A Study on the Feasibility and Acceptability of Pericoital Levonorgestrel 1.5mg
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|ClinicalTrials.gov Identifier: NCT04058873|
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment|
|Pregnancy Related||Drug: Levonorgestrel 1.5mg|
The study would consist of distributing pericoital LNG 1.5mg tablet across 75 pharmacy sites in Ghana over the course of 12 months. Recruitment will be staggered, and women will be recruited up to 6 months into the study. As such, the data collection period per participant will be at least 6 months per participant.
Consistent with the recent WHO study (Festin et al. " A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using LNG 1.5mg" (2016)), participants will be given instructions on how to correctly use LNG 1.5mg, namely to take one pill 24 hours before or after sexual relations, and no more than 6 times per month. Contraceptive protection requires use only once per 24 hours, regardless of how many times sexual relations are had during those 24 hours.
Participants will include a broad population of women age 18-49, not currently on any long-term modern method, who do not wish to get pregnant in the following 6 months but would not consider it a serious issue if they did become pregnant. They will be asked to use LNG 1.5mg as their exclusive method of contraception for the period of the study, with the exception of condoms.
The drug used for the study is LNG 1.5mg, specifically Marie Stopes International's BK-1 pill, repackaged for the study purposes. The BK-1 pill is currently registered as an emergency contraceptive and sold in Ghana with good quality assurance procedures in place. The BK-1 emergency contraception pill is manufactured for Marie Stopes International by Acme Formulation Pvt., Limited, one of the leading drug manufacturers of India. It is registered as an emergency contraception by the Food and Drugs Authority in Ghana and assigned registration number FDA/SD.183-11710. The package will read "LNG 1.5mg for Pericoital Use - for study purposes only" and be devoid of any other branding (please see Appendix for artwork).
Data collection components with research participants include:
- Baseline background information about the research participants will be collected during the screening (e.g., qualifications for inclusion/ exclusion) and enrollment process
- Weekly SMS / WhatsApp / phone call surveys with research participants. They will be asked 10 questions about user satisfaction, circumstances of use, and outcomes (e.g., self-reported side effects)
- Two follow up face to face surveys per participant to better understand participant perception of LNG 1.5mg, customer satisfaction with product and service, and future contraceptive intentions (at month 2 and month 6)
Data collection components with pharmacies will include:
- Baseline data of average packs of FP products sold at the pharmacy, in order to understand the overall increase in FP methods sold over the course of the study
- A mystery shopping survey to check the quality of service provision and monitoring of recruitment/quality of information at each of the 75 study sites every 4 to 6 weeks. This will amount to at least 6 visits per site over the 12 months of the study.
- Register collected at pharmacy point of sale, with units sold over the course of the 12-month pilot. Note: participants will be able to go to any of the participating pharmacies during the course of the project.
- Pharmacists feedback surveys to understand the provision of LNG 1.5mg: a baseline survey before the training and a survey during month 8 of the study
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|Official Title:||A Study on the Feasibility and Acceptability of Pericoital Levonorgestrel 1.5mg|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||October 1, 2020|
- Drug: Levonorgestrel 1.5mg
Levonorgestrel 1.5mg for pericoital use
- feasibility of use [ Time Frame: 6 months ]Self reported via bi-weekly survey: women are able to access and use product correctly (consistent with instructions from health care provider / pharmacist)
- acceptability [ Time Frame: 6 months ]Self reported via bi-weekly survey: Understand drivers behind decision-making of using pericoital LNG 1.5mg, conditions of use, and potential impact on increased mCPR and intention to use longer-term methods in the future
- side effects [ Time Frame: 6 months ]Self reported via bi-weekly survey: self reported side effects from using product
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): NCT04058873
|Contact: Jessica Vandermarkfirstname.lastname@example.org|
|Marie Stopes International Ghana||Recruiting|
|Contact: Henry Bruce +233 (0) 302 241 517 ext 132 email@example.com|
|Principal Investigator:||Saumya Ramarao||Population Council|
|Principal Investigator:||Emmanuel Kuffour||Population Council|