Increasing malaria diagnosis in the private sector in Tanzania

• Register: ISRCTN
• Last refreshed on: 6 February 2017
• Main ID: ISRCTN14115509
• Date of registration: 07/07/2016
• Prospective Registration: No
• Primary sponsor: Clinton Health Access Initiative
• Public title: Increasing malaria diagnosis in the private sector in Tanzania
• Scientific title: Expanding access to parasite-based malaria diagnosis through retail drug shops in Tanzania: evidence from a randomized trial and implications for treatment
• Date of first enrolment: 01/03/2013
• Target sample size: 1500
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN14115509
• Study type: Interventional
• Study design: Unblinded cluster randomized controlled intervention trial (Diagnostic)

Countries of recruitment

Tanzania

Contacts

• Name: Abigail Ward

Key inclusion & exclusion criteria

Inclusion criteria: ADDO dispenser inclusion criteria:
1. A certified ADDO dispenser in Kilosa or Kilombero District
2. Attended and passed the two-day RDT training

Survey participants (exit interview):
1. 18 years or older unless accompanied by a parent, guardian, or family member 18 years or older
2. A patient presenting at the ADDO with fever, suspected malaria, or wishing to purchase an RDT or antimalarial
OR
3. A customer at an ADDO wishing to purchase an antimalarial for someone else
Exclusion criteria: ADDO dispenser exclusion criteria
1. An ADDO employee who is not a certified ADDO dispenser in Kilosa or Kilombero District
2. Any ADDO employee in Mvomero District

Survey participants (exit interview):
1. A patient presenting at the ADDO with symptoms of severe illness or reasons other than fever, suspected malaria, or wishing to purchase an RDT or antimalarial
2. A customer at an ADDO wishing to purchase something other than for fever or suspected malaria
3. Children under 18 years old and unaccompanied by a parent, guardian, or family member 18 years or older

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
Infections and Infestations
Malaria

Intervention(s)

Districts are assigned to one of three study arms via a random number generator.

Intervention arm 1:
All certified ADDO dispensers are offered RDT stocking and performance training, and those who successfully complete the two-day training are allowed to stock and sell RDTs in their ADDO for the duration of the study. ADDOs with a certified RDT-trained dispenser are given a storefront sign advertising availability of RDTs within the ADDO. Suspected malaria customers have the option of purchasing RDTs at these shops. The RDTs in this district are partially subsidized and the recommended retail price was set at 500 TSH.

Intervention arm 2:
All certified ADDO dispensers are offered RDT stocking and performance training, and those who successfully complete the two-day training are allowed to stock and sell RDTs in their ADDO for the duration of the study. ADDOs with a certified RDT-trained dispenser are given a storefront sign advertising availability of RDTs within the ADDO. Suspected malaria customers have the option of purchasing RDTs at these shops. The RDTs in this district are not subsidized and the recommended retail price was 1100 TSH.

Control arm:
No RDT trainings are offered in this district, but the same survey questions are asked at baseline and endline around treatment choices.

Each ADDO dispenser is surveyed regarding RDT and ACT stocking, pricing, and safety practices. Additionally, exit interviews took place outside the selected ADDOs at 13 months. Survey participants who met inclusion/exclusion criteria and signed an informed consent form were asked questions from a pre-tested, structured questionnaire (approximately 30 minutes) during a face-to-face interview. Participants were asked to show their RDT results slip and/or drug purchases if available.

Primary Outcome(s)

Blood-based diagnosis of malaria rate is measured by the percentage of suspected malaria customers that received an RDT in an ADDO at baseline and 13 months.

Secondary Outcome(s)

1. Availability of blood-based diagnostic tests is measured by the percentage of ADDOs with a trained dispenser and RDTs in stock at baseline and 13 months
2. Positive adherence is measured by the percentage of customers who tested positive with an RDT and also purchased an artemisinin-combination therapy (ACT) at baseline and 13 months
3. Negative adherence is measured by the percentage of customers who tested negative with an RDT and also purchased an artemisinin-combination therapy (ACT) at baseline and 13 months
4. Affordability is measured by reported price paid for an RDT at baseline and 13 months
5. RDT performance safety is measured using a 17-point checklist at 1, 4, 8, and 13 months
6. RDT disposal safety is measured by the percentage of shops disposing of waste at a public health facility at 1, 4, 8, and 13 months

Secondary ID(s)

N/A

Source(s) of Monetary Support

Department for International Development