Testing behavioral interventions to increase intention to and use of modern contraception among women with at least one child
| ISRCTN | ISRCTN55316336 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55316336 |
| Sponsors | Surgo Ventures (now Surgo Health), Clinton Foundation |
| Funder | Surgo Foundation |
- Submission date
- 05/03/2026
- Registration date
- 09/03/2026
- Last edited
- 09/03/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sema Sgaier
Public, Scientific, Principal investigator
Public, Scientific, Principal investigator
1701 Rhode Island Avenue NW
Washington DC
20036
United States of America
| Phone | +1 206 330 6272 |
|---|---|
| semasgaier@surgohealth.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Active | |
| Assignment | Single | |
| Purpose | Health services research | |
| Scientific title | Understanding the potential of interventions based on causal drivers in increasing intent and uptake of modern contraceptives (esp. MET) among single-parity women | |
| Study objectives | ||
| Ethics approval(s) |
Approved 27/05/2022, Convergent Institutional Review Board (Suit No-104, C-51, BSI Business Park, C-Block Ph-II, Sector-62, Noida, 201309, India; +91 (0)9999369375; info@convergentview.com), ref: 06/Convergent-IRB/2022-23 | |
| Health condition(s) or problem(s) studied | Contraception among postpartum women | |
| Intervention | ASHAs' (Community Health Workers') catchment areas in three blocks (Nasrullaganj, Shyampur, and Icchawar) of Sehore district, Madhya Pradesh, India, were randomly assigned to intervention or control arms. The random assignment was performed by using a random number generator using Excel. Enrolled participants in the ASHAs' catchment areas were then surveyed at baseline and follow-up. Intervention arm: Accredited social health activists (ASHAs) (community health workers) received training to deliver structured family planning counselling over five visits during a 5-month period (November 2022–March 2023). The intervention included: 1. Counselling on birth spacing 2. Information on modern, effective, and temporary (MET) methods (daily oral pill, weekly oral pill, intrauterine device, injectable) 3. Printed behavior change communication (BCC) materials delivered in stages 4. Information on government service points for free access Control arm: ASHAs continued routine government family planning programming without structured intervention | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 10/05/2023 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Female |
| Target sample size at registration | 1760 |
| Total final enrolment | 1767 |
| Key inclusion criteria | 1. Married women 2. At least one 1+ parity 3. Fecund and not currently pregnant 4. Neither woman nor spouse sterilized 5. 3 to 9 months postpartum at baseline enrollment 6. Had not opted for an irreversible contraception method 7. Planned to remain in the same locality for the upcoming 6 months 8. 18 years of age or over (to provide consent) 9. Provided informed consent |
| Key exclusion criteria | 1. Sterilized 2. Currently pregnant 3. Planning relocation within 6 months 4. Declined consent |
| Date of first enrolment | 06/09/2022 |
| Date of final enrolment | 14/10/2022 |
Locations
Countries of recruitment
- India
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The data generated during the current study are available upon request on a case-by-case basis. Please contact Dr Sema K. Sgaier at semasgaier@surgohealth.com. |
Editorial Notes
06/03/2026: Study's existence confirmed by the Convergent Institutional Review Board.
