Postpartum Family PlanningNCT06266780
Impact Evaluation of a Targeted mHealth Intervention to Improve Uptake of Postpartum Contraception in Kenya
A study testing PROMPTS Enhanced Family Planning Counselling in people with Postpartum Family Planning, run by Jacaranda Health at 1 site in Kenya.
Trial summary
The goal of this study is to explore approaches to improve postpartum contraceptive counseling, information, and uptake through a collaboration between the Harvard Chan School, Rutgers School of Public Health, Jacaranda Health, Jhpiego, and IPSOS, leveraging an existing mobile health platform for intervention delivery… Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Family Planning
- What is being tested?
- PROMPTS Enhanced Family Planning Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,190 participants
- Where
- 1 siteKenya
- Study dates
- 2 Feb 2024to 31 Dec 2024
- 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 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 15 and over,
- Pregnant at 7-8 months gestation,
- Consented to be enrolled in the PROMPTS text-messaging platform and who have provided informed consent to be part of this research study
- Have access to a mobile phone
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Kenya1 site, 1 recruiting
- Recruiting
Jacaranda Health
Nairobi, 00000
Anneka Wickramanayake, Masters, +254700164229, awickramanayake@jacarandahealth.org
Jessica Cohen, Ph.D, +16174327577, cohenj@hsph.harvard.edu
About this study
The goal of this study is to explore approaches to improve postpartum contraceptive counseling, information, and uptake through a collaboration between the Harvard Chan School, Rutgers School of Public Health, Jacaranda Health, Jhpiego, and IPSOS, leveraging an existing mobile health platform for intervention delivery and Jacaranda's established partnership with the Kenyan Ministry of Health, county health offices and public maternity hospitals.
Jacaranda's PROMPTS mHealth platform has reached over two million pregnant women and new mothers, providing them with needed, tailored information about prenatal and postpartum health along with access to a mobile helpdesk to triage users' questions. Using a targeted human-centered-design process with early postpartum mothers, we developed targeted messaging around family planning and contraceptive method options, with the goal of integrating this new content into Jacaranda's PROMPTS platform. We will conduct a randomized controlled trial with pregnant women engaged with the PROMPTS platform to determine the impact of the intervention package on information and utilization of postpartum contraception. If proven effective, the results of this intervention will be integrated into Jacaranda's PROMPTS system at full scale.
- Conditions
- Postpartum Family Planning
- Being tested
- PROMPTS Enhanced Family Planning Counselling
- Keywords
- Maternal Health, Postpartum Health, Contraception, Family Planning, Birth Spacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMPTS Enhanced Family Planning CounsellingBehavioural
Based on a targeted human-centered-design process with pregnant and early postpartum mothers, the intervention consists of informative messages, counselling and reminders regarding postpartum family planning and birth spacing, leveraging an existing mobile health platform (PROMPTS) for intervention delivery and Jacaranda's established partnership with the Kenyan Ministry of Health, county health offices and public maternity hospitals method options. The intervention includes several features: activation of family planning discussions between pregnant and postpartum women and their health care providers, information provision, method selection support to help women choose their preferred method, and reminders to follow-up. The key feature is to help women make an informed plan about family planning in the prenatal or early postpartum period and follow through with this plan.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Group receiving enhanced package of postpartum family planning support Receives: Behavioral: PROMPTS Enhanced Family Planning Counselling |
| Control Group | No intervention | Group receiving basic postpartum family planning information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of postpartum family planning at 3 months
The outcome is a binary variable, set to 1 if a participant reports using any modern family planning method (including Lactational Amenorrhea Method (LAM)) at the time of the survey. The modern methods considered will include sterilization (both male and female), implants, Intrauterine Device (IUD), injectables, oral contraceptives (pill), condoms (both male and female), diaphragm, foam/jelly, and LAM.
Measured: 3 months
Use of postpartum family planning at 6 months
The outcome is a binary variable, assigned a value of 1 if a participant reports using any modern family planning method, excluding LAM, at the time of the survey. The modern methods considered include sterilization (both male and female), implant, IUD, injectables, oral contraceptives (pill), condoms (both male and female), diaphragm, foam, and jelly.
Measured: 6.5 months
Secondary outcomes (13)
Knowledge of return to fertility
The outcome is a binary variable, set to 1 if a participant is aware of the possibility of becoming pregnant after giving birth, even if she has not yet seen her period
Measured: 3 months postpartum
Knowledge of safe birth spacing
The outcome is a binary variable, set to 1 if a participant is aware of the minimum recommended delay between the delivery of a baby and the start of the next pregnancy (two years) to promote the health of both the mother and the child.
Measured: 3 months postpartum
Knowledge of lactational amenorrhea (LAM) method
This outcome is an index assessing knowledge of LAM as a method to avoid or delay pregnancy and consists of three items. The first item is a binary indicator, set to 1 if a participant has any familiarity with LAM. The second item is a binary variable, set to 1 if the participant, among those familiar with LAM, knows the recommended duration of LAM use post-delivery (up to 6 months after delivery). The third item is a binary variable, set to 1 if the participant, again among those familiar with LAM, is aware of the other two factors that can reduce the effectiveness of LAM (return of menstruation and the introduction of liquids/foods to the baby). Participants who are not familiar with LAM will automatically receive a score of 0 for the second and third items.
Measured: 3 months postpartum
Intention to continue family planning method
The outcome is a binary variable, assigned a value of 1 if a participant reports an intention to continue using the same family planning method that they were using at the time of the survey.
Measured: 3 and 6.5 months postpartum
Intended duration of continued family planning method use
Among participants who reported an intention to continue with their current family planning method, this outcome quantifies the number of months they plan to maintain its use, as indicated during the survey.
Measured: 3 and 6.5 months postpartum
Desired pregnancy spacing of two years or more
This outcome assesses participants' intentions regarding birth spacing following their recent pregnancy. The primary focus is to determine the proportion of participants planning a gap of at least two years before the onset of their next pregnancy. Participants' intentions are categorized into:
- Less than 6 months
- 6 months to less than 12 months
- 1 year to less than 2 years
- 2 years or more (main outcome of interest).
Measured: 3 months postpartum
Short interpregnancy interval
The outcome is a binary variable, assigned a value of 1 if a participant reports being pregnant at either of the two follow-up surveys conducted at 3 months or 6.5 months.
Measured: 3 and 6.5 months postpartum
Method satisfaction
This outcome is a discrete variable with values ranging from 1 (very unsatisfied) to 5 (very satisfied), assessing overall satisfaction with the current family planning method. It is evaluated only among participants who reported using a family planning method at the time of the survey.
Measured: 3 and 6.5 months postpartum
Uptake of most effective family planning methods
The outcome is a binary variable, set to 1 if a participant reports using any of the most effective family planning methods as classified by the US CDC at the time of the survey. The subset of the most effective methods includes: implant, IUD, sterilization, injectable, pill, patch, diaphragm, and ring.
Measured: 3 and 6.5 months postpartum
Time to take-up of most effective methods
This outcome is a continuous time variable, measured in weeks, representing the interval between delivery and first adoption of one of the most effective methods of family planning, as classified by the CDC. This outcome is calculated only for participants who reported using one or more of these most effective methods.
Measured: 0-6.5 months postpartum
Discussion of FP at any prenatal visit
The outcome is a binary variable, assigned a value of 1 if a participant reports having had a discussion about family planning with their antenatal care provider at any point during the prenatal period.
Measured: 3 months postpartum
Discussion of FP at any postnatal visit
The outcome is a binary variable, assigned a value of 1 if a participant reports having had a discussion about family planning with health staff at their postnatal care facility at any point during the postnatal period.
Measured: 3 months postpartum
Reproductive empowerment: health care provider communication
The outcome is an average score across 3 items measuring one aspect of reproductive empowerment: health care provider communication (participant reports being able to initiate conversations about using contraception with health care providers, ask health care provider questions about using contraception, and share opinions about using contraception with health care providers.)
Measured: 3 and 6.5 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start2 Feb 2024
- Primary completion30 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Family PlanningStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacaranda Health
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Jhpiego, IPSOS
- Responsible party
- Sponsor
- Investigators
- Anneka Wickramanayake, MPH, Principal investigator, Jacaranda Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266780
- Sponsor's protocol ID
- P1473-2023
- Status last verified
- Feb 2024
- First submitted
- 11 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of a Targeted mHealth Intervention to Improve Uptake of Postpartum Contraception in Kenya
- ClinicalTrials.gov ID
- NCT06266780
- Acronym / sponsor ID
- P1473-2023
- Conditions
- Postpartum Family Planning
- Keywords
- Maternal Health, Postpartum Health, Contraception, Family Planning, Birth Spacing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,190 participants (estimated)
- Lead sponsor
- Jacaranda HealthUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Jhpiego, IPSOS
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Feb 2024 (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.
The goal of this study is to explore approaches to improve postpartum contraceptive counseling, information, and uptake through a collaboration between the Harvard Chan School, Rutgers School of Public Health, Jacaranda Health, Jhpiego, and IPSOS, leveraging an existing mobile health platform for intervention delivery and Jacaranda's established partnership with the Kenyan Ministry of Health, county health offices and public maternity hospitals.
Jacaranda's PROMPTS mHealth platform has reached over two million pregnant women and new mothers, providing them with needed, tailored information about prenatal and postpartum health along with access to a mobile helpdesk to triage users' questions. Using a targeted human-centered-design process with early postpartum mothers, we developed targeted messaging around family planning and contraceptive method options, with the goal of integrating this new content into Jacaranda's PROMPTS platform. We will conduct a randomized controlled trial with pregnant women engaged with the PROMPTS platform to determine the impact of the intervention package on information and utilization of postpartum contraception. If proven effective, the results of this intervention will be integrated into Jacaranda's PROMPTS system at full scale.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: PROMPTS Enhanced Family Planning CounsellingGroup receiving enhanced package of postpartum family planning support |
| Control Group | No intervention | –Group receiving basic postpartum family planning information |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age 15 and over,
- Pregnant at 7-8 months gestation,
- Consented to be enrolled in the PROMPTS text-messaging platform and who have provided informed consent to be part of this research study
- Have access to a mobile phone
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| PROMPTS Enhanced Family Planning CounsellingBased on a targeted human-centered-design process with pregnant and early postpartum mothers, the intervention consists of informative messages, counselling and reminders regarding postpartum family planning and birth spacing, leveraging an existing mobile health platform (PROMPTS) for intervention delivery and Jacaranda's established partnership with the Kenyan Ministry of Health, county health offices and public maternity hospitals method options. The intervention includes several features: activation of family planning discussions between pregnant and postpartum women and their health care providers, information provision, method selection support to help women choose their preferred method, and reminders to follow-up. The key feature is to help women make an informed plan about family planning in the prenatal or early postpartum period and follow through with this plan. | Behavioural | Intervention Group |
Primary outcome
Use of postpartum family planning at 3 months
Time frame: 3 months
The outcome is a binary variable, set to 1 if a participant reports using any modern family planning method (including Lactational Amenorrhea Method (LAM)) at the time of the survey. The modern methods considered will include sterilization (both male and female), implants, Intrauterine Device (IUD), injectables, oral contraceptives (pill), condoms (both male and female), diaphragm, foam/jelly, and LAM.
Use of postpartum family planning at 6 months
Time frame: 6.5 months
The outcome is a binary variable, assigned a value of 1 if a participant reports using any modern family planning method, excluding LAM, at the time of the survey. The modern methods considered include sterilization (both male and female), implant, IUD, injectables, oral contraceptives (pill), condoms (both male and female), diaphragm, foam, and jelly.
13 secondary outcomes
Knowledge of return to fertility
Time frame: 3 months postpartum
Knowledge of safe birth spacing
Time frame: 3 months postpartum
Knowledge of lactational amenorrhea (LAM) method
Time frame: 3 months postpartum
Intention to continue family planning method
Time frame: 3 and 6.5 months postpartum
Intended duration of continued family planning method use
Time frame: 3 and 6.5 months postpartum
Desired pregnancy spacing of two years or more
Time frame: 3 months postpartum
Short interpregnancy interval
Time frame: 3 and 6.5 months postpartum
Method satisfaction
Time frame: 3 and 6.5 months postpartum
Uptake of most effective family planning methods
Time frame: 3 and 6.5 months postpartum
Time to take-up of most effective methods
Time frame: 0-6.5 months postpartum
Discussion of FP at any prenatal visit
Time frame: 3 months postpartum
Discussion of FP at any postnatal visit
Time frame: 3 months postpartum
Reproductive empowerment: health care provider communication
Time frame: 3 and 6.5 months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Mental and Reproductive Health Integration and Access
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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.
Anneka Wickramanayake, MPH principal investigator
Jacaranda Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROMPTS Enhanced Family Planning Counselling in people with Postpartum Family Planning, run by Jacaranda Health at 1 site in Kenya.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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 Kenya. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anneka Wickramanayake, MPH (254 70 0164229, awickramanayake@jacarandahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of postpartum family planning at 3 months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.