Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03973593 |
| Other study ID # |
00009062 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2019 |
| Est. completion date |
June 30, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Jhpiego |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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. To assess the quality of family planning services offered in health facilities in Migori
and Kitui counties, Kenya
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. 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
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:
1. 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.
2. 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.
3. 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.
