Improving Access to Abortion in the Republic of Georgia

Study Overview
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Brief Summary
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In the Republic of Georgia, the medical abortion regimen involves three in-person visits. This study aims to pilot and evaluate a simplified medical abortion service delivery model that will reduce the number of in-person visits to only one visit for diagnosis and counseling. Medication will be mailed along with two multi-level pregnancy tests to study participants, who will assess their abortion outcome at home.

Detailed Description
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This prospective cohort study of patients obtaining medical abortion medications by mail. The study investigators aim to recruit approximately 120 patients for this study across three study sites that have extensive experience providing early medical abortion. Five days after undergoing in-person consultation and necessary exams to assess eligibility for medical abortion, study team will mail study participants medical abortion pills and two multi-level urine pregnancy tests. Medical abortion follow-up will occur at the participant's home approximately two weeks after the initial visit, and the multi-level pregnancy test will be used to assess abortion outcome. At follow-up, study participants will be asked questions about the results of the multi-level pregnancy test, and their experience and feedback about the acceptability of the process. At the conclusion of the study, investigators will interview providers to better undertand their experience with the simplified medical abortion service delivery model.

Official Title
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Improving Access to Abortion in the Republic of Georgia

Conditions
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Abortion Early, Pregnancy Related

Intervention / Treatment
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* Drug: Mifepristone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women seeking medical abortion through 58 days gestation Eligible for medical abortion according to study provider's assessment Able to receive physical mail Have access to a phone Be willing and able to consent to participate in the study Be willing to follow study procedures Exclusion Criteria: Not seeking medical abortion Contraindications to medical abortion

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective Cohort
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical abortion patients<br>Oral mifepristone 200 mg followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone). | Drug: Mifepristone<br>* Participants will receive mifepristone at a preferred address by mail rather than standard care at clinic visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who report satisfactory experience | Number of participants who report being satisfied or very satisfied with the simplified medical abortion service delivery model | Day 14 following initial medical abortion visit | 
| Number of providers who report satisfactory experience | Number of providers who report being satisfied or very satisfied with the simplified medical abortion service delivery model | End of the study, month 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse event | Number of participants who had a medical problem that required them to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving medical abortion pills | Up to 6 weeks after initial medical abortion visit | 
| Number of participants with a complete abortion with medication alone and who do not require additional interventions to complete the procedure | Number of participants who report that their abortion is complete as assessed by the multi-level pregnancy test and medical history. | Up to 6 weeks after initial medical abortion visit | 
| Number of particpants with adverse event associated with mailing of medical abortion medications | Number of participants who had a problem (such as delayed and lost packages) receiving medical abortion medications by mail | Up to 6 weeks after initial medical abortion visit | 
| Cost associated with the simplified medical abortion service delivery model | Cost savings associated with participant travel to the clinic and cost of the standard care at the clinic. | Up to 6 weeks after initial medical abortion visit | 
| Number of participants who refuse to receive medical abortion pills by mail | Number of participants who refuse to receive medical abortion pills by mail during the study period | End of the study, month 15 |