Pharmacy and Poisons Board
Protocol No: ECCT/20/02/03 Date of Protocol: 25-02-2020
Study Title:

A Study on the Feasibility and Acceptability of Pericoital Levonorgestrel 1.5mg 
Study Objectives:

The primary objective of this actual use study is to provide users with clear advice and support on pericoital use of LNG 1.5mg, and monitor for their correct and incorrect use in Kenya. We will test the feasibility and acceptability of e-commerce provision of LNG 1.5mg for pericoital use to women; gather information on use practices and associated behaviors; and document side-effects, if any. The evidence generated will include self-reported medical outcomes and provide an understanding of women’s needs and interest in this contraceptive method. As such, primary objectives of the study are indicated below:

Figure 1. Objectives & Areas of Exploration

 

Primary Objectives

Use Outcomes: Medical

Identify self-reported side effects associated with pericoital LNG 1.5mg

Demand & Social:  Customer Satisfaction & Use Circumstances

 

Measure demand for pericoital LNG 1.5mg

Identify factors behind decision-making of using pericoital LNG 1.5mg

Understand perception of pericoital LNG 1.5mg vs. other methods and intention to use longer term modern contraceptive methods in the future

Document behavior patterns and circumstances of use

Provider Perspective

& Service Provision

List ecommerce provider’s barriers to providing pericoital LNG 1.5mg

Assess accuracy of information provided to study participants

Track product availability

Track type and availability of other contraceptive methods offered
 

 

 
Laymans Summary:

The primary objective of this actual use study is to provide users with clear advice and support on pericoital use of LNG 1.5mg, and monitor for their correct and incorrect use in Kenya. We will test the feasibility and acceptability of e-commerce provision of LNG 1.5mg for pericoital use to women; gather information on use practices and associated behaviors; and document side-effects, if any. The evidence generated will include self-reported medical outcomes and provide an understanding of women’s needs and interest in this contraceptive method
Abstract of Study:

Background: Globally there are a number of different contraceptive options available to women, but there is currently no modern method that women can use discretely, only when they need it, is easy to remember, and also doesn’t interrupt intercourse.  Thus, experts have been exploring the possibility of developing a contraceptive method that women can take as an on-demand, or pericoital (“around the time of sex”) contraceptive. Recent research on pericoital LNG 1.5mg suggest the method is safe, effective, and acceptable to women, recommending further research be conducted exploring pericoital use of LNG 1.5mg.

Purpose: The goal of this actual use study is to equip users with clear advice and support on pericoital use of LNG 1.5mg,and monitor for their correct and incorrect use in Kenya. We will test the feasibility and acceptability of e-commerce provision of LNG 1.5mg to women; gather information on use practices and associate behaviors; and document side-effects, if any.

Research Type: This is an actual use study. Data collection will include self-reported medical outcomes and provide an understanding of women’s needs and interest in this contraceptive method.

Participants: The research population broadly includes women of reproductive age participating in the study in Nairobi County and Kiambu County using an e-commerce platform for women’s health products.

Duration: 13 months, planned for March 2020- April 2021, including 1-month pilot; as recruitment for the study is on a rolling basis, baseline data will be collected for new joiners to the study for the duration of the pilot month + 6 months