Pharmacist-Administered Injections for Contraception

Study Overview
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Brief Summary
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The purpose of this study is to see if it is a feasible arrangement to have women receive their second and third birth control injection (with Depo-Provera) at a pharmacy compared with receiving it a Planned Parenthood Clinic. Compliance with returning for injections as well as patient satisfaction with the method, providers, and location where injection was received will be assessed and compared between the two sites. The hypothesis is that there will be no difference in return rates for injections at either the pharmacy or the clinic site.

Detailed Description
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Women who want to use or are currently using Depo-Provera for contraception will be randomized to receive their next two injections either back at the Planned Parenthood clinic or at a local pharmacy where pharmacists are trained to give injections. After each injection, women will be asked to complete a questionnaire to assess their attitudes about the method of birth control, their providers, and the location where they received the injection.

Official Title
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Pharmacist-Administered Injections of Depo-Medroxyprogesterone Acetate for Contraception: A Pilot Randomized Controlled Trial

Conditions
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Contraception

Intervention / Treatment
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* Other: Pharmacist-administered
* Other: clinic-administered injections


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 y.o., English speaking/reading, presenting to Planned Parenthood to use Depo Provera (restarting, first use, or continuing use) Exclusion Criteria: Under 18 years of age, English illiterate (reading and verbal)

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacy<br>Women receive their second and third depot-medroxyprogesterone acetate injections at the pharmacy by clinical pharmacists | Other: Pharmacist-administered<br>* women will receive their injections at a pharmacy by a clinical pharmacist<br>* Other names: SQ Depo-Provera;|
| Active Comparator: Planned Parenthood clinic<br>Women receive their second and third depot-medroxyprogesterone acetate injections per usual care at their Planned Parenthood clinic. | Other: clinic-administered injections<br>* women will return for their injections to the clinic where recruitment took place. They will receive one at 3 months and 6 months.<br>* Other names: SQ Depo-Provera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance in returning for 3 month and 6 month injections |  | 3 months and 6 months after first injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitudes about clinical setting |  | 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depo medroxyprogesterone acetate, Depo Provera, contraceptive compliance, pharmacists, Compliance in receiving additional Depo Provera injections, Satisfaction in receiving Depo Provera injections at a pharmacy compared with usual clinic