Study of Self or Clinic Administration of DepoProvera

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Clinical Trial of Self Versus Clinical Administration of Depot Medroxyprogesterone Acetate

Conditions
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Contraception

Intervention / Treatment
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* Drug: Medroxyprogesterone 17-Acetate
* Drug: Medroxyprogesterone 17-Acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age greater than or equal to 18 years seeking DMPA for contraception English or Spanish speaking consistent access to a working telephone availability for follow up for one year Exclusion Criteria: suspected or continuing pregnancy undiagnosed vaginal bleeding known or suspected breast cancer acute liver disease known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA desire for pregnancy within one year

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: Self Administration of DMPA<br>Self administration of subcutaneous depot medroxyprogesterone acetate | Drug: Medroxyprogesterone 17-Acetate<br>* Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year<br>* Other names: depo-subQ 104;|
| Active Comparator: Clinic administration of DMPA<br>Clinic administration (routine care) of DMPA | Drug: Medroxyprogesterone 17-Acetate<br>* Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year<br>* Other names: depo-subQ 104;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Continuing DMPA at 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Continuing DMPA | 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. | 3, 9, 12 months | 
| Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available | The study was designed to examine if self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA | 6, 12 months | 
| Prevalence of Participants With Persistent Skin Changes | The study was designed to examine if using SC DMPA will cause skin changes (dimpling, induration, or atrophy) | 12 months | 
| Scaled Satisfaction Score | This study was designed to examine if age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates with questionnaires. | 6, 12 months | 
| Average Minutes Spent Getting Ready for and Giving the Injection | 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. | 0-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Medroxyprogesterone 17-acetate, Self administration