Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector

14 december 2015 uppdaterad av: Duke University
There are compelling medical and public health reasons to reduce unnecessary consumption of antimalarials and strong evidence to support the use of RDTs in malaria case management. The primary study hypothesis to be tested is that clients who know they will receive a subsidy conditional on a positive test are more likely to opt for testing before deciding which drug to buy. The primary endpoint is whether subjects choose to be tested for malaria with a rapid diagnostic test. The secondary endpoint is whether they purchased an artemisinin combination therapy (ACT) or not. The primary outcome of interest is to compare the proportion of participants who choose to receive a free malaria diagnostic test when they can receive a subsidy for a discounted drug conditional on a positive test (Group A compared to Group B) compared to those without the offer of a conditional subsidy. The investigators will use an experimental design that randomly assigns clients to one of four groups. Field workers will canvas households in the study area looking for individuals who have fever or history of fever or illness in the last 24 hours (current illness) who have not yet taken drugs or sought treatment outside the home. Clients who meet the inclusion criteria and give verbal consent to participate will be randomly assigned to one of the four groups. They will be given the location and contact information for their local community health worker who can provide a malaria rapid diagnostic test if they choose to be tested. They will also complete a survey tool. One week later, the field worker will return to interview the participant and determine whether they were tested, what action they took for their illness, what medicine they purchased and how much they paid. The investigators will summarize clients' choice by the four randomized study groups.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Faktisk)

444

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Eldoret, Kenya
        • Moi University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

1 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Client is older than 1 year
  • Client has fever or history of fever or feeling unwell with a malaria-like illness within the last 24 hours
  • Client or their parent/legal guardian consents to participate

Exclusion Criteria:

  • Client has signs of severe disease or other problem requiring immediate referral to a community health worker (CHW) / health facility
  • Client has already sought treatment, purchased medicine or taken medicine for the current illness.

Note:

If more than one febrile person who meet the inclusion criteria are found in a single household, all of the individuals will be enrolled in the same group, but only one individual (the first enrolled) will be used for the purposes of the analysis.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: test only (free)
The participant is entitled to a free malaria rapid diagnostic test, but no ACT voucher.
Malaria RDT is offered free if patients choose to be tested
Övrig: test (free) & conditional ACT voucher
The participant is entitled to a free malaria rapid diagnostic test, and an ACT voucher conditional on a positive test result.
Malaria RDT is offered free if patients choose to be tested
Participants will be eligible to receive a drug subsidy for a set amount (in the form of a voucher) conditional on a positive malaria test. When a conditional subsidy is offered, it is valid for use on a "Green Leaf" approved malaria drug.
Övrig: test only (not free)
The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), but no ACT voucher.
Participants can receive a malaria RDT for a set amount (i.e., not for free).
Övrig: test (not free) & conditional ACT voucher
The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), and an ACT voucher conditional on a positive test result.
Participants will be eligible to receive a drug subsidy for a set amount (in the form of a voucher) conditional on a positive malaria test. When a conditional subsidy is offered, it is valid for use on a "Green Leaf" approved malaria drug.
Participants can receive a malaria RDT for a set amount (i.e., not for free).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Effect of conditional drug subsidy on proportion of participants who choose to receive a free malaria diagnostic test
Tidsram: Within two days of group assignment
The primary outcome of interest is to compare the proportion of participants who choose to receive a free malaria diagnostic test when they can receive a subsidy for a discounted drug conditional on a positive test compared to those without the offer of a conditional subsidy.
Within two days of group assignment

Sekundära resultatmått

Resultatmått
Tidsram
Effect of malaria RDT subsidy on the uptake of testing (free versus paid RDT)
Tidsram: Within 2 days of group assignment
Within 2 days of group assignment
Effect of a conditional ACT subsidy on uptake of testing when the RDT is not free.
Tidsram: Within 2 days of group assignment
Within 2 days of group assignment

Andra resultatmått

Resultatmått
Tidsram
Percent of clients with a negative test, a positive test or no test who choose to purchase an ACT in all four groups.
Tidsram: Within 2 days of test results
Within 2 days of test results

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Utredare

  • Huvudutredare: Wendy O'Meara, PhD, Duke University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2014

Primärt slutförande (Faktisk)

1 juli 2015

Avslutad studie (Faktisk)

1 juli 2015

Studieregistreringsdatum

Först inskickad

22 juli 2014

Först inskickad som uppfyllde QC-kriterierna

23 juli 2014

Första postat (Uppskatta)

25 juli 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

15 december 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 december 2015

Senast verifierad

1 december 2015

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • Pro00052602
  • 1R01AI110478-01 (U.S.S. NIH-anslag/kontrakt)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera