Family PlanningNCT03973593
Evaluation of Dynamics of Contraceptive Use, Discontinuation and Method Switching in Migori and Kitui Counties, Kenya
An observational study of Family Planning and Contraception, run by Jhpiego at 2 sites in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Family Planning, Contraception
- What is being tested?
- Enhancing contraceptive counseling on method continuation and switching
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,016 participants
- Where
- 2 sitesKenya
- Study dates
- 1 Nov 2019to 30 Jun 2021
- Phase
- Observational
- 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 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
Kitui County Health facilities
Kitui
Migori County facilities
Migori
About this study
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.
Read more
The specific objectives are to:
- To assess the quality of family planning services offered in health facilities in Migori and Kitui counties, Kenya
- To explore describe barriers and facilitators of modern contraceptive discontinuation and method switch among women of reproductive age in Migori and Kitui counties.
- 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
Read the detailed description
The 24 month prospective cohort study will seek to understand reasons for contraceptive discontinuation among women of reproductive age including adolescents in Kitui and Migori Counties, Kenya. The study will be implemented to assess determinants of contraceptive discontinuation after the barrier of lack of adequate counseling is removed. The barrier will be addressed by implementing an intervention focusing on a client-centered counseling approach in reducing contraceptive discontinuation among women accepting a contraceptive method. Ten health facilities with a high family planning caseload will be enrolled into the study. Counseling sessions will be conducted at the facilities using three channels:
- Counseling by Community Health Volunteers (CHVs) The proposed intervention will identify CHVs and build their capacity on contraception with an aim of having them providing FP counseling and services in high volume facilities - thus providing additional human resources. Their current training on family planning focuses on general information for each contraceptive method but lacks adequate content on counseling for family planning. The CHV training package will be enhanced with additional content on contraceptive methods that will equip them with the necessary skills on counseling. They will also be trained on adolescent focused counseling as well. Once trained, the CHVs will offer counseling for family planning at facility level. Following the counseling, CHVs will provide a method including pills and injectables to women and girls who have come for a revisit, unless they request for contact with the health care worker. This is in line with the Kenya's Ministry of Health task sharing policy and family planning guidelines that allows CHVs to conduct community distribution of pills, condoms and injectables.
- Individualized Counseling by Health Care Workers Once counseling has been done by the CHVs, the heath care workers will attend to the women in need for additional counseling and a method that the CHVs were unable to provide, for instance LARCs. The current counseling method used by the health care worker is the Balanced Counseling Strategy, which is cumbersome as it has a lot of information that overwhelms the providers and clients. The study proposes to adopt the counseling for continuation materials that will used to develop a simplified job aid for use by heath care workers to provide individualized counseling.
- Partner Counseling by Health Care Workers (HCWs) CHVs will mobilize potential couples to jointly attend contraceptive counseling sessions by the health care workers. The health care workers will be trained on how to conduct couple counseling. Existing couples counseling materials will be adapted based on the information gathered from the formative assessment. The facility will identify a package of additional non-contraceptive related services for the men who will have accompanied their spouses for family planning services.
The investigators will enroll 1016 women of reproductive age in the following sub groups; Implant, IUD, Injectables and Pill users. Follow up interviews at 3, 6, and 12 months will be done to establish contraceptive use, discontinuation and method switching among women.
- Conditions
- Family Planning, Contraception
- Being tested
- Enhancing contraceptive counseling on method continuation and switching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhancing contraceptive counseling on method continuation and switchingBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Secondary outcomes (1)
Proportion of women reporting satisfaction with the quality of FP services offered at baseline
Proportion of women reporting extremely satisfied and satisfied with the information and services received at the health facility during initiation of contraception. Information will be collected from the baseline questionnaire to assess relationship between women reporting discontinuation and level of satisfaction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Nov 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Gathari Ndirangu, ObGyn, Study director, Jhpiego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973593
- Sponsor's protocol ID
- 00009062
- Status last verified
- Oct 2021
- First submitted
- 27 May 2019
- Last updated
- 19 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study protocol will be shared through publication in a peer-reviewed journal. De-identified participant data will be submitted to a data repository in accordance with the USAID policy where other researchers will have access.
Publications
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.
PubMed 31488170
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dynamics of Contraceptive Use, Discontinuation and Method Switching in Migori and Kitui Counties, Kenya
- ClinicalTrials.gov ID
- NCT03973593
- Acronym / sponsor ID
- 00009062
- Conditions
- Family Planning, Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,016 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 4 Jun 2019 (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.
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:
- To assess the quality of family planning services offered in health facilities in Migori and Kitui counties, Kenya
- To explore describe barriers and facilitators of modern contraceptive discontinuation and method switch among women of reproductive age in Migori and Kitui counties.
- 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
Detailed description
The 24 month prospective cohort study will seek to understand reasons for contraceptive discontinuation among women of reproductive age including adolescents in Kitui and Migori Counties, Kenya. The study will be implemented to assess determinants of contraceptive discontinuation after the barrier of lack of adequate counseling is removed. The barrier will be addressed by implementing an intervention focusing on a client-centered counseling approach in reducing contraceptive discontinuation among women accepting a contraceptive method. Ten health facilities with a high family planning caseload will be enrolled into the study. Counseling sessions will be conducted at the facilities using three channels:
- Counseling by Community Health Volunteers (CHVs) The proposed intervention will identify CHVs and build their capacity on contraception with an aim of having them providing FP counseling and services in high volume facilities - thus providing additional human resources. Their current training on family planning focuses on general information for each contraceptive method but lacks adequate content on counseling for family planning. The CHV training package will be enhanced with additional content on contraceptive methods that will equip them with the necessary skills on counseling. They will also be trained on adolescent focused counseling as well. Once trained, the CHVs will offer counseling for family planning at facility level. Following the counseling, CHVs will provide a method including pills and injectables to women and girls who have come for a revisit, unless they request for contact with the health care worker. This is in line with the Kenya's Ministry of Health task sharing policy and family planning guidelines that allows CHVs to conduct community distribution of pills, condoms and injectables.
- Individualized Counseling by Health Care Workers Once counseling has been done by the CHVs, the heath care workers will attend to the women in need for additional counseling and a method that the CHVs were unable to provide, for instance LARCs. The current counseling method used by the health care worker is the Balanced Counseling Strategy, which is cumbersome as it has a lot of information that overwhelms the providers and clients. The study proposes to adopt the counseling for continuation materials that will used to develop a simplified job aid for use by heath care workers to provide individualized counseling.
- Partner Counseling by Health Care Workers (HCWs) CHVs will mobilize potential couples to jointly attend contraceptive counseling sessions by the health care workers. The health care workers will be trained on how to conduct couple counseling. Existing couples counseling materials will be adapted based on the information gathered from the formative assessment. The facility will identify a package of additional non-contraceptive related services for the men who will have accompanied their spouses for family planning services.
The investigators will enroll 1016 women of reproductive age in the following sub groups; Implant, IUD, Injectables and Pill users. Follow up interviews at 3, 6, and 12 months will be done to establish contraceptive use, discontinuation and method switching among women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Enhancing contraceptive counseling on method continuation and switchingHealth 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. | Behavioural | – |
Primary outcome
Contraceptive discontinuation rate among FP users
Time frame: up to 12 months
The rate of contraceptive discontinuation among the prospective cohort FP users. Discontinuation will be of the baseline contraceptive method that the woman has initiated.
1 secondary outcome
Proportion of women reporting satisfaction with the quality of FP services offered at baseline
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Derived from this study: PubMed 31488170Ontiri 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.
- Individual participant dataSharing planned: Undecided. The study protocol will be shared through publication in a peer-reviewed journal. De-identified participant data will be submitted to a data repository in accordance with the USAID policy where other researchers will have 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.
Gathari Ndirangu, ObGyn study director
Jhpiego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Family Planning and Contraception, run by Jhpiego at 2 sites 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 3 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: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive discontinuation rate among FP users (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973593, which also lists 1 linked publication.
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 19 Oct 2021.