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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05725278
Other study ID # Triggerise Protocol V2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2021
Est. completion date March 20, 2022

Study information

Verified date February 2023
Source Network for Engineering and Economics Research and Management
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Triggerise designed web and phone based Tiko platform to connect young girls and women to the health products, services and information. The platform uses principles of behaviour economics to motivate positive choices-including rewards, promotions, discounts, coupons, reminders, alerts etc. The platform was implemented in several cities from seven states of India to provide Sexual Reproductive Health (SRH) and maternal and child health (MCH) products and services. The consumers (called Rafikis) use Tiko card to get discounts and to earn 'Tiko miles' rewards at Tiko franchised healthcare providers and pharmacies. Tiko miles are redeemable towards lifestyle products or services (e.g., beauty salons). The local Tiko health promoter (celled Pro agent) can also buy health and hygiene products at bulk discounts and sell them at profit. Triggerise appointed Network for Engineering, Economics Research and Management (NEERMAN) to conduct an independent impact assessment of the Tiko platform with multiple research objectives include health impact evaluation at the Rafiki level. NEERMAN used an ex-post observational design to compare usage of SRH and MCH services and family planning (FP), antenatal care (ANC) and postnatal care (PNC) practices by comparing Users and Non-Users of Tiko platform, and accounting for the selection bias statistically. The structured questionnaire collected data on knowledge, practices, barriers, enablers for SRH and MCH services, exposure o Tiko platform, and how it helped or did not help. The survey participants were approx. 1200 users and 600 non-users being served by approx. 350 pro-agents in their respective operations area. The association between use of Tiko platform and various outcomes were identified using a generalized linear model with fixed effects at pro-agent level and including a set of covariates. To evaluate the effect modification by type of pro agent - government community health worker (CHW) versus others - an interaction model was used. The standard errors were automatically clustered at pro-agent level due to fixed effects. Primary outcomes are proportion of married Rafikis currently using any contraceptives, currently using modern short-term contraceptives, proportion of Rafikis who delivered a child post Jan 2019 and received at least 4 ANC check-ups, consumed at least 100 iron folic acid (IFA( during pregnancy, and received a PNC check-up within 6 weeks of birth.


Description:

See subsequent sections


Recruitment information / eligibility

Status Completed
Enrollment 1708
Est. completion date March 20, 2022
Est. primary completion date May 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Women who are registered on Tiko Platform with Pro-agents active in 2020-21 - Age 18-50 - Address and contacts details are found with help of Pro-agent Exclusion Criteria: - Does not consent to participation - Does not agree or confirm registering on Tiko Platform - If a woman is never married, she is excluded from survey on family planning but surveyed for use of Tiko platform - If a married woman does not have a child born on/after 1 January 2019, then she is excluded from the survey on antenatal care, delivery and postnatal care but surveyed for use of Tiko platform

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Tiko Platform Behavioural cum mHealth Intervention
Tiko platform is a mix of social franchising and social marketing concepts to promote health behaviours through rewards to health promoters (pro agents), healthcare providers (doctors and pharmacies), Beneficiaries (women needing FP and/or ANC services), and shop keepers and life-style service providers where beneficiaries, providers and promoters could use their rewards points. The health promoters could purchase from wholesale retailers products such as sanitary napkins, condoms and then resale these at profit. Beneficiaries were given discounts and their rewards points can be used as cash to avail certain lifestyle services at participating locations, and so did the health care providers. Pro agents also got incentives for recruiting the beneficiaries and after beneficiaries reached certain service access/use milestones. All this was integrated on a mHealth platform using smart phones and smart cards (for those without access to Tiko card).
Other:
Standard of Care / Business as Usual
Non-Users of Tiko did not use Tiko platform but they could access any health care provider or pharmacy to avail same services related to Family planning, antenatal care, postnatal care

Locations

Country Name City State
India NEERMAN Mumbai Maharashtra

Sponsors (1)

Lead Sponsor Collaborator
Network for Engineering and Economics Research and Management

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of women currently using any contraceptives Whether a woman used any contraceptive - traditional or modern methods, and permanent or temporary methods Through survey completion, an average of 1 month
Primary Proportion of women currently using modern short-term contraceptives Whether a woman used modern and temporary contraception methods Through survey completion, an average of 1 month
Primary Proportion of women who consumed 100 or more Iron Folic Acid (IFA) tablets during last pregnancy Whether the study participant recalled consuming 100 or more IFA tablets when pregnant with youngest child born after 1 January 2019 9 months during pregnancy with the youngest child
Primary Proportion of women who received 4 or more antenatal check-ups during last pregnancy Whether the study participant recalled receiving 4 or more ANC check-ups from any health care provider when pregnant with youngest child born after 1 January 2019 9 months during pregnancy with the youngest child
Primary Proportion of women who received a postnatal check-up within 6 week of the delivery from a healthcare provider Whether the study participant recalled receiving at least one postnatal health check up within 6 weeks of the youngest child's birth Within 6 weeks after delivery of the youngest child
Secondary Out of pocket expenditure on antenatal care, iron folic acid tablets, delivery, and postnatal check-ups Reported expenditure in Indian Rupees for antenatal care, iron folic acid tablets, delivery, and postnatal check-ups associated with the youngest child born after 1 January 2019 9 months during pregnancy with the youngest child
Secondary Out of pocket expenditure on Family planning services and products Reported expenditure in Indian Rupees for permanent or temporary contraceptive methods Past 24 months (from survey date)
Secondary Proportion of women receiving Antenatal check-ups at (a) Tiko franchisee doctors, (b) other private doctors, or (c) government healthcare provider Separate proportions are estimated for each of the three locations of antenatal check-ups when pregnant with youngest child born after 1 January 2019 9 months during pregnancy with the youngest child
Secondary Proportion of women receiving postnatal check-ups at (a) Tiko franchisee doctors, (b) other private doctors, or (c) government healthcare provider Separate proportions are estimated for each of the three locations of postnatal check-ups within 6 weeks after delivery of the youngest child born after 1 January 2019 Within 6 weeks after delivery of the youngest child
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