must be motivated to purchase the test 
and adhere to the results. We hypothesize that offering ACT subsidies for the client 
(conditional on a positive test), and incentives to the provider to offer malaria testing, will 
each, on their own, have a very modest impact on uptake of testing and targeting of 
ACTs in the retail sector. We further hypothesize that when combined, they will have a 
synergistic effect on RDT testing and ACT targeting. However, it is important to estimate the 
effect of each intervention separately and in combination in order to provide cogent evidence to 
support joint implementation. We will test the combination of subsidies for ACTs and RDTs 
(selected from Aim 1) paired with a provider-directed testing incentive in a four-arm cluster-
randomized controlled trial to evaluate their impact on the proportion of ACTs sold to individuals 
with parasitologically-confirmed malaria among those seeking care in the retail sector.  

 
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8 
1.2 
Scientific Rationale  
 
The study will be conducted in Lagos, a state in southwest Nigeria with a total population 
of ~21-23m at risk for malaria (National Malaria Indicator Survey, 2015). Much like in other parts 
of Nigeria, the retail sector is an important resource for people seeking treatment for fever 
management. Approximately 67% of fever cases in Nigeria first seek care in the retail sector 
(National Malaria Indicator Survey, 2015). Given the large proportion of ACTs and other 
antimalarials distributed through the retail sector, efforts to improve targeting of ACTs must 
include the retail sector.  
 
Nigeria’s national strategic plan aims to provide universal access to prompt 
parasitological diagnosis before treatment and has endorsed the use of malaria RDTs in the 
public and private health sector (National Malaria Strategic Plan 2014-2020). However, very 
high rates of self-treatment in the retail sector undermine the explicit policy that all malaria 
cases should be confirmed by parasitological diagnosis. Private medicine retailers in Nigeria, 
consisting of private pharmacies and chemists, can conduct RDTs with adequate training and 
stakeholder management. For this project, we will partner with the Lagos State Ministry of 
Health, Pharmaceutical Council of Nigeria (PCN) and the National Association of Patent and 
Proprietary Medicines (NAPPMED) in exploring new ways to engage Patent Proprietary 
Medicines Vendors (PPMVs) in malaria case management. 
 
 
While simulations of clients’ 
decisions around testing and ACT 
purchasing based on prices of 
these commodities exist [25], they 
do not consider the motivations of 
providers in the retail sector to offer 
malaria diagnostic testing. The 
proposed project is a real-world 
implementation study that will 
provide insights into whether an 
innovative and scalable approach 
can help overcome the practical 
challenges of working through the 
retail sector while improving the 
targeting of ACTs to individuals 
with confirmed malaria infection.  
 
 
 
 
Table 1: Study country characteristics 
 
Nigeria 
First line drug 
AL1 
Year adopted universal testing policy 
2011 
Estimated malaria cases [2] 
53.7 million 
Total population 
~198M 
Percent of cases confirmed [2] 
22% 
Percent of fevers that seek care in 
retail sector (MIS 2015) 
67% 
Current price of ACT in retail sector 
(adult dose) 
$3.332 
Expected price in 2018 
$2.692 
Use of RDTs in retail sector?  
Yes 
Current retail cost of RDT  
$0.28 
Study area 
Urban 
Prevalence of malaria in study area 
(2017 Lagos MIS) 
7.1% 
1Artemether Lumefantrine 
2Recent CHAI field assessment in 2019 

 
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9 
1.3 
Potential Risks and Benefits 
1.3.1 Potential Risks 
The intervention proposed is an incentive to providers to perform malaria diagnostic 
testing and the offer of a conditionally subsidized ACT for the client in case of a positive test. 
The provider incentive is relatively small, so it is not likely to distort the providers’ behavior to the 
extent where they would perform unnecessary malaria tests in order to obtain the incentive. The 
subsidized ACT is offered only to patients with a positive test (and only in some arms) but, the 
client is free to choose whether or not to use the subsidy. Participating in this study involves 
allowing us to record information about clients’ malaria testing and treatment decisions. This 
includes the clients’ decisions about whether to get tested for malaria using the RDT, and 
whether to buy an ACT. There is a small risk of breach of confidentiality of this information.  
The RDTs to be used in this study will be procured from reputable local suppliers of 
quality assured mRDTs. Conducted properly, finger-sticks pose no greater than minimal risk to 
clients, including children. While unlikely, there is a small potential for excess bleeding or 
infection associated with finger pricks conducted in the course of administering an RDT. 
However, there is no WHO-recommended alternative to a blood sample for diagnosing malaria 
and these risks are equivalent to the risk of seeking the same test from a facility or a community 
health worker. A finger prick blood sample is the least invasive and safest method to diagnose 
malaria. Several studies have demonstrated that RDTs can be safely and effectively used 
following training, even by those with limited formal training and no medical training. Previous 
work in Uganda, Nigeria and elsewhere [18, 20, 22, 24] has demonstrated that clients are willing 
to be tested with RDTs at pharmacies and the WHO has expressed strong support for this 
approach [26]. The study will ensure availability of proper sharps disposal equipment and 
services to participating outlets. All clients who choose to be tested will be advised on what to 
do if they experience any adverse events as a result of the finger prick.  
No venous blood will be drawn.  
1.3.2 Known Potential Benefits 
There is significant health benefit to the client in knowing their malaria infection status 
prior to purchasing a drug. There is also a benefit to the client to be able to purchase an 
effective drug at a reduced, fixed price when they have a confirmed malaria infection, which 
may also reduce the likelihood that they would purchase an inappropriate or outdated therapy.  
The providers benefit from learning how to perform malaria testing. In some arms, the 
providers get a direct monetary incentive for performing malaria diagnostic tests.  
More broadly, there are important future benefits to rigorous testing of subsidy schemes 
that promote appropriate testing before treatment. This work will contribute to evidence-based 
policy making, improved access to malaria diagnosis and ultimately reduced potential for the 
spread of antimalarial resistance. 

 
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10 
2 
OBJECTIVES 
The objective of this study is to test the effect of provider-direct and patient-directed incentives 
on improving the management of suspected malaria fevers that seek care in the retail sector. 
The ultimate goal of a conditional subsidy scheme is to limit both inappropriate use of ACTs by 
those without a test or with a negative test, as well as to reduce the programmatic cost of ACT 
subsidies by offering them conditionally on a positive test at the point of sale. 
 
 
 
 

 
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11 
3 
STUDY DESIGN 
This will be a four-arm cluster-randomized trial based on an underlying 2x2 factorial design. A 
random sample of 48 PPMVs (clusters) will be selected from a complete sampling frame of all 
eligible outlets and subsequently randomly assigned in a 1:1:1:1 ratio to each of the 4 arms (see 
Table 2).  
 
All clusters (Arm 1-4) will have access to RDTs at the wholesale price that enables the outlet to 
charge the desired retail price. The study will pre-specify the retail price so that it is consistent 
across all the arms and pharmacies and will work with in-country wholesalers to provide RDTs 
at the appropriate price to all participating outlets. In addition, all outlets will be trained on a 
mobile reporting app and asked to use it to record RDT and ACT sales and to facilitate payment 
of financial incentives. The four treatment arms are as follows:  
 
(1) Control (Arm 1): No price subsidy or incentive. RDTs are made available at 
wholesale price to the retail outlet.  
 
(2) Provider-directed intervention (Arm 2): Retail outlet in this arm receives a small 
incentive to perform an RDT for suspected malaria cases  
 
(3) Client-directed conditional ACT subsidy (Arm 3): Clients visiting outlets in this arm 
will receive an ACT discount if they purchase a malaria test and have a positive test 
result.  
 
(4) Combined interventions (Arm 4): Retail outlets in this arm receive an incentive to test 
for malaria and clients visiting these outlets receive an ACT discount conditional on a 
malaria positive test (i.e. this arm is a combination of the provider-directed and client-
directed interventions that are offered in Arm 2 and Arm 3).  
 
Our four-arm study design will allow us to measure the effect of joint incentives to the 
provider and consumer, relative to no incentives and relative to either incentive alone.  
 
Data will be collected by two independent mechanisms – provider reporting and exit 
interviews. First, we will examine routine reporting data submitted via mobile phones using the 
mobile app. All shopkeepers within each enrolled outlet will be trained to use the mobile app 
which reports on volume of clients, number of ACTs or other antimalarials sold, number of RDT 
sold. Data reported through the app will primarily be used to track RDT and ACT sales in real-
time and will be regularly reviewed to track proportion of positive tests, volume of RDTs used, 
and visualization of a random sample of uploaded RDT photos. This routine monitoring will 
detect potential problems (i.e. providers who have unusually high or low test positivity rate, 
problems with RDT interpretation). Problems detected will trigger support supervision and/or 
additional on-the-job training to ensure compliance and quality of diagnosis.  

 
 ____________________________________________________________________________________________ 
12 
Data for our main study outcomes will be collected by exit interviews with customers in order 
to avoid bias that may arise by relying on provider-reported data. In previous retail-sector 
studies, results from exit interviews and provider reports differed significantly, with exit interview 
results considered more reliable [22, 27]. Trained data collectors will approach customers who 
have transacted at the outlet and ask them if they are willing to participate in an exit interview. 
Customers will be eligible if they sought treatment for a febrile illness or malaria-like symptoms 
for themselves or their child, provided the child is present. Exit interviews will be conducted on 
randomly selected days each month and data collectors will be randomly assigned to outlets in 
order to minimize behavior change prompted by the presence of the interviewer. The number of 
days of data collection at each outlet will depend on the sales volume with a target of 10 
participants per outlet per month. Customers will be asked to report whether they had a test, the 
results of the test, and what medicine they purchased.  
Exit interview and provider reporting data will be compared to assess agreement between 
the sources. Specifically, we will compare the following indicators aggregated by outlet: the 
proportion tested, the proportion of tests positive and, the proportion of individuals using ACTs 
by test status (untested, positive or negative).  
The primary outcome will be the proportion of all ACTs that are sold to individuals with a 
positive malaria diagnostic test. The ultimate goal of a conditional subsidy scheme is to limit 
both inappropriate use of ACTs by those without a test or with a negative test as well as to 
reduce the programmatic cost of ACT subsidies by offering them conditionally on a positive test 
at the point of sale. For this outcome, a positive test is anyone who is tested at the outlet and 
receives a positive result or is referred from a health facility or diagnostic lab with a documented 
positive test result. Although all ACTs purchased after a test, whether tested at the outlet, health 
facility or diagnostic lab, are included in the outcome measure, only ACTs purchased following a 
test at the outlet are eligible for the conditional subsidy. Our major secondary outcome is 
proportion of suspected malaria cases that are tested. This outcome will allow us to determine 
whether the conditional subsidy can drive demand for testing. Other secondary outcomes will 
measure 1) adherence to the RDT result among all those tested, 2) proportion of all suspected 
malaria cases that are managed appropriately (tested for malaria, and use ACT following a 
positive test and do not purchase an ACT after a negative test), and 3) ACT use by test status 
(untested, negative, positive). 
 

 
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13 
4 
Study Population 
4.1 
Selection of the Study Population 
All clients attending a participating outlet on the day selected for exit interviews will be eligible to 
be screened for inclusion into the interview sample.   
4.2 
Inclusion/Exclusion Criteria 
INCLUSION CRITERIA: 
- 
Participants with fever, or history of fever in the last 48 hours, or suspects they may have 
malaria 
- 
Individual with malaria-like illness must be present at recruitment 
- 
Older than one year of age 
EXCLUSION CRITERIA:  
- 
Any individual with signs of severe illness requiring immediate referral 
- 
Individuals who have taken an antimalarial in the last seven days, including for the 
current illness 
- 
Patients <18 years without a parent or legal guardian present 
 

 
 ____________________________________________________________________________________________ 
14 
5 
STUDY PROCEDURES/EVALUATIONS 
5.1 
Study Procedures 
PPMV owners will be trained to provide malaria RDTs routinely to clients with malaria-like 
illness who wish to purchase a test. RDTs will be available in all participating PPMVs at the 
same price. Those who do not wish to purchase an RDT are free to conduct their transaction as 
planned.  
The intervention consists of different subsidy schemes (client-facing conditional ACT subsidy or 
provider facing subsidy for RDT). The intervention is applied at the level of the PPMVs (cluster) 
and the effect of the intervention will be measured for a sample of clients served at each cluster 
(PPMV).  
On random days of the month, clients leaving the PPMV will be asked to participate in a brief 
survey. Those who meet the inclusion/exclusion criteria will provide verbal consent before 
responding to questions about their current illness and their decisions regarding testing and 
medicines purchased. The survey will be conducted in one session and last approximately 30 
minutes.  
5.2 
Laboratory Evaluations 
None 

 
 ____________________________________________________________________________________________ 
15 
6 
STATISTICAL CONSIDERATIONS 
6.1 
Study Outcome Measures 
The primary outcome measure is the proportion of selected ACTs3 that are sold to individuals 
with a positive malaria diagnostic test defined as anyone who is tested at the outlet and receives 
a positive test result or is referred from a health facility or diagnostic lab with a documented 
positive test result. 
# 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝 𝑤𝑤ℎ𝑜𝑜 𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝 𝑎𝑎𝑎𝑎𝑎𝑎 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝ℎ𝑎𝑎𝑎𝑎𝑎𝑎𝑎𝑎 𝐴𝐴𝐴𝐴𝐴𝐴
# 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝 𝑤𝑤ℎ𝑜𝑜 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝ℎ𝑎𝑎𝑎𝑎𝑎𝑎𝑎𝑎 𝐴𝐴𝐴𝐴𝐴𝐴
 
Among secondary outcomes, behavior will be measured for individuals who were tested at the 
outlet. Untested clients are those who chose not to be tested and did not come with a test result 
from another facility. The major secondary outcome is the proportion of suspected malaria 
cases that are tested. This outcome will allow us to determine whether the conditional subsidy 
can drive demand for testing. Note that “untested people” here refers specifically to individuals 
that present at the shop without a referral but decline to be tested. 
 
Other secondary outcomes will measure 1) adherence to the RDT result among all those tested 
at the outlet, 2) proportion of all suspected malaria cases that are managed appropriately 
(tested for malaria, and use ACT following a positive test or do not purchase an ACT after a 
negative test), and 3) ACT use by untested clients.  
- Secondary outcome 2: Adherence to the RDT result among all those tested in the shop 
 
 For those who are negative, if they buy any antimalarial (AM), including monotherapies and 
older therapies, they are not adhering to test result. 
- Secondary outcome 3: Proportion of all suspected malaria cases that are managed 
appropriately in the shop 
 
“Untested people” here refers specifically to individuals that present at the shop without a 
referral but decline to be tested 
 
- Secondary outcome 4: ACT use among untested clients 
                                               
3 The selected ACTs represent the most commonly used ACTs used in the PPMVs as determined in a CHAI 
conducted 2019 retail CPM audit of available ACTs in the private retail sector in Lagos, Nigeria. 

 
 ____________________________________________________________________________________________ 
16 
# 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝 𝑤𝑤ℎ𝑜𝑜 𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤 𝑛𝑛𝑛𝑛𝑛𝑛 𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡 𝑖𝑖𝑖𝑖 𝑡𝑡ℎ𝑒𝑒 𝑠𝑠ℎ𝑜𝑜𝑜𝑜 𝑎𝑎𝑎𝑎𝑎𝑎 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝ℎ𝑎𝑎𝑎𝑎𝑎𝑎𝑎𝑎 𝑎𝑎𝑎𝑎 𝐴𝐴𝐴𝐴𝐴𝐴
# 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝 𝑤𝑤ℎ𝑜𝑜 𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤 𝑛𝑛𝑛𝑛𝑛𝑛 𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡 𝑖𝑖𝑖𝑖 𝑡𝑡ℎ𝑒𝑒 𝑠𝑠ℎ𝑜𝑜𝑜𝑜, 𝑑𝑑𝑑𝑑𝑑𝑑 𝑛𝑛𝑛𝑛𝑛𝑛 ℎ𝑎𝑎𝑎𝑎𝑎𝑎 𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑 𝑜𝑜𝑜𝑜 𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡 𝑎𝑎𝑎𝑎𝑎𝑎 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝ℎ𝑎𝑎𝑎𝑎𝑎𝑎𝑎𝑎 𝑎𝑎𝑎𝑎𝑎𝑎 𝐴𝐴𝐴𝐴 
 
For the primary outcome, we include in both numerator and denominator those individuals who 
were referred from a health facility or diagnostic lab with a documented positive test result. That 
is, for the primary outcome we are interested in evaluating the degree to which the interventions 
impacted the purchasing behavior of all suspected malaria cases seeking treatment. Our 
secondary outcomes do not include these individuals (i.e. the outcomes are calculated on the 
subset of individuals that present at the shop for testing without a referral). That is, for the 
secondary outcomes we are specifically interested in evaluating the degree to which the 
interventions impacted purchasing behavior among individuals who present at the shop for 
testing. 
 
6.2 
Sample Size Considerations 
 
Our primary comparison of interest is the effect on targeting of ACTs, offering a 
combination of outlet incentives for testing (provider-directed intervention), and ACT subsidies 
for malaria test-positive clients (client-directed intervention) relative to a control arm where 
outlets are able to offer malaria testing but neither the provider nor the client receives any 
extrinsic incentive to test (Arm 4 versus Arm 1). In order to evaluate whether the client-directed 
intervention and the provider-directed intervention do, in fact, have a synergistic effect on the 
outcome, we also have two secondary comparisons of interest: (1) the combined provider- and 
client-directed interventions relative to the provider-directed intervention alone (Arm 4 versus 
Arm 2) and (2) the combined provider- and client- directed interventions relative to the client-
directed intervention alone (Arm 4 versus Arm 3).  
  
We calculated power based on a cluster randomized two-sample two-tailed t-test for the 
comparison of two proportions using standard formulae [28]. We calculated power for 
differences in our primary outcome for each of the three comparisons of interest noted above. 
To ensure that our overall two-tailed Type I error (alpha) is 5%, we fixed the alpha level at 
1.667% (i.e. 5%/3) for each of the 3 comparisons of interest, using the conservative Bonferroni 
correction [29]. We estimated the intra-class correlation coefficients (ICCs) for the primary 
outcome to be 0.006 in Nigeria.  
 
 

 
 ____________________________________________________________________________________________ 
17 
Our primary outcome—the 
proportion of ACTs that are taken 
by malaria test-positive clients— 
is a combination of the proportion 
of individuals who get tested for 
malaria and the proportion of 
tested individuals who treat 
according to the test result. We 
anticipate that 15% of ACTs will 
be purchased by clients with a 
positive test in the control arm 
(with 85% of ACTs purchased by 
those without a test or with a 
negative test). Moreover, we 
hypothesize that both the 
provider-directed intervention, 
and the client directed 
intervention on their own will only 
increase testing marginally (on 
the order of ~5 percentage 
points), but that among those who do test, the client-directed intervention alone will substantially 
increase the proportion of malaria-positive individuals who take an ACT [30]. As a result, we 
expect that the provider-directed intervention (Arm 2) will have only a small effect on ACT 
targeting, that the client-directed intervention (Arm 3) will have a somewhat larger effect, but 
that the largest effect will come from combining the two interventions (Arm 4) (i.e., we assume a 
statistical interaction). With a sample of 170 exit interviews per outlet (48 outlets in Nigeria), we 
will have >90% power to detect a minimum difference between Arms 1 and 4 in the primary 
outcome of 25 percentage points. We will also have >89% power to detect a minimum 
difference of 16 percentage points for the main secondary comparison of interest (testing 
uptake). 
 
Due to the nature of the interventions, it is not possible to blind participants and the 
implementation team to the allocation received. Data collectors will be blinded throughout 
collection and study statisticians will be blinded during the analysis phase.  
 
6.3 
Participant Enrollment and Follow-Up 
Medicine retail outlets will be eligible if they regularly stock and sell regulatory approved 
ACTs and are licensed medicine outlets. From this roster of all eligible outlets, 56 will be 
randomly selected (8 additional above the required sample size). Of those retail outlets, 48 
outlets will be randomly selected for training and enrollment in the study and will be randomized 
to one of the 4 study arms in a 1:1:1:1 ratio. The remaining 8 outlets will be alternates in the 
event that any of the initial outlets drop out of the intervention. The alternate outlets will also be 
Table 2: Assumptions in Nigeria for sample size calculation for 
Aim 2  
  
Expected 
Percentage of 
ACTs taken by 
Clients Testing 
Positive for 
Malaria 
Power 
 (# of exit 
interviews  
per arm)  
 
  
 
Nigeria 
 (2040) 
Arm 1: Control Arm  
(RDT only, no incentives) 
15% 
>99% 
Arm 2: Provider-Directed 
Intervention (Shopkeeper 
incentives for malaria 
testing) 
17% 
>99% 
Arm 3: Client-Directed 
Intervention (ACT subsidy 
to client conditional on 
positive test) 
26% 
89% 
Arm 4: Combined 
Provider- and Client-
Directed Interventions  
40% 
Ref. Group 

 
 ____________________________________________________________________________________________ 
18 
randomized equally across the 4 study arms (2 alternates per arm per site), but they will not 
undergo training unless they are needed for replacement. 
 
We will retain these enrolled outlets through effective supportive supervision and 
communication between providers at participating outlets and study staff. All outlets will receive 
thorough, in-person training on using the mobile reporting tool, conducting RDTs and overall 
study procedures. They will also receive extra support during the start of the intervention and 
burn in period (3 months), including an initial stock of RDTs provided by the study at no cost. At 
least once per month, the Project Manager, and/or Field Coordinator will visit each outlet in 
person to answer questions, check RDT stock and testing performance, and identify and 
address any problems. Providers will also receive phone calls from the Field Coordinator and 
Project Manager between in-person visits and will themselves be provided with phone numbers 
and encouraged to call the study staff with any questions or concerns. Additionally, outlets will 
be reimbursed promptly to ensure participation in the study presents no financial strain.  
 
In our previous work, we have experience on the retention of outlets in research 
activities and therefore expect attrition of clusters. Should one of the outlets selected choose to 
leave the study within the first 6 months of the intervention, the outlet will be replaced by one of 
the alternate outlets assigned to the same arm. If any outlet chooses to leave the study after the 
first 6 months of the intervention, they will not be replaced because, after joining the intervention 
at such a late stage, a newly added outlet is not likely to be comparable to that of all other 
participating outlets. Changes in the clusters (dropped and/or replaced) will be accounted for in 
the analysis.  
 
Our sample size estimates correspond to a total of 8160 exit interviews with clients. 
Since not everyone interviewed will have purchased an ACT, our estimates account for the fact 
that only a subset will enter into our analysis for the primary outcome.  
6.4 
Analysis Plan 
We will analyze client-level outcomes by fitting a modified Poisson regression model [31, 
32] with log link to estimate risk ratios (RRs) and identity link to estimate risk differences. Such 
an approach assumes a Poisson distribution for the binary outcome and then ‘fixes’ the 
estimated standard errors to correct for model misspecification.  
 
To account for clustering by outlet we will use a generalized estimating equations (GEE) 
[33, 34] approach with exchangeable working covariance matrix and robust standard errors (to 
correct for model misspecification due to specifying a Poisson distribution). The outcome will be 
regressed on three binary indicators for each of the treatment arms 1-3, with treatment arm 4 
(the combined interventions) serving as the reference group. The model will also include a 
vector of potential confounder variables (e.g., age, gender, education, household distance to 
closest health facility, study quarter) to account for possible imbalances between study arms. All 
analyses will be based on the intention-to-treat principle whereby all clients will be included in 
the analysis irrespective of whether they complied with the intervention in the outlet at which 
they sought care (e.g. even if they did not use the ACT subsidy if they tested positive in an 
outlet in Arms 3 and 4 that received the client-directed intervention).  

 
 ____________________________________________________________________________________________ 
19 
 
Given that the literature indicates that when there are fewer than 40 clusters in a cRCT, 
small sample correction methods should be used to ensure that standard error estimates are 
correctly estimated when using GEE to analyze binary outcomes, and given that the size of the 
cRCTs in each country are close to this cut-off, we plan to adopt the use of the Kauerman-
Carroll correction to avoid any possible problems [35, 36]. We will compare secondary 
outcomes using the same modeling approach. 
 
 
 

 
 ____________________________________________________________________________________________ 
20 
7 
SUBJECT CONFIDENTIALITY 
Participant confidentiality will be maintained during and after the interview in several ways: 
- 
The interview will be conducted in a private place where the interview cannot be 
overheard. 
- 
Interviewers will be trained in research integrity and ethics, including protecting 
participant information. 
- 
Informed consent will be conducted verbally, thereby reducing the risk of a breach of 
client confidentiality by eliminating any paper record of clients’ participation in the study 
with signature. 
- 
Data will be collected on tablets which will be encrypted and password protected. 
- 
Individuals will be assigned a unique study ID. No information that could be used to 
identify the participant will be recorded such as names, identification numbers, dates of 
birth or address.  
- 
Anyone older than 80 years of age will be recorded as ‘80.’ 
- 
Data will be transferred from the tablet to a secure, password protected computer once 
per week.  
- 
Data will be stored on an encrypted, password protected computer and backed up on 
Duke Box. The data will only be accessible to the Data Manager and the PI. It will be 
reviewed regularly to ensure quality and completeness. 
- 
Only fully de-identified data will be provided to other study personnel or statisticians. 
Only fully de-identified data will be shared.  
 
 
7.1 Future Use of Stored Specimens 
Not applicable. 
 

 
 ____________________________________________________________________________________________ 
21 
8 
INFORMED CONSENT PROCESS 
Informed consent will be obtained prior to collecting any participant information for research 
purposes. Clients will be approached as they leave the PPMV and asked if they would be willing 
to participate in a brief interview. If so, the interviewer will conduct screening and consent in a 
private area away from other clients. The client will be given time to ask questions and will be 
asked to give verbal consent for the interview, which will be documented by the interviewer. The 
interviewer will explain the purpose of the study, the risks, benefits, and safeguards in place to 
protect the participant’s information. A printed copy of the consent script will be available for 
them to read and to keep. Contact information for the Study Coordinator or PI will be provided 
so the participant can ask questions after the interview.  
No individual identifying information will be collected during the interview, therefore withdrawing 
consent after the interview is closed will not be possible. To mitigate this, the interviewer will 
confirm consent by asking at the end of the survey if the participant is comfortable with all the 
answers and agrees for their information to be retained.  
8.1 
Informed Consent/Assent Process (in Case of a Minor or 
Others Unable to Consent for Themselves) 
 
The study will only enroll minor participants present with a parent or guardian and all questions 
will be directed to the parent/guardian. Therefore, we do not anticipate interacting with minors or 
needing assent from the minor.  
 
We will not enroll individuals who are unable to consent for themselves such as those who are 
mentally impaired or are experiencing impaired consciousness.  

 
 ____________________________________________________________________________________________ 
22 
9 
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26 
SUPPLEMENTS/APPENDICES 
 
Aim 2: TESTsmART Participant exit interview - Screening Questions 
Number QUESTION 
RESPONSE 
SKIP 
0.01 
Did the person meet all of the 
inclusion criteria? 
1. Yes   
2. No 
If yes, skip to 
0.03 
0.02 
If no, why were they excluded 
from participating in the study 
today? (select all that apply) 
1. Person did not have a fever or malaria-
like illness 
2. Patient with malaria-like symptoms not 
present 
3. Patient younger than 1 year of age 
4. Had symptoms of severe malaria and 
referred for care 
5. Took antimalarial in the last seven days 
for current illness 
6. No parent or guardian present 
STOP 
0.03 
Did the person consent to 
participate in the study? 
1. Yes  
2. No 
If No, STOP 
 
 
GENERAL STUDY INFORMATION 
Number QUESTION 
RESPONSE 
SKIP 
0.1 
Date 
MM/YYYY 
 
0.2 
Participant ID 
 
 
0.3 
Outlet ID 
 
 
0.4 
Interviewer ID 
 
 
0.5 
Language of interview 
 1. English 
 2. Yoruba 
 3. Igbo 
 4. Hausa 
 5. Other 
 
 
SECTION 1: RESPONDENT INFORMATION 
Number QUESTION 
RESPONSE 
SKIP 
1.1 
Who is the respondent? 
Adult with fever………………………...1 
Guardian of the child………………….2 
Q1.5 
 
1.2 
What is your relationship with the 
child?  
 
Parent…………………………………..1 
Grandmother/grandfather…………….2 
Brother/Sister………………………….3 
Uncle/Aunt…………………………..…4 
Other……………………………………5 
 

 
 ____________________________________________________________________________________________ 
27 
        Specify:  
1.3 
Gender of the child 
Female…………………………..1 
Male……………………………..0 
 
1.4 
 
 
How old is the child? 
 
      __  ___  .  __ years  
 
1.5 
Gender of the respondent 
Female…………………………..1 
Male……………………………..0 
 
1.6 
How old are you? 
[In the case the child is ill, please 
collect this information for the 
parent/guardian of the child] 
 
  
     _____  _____  years 
 
 
 
SECTION 2:  CURRENT ILLNESS 
 
Number QUESTION 
RESPONSE 
 
SKIP 
2.1 
Which symptoms do you/your child 
have or had in the last 24 hours? 
[Mark all that apply] 
 
1. Fever  
2. Nausea  
3. Headache  
4. Body aches  
5. Vomiting  
6. Shivering  
7. Stomach ache  
8. Other______________________ 
99. Don’t know  
    
2.2 
How serious is this illness in your 
opinion? 
 
[Guardian of the child can guess how the 
child feels]  
1. Not very serious/minor 
2. Moderate 
3. Very serious 
 
 
2.3 
 How many days ago did the symptoms 
start?  
_______days 
99=Don't 
know 
2.4 
How likely is it that the illness that 
you/your child have today is malaria? 
 
1. Not possible  
2. Unlikely but not impossible 
3. 50/50 
4. Likely 
5. Absolutely sure 
99.  Don’t know  
 
2.5  
Have you sought treatment or care 
elsewhere for this illness?  
1. Yes   
2. No 
      99. Don’t know 
If no or 
don’t know, 
go to 3.1 

 
 ____________________________________________________________________________________________ 
28 
2.6 
What did you do? Check all that apply 
1. Buy medicine at general shop  
2. Visit pharmacy/chemist  
3. Visit government health 
center/dispensary 
4. Visit private clinic  
5. Visit hospital  
6. Visit private laboratory  
7. Gave medicine available at home   
8. Visit traditional healers  
9. Visit religious/cultural healers  
10. Visit community health worker  
11. Other_____________________ 
99. Don’t know (i.e., another caregiver 
was involved) 
 
2.7 
Why did you come to this facility? 
1. Treatment was not available in 
other facilities 
2. RDT tests were not available in 
other facilities 
3. It’s the closest chemist shop to me  
4. This chemist shop has better prices 
5. I was referred here for treatment 
99. Don’t know (i.e., another caregiver 
was involved) 
 
2.8 
Did you have a malaria test from 
another provider/facility/lab before 
coming here today? 
1. Microscopy 
2. RDT 
3. Don’t know 
4. No test 
If 4, go to 
3.1 
2.9 
Malaria test results from elsewhere 
1. Negative – report observed 
2. Positive – report observed 
3. Reported negative by respondent 
4. Report positive by respondent 
5. Doesn’t recall result 
 
2.10 
Do you have a copy of the test result? 
1. No, nothing written 
2. Yes  
 
2.11 
Have you taken/given to the child any 
medication for this illness since it 
started?  
1. Yes   
2. No 
99. Don’t know  
If 1, go to 
2.12 
If 2 or 99, 
go to 
Section 3 
2.12 
If so, which medicines (select all that 
apply) 
1. AL (Lonart/CoArtem/Artefan) 
2. Other ACT (DHAP, DP, 
Duocotexin, P-alaxin) 
If 1, 2 or 3 
STOP 

 
 ____________________________________________________________________________________________ 
29 
3. Monotherapy (Artesunate, Quinine, 
Chloroquine, SP/Fansidar) 
4. Antibiotic (Amoxyl/Septrin, 
Metronidazole/Flagyl, Ampicillin) 
5. Painkiller/fever medicine 
(Panadol/Brufen/Hedex/ Action/) 
6. Cough medicine or decongestant 
7. Other________________ 
99. Don’t know 
2.13 
Did you come to the chemist/shop 
today with a prescription from another 
provider/facility/lab?  
1. Yes   
2. No 
 
If 2 skip to 
Section 3. 
2.14 
If yes, what was the prescription for? 
1. AL (Lonart/CoArtem/Artefan) 
2. Other ACT (DHAP, DP, 
Duocotexin, P-alaxin) 
3. Monotherapy (Artesunate, Quinine, 
Chloroquine, SP/Fansidar) 
4. Antibiotic (Amoxyl/Ceptrin, 
Metronidazole/Flagyl/Ampicillin) 
5. Painkiller/fever medecine 
(Panadol/Brufen/Hedex/ 
Action/Maramoja) 
6. Cough medicine or decongestant 
7. Other________________ 
99. Don’t know 
 
 
Section 3: Test at Shop 
 
Number 
QUESTION 
RESPONSE 
SKIP 
3.1 
Did you (or your child) have your blood 
tested for malaria today at the shop? 
1. Yes 
2. No 
If yes skip 
to 3.3 
3.2 
Why not? (Mark all that apply) 
1. Too expensive 
2. RDT was not offered 
3. RDT not in stock 
4. No time 
5. Already sure illness is malaria 
6. Already sure illness is not malaria 
7. Don’t want to get finger pricked 
8. Was tested elsewhere before 
coming 
9. Had a prescription for drug I 
needed before coming  
99. Other 
Next skip to 
section 4 

 
 ____________________________________________________________________________________________ 
30 
                Specify: ________________ 
3.3 
RDT results from shop (self-report) 
1. Negative 
2. Positive 
3. Invalid 
 
3.4 
How much did you pay for the RDT?  
  
__________ Naira 
 
 
Section 4: Purchase Questions 
 
Number QUESTION 
RESPONSE 
SKIP 
4.1 
 
Which medicine(s) did you obtain from 
the shop today to treat your/your child’s 
illness 
Choose all that apply 
1. AL (Lonart/CoArtem/Artefan) 
2. Other ACT (DHAP, DP, 
Duocotexin, P-alaxin) 
3. Other antimalarial (Artesunate 
injection, Quinine, Chloroquine, 
SP/Fansidar) 
4. Antibiotic (Amoxyl/Ceptrin, 
Metronidazole/Flagyl, Ampicillin) 
5. Painkiller/fever medicine 
(Panadol/Brufen/Hedex/ Action) 
6. Cough medicine or decongestant 
7. Other________________ 
8. None 
99. Don’t know 
If 2, 3, 4, 5, 
6, 7 or 99 
Skip to 4.4 
 
If 8, skip to 
5.1 
4.2 
How much did you pay today for the 
ACT? 
   
(The amount refers to how much money 
respondent paid for the ACT. Don’t add 
the amount of the voucher if any was 
used-the amount should be between 0-
5000, or 9999 for don’t know) 
 
 
    
      ACT= ________Naira 
 
OR 
 
      Don’t know/remember…9999 
 
4.3 
How much did you spend at the 
chemist/shop today? (Total cost to 
client including RDT, ACT and any other 
drugs)  
 
      _________ Naira 
 
4.4 
Was there any discount for your ACT at 
the shop today? 
1. Yes  
2. No 
3. Don’t know 
 

 
 ____________________________________________________________________________________________ 
31 
 
4.5 
I would like to record information about 
each drug you purchased today. May I 
see the packaging?  
1. Type _______________ 
2. Brand Name _______________ 
3. Price _______________ Naira 
4. Did participant show you the drug? 
1. Yes 
2. No 
Repeat for 
every drug 
purchased 
for illness 
 
Section 5: Household Characteristics 
 
Number 
QUESTION 
RESPONSE 
SKIP 
5.1 
What is the main source of drinking 
water for your household?   
1. Piped water/Public Tap/borehole  
2. Unprotected well 
3. Protected well 
4. Protected Spring 
5. Unprotected Spring 
6. Surface water (river, dam, lake, 
pond, stream, canal, irrigation 
channel) 
7. Rain water 
8. Bottled water 
9. Other ........................................ 
 
 
 
 
 
 
5.2 
Does your household have the 
following items:  
  
 
a) 
Electricity? 
1. Yes 
2. No 
99. Don’t know 
 
 
b) 
A television? 
1. Yes 
2. No 
99. Don’t know 
 
c) 
A refrigerator? 
1. Yes 
2. No 
     99. Don’t know 
 
d) 
A radio? 
1. Yes 
2. No 
      99. Don’t know 
 
e) 
A mobile phone (at least one member 
of the household has)? 
1. Yes 
2. No 
      99. Don’t know 
 
 
 

 
 ____________________________________________________________________________________________ 
32 
f) 
A motorcycle (at least one member of 
the household has)? 
1. Yes 
2. No 
      99. Don’t know 
 
 
g) 
A car/truck? 
1. Yes 
2. No 
      99. Don’t know 
 
 
h) 
A bank account (at least one member 
of the household has)? 
1. Yes 
2. No 
      99. Don’t know 
 
5.3 
 
How many of the following livestock 
does your household have? 
1. None  
99. Don't know 
 
a) 
Cows 
  
 
b) 
Sheep 
  
 
c) 
Goats 
 
 
d) 
Pigs 
 
 
5.4 
What kind of toilet does your 
household have? 
2. Flush or pour flush toilet  
3. VIP / Ventilated improved pit latrine  
4. Pit latrine with slab  
5. Pit latrine without slab  
6. Composting toilet  
7. Bucket toilet 
8. No facility / bush / field  
9. Other (Please specify): 
____________________ 
 
5.5 
What type of fuel does your household 
mainly use for cooking? 
1. Liquefied petroleum gas 
2. Paraffin/Kerosene 
3. Charcoal 
4. Firewood 
5. Dung 
6. Biogas 
7. Crop residue 
8. Other (Specify)_____________ _ 
 
5.6 
Do you/your family own the house you 
live in? 
1. Own the house 
2. Rent the house 
 
5.7 
What is the main material of the floor in 
your house? 
3. Earthen  
4. Cement 
5. Floor Tiles  
6. Wood planks  
 

 
 ____________________________________________________________________________________________ 
33 
7. Polished wood 
8. Other (please specify) 
______________________ 
5.8 
What is the main material of the walls 
in your house? 
1. Cement  
2. Brick  
3. Timber 
4. Iron Sheet 
5. Mud  
6. Wood  
7. Stone 
8. Other (please 
specify)_____________ 
 
5.9 
What is the main material of the roof of 
your house? 
1. Iron sheets  
2. Roof tiles  
3. Asbestos 
4. Grass Thatched 
5. Wood  
6. Other (please 
specify)______________ 
 
5.10 
How many acres/hectares/feet of land 
for farming does your household own?  
 1.None .............................................. 0 
 2. Acres______ 
 3. Square Feet (xx by xx)_______ 
 
 9999. Don't know 
 
5.11 
What is the highest level of schooling 
you completed?  
[In the case the child is ill, please 
collect this information for the 
parent/guardian of the child] 
1. None 
2. Primary 
3. Secondary 
4. Polytechnic 
5. University 
 
 
 
5.12 
What is your primary occupation? 
In the case the child is ill, please collect 
this information for the parent/guardian 
of the child] 
 
Agriculture 
1. Farming/Livestock keeping 
Paid employee 
2. Government or parastatal 
3. Private (specify: ........................ ) 
Self-employed  
4. With employees 
5. Without employees (e.g. 
motorcycle taxi, vendor) 
6. Unpaid family helper in a business  
Other  
7. Casual worker/day laborer 
8. House help  
 

 
 ____________________________________________________________________________________________ 
34 
9. Homemaker 
10. Student 
11. Not available to work 
12. Other (Specify) ____________