NCT03973593

Brief Summary

Kenya has made tremendous strides in improving contraceptive prevalence rate for the last 20 years, however the rate of contraceptive discontinuation as remained almost constant at 1 out of 3 women using a family planning method. Contraceptive discontinuation increases unmet need of family planning. Hence understanding the underlying reasons for discontinuation helps in designing programs that improve method satisfaction. The primary goal of the study is to understand the factors leading to contraceptive discontinuation and switching among women of reproductive age (15 - 49 years) in Migori and Kitui counties, Kenya. The secondary goal is to assess whether a client-centered intervention focusing on contraceptive counseling can reduce modern contraceptive discontinuation and increase client satisfaction with use of modern contraceptive methods among women of reproductive age in the two counties. The specific objectives are to:

  1. 1.To assess the quality of family planning services offered in health facilities in Migori and Kitui counties, Kenya
  2. 2.To explore describe barriers and facilitators of modern contraceptive discontinuation and method switch among women of reproductive age in Migori and Kitui counties.
  3. 3.To assess the client-centered intervention focusing on contraceptive counseling in reducing contraceptive discontinuation among women of reproductive age in Migori and Kitui counties, Kenya

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,016

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

1.7 years

First QC Date

May 27, 2019

Last Update Submit

October 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Contraceptive discontinuation rate among FP users

    The rate of contraceptive discontinuation among the prospective cohort FP users. Discontinuation will be of the baseline contraceptive method that the woman has initiated.

    up to 12 months

Secondary Outcomes (1)

  • Proportion of women reporting satisfaction with the quality of FP services offered at baseline

    12 months

Interventions

Health care workers and Community Health Volunteers will be trained on a contraceptive counseling package that enhances information on method continuation and switching. This will be done in the ten intervention facilities prior to enrollment of clients into the cohort study.

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women of reproductive age 15-49 years receiving a contraceptive method in the intervention facilities as new users to either the method or family planning

You may qualify if:

  • Women of reproductive age (15-49 years) taking up a contraceptive method in the participating study facilities during the study enrollment period
  • A resident of the selected study region
  • Has access to a phone that they control for follow-up
  • Willing to be followed up to a period of 24 months after enrollment; four contacts.

You may not qualify if:

  • Women of reproductive age taking up a condom as their primary FP method, sterilization or an emergency contraceptive method
  • Participants not willing to consent
  • No access to phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kitui County Health facilities

Kitui, Kenya

Location

Migori County facilities

Migori, Kenya

Location

Related Publications (1)

  • Ontiri S, Mutea L, Muganda M, Mutanda P, Ajema C, Okoth S, Orero S, Odhiambo R, Biesma R, Stekelenburg J, Kabue M. Protocol for a prospective mixed-methods longitudinal study to evaluate the dynamics of contraceptive use, discontinuation, and switching in Kenya. Reprod Health. 2019 Sep 5;16(1):134. doi: 10.1186/s12978-019-0797-3.

Study Officials

  • Gathari Ndirangu, ObGyn

    Jhpiego

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2019

First Posted

June 4, 2019

Study Start

November 1, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations