Condition category
Pregnancy and Childbirth
Date applied
19/03/2009
Date assigned
30/03/2009
Last edited
30/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Maxine Wedderburn

ORCID ID

Contact details

25 Burlington Ave
Kingston
Kingston 10
Jamaica
+1 876 968 4976
Maxwed@cwjamaica.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protection of Human Subject Committee, study #9978

Study information

Scientific title

Building bridges from emergency contraceptive to regular contraceptive use in pharmacies: a multicentre participant-randomised unblinded trial

Acronym

Study hypothesis

Can non-users of a regular contraceptive method (a regular contraceptive method for the purposes of this study is defined as either an oral contraceptive pill, an injectable contraceptive method or an intra-uterine devide [IUD]) in Jamaica who intended to purchase an emergency contraceptive product in a pharmacy be encouraged to move toward adopting regular contraception by providing a discount coupon for one cycle of a regular oral contraceptive pill product?

Ethics approval

Family Health International Protection of Human Subjects Committee gave approval on the 28th November 2006 (ref: 9978)

Study design

Multicentre participant-randomised unblinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Family planning

Intervention

The intervention is a discount coupon given to randomly designated clients who arrive at a pharmacy to purchase an emergency contraceptive product.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Adoption of a regular contraceptive method. Adoption is defined as:
1. Use of oral contraceptive pills for at least two months
2. Receiving one injection of an injectable contraceptive method and either having received a second injection or intending to receive a second injection
3. Use of an IUD for at least one month

Measured at three and six months after participant enrolment (i.e., the pharmacy intercept interview).

Secondary outcome measures

Longest length of continuous use by women who adopt a regular contraceptive method. Measured at three and six months after participant enrolment (i.e., the pharmacy intercept interview).

Overall trial start date

01/12/2006

Overall trial end date

01/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Any woman (aged 16 - 46 years) who arrives at study pharmacy intending to purchase a dedicated emergency contraceptive product.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

800

Participant exclusion criteria

1. Males
2. Women under the age of 16
3. Women currently using a regular contraceptive method (a regular contraceptive method for the purposes of this study is defined as either an oral contraceptive pill, an injectable contraceptive method or an IUD)

Recruitment start date

01/12/2006

Recruitment end date

01/02/2008

Locations

Countries of recruitment

Jamaica

Trial participating centre

25 Burlington Ave
Kingston
Kingston 10
Jamaica

Sponsor information

Organisation

The William and Flora Hewlett Foundation (USA)

Sponsor details

2121 Sand Hill Road
Menlo Park
CA
94025
United States of America
info@hewlett.org

Sponsor type

Charity

Website

http://www.hewlett.org/Default.htm

Funders

Funder type

Charity

Funder name

The William and Flora Hewlett Foundation (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes