Study of Self or Clinic Administration of DepoProvera

Not Applicable

Completed

• Conditions: Contraception
• Interventions: Drug: Medroxyprogesterone 17-Acetate

• Registration Number: NCT01019369
• Lead Sponsor: Carolyn L. Westhoff

Brief Summary

Depot medroxyprogesterone acetate (DepoProvera) is an acceptable form of contraception for many women. However, difficulty in access may cause many women to discontinue use, often without the use of another effective method of contraception, thereby leaving them vulnerable to unintended pregnancy. This study will randomly assign women who present for contraceptive services to two groups: self or clinic administered SC DMPA. The participants will be followed for one year to compare continuation rates, acceptability, cost effectiveness, evidence of skin changes, and need for continued support between the two groups.

Detailed Description

Unintended pregnancy remains a worldwide problem in both developed and developing countries. In 2001, 49% of pregnancies in the United States were unintended. Moreover, more than 6 million women annually are at high risk of becoming unintentionally pregnant because of a gap in contraceptive use, and disadvantaged women are more likely to have more difficulty than others with continuous method use. Multiple strategies have been explored and implemented to increase the effective usage of contraception, including promoting the use of longer acting reversible contraceptives.

Difficulty in access to depot medroxyprogesterone acetate (DMPA) remains a problem. With the advent of a subcutaneous formulation of DMPA, administration outside of the clinical setting is possible. The acceptability of self administered DMPA has also been reviewed, with favorable outcomes; however, the actual intervention has not been studied.

This study will recruit women presenting for abortion or contraceptive services at the Columbia University and New York Presbyterian affiliated Family Planning Clinic and Special Gynecology Services who desire DMPA for contraception. Women will be randomized to two groups: self administration of SC DMPA or clinic administration of SC DMPA. The primary objective of this study is to compare the continuation rates of SC DMPA between the self and clinic administration groups at 6 months. Secondary outcomes include participant satisfaction, cost effectiveness of self-injected use of DMPA, baseline predictors of method continuation or discontinuation, evidence of persistent skin changes following administration of SC DMPA, and need for continued clinical support.

Study Timeline

• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Study Start: 2010-03
• Primary Completion: 2011-01
• Study Completion: 2012-11
• Results First Submitted: 2014-12-04
• Results First Submitted QC: 2015-04-14
• Results First Posted: 2015-04-15
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

Inclusion Criteria

1. age greater than or equal to 18 years
2. seeking DMPA for contraception
3. English or Spanish speaking
4. consistent access to a working telephone
5. availability for follow up for one year

Exclusion Criteria

1. suspected or continuing pregnancy
2. undiagnosed vaginal bleeding
3. known or suspected breast cancer
4. acute liver disease
5. known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA
6. desire for pregnancy within one year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self Administration of DMPA	Medroxyprogesterone 17-Acetate	Self administration of subcutaneous depot medroxyprogesterone acetate
Clinic administration of DMPA	Medroxyprogesterone 17-Acetate	Clinic administration (routine care) of DMPA

Primary Outcome Measures

Name	Time	Method
Number of Participants Continuing DMPA at 6 Months	6 months	The study was designed to examine if increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA

Secondary Outcome Measures

Name	Time	Method
Number of Participants Continuing DMPA	3, 9, 12 months	The study was designed to examine the increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase method continuation rates at all other endpoints.
Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available	6, 12 months	The study was designed to examine if self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA
Prevalence of Participants With Persistent Skin Changes	12 months	The study was designed to examine if using SC DMPA will cause skin changes (dimpling, induration, or atrophy)
Scaled Satisfaction Score	6, 12 months	This study was designed to examine if age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates with questionnaires.
Average Minutes Spent Getting Ready for and Giving the Injection	0-12 months	In total, how much time did the participant spend getting ready for and giving the injection. This includes the time the participant spent getting ready to come to the clinic, getting to the appointment, and waiting for the provider for the control group.

Trial Locations

Locations (1)

Columbia University/New York Presbyterian Hospital; 🇺🇸 New York, New York, United States