Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial AIM 1
Study Details
Study Description
Brief Summary
The TESTsmART Trial consists of two main aims. The overall goal of the two aims is to investigate the impact of malaria rapid diagnostic test (mRDT) subsidies and conditional artemisinin combination therapy (ACT) subsidies on the testing and treatment behavior of participants seeking care for their febrile illness in the private retail sector. Conditional ACT subsidies are discounts on quality-assured ACTs which are linked to the results of a malaria rapid diagnostic test administered at the retail outlet; only participants with a positive test will have access to an additional discount on a quality-assured ACT.
The main objective of Aim 1 of this study is to identify a combination of conditional ACT and RDT subsidies that maximizes the proportion of participants that choose to have a malaria diagnostic test before taking a drug. The investigators will test two levels of conditional ACT subsidy (100% subsidy versus ~67% subsidy) and two levels of RDT subsidy (0% subsidy and 50% subsidy) in a factorial designed experiment. Because dose size and therefore the price of an ACT course are dependent upon patient age, the ACT subsidy amount will also be scaled with patient age. These subsidy levels were chosen to keep the estimated program cost of the combined subsidy within $0.30-0.60 USD per person (assuming 100% testing uptake and between 20-40% of participants having a positive RDT). These estimates represent an upper bound since testing is unlikely to reach 100%. Current subsidy levels for ACT costs the program between 1.30-2.50 USD per treatment, with more than a third of that investment spent on individuals without malaria.
Individuals presenting to a retail outlet for a treatment of a fever or suspected malaria illness will be randomized to one of the four groups in equal proportions. A total of 840 participants will be enrolled (210 per arm). Their choices concerning uptake of testing and drug purchase will be recorded. The main outcome will be the proportion of participants that choose to take a test. Secondary outcomes include the proportion of participants who adhered to the results of the RDT among those who were tested (used ACT when positive and did not use an ACT when negative or without a test). The results of this study will be used to inform the subsidy levels in the intervention for Aim 2 of this trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
RATIONALE:
From previous studies and implementation experiences, we know that consumption of ACTs increases as the price declines. Declining prices of ACTs create a trade-off between access and targeting; lower prices improve uptake of effective therapies by those with malaria but also increase inappropriate use by those without malaria. Curbing inappropriate use and targeting ACTs to malaria cases requires parasitological diagnosis which is virtually absent in the retail sector. It has also been shown that RDTs can be safely deployed in the retail sector. Most clients will agree to have an RDT if it is free. However, uptake of RDTs is sensitive to the price of the RDT. Previous work has not specifically evaluated the relationship between the price of the drug and the price of the test, but available evidence suggests that uptake of the RDT is sensitive to the price of the ACT as well.
In this work, we will link these two commodities through a diagnosis-dependent ACT subsidy. Access to the additional ACT subsidy depends on having a positive RDT. What we need to understand before scaling up a conditional subsidy is how the price of these two commodities should be related. Should the conditionally-subsidized ACT be less expensive than the RDT? Must the RDT be considerably less expensive than the retail price of ACT in order to motivate people to purchase a test?
OBJECTIVES:
In this study (Aim 1) we will use an individually-randomized experiment conducted among customers at medicine retail outlets to identify the combination of RDT subsidy-level and conditional ACT subsidy-level that maximizes uptake of diagnostic testing. We choose to focus on diagnostic testing because this is the first step to achieving the downstream goals of ACT targeting and rational use.
STUDY DESIGN:
We will use a factorial design to test two ACT subsidy levels and two RDT subsidy levels. The unit of randomization will be the individual customer.
STUDY POPULATION:
This study will be carried out in a sample of retail shops that carry quality-assured ACTs in our study area in western Kenya. Ten shops will be randomly selected to participate in the study. The study population will be any individual presenting to the shop with a malaria-like illness. Children older than 1 year of age are eligible to be enrolled provided they are physically present and accompanied by a parent or legal guardian. Customers with a prescription from a health facility, who have already received a malaria diagnostic test or who have already taken antimalarials prior to coming to the outlet will be excluded. Individuals who have signs of severe disease will be excluded and referred immediately to a health facility for care.
STUDY PROCEDURES:
A research assistant (RA) will be stationed at participating outlets on random days in order to avoid influencing treatment seeking behavior - in other words, to avoid attracting customers because of the study team's presence. The RA will obtain consent and offer 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: 1) No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0) // 2) No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.40) // 3) 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0) // 4) 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-$0.40, dependent on patient age).
These four arms represent a 2x2 factorial experiment.
If the participant chooses to purchase a test at their assigned price (subsidy level), the outlet will collect the money and the RA will perform the test. (RAs have been trained in RDTs and blood safety and have conducted thousands of RDTs. If the test is positive, the participant is entitled to an additional discount on their ACT purchase according to their group identified on the scratch card. If the test is negative, the participant may purchase any medicine they choose, including a regularly-priced ACT. Those who opt not to purchase an RDT may continue with their transaction as they choose, including purchasing a regularly-priced ACT.
The outlet attendant will sell the medicines to the customer, including a discounted ACT, if eligible. The study team will reimburse the outlet the difference between the retail price and the discounted price.
The RDTs selected for the study will be a World Health Organization (WHO) approved product that exceed 95% sensitivity and 95% specificity for Plasmodium falciparum [Malaria Rapid Diagnostic Test Performance, Round 1-5, WHO 2014].
STUDY OUTCOME MEASURES:
The primary outcome for Aim 1 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) and of conditional ACT subsidies (2 levels) on the primary outcome.
The main secondary outcome is the proportion of tested participants who are adherent to the test result among those tested. Adherence is defined as taking a quality-assured ACT if the RDT is positive or taking another drug (or no drug) if the test is negative. We will also measure the proportion of people who purchase a full-price ACT among those who do not use an RDT.
SAMPLE SIZE:
We estimated the sample size required in each of the four study arms for a design with equal numbers of individuals allocated to each arm and where we wish to detect a 15-percentage point increase in RDT testing between an unsubsidized RDT compared to a subsidized RDT and to detect a 10 percentage-point difference in testing uptake between a partially and a fully subsidized ACT (conditional on a positive RDT) with at least 90% power and 5% chance of a two-tailed Type I error for each of the two comparisons. To do so, we estimate that we will need 210 subjects per arm (total=840).
ENROLLMENT AND FOLLOW UP:
All participants will be screened and enrolled on the day they visit the outlet. Data collection will be brief and will be completed on the same day. Participants will be screened as they arrive, enrolled if eligible and willing, tested if they choose and then allowed to proceed with their transaction at the outlet. Upon completion, they will be briefly interviewed again before leaving. Because the interaction with the participant is short and completed in one encounter, we expect minimal loss to follow-up (for example, participants leaving before the final questions).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0). |
Other: Conditional ACT subsidy, Arm 1 levels
The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
|
| Experimental: Arm 2 The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age). |
Other: Conditional ACT subsidy, Arm 2 levels
The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
|
| Experimental: Arm 3 The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0). |
Other: Conditional ACT subsidy, Arm 3 levels
The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
|
| Experimental: Arm 4 The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age) |
Other: Conditional ACT subsidy, Arm 4 levels
The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
|
Outcome Measures
Primary Outcome Measures
- Number of Participants That Purchase an mRDT (Malaria Rapid Diagnostic Test) [At the end of a participant's visit to participating retail outlet, up to 1 hour]
This outcome will be evaluated once for each customer
Secondary Outcome Measures
- Number of Participants With a Positive mRDT That Purchased an ACT (Artemisinin-based Combination Therapy) [At the end of a participant's visit to participating retail outlet, up to 1 hour]
- Number of Participants With a Negative mRDT That Did Not Purchase an ACT [At the end of a participant's visit to participating retail outlet, up to 1 hour]
- Number of Participants That Did Not Purchase an mRDT and Did Not Purchase an ACT [At the end of a participant's visit to participating retail outlet, up to 1 hour]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants with fever or history of fever or malaria like illness
-
Individual with malaria-like illness must be present at recruitment
-
1 year of age or older
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
-
Pregnant women will be enrolled and offered an mRDT, but will be advised to seek treatment through a health care provider.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Moi University | Eldoret | Kenya |
Sponsors and Collaborators
- Duke University
- National Institute of Allergy and Infectious Diseases (NIAID)
- Moi University
- Clinton Health Access Initiative, Nigeria
Investigators
- Principal Investigator: Wendy P O'Meara, PhD, Duke University
Study Documents (Full-Text)
More Information
Publications
None provided.- Pro00100425
- 1R01AI141444-01
Study Results
Participant Flow
| Recruitment Details | The study was carried out in a random sample of twelve retail outlets in two sub-counties of rural western Kenya. Potential participants were approached by the research assistants as they sought services at the outlets. Participants were then offered a scratch card with masked arm assignment, which randomized them to one of four study arms in a 1:1:1:1 ratio, each arm with a different combination of two different RDT prices and two different conditional ACT prices using a 2x2 factorial design. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm 1 | Arm 2 | Arm 3 | Arm 4 |
|---|---|---|---|---|
| Arm/Group Description | The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0). Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0). | The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age). Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age). | The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0). Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0). | The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age) Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age) |
| Period Title: Overall Study | ||||
| STARTED | 215 | 204 | 210 | 213 |
| COMPLETED | 213 | 202 | 210 | 211 |
| NOT COMPLETED | 2 | 2 | 0 | 2 |
Baseline Characteristics
| Arm/Group Title | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0). Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0). | The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age). Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age). | The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0). Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0). | The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age) Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age) | Total of all reporting groups |
| Overall Participants | 213 | 202 | 210 | 211 | 836 |
| Age (years) [Median (Inter-Quartile Range) ] | |||||
| Median (Inter-Quartile Range) [years] |
30
|
28.5
|
30
|
31
|
30
|
| Sex/Gender, Customized (Count of Participants) | |||||
| Female |
97
45.5%
|
96
47.5%
|
92
43.8%
|
103
48.8%
|
388
46.4%
|
| Male |
116
54.5%
|
106
52.5%
|
118
56.2%
|
107
50.7%
|
447
53.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
1
0.5%
|
1
0.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
213
100%
|
202
100%
|
210
100%
|
211
100%
|
836
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
213
100%
|
202
100%
|
210
100%
|
211
100%
|
836
100%
|
| White |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||||
| Kenya |
213
100%
|
202
100%
|
210
100%
|
211
100%
|
836
100%
|
Outcome Measures
| Title | Number of Participants That Purchase an mRDT (Malaria Rapid Diagnostic Test) |
|---|---|
| Description | This outcome will be evaluated once for each customer |
| Time Frame | At the end of a participant's visit to participating retail outlet, up to 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm 1 | Arm 2 | Arm 3 | Arm 4 |
|---|---|---|---|---|
| Arm/Group Description | The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0). Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0). | The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age). Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age). | The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0). Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0). | The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age) Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age) |
| Measure Participants | 213 | 202 | 210 | 211 |
| Count of Participants [Participants] |
205
96.2%
|
195
96.5%
|
207
98.6%
|
211
100%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm 1, Arm 2, Arm 3, Arm 4 |
|---|---|---|
| Comments | (Arm 3 + Arm 4) vs (Arm 1 + Arm 2) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.01 |
| Comments | ||
| Method | Generalized estimating equations | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 2.50 | |
| Confidence Interval |
(2-Sided) 98% 0.20 to 4.80 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm 1, Arm 2, Arm 3, Arm 4 |
|---|---|---|
| Comments | (Arm 3 + Arm 4) vs (Arm 1 + Arm 2) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | ||
| Method | Generalized estimating equations | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio, log |
| Estimated Value | 1.025 | |
| Confidence Interval |
(2-Sided) 98% 1.002 to 1.049 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Arm 1, Arm 2, Arm 3, Arm 4 |
|---|---|---|
| Comments | (Arm 1 + Arm 3) vs (Arm 2 + Arm 4) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.33 |
| Comments | ||
| Method | Generalized estimating equations | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | -0.60 | |
| Confidence Interval |
(2-Sided) 98% -2.20 to 0.90 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Arm 1, Arm 2, Arm 3, Arm 4 |
|---|---|---|
| Comments | (Arm 1 + Arm 3) vs (Arm 2 + Arm 4) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.332 |
| Comments | ||
| Method | Generalized estimating equations | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio, log |
| Estimated Value | 0.994 | |
| Confidence Interval |
(2-Sided) 98% 0.979 to 1.009 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With a Positive mRDT That Purchased an ACT (Artemisinin-based Combination Therapy) |
|---|---|
| Description | |
| Time Frame | At the end of a participant's visit to participating retail outlet, up to 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with a positive mRDT |
| Arm/Group Title | Arm 1 | Arm 2 | Arm 3 | Arm 4 |
|---|---|---|---|---|
| Arm/Group Description | The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0). Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0). | The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age). Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age). | The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0). Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0). | The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age) Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age) |
| Measure Participants | 51 | 46 | 31 | 46 |
| Count of Participants [Participants] |
47
22.1%
|
39
19.3%
|
24
11.4%
|
40
19%
|
| Title | Number of Participants With a Negative mRDT That Did Not Purchase an ACT |
|---|---|
| Description | |
| Time Frame | At the end of a participant's visit to participating retail outlet, up to 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with a negative mRDT. 5 participants were not included due to missing ACT purchasing behavior; four in Arm 2 and one in Arm 3. |
| Arm/Group Title | Arm 1 | Arm 2 | Arm 3 | Arm 4 |
|---|---|---|---|---|
| Arm/Group Description | The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0). Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0). | The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age). Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age). | The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0). Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0). | The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age) Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age) |
| Measure Participants | 154 | 145 | 175 | 165 |
| Count of Participants [Participants] |
144
67.6%
|
132
65.3%
|
166
79%
|
155
73.5%
|
| Title | Number of Participants That Did Not Purchase an mRDT and Did Not Purchase an ACT |
|---|---|
| Description | |
| Time Frame | At the end of a participant's visit to participating retail outlet, up to 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with no mRDT |
| Arm/Group Title | Arm 1 | Arm 2 | Arm 3 | Arm 4 |
|---|---|---|---|---|
| Arm/Group Description | The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0). Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0). | The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age). Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age). | The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0). Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0). | The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age) Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age) |
| Measure Participants | 8 | 7 | 3 | 0 |
| Count of Participants [Participants] |
4
1.9%
|
5
2.5%
|
3
1.4%
|
0
0%
|
Adverse Events
| Time Frame | up to 1 hour | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Arm 1 | Arm 2 | Arm 3 | Arm 4 | ||||
| Arm/Group Description | The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0). Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0). | The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age). Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age). | The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0). Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0). | The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age) Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age) | ||||
All Cause Mortality |
||||||||
| Arm 1 | Arm 2 | Arm 3 | Arm 4 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/213 (0%) | 0/202 (0%) | 0/210 (0%) | 0/211 (0%) | ||||
Serious Adverse Events |
||||||||
| Arm 1 | Arm 2 | Arm 3 | Arm 4 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/213 (0%) | 0/202 (0%) | 0/210 (0%) | 0/211 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Arm 1 | Arm 2 | Arm 3 | Arm 4 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/213 (0%) | 0/202 (0%) | 0/210 (0%) | 0/211 (0%) | ||||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Wendy P O'Meara, PhD |
|---|---|
| Organization | Duke University |
| Phone | 919-681-7711 |
| wpo@duke.edu |
- Pro00100425
- 1R01AI141444-01