Effect of Joint Provision of Community Group-based Counseling with Individual Counseling on Postpartum Contraception

NCT06766409 | Not Yet Recruiting

• 1 other identifier: Stpaulhospitalmilleniummedical
• Study Type: interventional
• Target: 598
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to assess the effectiveness of joint provision of community group-based demonstration counseling methods with routine individual family planning counseling provided to prenatal and postnatal women on postpartum contraception acceptance in the West Shoa Zone, Oromia, Ethiopia. A two-arm cluster randomized control trial will be conducted to compare the routine individual facility-based family planning counseling with the joint provision of individual and community group-based counseling with a process of arranged demonstration on the later part. The study will be conducted from March 1, 2025, to May 30, 2026. A sample of 598 women (21 women per 28 clusters) will be selected by a two-stage (stratification and clustering) sampling. A structured questionnaire will be used to collect the data. The data will be entered into STATA (V16). A goodness of fit test using Pearson's chi-square and a multicollinearity test will be checked. Multinomial logistic regression will be used for analysis. The main questions it aims to answer are:

1. 1.Will postpartum women in the intervention group (joint provision of individual and community group-based counseling) be more likely to use contraception?
2. 2.Percent of postnatal women who receive any method from the intervention group.
3. 3.Percent of postnatal women who receive any method from the control group.
4. 4.Will postpartum women in the intervention group, subject to an intervention group, prefer highly effective contraceptive methods?
5. 5.Percent of postnatal women who receive highly effective methods from the intervention group.
6. 6.Percent of postnatal women who receive low-effective methods from the control group.
7. 7.Percent of postnatal women who receive highly effective methods from the control group.
8. 8.Percent of postnatal women who receive low-effective methods from the intervention group.

Conditions

Postpartum Contraception

Keywords

Postpartum contraception; Postpartum family planning; Ethiopia

Outcome Measures

Primary Outcomes (1)

• Magnitude (percentage) of postnatal women who use any contraceptive method; 2. The percentage of each contraceptive method (choices) utilized by postnatal women

  Based on the data obtained from a quantitative questionnaire filled out by each participant, the magnitude of postpartum contraception among postnatal women will be determined at the baseline questionnaire (T0) and at the endline questionnaire (12 months later). Use will be dichotomized into the use of any method versus nothing used. The survey question will be: Do participants currently using any method on a regular basis to space between pregnancies? If they do, then the investigator will pass on to the second question on the method choices. Women's contraceptive preferences for intervention and control populations will be collected at the mentioned time points. Preferences will be dichotomized into more effective and less effective methods. Choices will also be grouped by tiers based on their effectiveness (tier 1, tier 2, and tier 3). The effect of group vs. individual counseling on the use of and preferences for postpartum contraception will then be assessed by using odds ratios.

  Recruitment to end of the study: 1 year

Study Arms (2)

Group-based counseling

ACTIVE COMPARATOR

A perinatal woman in the intervention arm will receive group-based family planning counseling at the community level, which includes a process of arranged demonstration of all available family planning methods jointly with routine individual family planning counseling.

Behavioral: A community group-based demonstration counseling method

Individual-based counseling

PLACEBO COMPARATOR

Prenatal and postnatal women in the control arm will just receive routine individual FP counseling only based on the Ethiopian national guidelines.

Behavioral: An individual family planning counseling

Interventions

A community group-based demonstration counseling method BEHAVIORAL

At the community level, a perinatal woman in the intervention arm will get individual family planning counseling along with group-based counseling that includes a planned demonstration of all possible techniques.

Group-based counseling

An individual family planning counseling BEHAVIORAL

The control group's pregnant and postpartum women will simply get standard individual FP counseling in accordance with Ethiopian national recommendations.

Individual-based counseling

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: Prenatal and postnatal women (females) who found in the selected Kebeles will be included in the study.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Prenatal women in their late pregnancy (near term, term, and post-term pregnancy)
• Women who will be in the postpartum time at the endline questionnaire
• Women who will live in the selected address for 1 year after delivery

You may not qualify if:

• Clients who are in unstable medical states and who are unable to converse without assistance
• Women whose postpartum time will be above 1 year at the endline questionnaire
• Women who are not available at the selected address for the next 1 year for the endline questionnaire

Sponsors & Collaborators

• St. Paul's Hospital Millennium Medical College, Ethiopia: lead

Study Sites (1)

St. Paul's Hospital Millennium Medical College, Ethiopia

Addis Ababa, 1271, Ethiopia

Location

Study Officials

• Zewdie Aderaw Alemu, PhD

  St. Paul's Hospital Millennium Medical College, Ethiopia

  STUDY DIRECTOR

Central Study Contacts

Getachew Adela Kasa, MSc

CONTACT

+251919292590; getachew.adela@sphmmc.edu.et

Aman yesuf Endries, MSc

CONTACT

+251911482646; aman.yesuf@sphmmc.edu.et

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-arm parallel cluster randomized control trial

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 9, 2025
• Study Start: March 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Currently available

Locations

ET (1)