Condition category
Not Applicable
Date applied
10/04/2019
Date assigned
12/04/2019
Last edited
16/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Over the past two decades, there have been significant advancements in improving access and quality of care for family planning and reproductive health services in Ethiopia. However, contraceptive discontinuation rates remain high, posing a significant opportunity for ensuring that women can follow through on their fertility intentions with methods of their choosing. The Last Ten Kilometers (L10K) project of the JSI Research & Training Institute, Inc. (JSI) proposes to implement and test a behavioral economics approach to address the issue of discontinuation of injectable contraceptives among women of reproductive age in Ethiopia. Behavioral economics studies how people form intentions, and make and act on (or fail to act on) decisions to identify predictable and systematic patterns in human behavior. A behavioral economics perspective allows us to approach and, if necessary, reframe behavioral problems in a way that helps us to understand the key psychological phenomena underlying undesirable behaviors, and thus open up avenues to design innovative solutions that can lead to desired behavioral outcomes.

With technical assistance from ideas42, a non-profit behavioral research and design firm, L10K/JSI has conducted a situational analysis of behavioral factors contributing to the discontinuation of injectable contraceptives. This analysis revealed five primary behavioral bottlenecks disrupting continuation of injectables. L10K/JSI has developed a preliminary package of proposed behavioral interventions intended to support new users of injectable contraceptives and enable them to follow through with their family planning intentions. In collaboration with Federal Ministry of Health (FMOH) and Regional Health Bureaus (RHBs), L10K/JSI finalized the package of behavioral interventions and implement a paired treatment-comparison pilot study in eight woredas (districts) in the L10K project area to test the impact of the package. Outcome data will be collected from eligible injectable contraceptive client interviews 12 months post exposure to the intervention.

The primary research questions at hand are, 1) Can behaviorally informed HEW job aids and tools increase contraceptive continuation at six months post initial take-up? and 2) Can this intervention package be feasibly implemented across the entire L10K project area?

Who can participate?
Women of reproductive age visiting the study area health-posts who are interested in using injectable contraceptives.

What does the study involve?
All participants from the study area will benefit from national family planning program including the family planning interventions supported by L10K/JSI. In addition, the intervention area participants are expected to benefit from the behavioural economics tools introduced to the HEWs

What are the possible benefits and risks of participating?
Although both the study arm participants are expected to be provided with proper counselling (informed choice and proper management of side-effects) and reminders for subsequent injectable contraceptive doses; the behavioural economics intervention would insure compliance with service delivery procedures better; thus more likely to meet their fertility goals.

Where is the study run from?
The Last Ten Kilometres Project, JSI Research & Training Institute, Inc., Kebele 03/05, Bole Sub City, Addis Ababa

When is the study starting and how long is it expected to run for?
February 2016 to December 2017

Who is funding the study?
Bill and Melinda Gates Foundation
William and Flora Hewlett Foundation

Who is the main contact?
Dr Ali Karim, ali.karim@gatesfoundation.org

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ali Karim

ORCID ID

http://orcid.org/0000-0002-9396-6861

Contact details

Bill & Melinda Gates Foundation
c/o ILRI
Kebele 12/13
Bole Sub City
Addis Ababa
1000
Ethiopia
+251944306780
ali.karim@gatesfoundation.org

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

BE1

Study information

Scientific title

Application of behavioral economics principles to reduce injectable contraceptive discontinuation rate in rural Ethiopia: A stratified-pair, cluster-randomized field study

Acronym

Study hypothesis

Behaviorally informed job aids for the health extension workers and client appointment cards can increase contraceptive continuation at 12 months post initial take-up

Ethics approval

Approved 26/10/2015, John Snow, Inc. IRB #1 (44 Farnsworth Street, Boston, MA 02210, USA; IRB@jsi.com; +1 617 482 9485), ref: 15-022

And IRBs of the regional health bureaus of Amhara, Oromia, Tigray and Southern Nations, nationalities and Peoples' (SNNP) regions.

Study design

Stratified-pair cluster-randomized field trial

Primary study design

Interventional

Secondary study design

Stratified-pair, cluster-randomized field trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Contraceptive use

Intervention

The study domain included two primary health care units (PHCU) from two districts from each of the four regions where JSI was implementing a family planning program. From each region one PHCU was randomly selected for intervention while the other was the control. The PHCUs are comprised of one health center and three to six satellite health posts serving a population of about 25,000 people. Two health extension workers (HEWs) at the health posts provide mainly preventive and basic curative services including injectable contraceptive services. The intervention area included 19 health posts while the control area included 21 health posts. The intervention area HEWs were trained to implement the intervention. The intervention package included 1) a planning calendar for the HEWs for prospective time management aid for future appointments and outreach services and sending reminders to injectable contraceptive clients; 2) client care checklist to ensure proper counselling of clients; and 3) an appointment card to be given to the family planning client as a reminder of the next does of injectable relating the date with religious events. Based on the study participation eligibility criteria, it was decided at least 10 months would be required to recruit the desired sample size (330 from each of the two study arms). The training of the HEWs was initiated in February 2016.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Injectable contraceptive discontinuation rate within 12 months of uptake.

To measure the primary outcome of interest, i.e., the injectable contraceptive discontinuation rate within 12 months of uptake, first the duration of injectable contraceptive use was measured from the three survey items: (1) the month and year the eligible participant visited the health post between intervention onset and November 2016 (uptake month); (2) whether the participant was still using the injectable contraceptive without interruption at the time of the survey, or with a maximum of a month (30 days) of interruption (survey month); and (3) if the participant was not currently using the injectable contraception, then the month and year the participant had last obtained injectable contraceptive without interruption or with a maximum of one month of interruption (dropout month). The duration of injectable contraceptive use from uptake is the difference between uptake month and survey month, or uptake month and dropout month. The duration was measured in months. In a few of the dropout cases, where the participant could not accurately describe the last time she obtained an injectable contraceptive (without interruption), then the duration of use was obtained by asking how long (in months) she had used injectable contraception without interruption.

Secondary outcome measures

1. Mean number of correct side effects of injectable contraceptive spontaneously recalled by the participant
2. Mean number of different types of contraceptive methods spontaneously recalled by the provider
3. Mean number of correct actions to be taken spontaneously recalled by the participant if she experienced side effects from injectable contraceptives
4. Whether the participant was told about the side effects of injectable contraceptives by the provider
5. Whether the participant was told what to do if she experienced side effects
6. Whether the participant was informed about other methods of contraception
7. Whether the participant was told, during her last visit to the health post for injectables, about a local holiday or event as a reminder of the next appointment date
8. Whether the participant was given an appointment card during the last visit to obtain an injectable contraceptive
9. Whether the participant missed an appointment for injectable contraceptives.

Overall trial start date

10/08/2014

Overall trial end date

01/12/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women of reproductive age who visited the study area health posts during the intervention period and fulfilled any of the following three criteria
1.1 Initiating use of injectable contraceptives
1.2 Returning to the use of injectable contraceptives after at least a six-month lapse
1.3 Switching to injectable contraceptives from another family planning method

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

660 (330 from the intervention and 330 from the control areas)

Participant exclusion criteria

1. Not a family planning client
2. Using other methods of contraceptives
3. Other method users not planning to switch to injectable contraceptives
4. Already an injectable contraceptive client before the study period

Recruitment start date

01/02/2016

Recruitment end date

30/11/2016

Locations

Countries of recruitment

Ethiopia

Trial participating centre

AdalAgata, Alefa, Gulim, Wadra, and Zalema health posts under Alefa health center
Burie Zuria district, Amhara
0000
Ethiopia

Trial participating centre

Denibinagirarigie, Diremu, and Wokello health posts under Lemi health center
Ensaro district, Amhara
0000
Ethiopia

Trial participating centre

Dabotobo, Delebe, Halilu Adhessa, Hawaenber, Hawa Geba, Shengela, Sololo, and Utanone health posts under Kumbabe health center
Illu Ababora district, Oromia
0000
Ethiopia

Trial participating centre

Budo Kera, Gersha Luchine, Sentema Goru, and Sikba Kake health posts under Sentema health center
Seka-Chekorssa district, Oromia
0000
Ethiopia

Trial participating centre

Dube Godebamo, Golecheba, Hebot, Hebot Tirora, and Wanja Shola health posts of Ebot Tirora health center
Dalocha district, SNNP
0000
Ethiopia

Trial participating centre

Azege Zemeda, Edeya, Hanger, Kerewa, Meleka, OyaKepho, and Shemona health posts of Fofa health center
Yem district, SNNP
0000
Ethiopia

Trial participating centre

Adikahisu, Adiklite, Ftihi, Godifay, and Midrefelasi health posts of Adinebried health center
Laelay Adiabo district, Tigray
0000
Faroe Islands

Trial participating centre

Dekera, Finarwa, and Weyen health posts of Finarwa health center
Samre Sehart district, Tigray
0000
Ethiopia

Sponsor information

Organisation

JSI Research & Taining Institute, Inc.

Sponsor details

1616 North Fort Myer Drive
16th Floor
Arlington
22209
United States of America
+17035287474
jsinfo@jsi.com

Sponsor type

Other

Website

http://www.jsi.com

Funders

Funder type

Charity

Funder name

William and Flora Hewlett Foundation

Alternative name(s)

William & Flora Hewlett Foundation, Hewlett Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United States of America

Funder name

Bill and Melinda Gates Foundation

Alternative name(s)

Bill & Melinda Gates Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

United States of America

Results and Publications

Publication and dissemination plan

Disseminated at International SBCC Summit, Nusa Dua, Indonesia, April 2018, and International Family Planning Conference, Kigali, Rwanda, November 2018. Submitted for publication at Gates Open Research

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository.
The raw data (*.csv) and analysis procedures (in Stata 15.1) are stored in publically available repository (Karim AM. 2019. DOI: 10.5281/zenodo.2592313) and remain there.

Intention to publish date

01/05/2019

Participant level data

Stored in repository

Basic results (scientific)

Other than the planner, intervention adherence was universal among the intervention area health post service providers. Injectable discontinuation rate was 10.8 % points (95% Confidence Interval: 2.4 %, 19.1 %) lower in the intervention area compared to the control area during the post intervention follow-up survey.

Publication list

Publication citations

Additional files

Editorial Notes

16/04/2019: Internal review. 11/04/2019: Trial’s existence confirmed by Gates Open Research