RCT: Can a Single Counseling Phone Call Improve Contraception After an Abortion?

Study Overview
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Brief Summary
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Hypothesis: Use of an effective contraceptive six weeks after abortion will be higher in the treatment group than in the control group. Primary Aim ·To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention. Secondary Aims To describe the most common concerns and logistical problems women experience with initiating and adhering to CHC after abortion. To describe the concerns that lead to discontinuation or method change. *To assess feasibility of conducting a follow-up telephone call in this population This is a randomized, controlled trial to assess the effect of a three-week follow-up phone call in women who choose combined hormonal contraception on the day of their abortion at the San Francisco General Hospital Women's Options Center. Subjects randomized to the treatment group will receive an interventional phone call three weeks after their abortion; participants randomized to the control group will not receive the call. All subjects will receive a follow-up call six weeks after their abortion to assess and compare method use between the two groups. Calls will be made at three- and six-weeks post abortion in order to give subjects enough time to initiate CHC and to assess continuation into the second month of the method. Data will be collected at baseline, during the intervention for the treatment group and during the final follow-up call for both groups. The primary outcome is use of an effective contraceptive six weeks after abortion.

Official Title
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A Randomized Controlled Trial: Contraceptive Counseling After an Abortion

Conditions
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Contraception

Intervention / Treatment
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* Behavioral: Treatment group: receives counseling phone call intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women over the age of 15 who choose pill, patch or ring to begin after their abortion Women able and willing to be contacted by phone for up to 2 months after enrollment Exclusion Criteria: Women who do not speak and read English or Spanish

Ages Eligible for Study
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Minimum Age: 15 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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control group will not receive a counseling phone call one month after enrollment. | |
| Experimental: Intervention<br>Intervention arm receives a counseling phone call 3 to 4 weeks after enrollment. The call is from a health educator intended to assist with contraception. | Behavioral: Treatment group: receives counseling phone call intervention<br>* Subjects in the treatment arm will receive a phone call from a health educator to assist with contraception, 3 to 4 weeks after enrollment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Using an Effective Contraceptive Method 6 Weeks After Abortion | To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention. | 6 weeks after abortion procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons for Discontinuation of Contraception | To describe the most common concerns and logistical problems women experience with initiating and adhering to CHC after abortion. To describe the concerns that lead to discontinuation or method change. To assess feasibility of conducting a follow-up telephone call in this population | 6 weeks after abortion procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contraception