Impact Evaluation of a Targeted mHealth Intervention to Improve Uptake of Postpartum Contraception in Kenya

Postpartum Family Planning Clinical Trial

Official title:

Impact Evaluation of a Targeted mHealth Intervention to Improve Uptake of Postpartum Contraception in Kenya

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06266780
• Other study ID #: P1473-2023
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Jacaranda Health
• Contact: Anneka Wickramanayake, MPH
• Phone: 254 70 0164229
• Email: awickramanayake[@]jacarandahealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4190
• Est. completion date: December 31, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Postpartum Family Planning

Intervention

Behavioral:
• PROMPTS Enhanced Family Planning Counselling
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.

Locations

Country	Name	City	State
Kenya	Jacaranda Health	Nairobi

Sponsors (4)

Lead Sponsor	Collaborator
Jacaranda Health	Harvard School of Public Health (HSPH), IPSOS, Jhpiego

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of helpdesk team in counselling on family planning	This outcome is a discrete variable with values ranging from 1 (not helpful at all) to 5 (very helpful), indicating the quality of the helpdesk team's counseling on family planning methods. This outcome is measured only among participants who have interacted with a helpdesk agent.	6.5 months postpartum
Other	Quality of message flow on method selection	This outcome is an index with scores ranging from 3 to 15, based on three items with discrete scales measuring the quality of the message flow from the PROMPTS platform regarding method selection. Each item ranges from 1 (not helpful at all) to 5 (very helpful), assessing the usefulness of the messaging platform in: 1) educating about different family planning methods, 2) providing information related to any concerns or issues they had with family planning methods, and 3) assisting in the selection of a family planning method.	6.5 months postpartum
Primary	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.	3 months
Primary	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.	6.5 months
Secondary	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	3 months postpartum
Secondary	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.	3 months postpartum
Secondary	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.	3 months postpartum
Secondary	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.	3 and 6.5 months postpartum
Secondary	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.	3 and 6.5 months postpartum
Secondary	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).	3 months postpartum
Secondary	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.	3 and 6.5 months postpartum
Secondary	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.	3 and 6.5 months postpartum
Secondary	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.	3 and 6.5 months postpartum
Secondary	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.	0-6.5 months postpartum
Secondary	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.	3 months postpartum
Secondary	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.	3 months postpartum
Secondary	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.)	3 and 6.5 months postpartum