Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
This study aimed to identify ways of making the benefits of a health insurance scheme in Gujarat, India, more accessible to its poorest members. Normally, in order to be eligible for reimbursement under this insurance scheme, a member had to be hospitalized, had to pay for her hospitalization out-of-pocket, and then had to submit an insurance claim. Research we conducted in 2003 suggested that the poorest members of this insurance scheme were the least likely to benefit from it. Among the problems they faced were jobs and responsibilities that prevented them from seeking hospitalization, and difficulties paying for hospitalization. This study involves testing two different interventions intended to make health insurance benefits more accessible.

Who can participate?
All female and male members of SEWA insurance for 2004 and 2005.

What does the study involve?
One intervention involves paying the insurance benefits upfront when the woman was admitted to hospital, rather than by reimbursement. The second intervention involves strengthening contacts between members and administrators, to make the process of submitting a claim easier and less expensive. Participants are randomly allocated to either the first intervention, the second intervention, or the two interventions together.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
London School of Hygiene and Tropical Medicine (UK)

When is the study starting and how long is it expected to run for?
October 2003 to April 2006

Who is funding the study?
Wellcome Trust (UK)

Who is the main contact?
Prof Anne Mills

Trial website

Contact information



Primary contact

Prof Anne J Mills


Contact details

London School of Hygiene and Tropical Medicine
Keppel Street
United Kingdom

Additional identifiers

EudraCT number number


Protocol/serial number

067926; PHHPBD25

Study information

Scientific title

Experimental study to assess interventions aimed at improving the equity impact of community-based health insurance


Study hypothesis

Community based health insurance is often cited as a means of improving access and financial protection in developing countries, but such schemes may not benefit the poorest. We evaluate alternative strategies for improving the uptake of benefits of a community based health insurance scheme by its poorest members.

The purpose of this study is to assess interventions aimed at improving the distributional impact of a community based health insurance scheme in rural India.

Ethics approval

Received from the local medical ethics committee on 15/03/2003, ref: 948

Study design

Health services research, randomised, open label, active control, factorial assignment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet


Health insurance


Three groups are compared to standard insurance scheme members (control):
1. Group one is provided with After-Sale Service and supportive supervision (AfterSS)
2. Group two is provided with Prospective Reimbursement (PR)
3. Group three is provided with these two interventions together (both)

Intervention type



Not Applicable

Drug names

Primary outcome measure

Socioeconomic status of claimants relative to the membership base in their subdistricts of residence.

Secondary outcome measures

1. Enrolment rates in Vimo SEWA
2. Mean socioeconomic of the insured relative to the general rural population
3. Rate of insurance claim submission

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Subdistrict inclusion criteria:
500 or more female (greater than or equal to 18 years of age) Self Employed Womens Association (SEWA) insurance members in 2003.

Individual inclusion criteria:
All female and male members of SEWA insurance for 2004 and 2005.

Participant type


Age group




Target number of participants


Participant exclusion criteria

Subdistrict exclusion criteria:
1. All members were mandatorily enrolled in the scheme by a donor agency
2. The sub-district had no general hospital of 25 beds or more

Individual exclusion criteria:
Those whose home could not be found based on given address data.

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

London School of Hygiene and Tropical Medicine
United Kingdom

Trial participating centre

Self Employed Women's Association
SEWA Reception Centre Opp. Victoria Garden Bhadra
380 001

Sponsor information


London School of Hygiene and Tropical Medicine (UK)

Sponsor details

Keppel Street
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Wellcome Trust (UK) (grant ref: 067926)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

International organizations


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Available on request

Basic results (scientific)

Publication list

Results in:
1. 2006 results in
2. 2006 barriers to trial results:
3. 2006 challenges to trial results:
4. 2006 preferred provider system results:
5. 2007 measuring improved targeting results:
6. 2007 equitable utilisation results:
7. 2007 management initiatives results:

Publication citations

  1. Results

    Ranson MK, Sinha T, Chatterjee M, Acharya A, Bhavsar A, Morris SS, Mills AJ, Making health insurance work for the poor: learning from the Self-Employed Women's Association's (SEWA) community-based health insurance scheme in India., Soc Sci Med, 2006, 62, 3, 707-720, doi: 10.1016/j.socscimed.2005.06.037.

  2. Barriers to trial results

    Sinha T, Ranson MK, Chatterjee M, Acharya A, Mills AJ, Barriers to accessing benefits in a community-based insurance scheme: lessons learnt from SEWA Insurance, Gujarat., Health Policy Plan, 2006, 21, 2, 132-142, doi: 10.1093/heapol/czj010.

  3. Challenges to trial results

    Ranson MK, Sinha T, Morris SS, Mills AJ, CRTs--cluster randomized trials or "courting real troubles": challenges of running a CRT in rural Gujarat, India., Can J Public Health, 97, 1, 72-75.

  4. Preferred provider system results

    Ranson MK, Sinha T, Gandhi F, Jayswal R, Mills AJ, Helping members of a community-based health insurance scheme access quality inpatient care through development of a preferred provider system in rural Gujarat., Natl Med J India, 19, 5, 274-282.

  5. Measuring improved targeting results

    Morris SS, Ranson MK, Sinha T, Mills AJ, Measuring improved targeting of health interventions to the poor in the context of a community-randomised trial in rural India., Contemp Clin Trials, 2007, 28, 4, 382-390, doi: 10.1016/j.cct.2006.10.008.

  6. Equitable utilisation results

    Ranson MK, Sinha T, Chatterjee M, Gandhi F, Jayswal R, Patel F, Morris SS, Mills AJ, Equitable utilisation of Indian community based health insurance scheme among its rural membership: cluster randomised controlled trial., BMJ, 2007, 334, 7607, 1309, doi: 10.1136/bmj.39192.719583.AE.

  7. Management initiatives results

    Sinha T, Ranson MK, Chatterjee M, Mills A, Management initiatives in a community-based health insurance scheme., Int J Health Plann Manage, 22, 4, 289-300, doi: 10.1002/hpm.898.

Additional files

Editorial Notes