Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Randomized-Controlled Trial to Increase the Uptake of LARCs in Cameroon (HGOPY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03733678
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : April 13, 2021
Sponsor:
Collaborators:
Stanford University
George Washington University
University of Exeter
University of California, San Diego
Yaounde Gynecology, Obstetrics and Pediatrics Hospital
Information provided by (Responsible Party):
Berk Ozler, World Bank

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Cameroon exhibits a high and non-decreasing level of maternal mortality (roughly 600 per 100,000 live births), partially related to its relatively high total fertility rate (roughly 4.6). Survey evidence furthermore suggests that a significant fraction of these pregnancies is unwanted or considered mistimed by the mother, especially among females aged 15-19. Despite this, the rate of utilization of family planning (FP) is low: e.g. only 48% of sexually active unmarried women use any form of (modern) contraception, or MC, and even then, it is primarily condoms. The use of LARCs (long-acting reversible contraceptives, i.e. the IUD and implant) is less than 1% according to the most recent Demographic Health Survey.

The study investigators propose to use an integrated behavioral science approach to increase the take-up of both SARCs (short-acting reversible contraceptives, i.e. the pill and injectable) and especially LARCs among reproductive-age females in Cameroon, including adolescents who may be unmarried and/or nulliparous. In addition to decreasing maternal mortality and undesired pregnancies, indirect effects for the community will include: increased welfare from reduced side effects that arise due to current one-size-fits-all FP counseling; healthier children due to improved birth spacing; and increased human capital formation both for children and for young (often school-aged) potential mothers.

The study investigators propose to conduct the study at HGOPY for a duration of 12 months. The study investigators will provide tablets to each of five nurses that conduct FP counseling to participants at the hospital. The tablets contain a counseling "app" (or decision-support tool or a job-aid) that was jointly developed by professionals from HGOPY, the World Bank, and the Ministry of Health. The study investigators propose an individually-randomized experiment, where the participants will be offered randomly varying discounts for the modern contraceptive methods they wish to adopt. The study investigators also propose to experiment with certain aspects of the "app" to improve its effectiveness - both for the participant and for the nurse. More details on the experimental design are provided below.


Condition or disease Intervention/treatment Phase
Contraception Contraception Behavior Contraceptive Usage Contraceptive Method Switching Behavioral: Price discounts for SARCs Behavioral: Price discounts for LARCs Behavioral: Sequential vs. simultaneous recommendations Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

The study independently experiments with two aspects of the health provider-client relationship:

  1. First, a tablet-based counseling app that is used by the provider gives random discounts to clients - separately for LARCs and SARCs.
  2. Second, the tablet-based app presents recommendations to the client sequentially (i.e. the top-ranked method, followed by the next one if that recommendation is declined by the client, etc.) vs. simultaneously (i.e. presenting the top recommendations to the client all at once and asking her to choose which one to discuss further).
Masking: Single (Participant)
Masking Description: Participants are masked in some interventions related to the workings of the tablet-based decision-support tool, but not to the price discounts they receive for the contraceptive methods.
Primary Purpose: Health Services Research
Official Title: A Sequential and Adaptive Experiment to Increase the Uptake of Long-acting Reversible Contraceptives in Cameroon
Actual Study Start Date : March 23, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Free SARC, Free LARC, Recommendation
Free SARC, Free LARC, Sequential recommendation
 Behavioral: Price discounts for SARCs
SARCs are offered free to the client

Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client
Experimental: Free SARC, LARC=500, Recommendation
Free SARC, LARC=500 CFA, Sequential recommendation
 Behavioral: Price discounts for SARCs
SARCs are offered free to the client

Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client
Experimental: Free SARC, LARC=1000, Recommendation
Free SARC, LARC=1000 CFA, Sequential recommendation
 Behavioral: Price discounts for SARCs
SARCs are offered free to the client

Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client
Experimental: Free SARC, LARC=2140, Recommendation
Free SARC, LARC=2140 CFA, Sequential recommendation
 Behavioral: Price discounts for SARCs
SARCs are offered free to the client

Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client
Experimental: Free SARC, LARC=5000, Recommendation
Free SARC, LARC=5000 CFA, Sequential recommendation
 Behavioral: Price discounts for SARCs
SARCs are offered free to the client
Experimental: Regular SARC, Free LARC, Recommendation
Regular price SARC, Free LARC, Sequential recommendation
 Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client
Experimental: Regular SARC, LARC=500, Recommendation
Regular price SARC, LARC=500 CFA, Sequential recommendation
 Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client
Experimental: Regular SARC, LARC=1000, Recommendation
Regular price SARC, LARC=1000 CFA, Sequential recommendation
 Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client
Experimental: Regular SARC, LARC=2140, Recommendation
Regular price SARC, LARC=2140 CFA, Sequential recommendation
 Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client
No Intervention: Regular SARC, LARC=5000, Recommendation
Regular price SARC, LARC=5000 CFA, Sequential recommendation
Experimental: Free SARC, Free LARC, No Recommendation
Free SARC, Free LARC, Simultaneous recommendation
 Behavioral: Price discounts for SARCs
SARCs are offered free to the client

Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client

Behavioral: Sequential vs. simultaneous recommendations
Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Free SARC, LARC=500, No Recommendation
Free SARC, LARC=500 CFA, Simultaneous recommendation
 Behavioral: Price discounts for SARCs
SARCs are offered free to the client

Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client

Behavioral: Sequential vs. simultaneous recommendations
Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Free SARC, LARC=1000, No Recommendation
Free SARC, LARC=1000 CFA, Simultaneous recommendation
 Behavioral: Price discounts for SARCs
SARCs are offered free to the client

Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client

Behavioral: Sequential vs. simultaneous recommendations
Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Free SARC, LARC=2140, No Recommendation
Free SARC, LARC=2140 CFA, Simultaneous recommendation
 Behavioral: Price discounts for SARCs
SARCs are offered free to the client

Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client

Behavioral: Sequential vs. simultaneous recommendations
Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Free SARC, LARC=5000, No Recommendation
Free SARC, LARC=5000 CFA, Simultaneous recommendation
 Behavioral: Price discounts for SARCs
SARCs are offered free to the client

Behavioral: Sequential vs. simultaneous recommendations
Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Regular SARC, Free LARC, No Recommendation
Regular Price SARC, Free LARC, Simultaneous recommendation
 Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client

Behavioral: Sequential vs. simultaneous recommendations
Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Regular SARC, LARC=500, No Recommendation
Regular Price SARC, LARC=500 CFA, Simultaneous recommendation
 Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client

Behavioral: Sequential vs. simultaneous recommendations
Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Regular SARC, LARC=1000, No Recommendation
Regular Price SARC, LARC=1000 CFA, Simultaneous recommendation
 Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client

Behavioral: Sequential vs. simultaneous recommendations
Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Regular SARC, LARC=2140, No Recommendation
Regular Price SARC, LARC=2140 CFA, Simultaneous recommendation
 Behavioral: Price discounts for LARCs
LARCs are offered at lower prices to the client

Behavioral: Sequential vs. simultaneous recommendations
Top ranked methods are presented to the client sequentially or simultaneously
Experimental: Regular SARC, LARC=5000, No Recommendation
Regular Price SARC, LARC=5000 CFA, Simultaneous recommendation
 Behavioral: Sequential vs. simultaneous recommendations
Top ranked methods are presented to the client sequentially or simultaneously


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The client adopted a LARC [ Time Frame: 1-day ]
    using data from the counseling sessions

  2. The client adopted a modern contraceptive method (LARC or SARC) [ Time Frame: 1-day ]
    using data from the counseling sessions


Secondary Outcome Measures :
  1. Was the client treated with respect by the provider during the counseling session? [ Time Frame: 2-weeks ]
    Self-reported indicator variable using follow-up surveys two weeks after counseling session

  2. Did the client trust the provider during the counseling session? [ Time Frame: 2-weeks ]
    Self-reported indicator variable using follow-up surveys two weeks after counseling session

  3. Did the health provider give information about contraceptive methods that was easy to understand during the counseling session? [ Time Frame: 2-weeks ]
    Self-reported indicator variable using follow-up surveys two weeks after counseling session

  4. Client satisfaction with adopted contraceptive method [ Time Frame: 2-week and 16-week measurements ]
    using 2-week and 16-week follow-up surveys

  5. Discontinuation of adopted contraceptive method [ Time Frame: 2-week, 16-week, and 52-week measurements ]
    using 2-week, 16-week, and 52-week follow-up surveys

  6. Percentage of participants with unintended pregnancy within the time frame [ Time Frame: 16-week and 52-week measurements ]
    using 16-week and 52-week follow-up surveys


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Ages 10-49
  • Presenting at HGOPY seeking FP counseling/services
  • HGOPY clients referred to the family planning unit for consultation

Exclusion Criteria:

* No exclusion criteria

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733678


Contacts
Layout table for location contacts
Contact: Berk Ozler, PhD 2023684109 bozler@worldbank.org

Locations
Layout table for location information
Cameroon
Hôpital gynéco-obstétrique et pédiatrique de Yaoundé (HGOPY) Recruiting
Yaoundé, Cameroon
Contact: Dohbit Sama, MD    +23777786059    dohbit@yahoo.com   
Sponsors and Collaborators
World Bank
Stanford University
George Washington University
University of Exeter
University of California, San Diego
Yaounde Gynecology, Obstetrics and Pediatrics Hospital
Investigators
Layout table for investigator information
Principal Investigator: Berk Ozler, PhD World Bank
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Berk Ozler, Principal Investigator, World Bank
ClinicalTrials.gov Identifier: NCT03733678    
Other Study ID Numbers: LARCs-2018
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will likely share de-identified anonymous participant data publicly after the trial ends and our analyses are completed.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Berk Ozler, World Bank:
adolescent sexual and reproductive health, maternal mortality, teen pregnancy, LARCs, family planning counseling