PAD: Pharmacist-Administered Injections for Contraception

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT00775047
Collaborator
Pfizer (Industry)
50
1
2
23
2.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pharmacist-administered
  • Other: clinic-administered injections
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Pharmacist-Administered Injections of Depo-Medroxyprogesterone Acetate for Contraception: A Pilot Randomized Controlled Trial
Study Start Date :
Aug 1, 2006
Actual Primary Completion Date :
Sep 1, 2007
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pharmacy

Women receive their second and third depot-medroxyprogesterone acetate injections at the pharmacy by clinical pharmacists

Other: Pharmacist-administered
women will receive their injections at a pharmacy by a clinical pharmacist
Other Names:
  • SQ Depo-Provera
  • Active Comparator: Planned Parenthood clinic

    Women receive their second and third depot-medroxyprogesterone acetate injections per usual care at their Planned Parenthood clinic.

    Other: clinic-administered injections
    women will return for their injections to the clinic where recruitment took place. They will receive one at 3 months and 6 months.
    Other Names:
  • SQ Depo-Provera
  • Outcome Measures

    Primary Outcome Measures

    1. Compliance in returning for 3 month and 6 month injections [3 months and 6 months after first injection]

    Secondary Outcome Measures

    1. Attitudes about clinical setting [3 months and 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Planned Parenthood of Central North Carolina Chapel Hill North Carolina United States 27514

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill
    • Pfizer

    Investigators

    • Principal Investigator: Carla Picardo, MD, MPH, Dept. of Social Medicine, University of North Carolina

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00775047
    Other Study ID Numbers:
    • 05-EPID-52
    First Posted:
    Oct 17, 2008
    Last Update Posted:
    Oct 17, 2008
    Last Verified:
    Oct 1, 2008

    Study Results

    No Results Posted as of Oct 17, 2008