Contraception
Conditions
Keywords
Contraception, Medroxyprogesterone 17-acetate, Self administration
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.
Interventions
Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
Sponsors
Family Planning Fellowship
Pfizer
Carolyn L. Westhoff
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Self Administration of DMPA Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year | 86 |
| Clinic Administration of DMPA Clinic administration (routine care) of DMPA
Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year | 46 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 6 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Self Administration of DMPA | Clinic Administration of DMPA | Total |
|---|---|---|---|
| Age, Continuous | 26 years STANDARD_DEVIATION 6.1 | 26.1 years STANDARD_DEVIATION 6.3 | 26.03 years STANDARD_DEVIATION 6.2 |
| Region of Enrollment United States | 86 participants | 46 participants | 132 participants |
| Sex: Female, Male Female | 86 Participants | 46 Participants | 132 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 86 | 0 / 46 |
| serious Total, serious adverse events | 0 / 86 | 0 / 46 |
Outcome results
Primary
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
Time frame: 6 months
Population: Data was analyzed with the assumption that participants who were lost to follow-up had discontinued DMPA use.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self Administration of DMPA | Number of Participants Continuing DMPA at 6 Months | 61 participants |
| Clinic Administration of DMPA | Number of Participants Continuing DMPA at 6 Months | 29 participants |
Secondary
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.
Time frame: 0-12 months
Population: Data were not collected. No analysis was performed.
Secondary
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.
Time frame: 3, 9, 12 months
Population: 115 women w 12 month follow-up data (76 and 39) . 10 participants LTFU in self-administration group, and 7 participants LTFU in the clinic administration group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self Administration of DMPA | Number of Participants Continuing DMPA | 61 Participants |
| Clinic Administration of DMPA | Number of Participants Continuing DMPA | 29 Participants |
Secondary
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
Time frame: 6, 12 months
Population: Data were not collected. No analysis was performed.
Secondary
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)
Time frame: 12 months
Population: Data were not collected. No analysis was performed.
Secondary
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.
Time frame: 6, 12 months
Population: Data were not collected. No analysis was performed.