Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial AIM 1
Phase: NA
Conditions: Malaria, Febrile Illness
Sponsor: Duke University

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A randomized experiment of malaria diagnostic testing and 
conditional subsidies to target ACTs in the retail sector: the 
TESTsmART trial AIM 1 
 
NCT03810014 
 
Sponsored by: 
National Institute of Allergy and Infectious Diseases (NIAID) 
 
DMID Funding Mechanism: 
 
 
Principal Investigator: 
Wendy Prudhomme O’Meara 
 
 
Draft or Version Number: version 1.3 
 
Day Month Year 
20 September 2019 
 
 
 

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 i
Statement of Compliance 
 
• 
The study will be carried out in accordance with the principles set forth in The Council for 
International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for 
Biomedical Research Involving Human Subjects.  
• 
All key personnel (all individuals responsible for the design and conduct of this study) have 
completed Human Subjects Protection Training. 

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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. All personnel 
involved in the conduct of this trial will complete prior to their involvement Human Subjects 
Protection Training. 
 
 
________________________________  
 
Principal Investigator, Duke University 
 
 
________________________________  
Signed 
 
 
______________ 
Date 
 
________________________________  
Principal Investigator, Moi University 
 
 
________________________________  
Signed 
 
 
______________ 
Date 
 
________________________________  
Principal Investigator, Clinton Health Access Initiative 
 
 
________________________________  
Signed 
 
 
______________ 
Date

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Table of Contents 
 
 
page 
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Statement of Compliance ............................................................................................................. i 
Signature Page ........................................................................................................................... ii 
List of Abbreviations ................................................................................................................... iv 
Protocol Summary .................................................................................................................. …v 
 
1 
Key Roles ........................................................................................................................... 1 
2 
Background Information and Scientific Rationale................................................................ 1 
2.1 
Background Information .......................................................................................... 3 
2.2 
Scientific Rationale ................................................................................................. 4 
2.3 
Potential Risks and Benefits ................................................................................... 5 
2.3.1 Potential Risks ............................................................................................ 5 
2.3.2 Known Potential Benefits............................................................................. 6 
3 
Objectives .......................................................................................................................... 7 
4 
Study Design ...................................................................................................................... 7 
5 
Study Population .............................................................................................................. 10 
5.1 
Selection of the Study Population ......................................................................... 10 
5.2 
Inclusion/Exclusion Criteria ................................................................................... 10 
6 
STUDY PROCEDURES/EVALUATIONS ......................................................................... 11 
6.1 
Study Procedures ................................................................................................. 11 
6.2 
Laboratory Evaluations ......................................................................................... 11 
6.2.1 Laboratory Evaluations/Assays ................................................................. 11 
6.2.2 Specimen Collection, Preparation, Handling and Shipping ........................ 12 
7 
Statistical Considerations ................................................................................................. 13 
7.1 
Study Outcome Measures .................................................................................... 13 
7.2 
Sample Size Considerations ................................................................................. 13 
7.3 
Participant Enrollment and Follow-Up ................................................................... 15 
7.4 
Analysis Plan ........................................................................................................ 15 
8 
Subject Confidentiality ...................................................................................................... 17 
8.1 
Future Use of Stored Specimens .......................................................................... 17 
9 
Informed Consent Process ............................................................................................... 18 
9.1 
Informed Consent/Assent Process (in Case of a Minor or Others Unable to 
Consent for Themselves) ...................................................................................... 18 
10 
Literature References ....................................................................................................... 19 
 
SUPPLEMENTS/APPENDICES 
A.1 Informed consent for participation in TESTsmART Aim 1 (English and Kiswahili) 
A.2 Questionnaire for participants 

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List of Abbreviations 
 
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ACT 
AE 
Artemisinin Combination Therapy 
Adverse Event 
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 
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 
RA 
RD 
RDT 
RR 
Principal Investigator 
Research Assistant 
Risk Difference 
Rapid Diagnostic Test 
Risk Ratio 
SAE 
Serious Adverse Event 
SMC 
Safety Monitoring Committee 
SOP 
USAID 
Standard Operating Procedure 
United States Agency for International Development 
WHO 
World Health Organization 
 

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Title: 
A randomized experiment of malaria diagnostic testing and conditional 
subsidies to target ACTs in the retail sector: the TESTsmART trial AIM 1 
 
Population: 
We will enroll 840 participants and allocate them to four arms in equal 
proportions. Participants who are seeking treatment for acute, malaria-like 
illness will be recruited at medicine retail outlets in western Kenya. 
Eligible participants are >1 year of age seeking treatment for themselves 
or present with their parent/guardian at the time of recruitment. Individuals 
with signs of severe disease will not be eligible 
 
Number of Sites: 
Webuye West, Webuye East and Kiminini in western Kenya. 
 
Study Duration: 
12 months 
 
Subject Duration: 
30-45 minutes. Cross-sectional study with no follow-up 
 
 
Objectives: 
This objective of this experiment is to identify the combination of RDT and 
conditional (diagnosis-dependent) ACT subsidies that maximize the 
percent of clients receiving an RDT. We will test two different RDT price 
levels and two discounted ACT price levels in a factorial design. ACT 
discounts are conditional on a positive RDT result.  
The primary outcome measure is the decision to purchase an RDT 
before purchasing a drug.  
Secondary outcome measures are:  
1. 
Decision to purchase an ACT stratified by testing status 
a. Positive mRDT 
b. Negative mRDT 
c. No malaria test 
 
All outcomes will be measured by interviewing the participant after they 
make their decision about whether to be tested and which medicines to 
purchase.  
 
 
 

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1 
KEY ROLES 
For questions regarding this protocol, contact (insert name of DMID Protocol Champion or other 
appropriate DMID staff) at NIAID/DMID (insert contact information). 
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 
 
Jeremiah Laktabai, PhD 
Lecturer, Department of Medicine, Moi University School of Medicine 
P.O. Box 4605-30100 MTRH Complex, Nandi Road, Eldoret, Kenya 
FAX: +254 532 061 992 
PHONE: +254 722 685 542 
jlaktabai@gmail.com 
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 
 

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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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2 
BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE  
2.1 
Background Information  
Artemisinin combination therapies (ACTs) – the WHO-recommended first line therapy for 
uncomplicated malaria – have played a significant role in reducing global malaria mortality1, 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 consumed2. 
Approximately 75% of global ACT demand is subsidized with international public funds from 
sources such as The Global Fund, DFID, and USAID3. 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 
and contributes to population-wide drug pressure that accelerates the spread of drug 
resistance4-8.  
 
Global over-consumption of ACTs is driven in large part by its increased distribution 
over-the-counter in private retail outlets as a result of publicly-funded subsidies directed to the 
private sector9. In 2015, 44% of all donor-funded ACTs consumed world-wide were 
distributed through the private retail sector where studies have shown that between 65-91% 
of ACTs dispensed for malaria are actually purchased by people without malaria10-13. 
Malaria diagnostic testing is uncommon in the retail sector; fewer than 1 in 10 suspected cases 
are tested10. In the absence of parasitological testing, distinguishing fevers due to malaria from 
those due to other causes in not possible based on clinical presentation, and most fevers in 
malaria-endemic areas are assumed to be malaria-associated. As a result, presumptive 
treatment is prevalent and targeting ACTs to individuals with malaria infection is extremely poor.  
 
 
Point-of-care malaria rapid diagnostic tests (RDTs), which have excellent sensitivity and 
specificity and are simple enough to be used by trained laypersons14, could expand the reach of 
diagnostics into the retail sector and help improve the rational use of antimalarials.  
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 discretion15,16. More 
often, outlets were required to provide testing free of charge or at a low fixed price and 
instruction to the outlet was quite rigid regarding when an RDT should be performed and an 
ACT should be dispensed17-20. Providers were not explicitly incentivized to conduct RDTs.  
 
All 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 tested21. Adherence to a negative malaria test was 

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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 ACT21. Against this highly 
heterogeneous landscape of RDT implementation in the private retail sector, a few key lessons 
emerge. First, uptake of ACT is sensitive to the price of the drug22; subsidies are necessary to 
ensure malaria-positive customers purchase an ACT even though higher prices could 
discourage malaria-negative clients from taking the drug. Second, uptake of RDTs appears to 
be more sensitive to price than uptake of ACT22. Patients are not willing to pay much to confirm 
a disease they often think they can diagnose themselves23. Third, uptake of RDTs may also be 
sensitive to the price of the ACT, indicating that the relative price of the two commodities is 
important24. Finally, fixed low prices of RDTs or ACTs are not sufficient to ensure adherence to 
test results21,24. 
 
In studies of RDT implementation in retail outlets, uptake of testing is sensitive to the 
relationship between the price of the test and the price of the ACT. As the price of the RDT 
relative to that of the ACT increases, testing rates drop precipitously. If the price ratio is high, 
customers will forgo the RDT and simply purchase an ACT, given its lower relative price. 
Qualitative studies in Uganda confirm that clients with limited resources prefer to spend money 
on drugs and prioritize testing only when presumptive treatment with the drug has failed25. If the 
price of the ACT is higher than the RDT, then the investment in the RDT becomes a useful tool 
for discriminating between (more expensive) treatment options. When the price of the RDT is 
reduced to about a third of the cost of the ACT, uptake increases considerably. Our own work 
has shown that reducing the cost of the RDT from 40 Ksh (~$0.50, the unsubsidized price) to 0 
Ksh (fully subsidized) increases uptake by 25 percentage points26. However, there is limited 
evidence to guide joint implementation of these commodities and to identify relative subsidy 
levels to maximize impact and minimize wastage. Since high malaria testing rates are a 
necessary pre-condition for ensuring that ACTs are targeted appropriately, we focus on 
identifying the combination of RDT and ACT subsidies that maximizes the percent of 
clients receiving an RDT, given a set amount of public funds earmarked to provide subsidized 
malaria commodities.  We hypothesize that ACT subsidies that are conditional on the client 
receiving a malaria positive test can increase the uptake of malaria testing in the retail sector, 
while minimizing wastage of public funds.  Furthermore, we hypothesize that while the uptake of 
testing will be sensitive to both the prices of the RDT and the ACT, a 50% subsidy on the RDT 
price will result in greater uptake of testing than increasing the subsidy on an ACT (conditional 
on a positive malaria test result) from 67% to 100%.  
 
2.2 
Scientific Rationale  
We have chosen to conduct this study in Kenya for two main reasons. First, RDTs are not 
currently used in the retail sector in Kenya. Therefore, individuals presenting to an outlet for 
their illness would not have a prior expectation about receiving a test or have made a prior 
decision about whether they would like to receive a test. They will not have preconceived ideas 
about how much they should pay for an RDT. We would like to understand decision-making in 
the presence of a new tool (RDT) in a ‘naïve’ system.  

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Second, Kenya has maintained stable retail ACT prices for nearly five years. Although these 
prices are subsidized they are still likely to be a significant expense for households in the area. 
This offers two advantages – first, individuals know how much they expect to pay for an ACT 
before coming to the outlet and second, the ACT discounts we will offer (conditional on a 
positive test) are expected to be attractive to the customer (ie non-negligible). 
Researchers have previously developed a theoretical framework of the decision-making 
behavior of individuals purchasing subsidized RDTs and anti-malarials. They performed a 
simulation of the model, with a range of estimated values for each of the parameters to predict 
the optimal subsidy levels for both ACT and RDTs. However, the predictions of the model 
depend crucially on individual beliefs that remain unknown: about the likelihood their illness is 
malaria, whether malaria diagnostic test results are correct, and about the effectiveness of the 
available anti-malarial treatments. This study provides a platform to empirically measure the 
decision-making behavior of clients under different subsidy programs, thus testing the validity of 
the model which could then be extrapolated to other contexts. 
2.3 
Potential Risks and Benefits 
2.3.1 Potential Risks 
The intervention proposed is a subsidy for diagnostic testing and the use of a 
conditionally subsidized ACTs in case of a positive test. The subsidy for testing will vary across 
clients but they can choose whether or not to use a test once they are enrolled and receive a 
subsidy offer. The subsidized ACT is offered only to patients with a positive test but, once again, 
the client is free to choose whether or not to use it. 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 at the subsidized price, 
and whether to buy an ACT either at the subsidized price (if they test positive for malaria) or at 
the regular price (if they do not get tested or if they test negative). There is a small risk of breach 
of confidentiality of this information.  
The RDTs to be used in this study are the same brand and test as those used by the 
Government of Kenya in public health facilities and in their community-based case management 
for malaria. Conducted properly, finger-sticks pose no greater than minimal risk to participants, 
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 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. Study research assistants will be 
responsible for conducting RDTs and have been extensively trained in RDTs and dried blood 
spot collection. They have more than seven years of experience and have tested more than 
1,000 people each. They are required to maintain updated CITI certificates and GCP training. 

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Study staff will be required to carry an identification certifying them as trained in RDT use. Study 
participants will be advised to contact the study coordinator, or to visit the closest health facility, 
in the case of any adverse events which may occur after the visit. All participants will be advised 
to go to a health facility if symptoms persist. 
No venous blood will be drawn.  
2.3.2 Known Potential Benefits 
There is significant benefit to the client to 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.  
 
More broadly, there are important future benefits to rigorous testing of subsidy 
schemes that promote testing before treatment. This work will contribute to evidence-based 
policy making, improved access to malaria diagnosis and ultimately reduced potential for spread 
of antimalarial resistance.  
 

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3 
OBJECTIVES 
This objective of this experiment is to identify the combination of RDT and conditional 
(diagnosis-dependent) ACT subsidies that maximize the percent of clients receiving an RDT. 
We will test two different RDT price levels and two discounted ACT price levels in a factorial 
design. ACT discounts are conditional on a positive RDT result.  

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4 
STUDY DESIGN 
The study will be carried out in a random sample of 10 retail outlets that carry ACTs in the 
study area in western Kenya.  The study population will be any individual presenting to the 
outlet with a malaria-like illness on randomly selected days. Children are eligible to be enrolled 
provided they are physically present and are accompanied by a parent or legal guardian. A 
research assistant will offer eligible participants a scratch card with a secret subsidy offer that 
will be revealed after the participant is enrolled. Using the scratch card, the participants will be 
randomized, in a 1:1:1:1 ratio, to one of four study arms shown in Table 1.  
The research assistant will conduct RDTs for participants who choose to purchase an RDT. 
They will explain the results of the RDT to the participant, indicating whether the individual has 
malaria or not based on the test result. If the result is positive, the participant is entitled to an 
additional discount on their ACT purchase according to their scratch card. If the result is 
negative, the participant may purchase any medicine they choose, including an ACT at market 
price. Those who opt not to purchase an RDT may continue with their transaction as they 
choose, including purchasing a full-price ACT.  
The participant will be interviewed before they scratch their card to record their symptoms, 
age, actions taken prior to coming to the outlet, and their experience with RDTs and ACTs in the 
past. We will also ask what drug they intend to buy when coming to the outlet. After they scratch 
the card and complete their transaction at the outlet (including purchasing an RDT if they 
choose), they will be interviewed again briefly to see what drugs they purchased. All scratch-
card recipients will be interviewed regardless of whether or not they used their randomized offer. 
The two interviews combined will take approximately 20-30 minutes.   
The primary outcome for this study is the customer’s decision to purchase an RDT (yes/no). 
Using the 2x2 factorial design we will separately evaluate the effect of RDT price (2 levels: 50% 
vs. 0% subsidy) and of conditional ACT subsidies (2 levels: 100% vs. 67% subsidy) on the 
primary outcome of 
testing uptake. A 
factorial design is 
optimal when we are 
interested in the 
independent effects of 
two interventions, in this 
case, the two types of 
subsidies. A 67% 
discount for an ACT 
gives the following price 
to the consumer for 
each age-specific dose 
based on current 
market price: 6 tablets – 
$0.10; 12 tablets - $0.15; 18 tablets - $0.20; 24 tablets - $0.40. 
 
ACT Price to client if he/she 
tests positive for malaria  
(Price for RDT negative or 
untested client = $1.20) 
 
RDT Price to client  
Overall 
Proportion 
Tested* 
I.  
$0.20 USD 
(50% subsidy) 
II. 
$0.40 USD  
(No Subsidy) 
I.     $0 USD (100% subsidy) 
85% 
70% 
77.5% 
II.   $0.10-0.40 USD (67% 
subsidy) 
75% 
60% 
67.5% 
Overall Proportion Tested* 
80% 
65% 
 
* Assuming the same sample size in each of the 4 study arms 
** At current market prices, this subsidy level gives the following prices to 
the consumer: 6 tablets@$0.10; 12 tablets@$0.15; 18 tablets@$0.20; 24 
tablets@$0.40.  

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Secondary outcomes include adherence to the RDT test result (defined as using an ACT if 
positive and using another drug if negative) and purchase of regular price ACT without a test.  
Due to the short time frame of recruitment (i.e. before entering outlet) to data collection (i.e. after 
leaving outlet), we do not anticipate missing outcome data. 
 

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5 
Study Population 
5.1 
Selection of the Study Population 
The study population will be any individual coming to a participating medicine retail outlet to 
purchase medicine for an acute, malaria like illness. Ten randomly selected retail medicine 
outlets in the study area will be selected for recruitment, which will happen on random days of 
the month to avoid individuals seeking to be recruited.  
840 participants will be recruited and randomly assigned in equal numbers to each of four arms 
using secret scratch cards. Children are eligible to participate if they are present with a parent or 
guardian. Inclusion of children ensures that we get a comprehensive picture of malaria infection 
and treatment decisions across all age groups. Children are at higher risk of malaria infection 
and disease which increases their importance to the study. They will also benefit from the 
opportunity to receive diagnostic testing immediately at the retail outlet, and they, along with 
their parent or guardian, can use the test results in deciding what drugs to purchase or other 
treatment actions to take. We will attempt to recruit all eligible participants who attend the outlet 
on a recruitment day. This will ensure that our sample is representative of the population 
seeking care in retail outlets in terms of age, gender and ethnicity. We do not have targets for 
recruitment based on gender, age or ethnicity.  
5.2 
Inclusion/Exclusion Criteria 
INCLUSION CRITERIA: 
- 
Participants with fever, or history of fever, 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 
- 
Individuals who already have a prescription from a facility or medical provider, 
regardless of whether they have documentation of a test 
- 
Pregnant women will be enrolled and offered an mRDT, but will be advised to seek 
treatment through a health care provider.  

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6 
STUDY PROCEDURES/EVALUATIONS 
6.1 
Study Procedures 
Potential participants will be approached when they visit a participating medicine retail 
outlet. The research assistant will ask whether they are seeking medication for themselves 
or an individual present at the time of screening and whether they (or the minor child) have 
had fever or malaria-like symptoms in the last 24 hours. If so, then the RA will ask whether 
they would like to have more information about the study. Following informed consent, the 
RA will ask questions about the current illness, any medications taken before coming to the 
outlet, symptoms, and their familiarity with malaria diagnostic tests. After taking the basic 
history, they will be offered a scratch card. The cards mask the arm assignment. The 
participant selects their card and then scratches the panel to reveal their assignment. Once 
their price levels have been explained, they will be asked to choose whether they wish to 
have a malaria diagnostic test at the price indicated on the card. If they wish to be tested, 
the RA will perform the mRDT and explain the results to the participant. The mRDT is a 
simple immunochromatographic test which requires a drop of blood (approximately 5 
microliters) and the results are visible in 15 minutes. In the case of a positive test, the RA 
will instruct the participant to take the positive test and the scratch card to the shopkeeper in 
exchange for a discounted ACT. The price of the ACT for participants with a positive test will 
be determined by their arm assignment. Individuals with a negative test or who choose not 
to have a test can purchase an ACT at the normal retail price. After the participant has made 
a selection and purchased medicine for their illness, the RA will record the final treatment 
decisions.  
The encounter should take no more than 45 minutes including consenting, enrollment and 
mRDT. All responses will be recorded directly onto electronic forms running on android 
tablets. Electronic forms are pre-programmed with data quality checks to prohibit missing 
data or values out of range and pre-coded responses to ensure consistency and quality of 
data collection.  
6.2 
Laboratory Evaluations 
6.2.1 Laboratory Evaluations/Assays 
A single drop of blood will be collected from a finger prick. All research assistants 
are extensively trained in blood safety and specimen collection and have 
performed hundreds of RDTs. Finger prick blood samples will be collected using 
aseptic technique under strict protocols for participant and staff safety (see 
Section 2.3.1). 
 

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6.2.2 Specimen Collection, Preparation, Handling and Shipping 
6.2.2.1 
Instructions for Specimen Preparation, Handling, and Storage 
Not applicable 
6.2.2.2 
Specimen Shipment 
Not applicable 

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7 
STATISTICAL CONSIDERATIONS 
7.1 
Study Outcome Measures 
The primary outcome measure is the decision to purchase an RDT before purchasing a drug.  
Secondary outcome measures are:  
2. Decision to purchase an ACT stratified by testing status 
a. Positive mRDT 
b. Negative mRDT 
c. No malaria test 
7.2 
Sample Size Considerations 
Our sample size calculations are based on the expected changes in testing uptake with 
each of the price changes for the two commodities (RDT and ACT). We expect that reducing the 
price of the RDT from $0.40 USD to $0.20 will increase the percentage of clients who choose to 
get tested by 15 percentage points. We also expect that reducing the ACT price, conditional on 
a positive test result, from $0.40 to $0.00 will increase the uptake of testing by 10 percentage 
points (see Table 2).  
 
As is commonly done for 2X2 factorial trials that seek to separately test for main effects 
of each of the two factors, our study is powered to detect the effects of the price reductions of 
each commodity (RDT and ACT) independent of the price of the other commodity. That is, for 
the purposes of our power calculations we assume no statistical interaction between the two 
commodities because our previous evidence suggests that any interaction effects between the 
prices in the two commodities are likely to be small and therefore not large enough in terms of 
public health importance to choose to power on such interactions2. That is, while we expect the 
uptake of testing to be sensitive to the price of both the RDT and the ACT, we do not expect that 
price changes in one commodity will have a different effect on testing uptake depending on the 
price of the other commodity.  
 
Using a standard approach based on a two-sample Z-test for a comparison of 
proportions for each of the two main effects at a two-tailed 5% Type 1 error rate (alpha), our 
sample size should provide 90% power to detect each of our two comparisons of interest (i.e. 
two main effects). To determine the overall sample size of the study, we calculate the sample 
size needed for each of the two main comparisons of interest, and choose the larger overall 
sample required (see Table 2). Specifically, because we estimate that we need a total sample 
size of 838 participants (i.e. of 418 participants at each of the two conditional ACT price levels) 
to test for the main effect of the conditional ACT subsidy price levels compared to a total sample 
size of 374 (i.e. of 187 at each of the two RDT price levels) to test for the main effect of the RDT 

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price levels, we therefore plan the study by using the more restrictive sample size in order to be 
able to address both study goals. Given that the trial will be conducted within 10 drug retail 
outlets, there could be clustering of outcomes due to some participants being enrolled from the 
same shops. Based on our ongoing work in the region, we expect such clustering to be minimal 
with an intra-class correlation coefficient of at most 0.008. Even with this level of clustering, we 
would still have at least 80% power to detect our expected effect sizes. The sample size 
calculations were performed in Excel.  
 
Since clients generally enter the shop one at a time, we do not expect there to be any 
spillovers between the treatment arms (i.e. we do not expect that offering a client one 
combination of subsidies will affect the decision-making of a client assigned to another 
treatment arm within the same shop). Moreover, since the study will be administered by the 
research assistant (and not the shopkeeper), this should minimize the concern that individual 
testing decisions might be influenced by the shopkeeper. The interventions will be randomized 
at the individual level which reduces the likelihood that clients will visit specific retail outlets in 
order to get the highest subsidy levels of the two commodities. 
 
Each client who consents to be part of the study will receive a scratch card that will indicate their 
intervention arm (i.e. the combination of prices at which they will be offered an RDT and ACT, 
conditional on a positive result on the RDT). We will stratify on retail outlet to ensure that each 
of the 10 outlets has a similar number of clients who are assigned to the four study arms 
(approximately 21 per arm, per retail outlet for a total sample of 210 per arm). Scratch cards will 
be allocated in batches of 100 or 60 (25 of each or 15 of each arm) and shuffled thoroughly. 
Batches will be assigned to specific outlets based on sales volume (i.e., higher-volume outlets 
received larger batches of 100 cards, smaller outlets received batches of 60 shuffled cards). 
Participants will be asked to select a card from the shuffled stack. Cards will be replenished 
when ten were remaining. Due to the nature of the interventions, it is not possible to blind 
participants and research assistants to the allocation received. Study statisticians will be blinded 
during the analysis phase.  
 
Description of Comparison 
Expected Increase 
in Testing Uptake 
Total sample size required 
for 90% power (alpha=0.05) 
Effect of reducing conditional ACT 
price from $0.40 (67% subsidy) to 
$0.00 (100% subsidy) 
10 percentage points 
(from 67.5% to 
77.5%) 
838 
 
Effect of reducing RDT price from 
$0.40 (no subsidy) to $0.20 (50% 
subsidy) 
15 percentage points 
(from 65% to 80%) 
374 
Table 2: Expected effect sizes for the main comparisons of interest and sample size required for 90% 
power to detect those effect sizes (with two-tailed Type 1 error set at 0.05, and using standard methods 
for two-sample comparison of proportions).  

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7.3 
Participant Enrollment and Follow-Up 
 
We will enroll 840 participants attending a random sample of 10 retail medicine outlets. 
 
We will develop a sampling frame of all eligible retail medicine outlets by visiting all 
outlets within our study area. Outlets will be included in the sampling frame if they: 1) are within 
the study area; 2) carry quality assured (WHO-approved) ACTs; 3) are registered with the 
Kenya Pharmacy and Poisons Board; 4) would be willing to participate including selling ACTs at 
the subsidized price for study participants with a positive RDT. From this roster of all eligible 
outlets, 12 will be randomly selected. The first ten will be approached to request their 
participation. If any refuse or drop out, the two alternate outlets will replace them. We expect 
dropout to be minimal given that the role of the outlet/attendant is very minimal and the 
enrollment phase is very short. We expect enrollment to take less than 6 months, with each 
shop contributing data only a few days per month.  
 
On the randomly selected dates for study implementation at each outlet, a research 
assistant stationed outside the outlet will approach potential participants as they enter the outlet 
to ask if they would like to hear about the study and would consider participating. Any individual 
that is over the age of one year and has malaria-like symptoms will be eligible to participate. 
Once enrolled, participants’ involvement with the study consists of just one short interview 
before scratching off their card or transacting at the outlet and one short interview as they leave 
the outlet after completing their transaction. Following the second interview, participation in the 
study is complete. All participants will be informed of the duration of their participation 
(approximately 30 minutes) at the time of consent. Therefore, we expect loss to follow-up to be 
minimal, if any. If a participant is enrolled but withdraws before randomization, they will be 
replaced. If they withdraw before the exit interview but after randomization, we will at least have 
information on the primary outcome (tested or not tested with an RDT).  
.  
7.4 
Analysis Plan 
All outcomes will be binary (e.g. tested – yes/no) and will be analyzed using a modified 
Poisson regression model27,28 with log link to estimate risk ratios (RRs) and identity link to 
estimate risk differences (RDs) in order to provide both relative and absolute measures of 
intervention effect. Such an approach assumes a Poisson distribution for the binary outcome 
and then ‘fixes’ the estimated standard errors to correct for model misspecification. We minimize 
clustering of outcomes by outlet with highly controlled intervention delivery and careful outcome 
measurements by research assistants. However, to account for possible clustering due to 
multiple individuals being randomized within different (randomly-sampled) outlets we will use a 
generalized estimating equations (GEE) approach with exchangeable working covariance 
matrix, Kauerman-Carroll correction and robust standard errors (to correct for model 
misspecification due to specifying a Poisson distribution)29,30. The outcome will be regressed on 

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2 binary indicators, one each for the higher subsidy level of the two subsidies (50% RDT 
subsidy and 100% ACT subsidy), together with their interaction and a vector of potential 
confounder variables (e.g., age, gender) to account for possible imbalances between study 
arms. Although we hypothesize that there will be no evidence of a (statistical) interaction (see 
Sample Size details above), we will test for this interaction and, if significant, will separately 
report the effects of each subsidy conditional on levels of the other subsidy. In the absence of 
an interaction, we will estimate the overall ACT subsidy effect and the overall RDT subsidy 
effect by taking relative contrasts from the model. 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. 

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8 
SUBJECT CONFIDENTIALITY  
Participants will be consented and tested in a private area near the shop or private office inside 
the shop if available. Enrollment interview data will be collected electronically on password-
protected secure tablets and uploaded onto secured machines in the study office. No 
information that could positively identify an individual in the database, such as phone number, 
address, date of birth, or names will be collected on the tablet. Anyone older than 80 years of 
age will be recorded as ‘80’. Individuals in the database will be assigned a unique study ID. 
Signed consent forms will be locked in a secure cabinet in the office and only the project 
coordinator will have access to the key.  
 
Despite the aforementioned protections, there is a small risk of breach of client confidentiality if 
consent forms are viewed by someone external to the study team. However, since no identifying 
information will be stored with the health data, health information will be protected and cannot 
be linked to participants. Project staff will keep their human subjects training certificates up to 
date and will be instructed on the protocol with regards to confidentiality of human subjects data 
as relevant according to their job duties. 
8.1 
 Future Use of Stored Specimens 
Not applicable. 

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9 
INFORMED CONSENT PROCESS 
All participants enrolled in Aim 1 will be asked to give written informed consent with their 
signature or thumbprint before any data is recorded. On the randomly selected dates for study 
implementation at each outlet, a research assistant stationed outside the outlet will approach 
potential participants as they enter the outlet to ask if they would like to hear about the study 
and would consider participating. Any individual that is over the age of one year and has 
malaria-like symptoms will be eligible to participate. Parents or guardians of children under the 
age of 18 (the age of consent in Kenya) will be asked to consent for minors. In addition, verbal 
assent from children over the age of ten years will be required in conjunction with written 
parental consent. The study procedures will be explained, including the risks and benefits. 
Potential participants will be informed that their participation is voluntary and there will be no 
negative consequences should they choose not to participate. Consent will be obtained in as 
private an area as possible inside or nearby outside the retail outlet. Children will be assented 
with their guardian present. Participants will be informed that they may withdraw consent at any 
time during the study. A copy of the consent script will be available for each participant if they 
desire and will include study contact information. Once enrolled, participants’ involvement with 
the study consists of just one short interview before scratching off their card or transacting at the 
outlet and one short interview as they leave the outlet after completing their transaction. All 
participants will be informed of the duration of their participation (approximately 30 minutes) at 
the time of consent. 
9.1 
Informed Consent/Assent Process (in Case of a Minor or 
Others Unable to Consent for Themselves) 
Children are eligible to be enrolled provided they are physically present at enrollment and are 
accompanied by a parent or legal guardian. Minors will be defined as children under eighteen 
years of age. The assent process for minors will be to obtain consent from the minor’s parent or 
guardian for the participation of the minor and verbal informed assent from minors over ten 
years old. 
 
All study staff will be trained in human subjects’ protections, including how to explain the study 
appropriately to both children and parents/guardians and the correct procedures for obtaining 
assent and consent for study participation. Our study staff have many years of experience 
performing and training others to conduct RDT for both children and adults outside of formal 
clinic settings as part of other large trials conducted by the PI. During trainings for this study, 
they will review differences in care and patience required when performing RDTs for children. 
 

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10 
LITERATURE REFERENCES 
1. Gething, P.W., D.C. Casey, D.J. Weiss, D. Bisanzio, S. Bhatt, E. Cameron, K.E. Battle, 
U. Dalrymple, J. Rozier, P.C. Rao, M.J. Kutz, R.M. Barber, C. Huynh, K.A. Shackelford, 
M.M. Coates, G. Nguyen, M.S. Fraser, R. Kulikoff, H. Wang, M. Naghavi, D.L. Smith, 
C.J. Murray, S.I. Hay, and S.S. Lim, Mapping Plasmodium falciparum Mortality in Africa 
between 1990 and 2015. N Engl J Med, 2016. 375(25): p. 2435-2445. 
2. World Health Organization, World Malaria Report 2016. 2017: Geneva. 
3. Unitaid, GLOBAL MALARIA DIAGNOSTIC AND ARTEMISININ TREATMENT 
COMMODITIES DEMAND FORECAST; 2017 – 2020, World Health Organization, 2017. 
4. Opoka, R.O., Z. Xia, P. Bangirana, and C.C. John, Inpatient mortality in children with 
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Pediatr Infect Dis J, 2008. 27(4): p. 319-24. 
5. Lindblade, K.A., M.J. Hamel, D.R. Feikin, F. Odhiambo, K. Adazu, J. Williamson, J.M. 
Vulule, and L. Slutsker, Mortality of sick children after outpatient treatment at first-level 
health facilities in rural western Kenya. Trop Med Int Health, 2007. 12(10): p. 1258-68. 
6. Nsanzabana, C., I.M. Hastings, J. Marfurt, I. Muller, K. Baea, L. Rare, A. Schapira, I. 
Felger, B. Betschart, T.A. Smith, H.P. Beck, and B. Genton, Quantifying the evolution 
and impact of antimalarial drug resistance: drug use, spread of resistance, and drug 
failure over a 12-year period in Papua New Guinea. J Infect Dis, 2010. 201(3): p. 435-
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7. Hastings, I.M., Modelling parasite drug resistance: lessons for management and control 
strategies. Tropical Medicine & International Health, 2001. 6(11): p. 883-890. 
8. O'Meara, W.P., D.L. Smith, and F.E. McKenzie, Potential impact of intermittent 
preventive treatment (IPT) on spread of drug-resistant malaria. PLoS Med, 2006. 3(5): p. 
e141. 
9. Cohen, J.M., A.M. Woolsey, O.J. Sabot, P.W. Gething, A.J. Tatem, and B. Moonen, 
Public health. Optimizing investments in malaria treatment and diagnosis. Science, 
2012. 338(6107): p. 612-4. 
10. Organization, W.H., World Malaria Report 2015. 2016: Geneva. 
11. Mbonye, A.K., S. Lal, B. Cundill, K.S. Hansen, S. Clarke, and P. Magnussen, Treatment 
of fevers prior to introducing rapid diagnostic tests for malaria in registered drug shops in 
Uganda. Malar J, 2013. 12: p. 
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12. Briggs, M.A., A. Kalolella, K. Bruxvoort, R. Wiegand, G. Lopez, C. Festo, P. Lyaruu, M. 
Kenani, S. Abdulla, C. Goodman, and S.P. Kachur, Prevalence of malaria parasitemia 
and purchase of artemisinin-based combination therapies (ACTs) among drug shop 
clients in two regions in Tanzania with ACT subsidies. PLoS One, 2014. 9(4): p. e94074. 
13. Nwokolo, E., C. Ujuju, J. Anyanti, C. Isiguzo, I. Udoye, E. Bongos-Ikwue, O. Ezire, M. 
Raji, and W.A. Oyibo, Misuse of Artemisinin Combination Therapies by Clients of 
Medicine Retailers Suspected to Have Malaria Without Prior Parasitological 
Confirmation in Nigeria. International Journal of Health Policy and Management, 2017. 
6(x): p. 1-12. 
14. Boyce, M.R. and W.P. O'Meara, Use of malaria RDTs in various health contexts across 
sub-Saharan Africa: a systematic review. BMC Public Health, 2017. 17(1): p. 470. 
15. Cohen, J., G. Fink, K. Maloney, K. Berg, M. Jordan, T. Svoronos, F. Aber, and W. 
Dickens, Introducing rapid diagnostic tests for malaria to drug shops in Uganda: a 
cluster-randomized controlled trial. Bull World Health Organ, 2015. 93: p. 143-151. 
16. Maloney, K., A. Ward, B. Krenz, N. Petty, L. Bryson, C. Dolkart, T. Visser, A. Le Menach, 
V.K. Scott, J.M. Cohen, E. Mtumbuka, and S. Mkude, Expanding access to parasite-
based malaria diagnosis through retail drug shops in Tanzania: evidence from a 
randomized trial and implications for treatment. Malaria Journal, 2017. 16: p. 6. 
17. Onwujekwe, O., L. Mangham-Jefferies, B. Cundill, N. Alexander, J. Langham, O. Ibe, B. 
Uzochukwu, and V. Wiseman, Effectiveness of Provider and Community Interventions to 
Improve Treatment of Uncomplicated Malaria in Nigeria: A Cluster Randomized 
Controlled Trial. PLoS One, 2015. 10(8): p. e0133832. 
18. Awor, P., H. Wamani, T. Tylleskar, G. Jagoe, and S. Peterson, Increased access to care 
and appropriateness of treatment at private sector drug shops with integrated 
management of malaria, pneumonia and diarrhoea: a quasi-experimental study in 
Uganda. PLoS One, 2014. 9(12): p. e115440. 
19. Mbonye, A.K., P. Magnussen, S. Lal, K.S. Hansen, B. Cundill, C. Chandler, and S.E. 
Clarke, A Cluster Randomised Trial Introducing Rapid Diagnostic Tests into Registered 
Drug Shops in Uganda: Impact on Appropriate Treatment of Malaria. PLoS One, 2015. 
10(7): p. e0129545. 
20. Ansah, E.K., S. Narh-Bana, H. Affran-Bonful, C. Bart-Plange, B. Cundill, M. Gyapong, 
and C.J. Whitty, The impact of providing rapid diagnostic malaria tests on fever 
management in the private retail sector in Ghana: a cluster randomized trial. Bmj, 2015. 
350: p. h1019. 
21. Visser, T., K. Bruxvoort, K. Maloney, T. Leslie, L.M. Barat, R. Allan, E.K. Ansah, J. 
Anyanti, I. Boulton, S.E. Clarke, J.L. Cohen, J.M. Cohen, A. Cutherell, C. Dolkart, K. 
Eves, G. Fink, C. Goodman, E. Hutchinson, S. Lal, A. Mbonye, O. Onwujekwe, N. Petty, 

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J. Pontarollo, S. Poyer, D. Schellenberg, E. Streat, A. Ward, V. Wiseman, C.J. Whitty, S. 
Yeung, J. Cunningham, and C.I. Chandler, Introducing malaria rapid diagnostic tests in 
private medicine retail outlets: A systematic literature review. PLoS One, 2017. 12(3): p. 
e0173093. 
22. Morris, A., A. Ward, B. Moonen, O. Sabot, and J.M. Cohen, Price subsidies increase the 
use of private sector ACTs: evidence from a systematic review. Health Policy and 
Planning, 2015. 30(3): p. 397-405. 
23. Rennie, W., L. Lugo, E. Rosser, and S.A. Harvey, Willingness to use and pay for a new 
diagnostic test for malaria in children under 5: Results from Benin, Peru, and Tanzania. 
2009, Center for Human Services: Chevy Cahse, MD. 
24. Hansen, K.S., T.H. Lesner, and L.P. Osterdal, Optimal price subsidies for appropriate 
malaria testing and treatment behaviour. Malar J, 2016. 15(1): p. 534. 
25. Krenz, B., N. Petty, L. Bryson, C. Dolkart, T. Visser, A. Le Menach, V.K. Scott, J.M. 
Cohen, E. Mtumbuka, S. Mkude, J. Cohen, A. Cox, W. Dickens, K. Maloney, F. Lam, 
and G. Fink, Determinants of malaria diagnostic uptake in the retail sector: qualitative 
analysis from focus groups in Uganda. Malar J, 2015. 14: p. 89. 
26. Prudhomme O'Meara, W., M. Mohanan, J. Laktabai, A. Lesser, A. Platt, E. Maffioli, E.L. 
Turner, and D. Menya, Assessing the independent and combined effects of subsidies for 
antimalarials and rapid diagnostic testing on fever management decisions in the retail 
sector: results from a factorial randomised trial in western Kenya. BMJ Glob Health, 
2016. 1(2): p. e000101. 
27. Zou, G. and A. Donner, Extension of the modified Poisson regression model to 
prospective studies with correlated binary data. Statistical Methods in Medical Research, 
2013. 22(6): p. 661-670. 
28. Zou, G., A Modified Poisson Regression Approach to Prospective Studies with Binary 
Data. American Journal of Epidemiology, 2004. 159(7): p. 702-706. 
29. Li, P. and D.T. Redden, Small sample performance of bias-corrected sandwich 
estimators for cluster-randomized trials with binary outcomes. Stat Med, 2015. 34(2): p. 
281-96. 
30. Kauermann, G. and R.J. Carroll, A Note on the Efficiency of Sandwich Covariance 
Matrix Estimation. Journal of the American Statistical Association, 2001. 96(456): p. 
1387-1396. 

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SUPPLEMENTS/APPENDICES 
 
A.1 Informed consent for participation in TESTsmART Aim 1 (English and Kiswahili) 
A.2 Questionnaire for participants 
 
 
 

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A randomized experiment of malaria diagnostic testing and conditional subsidies to 
target ACTs in the retail sector: the TESTsmART trial AIM 1 
Informed consent for participants attending medicine retail outlets 
 
Jeremiah Laktabai, Primary Investigator 
Diana Menya, Investigator 
Wendy Prudhomme O’Meara, Primary Investigator 
 
Duke University and Moi University 
 
Study information and procedures -  Moi University, in collaboration with Duke University, is 
conducting a research study about purchasing of medicines for fevers such as malaria in this 
area and how malaria diagnostic tests could be used by people buying medicine in a pharmacy 
or drug store. You have been selected for this research because you (or your child) are visiting 
a shop to purchase medicines for an illness today. Taking part in this research study is 
voluntary.  You may choose not to take part in the study and it will not affect the normal services 
you receive at this pharmacy/chemist.  
 
As part of this study we are offering you a voucher that will entitle you to receive a malaria 
diagnostic test before you purchase your medicine. If the test shows you have malaria, you will 
be offered an additional discount on the recommended medicine for malaria. The amount of the 
discount for the test and the medicine is random like a lottery and it will be revealed once you 
have agreed to participate. There will be a small price for the test, but you are free to decide 
whether or not you would like to be tested after your secret price is revealed. The test requires a 
finger stick to take one or two drops of blood. The blood is placed on the cassette and after 15 
minutes the results can be seen.  The results of the test will tell you whether you have malaria 
parasites in your blood or not.  
 
We will also ask you a few questions about yourself and your (your child’s) illness now and a few 
questions about which drug you purchased when you leave. These questions should not take 
more than 30 minutes of your time. We will ask you to answer these questions even if you choose 
not to have a malaria test. All of your answers will be kept confidential, and we will do everything 
possible to protect your privacy.  
 
Risks of participation – There is a small risk of discomfort at the site of the finger prick. There is a 
very small risk of infection at the site. Our research assistants have been trained in blood safety 
and a new needle and test is used for every person so the test is very safe. There is a small risk 
of breach of confidentiality – your answers may become known to others unintentionally. 
However, we will do everything possible to protect this information and I will not discuss your 
answers with anyone else.  
 
Benefits of participation – You may benefit from knowing whether or not you have malaria if you 
choose to have a malaria diagnostic test. If the test shows you have malaria, you will benefit from 
a lower price for the medicine you need. If you do not have malaria, the test may help you make 
a different choice about the right medicine for you. Participation is voluntary and if you choose not 
to participate, you are free to purchase medicine as you normally would. 
 
You may stop the interview at any time if you change your mind about participating. If you wish to 
stop, you may proceed and purchase medicine as you normally would. 

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If you have any questions, you may contact the study at any time.   Contact: Joseph Kipkoech - 
0720393547 
 
A description of this study will be available at http://www.clinicaltrials.gov. This website will not 
include information that can identify you. At most, the website will include a summary of the 
results. You can view the website at any time. The identification number for this study is 
NCT03810014. 
 
Patient consent and signature 
I have read or have had read to me the description of the research study.  The investigator or 
his/her representative has explained the study to me and has answered all of the questions I 
have at this time. I have been told of the potential risks, discomforts and side effects as well as 
the possible benefits (if any) of the study.  I freely volunteer to take part in this study.  
 
Signature ____________________Date_____________ 
 
Study ID_______________ 
 
For participants 10 years up to 18 years, was assent obtained from the minor?  
Y       N         Not applicable 
 
Signature of person obtaining consent __________________________  Date_____________ 

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A randomized experiment of malaria diagnostic testing and conditional subsidies to target ACTs 
in the retail sector: the TESTsmART trial AIM 1 
IDHINI YA KUSHIRIKI KATIKA UTAFITI YA WANAOHUDHURIA MADUKA YA DAWA 
Watafiti 
Jeremiah Laktabai, Mtafiti mkuu 
Wendy Prudhomme O’Meara, Mtafiti mkuu 
Diana Menya, Mtafiti 
 
Duke University na Moi University 
 
HABARI NA UTARATIBU WA UTAFITI HUU 
Chuo Kikuu cha Moi, wa kishirikiana na Chuo Kikuu cha Duke, wanafanya utafiti kuhusu ununuzi 
wa madawa kwa ajili ya malaria katika eneo hili, na jinsi vipimo vya uchunguzi wa malaria au 
malaria RDT vinaweza kutumika na watu wanaonunua dawa katika maduka ya dawa. Hivi leo, 
umechaguliwa kwa ajili ya utafiti huu kwa sababu wewe (au mtoto wako) umetembelea duka hii, 
ili kununua dawa kwa ajili ya ugonjwa. Tungependa kukueleza kwamba, kushiriki katika utafiti huu 
ni kwa hiari yako. Unaweza kuchagua kutoshiriki katika utafiti hu una uamuzi wako hautaathiri 
huduma za kawaida unazopata kwenye duka hili la dawa. 
 
Kama sehemu ya utafiti huu, tunakupa chaguo ambayo itakuwezesha kupimwa kama una malaria 
kabla ya kununua dawa. Matokeo ya uchunguzi ikionyesha kuwa una malaria, basi utapewa dawa 
ya malaria iliyopendekezwa, kwa bei nafuu. Kiasi cha bei ya kupimwa ili kuchunguza kama una 
malaria na pia bei ya dawa itakuwa kama bahati nasibu na itafunuliwa kwako mara tu umekubali 
kushiriki. Kiasi cha bei ya kupimwa malaria itakuwa ya chini, una uhuru wa kupimwa kabla au 
baada ya bei yako ya siri kufunuliwa. Ili kupima malaria, tutakusanya tone moja au mbili ya damu 
kutoka kwenye kidole, kisha tuiweke kwenye kanda ya uchunguzi na baada ya dakika 15 hivi 
matokeo yataweza kuonekana. Matokeo ya uchunguzi wa malaria itakuambia kama una vimelea 
vya malaria au “malaria parasite” katika damu yako au la. 
 
Pia tutakuuliza maswali machache kuhusu ugonjwa wako au ugonjwa wa mtoto wako na pia 
maswali machache kuhusu dawa ulizonunua unapoondoka kwenye duka. Maswali haya 
hayapaswi kuchukua zaidi ya dakika 30 ya muda wako. Tutakuuliza kujibu maswali haya hata 
kama hukuchagua kupimwa malaria. Majibu yako yote yatahifadhiwa kwa siri, na tutafanya kila 
kitu iwezekanavyo ili kudumisha usiri wako. 
 
HATARI ZA USHIRIKI 
Kuna hatari ndogo ya uchungu kwenye kidole itakayo dungwa ili kukusanya tone moja au mbili 
za damu. Kuna hatari ndogo sana ya maambukizi kwenye kidole kilichodungwa. Wasaidizi wetu 
wa utafiti wamefundishwa kuhusu utaratibu na usalama wa damu na kila wakati wanapopima, 
sindano mpya hutumiwa kwa kila mtu. Hivyo uchunguzi wa malaria ni salama sana. Kuna hatari 
ndogo ya uvunjaji wa siri kama vile; majibu yako kuweza kujulikana kwa wengine bila ya nia yetu. 
Hata hivyo, tutafanya kila kitu iwezekanavyo kulinda habari hii na hatutajadili majibu yako na mtu 
mwingine yeyote. 
 
FAIDA ZA USHIRIKI 
Unaweza kufaidika kwa kujua kama una malaria ikiwa utaamua kupima malaria. Ikiwa uchunguzi 
utaonyesha kuwa una malaria, utafaidika na bei ya chini ya dawa unayohitaji. Ikiwa huna malaria, 

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uchunguzi huu unaweza kukusaidia kufanya uamuzi tofauti kuhusu dawa sahihi kwako. Kushiriki 
ni kwa hiari na ukichagua kutoshiriki, uko huru kununua dawa kama kawaida. 
 
 
Ikiwa una maswali yoyote, unaweza kuwasiliana nasi kupitia Joseph Kipkoech - 0720393547 
 
Maelezo ya utafiti huu yatapatikana kwa tovuti; http://www.clinicaltrials.gov. Tovuti hii 
haitajumuisha maelezo ambayo yanaweza kukutambua. Kwa zaidi, tovuti hii itajumuisha 
muhtasari wa matokeo. Unaweza kuona tovuti hiyo wakati wowote. Nambari ya utambuzi ya utafiti 
huu ni NCT03810014. 
 
IDHINI YA MGONJWA NA SAHIHI  
Nimesoma au nimeelezwa kuhusu utafiti huu na msaididizi wa utafititi, pia amejibu maswali yote 
niliyo nayo wakati huu. Nimeambiwa juu ya uwezekano wa hatari au madhara, pamoja na faida 
ya utafiti huu. Mimi najitolea kwa hiari yangu kushiriki katika utafiti huu. 
 
 
Sahihi ____________________Tarehe _____________ 
 
 Nambari ya utambulishu ya utafiti_______________ 
 
Je, umepata idhini ya mdomo kwa washiriki wa miaka 10 hadi miaka 18? 
Ndio ____________  Hapana ___________ Haihusiki______________ 
  
Sahihi ya anayepokea idhini __________________________  Tarehe_____________ 
 
 
 

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CHILD ASSENT FOR PARTICIPATION AND MALARIA RAPID DIAGNOSTIC TESTING 
 
For children 10 years or older and younger than 18 years 
 
We are asking you to be in a research study.  Research is a way to test new ideas.  Research 
helps us learn new things.   
 
Being in research is your choice.  You can say Yes or No.  Whatever you decide is OK.  We will 
still take good care of you. 
 
In our research study we want to find out if you have malaria today. During this study, the 
researchers will ask you and your parent some questions about your health.  They will also take 
a small blood sample.  
 
What are the good things that can happen from this research? 
 
We may learn about whether or not you have malaria today.  This will help you to know which 
drug you should take. 
 
What are the bad things that can happen from this research? 
 
You may also feel a little discomfort when we take some blood. 
  
Take the time you need to make your choice.  Ask us any questions you have.  You can ask 
questions any time.   
 
Do you agree to take a malaria test today?  
 
Yes (1) 
 
No (2) 
 
 
 
 

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IDHINI YA MDOMO KWA MTOTO ILI KUSHIRIKI NA KUPIMWA NA RDT 
 
Kwa watoto chini ya miaka 10 na wasiozidi miaka 18 
 
Tunakuuliza ruhusa ya kushiriki katika utafiti. Utafiti ni njia ya kudadisi mambo mapya. Utafiti 
hutusaidia kujifunza mambo mapya. 
 
Kushiriki katika utafiti ni kwa hiari yako. Unaweza kusema ndio au hapana. Kile utakachoamua 
ni sawa. Bado tutakuhudumia tu vyema. 
 
Katika utafiti wetu, tungependa kujua kama una malaria leo. Ukishiriki, msaidizi wa utafiti 
atakuuliza pamoja na mzazi wako maswali yanayohusu afya yako. Pia atachukua damu kidogo 
kutoka kwako. 
 
Kuna faida gani inayoweza kutokana na huu utafiti? 
 
Tutaweza kujua kama una malaria leo au la. Jambo hili litakusaidia kujua ni dawa ipi 
unayostahili kutumia. 
 
Kuna madhara gani yanoyoweza kutokana na huu utafiti? 
 
Kuna uwezekano wa wewe kuhisi uchungu kidogo tunapochukua sampuli kidogo ya damu. 
Chukua mda unaohitaji ili kufanya maamuzi. Uliza maswali yoyote unayoweza kuwa nayo. 
Unaweza kuuliza maswali wakati wowote. 
 
Je, unakubali kupewa kipimo cha malaria leo? 
 
Ndio (1) 
 
Hapana (2) 
 
 

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Appendix A.2 
 
Aim 1: TESTsmART Participant questionnaire 
 
Number QUESTION 
RESPONSE 
SKIP 
0.1 
Date 
DD/MM/YYY 
 
0.2 
Participant ID 
 
 
0.3 
Outlet ID 
 
 
0.4 
Interviewer ID 
 
 
0.5 
Arm assignment from scratch 
card 
 
 
 
SECTION 1: RESPONDENT INFORMATION 
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__________________________ 
 
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 
 
1.7 
How many people live in your 
household? 
 
 

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[In the case the child is ill, please 
collect this information for the 
parent/guardian of the child] 
 
 
 
1.8 
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. College 
5. University 
 
 
 
1.9 
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 .....................................  
Self -employed (Not in agriculture) 
4. With employees 
5. Without employees (e.g. motorcycle taxi, 
vendor) 
6. Unpaid family helper in a business 
 ................................................ 6 
Not working 
7. Casual worker/day laborer 
8. Househelp  
9. Homemaker 
10. Student 
11. Not available to work 
12. Other (Specify) ____________  
 
 
 
 
 
 
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  
    

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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 
Have you taken/given to the child any 
medication before coming here today?  
1. Yes   
2. No 
99. Don’t know  
If 1, go to 
2.5 
If 2, go to 
2.6 
2.5 
Which medicines (select all that apply) 
1. CoArtem/Artefan/other AL 
2. Quinine 
3. SP (ie Fansidar/metakelfin/ 
Malodar) 
4. Amoxyl 
5. Other antibiotic 
6. Painkiller (ie 
Panadol/Brufen/Hedex/ 
Action/Maramoja) 
7. Cough medicine or decongestant 
8. Other________________ 
      99. Don’t know 
If 1, 2 or 3 
STOP 
2.6  
Have you sought treatment elsewhere 
before coming here today?  
1. Yes   
2. No 
      99. Don’t know 
If no or 
don’t 
know→ skip 
to 2.8 
2.7 
What did you do?  
1. Visit hospital  
2. Visit health center  
3. Visit private clinic  
4. Visit dispensary  
5. Visit pharmacy/chemist  
6. Buy medicine at general shop  
7. Gave medicine available at home   
8. Visit traditional healers  
9. Visit religious/cultural healers  
10. Visit CHW    
11. Other_____________________ 
99. Don’t know (ie another parent was 
involved) 
NOTE: 
Confirm 
whether the 
participant 
has a 
prescription. 
If YES → 
STOP 

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2.8 
 
 
Which medicine are you planning to 
buy for you/ your child? 
9. CoArtem/Artefan/other AL 
10. Quinine 
11. SP (ie Fansidar/metakelfin/ 
Malodar) 
12. Amoxyl 
13. Other antibiotic 
14. Painkiller (ie 
Panadol/Brufen/Hedex/ 
Action/Maramoja) 
15. Whatever the doctor/shopkeeper 
recommend  
16. Whatever I can afford  
17. Other________________ 
12. Don’t know  
 
2.9 
Approximately how much do you 
expect to spend?  
 
9999= Don’t 
know 
 
 
 
 
SECTION 3: EXPECTATIONS 
 
Number 
QUESTION 
RESPONSE 
 
SKIP 
3.1 
As you know, fever can be a 
symptom of many different illnesses, 
including malaria. How likely is it that 
an ADULT person living in your 
village who currently has fever 
actually has malaria? 
 
 
 
1. Not possible  
2. Unlikely but not impossible 
3. 50/50 
4. Likely 
5. This is the only thing they 
could have 
99. Don’t know 
 
3.2 
How likely is 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. This is the only thing they 
could have 
99. Don’t know 
 
 
 

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3.3 
Are you aware you can have your blood 
tested for malaria? 
 
1. Yes   
2. No 
      99. Don’t know 
If no, skip to 
3.11  
3.4 
Have you ever had your blood tested for 
malaria?  
1. Ye Yes   
2. No 
      99. Don’t know 
If no skip to 
3.6 
3.5 
How much did it cost?  
 
9999=Don't 
know or 
don’t 
remember 
3.6 
Are you aware of malaria rapid diagnostic 
tests?   
1. Yes   
2. No 
      99. Don’t know 
If no, skip to 
3.11 
3.7 
Have you ever been tested for malaria 
using a malaria rapid diagnostic test?  
1. Yes   
2. No 
      99. Don’t know 
If no, skip to 
3.9 
3.8 
How much did it cost?  
 
9999=Don't 
know or 
don’t 
remember 
3.9 
If you believe you HAVE malaria and the 
test shows that you do not have malaria, 
how likely do you think the result from 
the test is correct? 
 
1. Not possible  
2. Unlikely but not 
impossible 
3. 50/50 
4. Likely 
5. No doubts 
      99. Don’t know 
 
3.10 
If you believe you DON’T have malaria 
and the test shows that you have malaria, 
how likely do you think the result from 
the test is correct? 
 
1. Not possible  
2. Unlikely but not 
impossible 
3. 50/50 
4. Likely 
5. No doubts 
 
 
3.11 
If you have malaria and use AL, how 
many days before you feel completely 
well? 
 
 
 
 
______ days 
98= don’t 
know 
99=never – 
Coartem is 
not very 
effective 

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3.12 
 If you have malaria and use Fansidar, 
how many days before you feel 
completely well? 
 
 
 
 
______ days 
98= don’t 
know 
99=never – 
Fansidar is 
not very 
effective 
3.13 
f you have malaria and don’t take any 
drug, how many days before you feel 
completely well? 
 
 
 
 
 
______ days 
98= don’t 
know 
99=never – 
you must 
take  a drug 
to treat 
malaria 
3.14 
If you DO NOT have malaria and you take 
AL, how many days until you will feel 
completely better?  
 
 
______ days 
98= don’t 
know 
99=never – 
CoArtem is 
not the right 
drug 
 
 
SECTION 4: INTENTIONS 
 
Number QUESTION 
RESPONSE 
SKIP 
4.1 
Did the participant choose to 
purchase an RDT?  
1. Yes 
2. No 
If yes skip 
to 4.3 
4.2 
Why not?  
1. Too expensive 
2. Already sure I have malaria 
3. Already sure I don’t have 
malaria 
4. Don’t want to get finger 
pricked 
5. Other?  
Next skip to 
section 5 
4.3 
RDT results 
1. Negative 
2. Positive 
3. Invalid 
 
4.4 
How likely is it that the result of the 
RDT was correct? 
Only if tested  
 
 
1. Not possible  
2. Unlikely but not impossible 
3. 50/50 
4. Likely 
5. Absolutely sure 
99.  Don’t know 
 

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4.5 
Now that you have the test result, 
how likely is that the illness 
you/your child has is malaria? 
Only if tested  
 
1. Not possible  
2. Unlikely but not impossible 
3. 50/50 
4. Likely 
5. Absolutely sure 
99. Don’t know 
 
 
 
 
SECTION 5: POST-PURCHASE FOLLOWUP QUESTIONS 
ACTIONS 
Number 
QUESTION 
RESPONSE 
SKIP 
5.1 
 
Which medicine did you buy? 
Choose all that apply 
1. CoArtem/Artefan/other AL 
2. Quinine 
3. SP/Fansidar/metakelfin/Ma
lodar 
4. Amoxyl 
5. Panadol/Brufen/Hedex/pai
nkiller/Action/Maramoja 
6. Don’t know/don’t 
remember 
7. Did not purchase any 
medicine 
8. Other……………….. 
If 7, skip to 5.5 
5.2 
[Ask the respondent to show you 
the drug she/he purchased] 
Did the respondent show you the 
drug he/she purchased? 
 
1. No 
2. Yes (if yes, write brand 
names) 
[Write down brand names] 
___________________________ 
 
 
 
 
5.3 
How much did you pay in total? 
(The amount refers to how much 
money respondent paid for the 
medicine and RDT. Don’t add the 
amount of the voucher if any was 
used) 
 
 
________KES 
Don’t know/remember…9999 
 

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5.4 
If possible, please tell me how 
much you paid for each drug you 
bought today 
Drug 1 
Name________ 
Amount________ 
Drug 2 
Name___________ 
Amount___________ 
 
5.5 
Did you use the study voucher 
(RDT-positive only) 
1. Yes  
2. No 
If yes, skip to 6.1 
5.6 
Why not? 
1. Lacked Money/still too 
expensive 
2. Preferred a drug not 
covered by the voucher 
3. The shop attendant 
counseled me to buy 
another drug 
4. Did not believe illness is 
malaria 
5. Other_________________ 
99. Don't know 
 
 
 
 
 
SECTION 6: POST-PURCHASE BELIEFS 
 
Number 
QUESTION 
RESPONSE 
SKIP 
6.1 
How likely is it that the result of the 
RDT was correct? 
Only if tested  
 
 
1. Not possible  
2. Unlikely but not 
impossible 
3. 50/50 
4. Likely 
5. Absolutely sure 
99.  Don’t know 
 
6.2 
How likely is that the illness you/your 
child has is malaria? 
1. Not possible  
2. Unlikely but not 
impossible 
3. 50/50 
4. Likely 
5. Absolutely sure 
99.  Don’t know 
 
 
SECTION 7: HOUSEHOLD CHARACTERISTICS 
Number 
QUESTION 
RESPONSE 
SKIP 

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7.1 
What is the main source of 
drinking water for your 
household?   
1. Piped water/Public Tap/borehole 
 ................................................ 1 
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 .......................................  
 
 
 
 
 
 
7.2 
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 
 
 
 
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 
 
 

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h) 
A bank account (at least one 
member of the household has)? 
1. Yes 
2. No 
      99. Don’t know 
 
 
7.3 
 
How many of the following 
livestock does your household 
have? 
1. None  
99. Don't know 
 
 
a) 
Cows 
  
 
b) 
Sheep 
  
 
c) 
Goats 
 
 
d) 
Pigs 
 
 
7.4 
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): 
____________________ 
 
7.5 
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)_____________ _ 
 
7.6 
What is the main material of the 
floor in your house? 
1. Earthen  
2. Cement 
3. Floor Tiles  
4. Wood planks  
5. Polished wood 
Other (please specify) ______________________ 
 
7.7 
What is the main material of the 
walls in your house? 
1. Stone  
2. Brick  
3. Timber 
4. Iron Sheet 
 

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SECTION 8: INTERVIEW SECTION NOTE 
 
Number 
QUESTION 
RESPONSE 
8.1 
 What is your evaluation of the 
accuracy of respondent's 
answer? 
 
1. Excellent 
2. Good 
3. Fair 
4. Not so good 
5. Very bad 
8.2 
What is your evaluation of the 
seriousness and attentiveness of 
the respondent? 
 
1. Excellent 
2. Good 
3. Fair 
4. Not so good 
5. Very bad 
 
 
 
 
5. Mud  
6. Wood  
7. Cement 
Other (please specify)_____________ 
7.8 
What is the main material of the 
roof of your house? 
1. Iron sheets  
2. Roof tiles  
3. Grass Thatched 
4. Wood  
Other (please specify)______________ 
 
7.9 
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