ContraceptionNCT05725278
Impact Evaluation of Triggerise's Tiko Platform
A study testing Tiko Platform Behavioural cum mHealth Intervention in people with Contraception and Iron Deficiency Anemia of Pregnancy, run by Network for Engineering and Economics Research and Management at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Iron Deficiency Anemia of Pregnancy, Antenatal Care
- What is being tested?
- Tiko Platform Behavioural cum mHealth Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,708 participants
- Where
- 1 siteIndia
- Study dates
- 15 Feb 2021to 20 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Impact Evaluation of Triggerise's Tiko Platform
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.
Read more
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.
Read the detailed description
See subsequent sections
- Being tested
- Tiko Platform Behavioural cum mHealth Intervention, Standard of Care / Business as Usual
- Keywords
- mHealth, Social Franchising, Social Marketing, Impact Evaluation, Market-Driven, Family Planning, Antenatal Care, Community Health Workers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiko Platform Behavioural cum mHealth InterventionBehavioural
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).
Standard of Care / Business as UsualOther
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
| Study group | Role | What they receive |
|---|---|---|
| Users of Tiko Platform | Experimental | These participants accessed various services on Tiko platform such as buying contraceptives, visiting doctors for ANC etc. They earned Tiko Miles/Points for such health seeking behaviours which they could then redeem at network of grocery shops, pharmacies, beauty salon etc. Tiko card also enabled them to get discounts at pharmacies and at health care providers. These participants were free to access any other government or private health care facility as free economic agents. Users of Tiko platform were identified by the backend system that recorded all health seeking behaviours / actions, reward point accumulation, and use of those reward points. Receives: Behavioral: Tiko Platform Behavioural cum mHealth Intervention |
| Non-Users of Tiko Platform | Active comparator | These participants registered on Tiko platform on basis of recruitment drive and pitch by Pro agents, but they did not access any service and became dormant. However, These participants were free to access any other government or private health care facility and could access fame family planning and ANC products and services. They could even access Tiko network doctors and pharmacies but they would not get any Tiko Miles/Points or discounts without the use of Tiko card. Non Users were identified as those registered women who did not have any record of using services using Tiko card as per the backend system Receives: Other: Standard of Care / Business as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women currently using any contraceptives
Whether a woman used any contraceptive - traditional or modern methods, and permanent or temporary methods
Measured: Through survey completion, an average of 1 month
Proportion of women currently using modern short-term contraceptives
Whether a woman used modern and temporary contraception methods
Measured: Through survey completion, an average of 1 month
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
Measured: 9 months during pregnancy with the youngest child
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
Measured: 9 months during pregnancy with the youngest child
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
Measured: Within 6 weeks after delivery of the youngest child
Secondary outcomes (4)
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
Measured: 9 months during pregnancy with the youngest child
Out of pocket expenditure on Family planning services and products
Reported expenditure in Indian Rupees for permanent or temporary contraceptive methods
Measured: Past 24 months (from survey date)
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
Measured: 9 months during pregnancy with the youngest child
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
Measured: Within 6 weeks after delivery of the youngest child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start15 Feb 2021
- Primary completion17 May 2021
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study compares family planning, antenatal care and postnatal care related outcomes (multiple) for women who had registered on Tiko Platform between those who used the platform and those who did not access any services on the platform. The comparison is done ex-post with a single cross sectional survey in March-April 2021. Model uses fixed effects at Pro-Agent level who is a local health promoter of a small geographical area and recruits and serves women in that area so that confounders at agent and levels beyond are controlled. For women/household level confounder control, a few socio-economic and demographic variables at the woman level were included in the model, and sensitivity of the results with and without adjusting for these control variables was investigated.
- Masking
- None (open label)
- Enrolment
- 1,708 participants (actual)
Sponsor and investigators
- Lead sponsor
- Network for Engineering and Economics Research and Management
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumeet Patil, PhD, Principal investigator, Network for Engineering and Economics Research and Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725278
- Sponsor's protocol ID
- Triggerise Protocol V2
- Status last verified
- Feb 2023
- First submitted
- 12 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: While NEERMAN holds data use and publication rights from Triggerise, the data ownership rests with Triggerise so data access to de-identify observations and variables used in pit is unclear published papers can be made available under certain conditions
Publications
Patil SR, Gopalakrishnan L, Sai VS, Matikanya R, Rajpal P. Markets, incentives, and health promotion can improve family planning and maternal health practices: a quasi-experimental evaluation of a tech-enabled social franchising and social marketing platform in India. BMC Public Health. 2024 Jan 23;24(1):264. doi: 10.1186/s12889-023-17413-w.
PubMed 38262982
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Impact Evaluation of Triggerise's Tiko Platform
- ClinicalTrials.gov ID
- NCT05725278
- Acronym / sponsor ID
- Triggerise Protocol V2
- Keywords
- mHealth, Social Franchising, Social Marketing, Impact Evaluation, Market-Driven, Family Planning, Antenatal Care, Community Health Workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,708 participants (actual)
- Lead sponsor
- Network for Engineering and Economics Research and ManagementUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See subsequent sections
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study compares family planning, antenatal care and postnatal care related outcomes (multiple) for women who had registered on Tiko Platform between those who used the platform and those who did not access any services on the platform. The comparison is done ex-post with a single cross sectional survey in March-April 2021. Model uses fixed effects at Pro-Agent level who is a local health promoter of a small geographical area and recruits and serves women in that area so that confounders at agent and levels beyond are controlled. For women/household level confounder control, a few socio-economic and demographic variables at the woman level were included in the model, and sensitivity of the results with and without adjusting for these control variables was investigated.
| Arm | Type | Receives |
|---|---|---|
| Users of Tiko Platform | Experimental | Behavioral: Tiko Platform Behavioural cum mHealth InterventionThese participants accessed various services on Tiko platform such as buying contraceptives, visiting doctors for ANC etc. They earned Tiko Miles/Points for such health seeking behaviours which they could then redeem at network of grocery shops, pharmacies, beauty salon etc. Tiko card also enabled them to get discounts at pharmacies and at health care providers. These participants were free to access any other government or private health care facility as free economic agents. Users of Tiko platform were identified by the backend system that recorded all health seeking behaviours / actions, reward point accumulation, and use of those reward points. |
| Non-Users of Tiko Platform | Active comparator | Other: Standard of Care / Business as UsualThese participants registered on Tiko platform on basis of recruitment drive and pitch by Pro agents, but they did not access any service and became dormant. However, These participants were free to access any other government or private health care facility and could access fame family planning and ANC products and services. They could even access Tiko network doctors and pharmacies but they would not get any Tiko Miles/Points or discounts without the use of Tiko card. Non Users were identified as those registered women who did not have any record of using services using Tiko card as per the backend system |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiko Platform Behavioural cum mHealth InterventionTiko 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). | Behavioural | Users of Tiko Platform |
| Standard of Care / Business as UsualNon-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 | Other | Non-Users of Tiko Platform |
Primary outcome
Proportion of women currently using any contraceptives
Time frame: Through survey completion, an average of 1 month
Whether a woman used any contraceptive - traditional or modern methods, and permanent or temporary methods
Proportion of women currently using modern short-term contraceptives
Time frame: Through survey completion, an average of 1 month
Whether a woman used modern and temporary contraception methods
Proportion of women who consumed 100 or more Iron Folic Acid (IFA) tablets during last pregnancy
Time frame: 9 months during pregnancy with the youngest child
Whether the study participant recalled consuming 100 or more IFA tablets when pregnant with youngest child born after 1 January 2019
Proportion of women who received 4 or more antenatal check-ups during last pregnancy
Time frame: 9 months during pregnancy with the youngest child
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
Proportion of women who received a postnatal check-up within 6 week of the delivery from a healthcare provider
Time frame: Within 6 weeks after delivery of the youngest child
Whether the study participant recalled receiving at least one postnatal health check up within 6 weeks of the youngest child's birth
4 secondary outcomes
Out of pocket expenditure on antenatal care, iron folic acid tablets, delivery, and postnatal check-ups
Time frame: 9 months during pregnancy with the youngest child
Out of pocket expenditure on Family planning services and products
Time frame: Past 24 months (from survey date)
Proportion of women receiving Antenatal check-ups at (a) Tiko franchisee doctors, (b) other private doctors, or (c) government healthcare provider
Time frame: 9 months during pregnancy with the youngest child
Proportion of women receiving postnatal check-ups at (a) Tiko franchisee doctors, (b) other private doctors, or (c) government healthcare provider
Time frame: Within 6 weeks after delivery of the youngest child
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Derived from this study: PubMed 38262982Patil SR, Gopalakrishnan L, Sai VS, Matikanya R, Rajpal P. Markets, incentives, and health promotion can improve family planning and maternal health practices: a quasi-experimental evaluation of a tech-enabled social franchising and social marketing platform in India. BMC Public Health. 2024 Jan 23;24(1):264. doi: 10.1186/s12889-023-17413-w.
- Individual participant dataSharing planned: No. While NEERMAN holds data use and publication rights from Triggerise, the data ownership rests with Triggerise so data access to de-identify observations and variables used in pit is unclear published papers can be made available under certain conditions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumeet Patil, PhD principal investigator
Network for Engineering and Economics Research and Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tiko Platform Behavioural cum mHealth Intervention in people with Contraception and Iron Deficiency Anemia of Pregnancy, run by Network for Engineering and Economics Research and Management at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women currently using any contraceptives (time frame: Through survey completion, an average of 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05725278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.