Contraceptive UsageNCT02411357
Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II
A study testing Treatment as usual, WHO contraception protocol and Incentives in people with Contraceptive Usage and Opioid Dependence, run by University of Vermont at 1 site in United States.
Trial summary
Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended and the majority of non-pregnant opioid-maintained women do not use contraception or use less effective methods like condoms. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Contraceptive Usage, Opioid Dependence
- What is being tested?
- Treatment as usual, WHO contraception protocol and Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2015to 9 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-44 years of age
- pre-menopausal and have no history of tubal ligation or hysterectomy
- have had heterosexual vaginal sex in the past 3 months
- have no plans to become pregnant in the next 6 months
- be medically eligible to use prescription contraceptives
- report no prescription contraceptive use (i.e., no use of pill, patch, ring, implants, or IUDs in the past 7 days or injections in the past 3 months)
Show all 11Show fewer
- be in opioid maintenance treatment
- at least 8 weeks postpartum
- not be facing imminent incarceration
- have no plans to leave the area in the next 12 months
- be English-speaking
Who cannot join
- failure to meet the aforementioned inclusion criteria
- refusal to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Vermont Center on Behavior and Health
Burlington, Vermont, 05401
About this study
Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended and the majority of non-pregnant opioid-maintained women do not use contraception or use less effective methods like condoms. This proposal aims to further test a novel contraceptive management program to increase use of more effective contraceptives among opioid-maintained women at risk of unintended pregnancy.
Read the detailed description
The rate of unintended pregnancy among opioid-dependent women is extremely high: nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended, a rate 2-3 times that of the general population. Despite these dire statistics, there is a dearth of scientific knowledge about contraceptive use in this population and about how to promote use of more effective contraceptives (e.g., birth control pills, intrauterine devices (IUDs), implants).
The aim of this Stage II Behavioral and Integrative Treatment Development Program application is to further test a novel contraceptive management program to increase use of more effective contraceptives among opioid-maintained (OM) women. OM women at risk for unintended pregnancy (N=195) will be randomly assigned to one of three conditions: (1) usual care, (2) the World Health Organization (WHO) contraception protocol, and (3) the WHO contraception protocol + financial incentives. Participants in the usual care condition will receive a referral to local contraceptive providers. Participants in the WHO alone condition will receive the WHO contraceptive initiation protocol and their choice of prescription contraceptive in consultation with a nurse practitioner. These participants will also subsequently be offered the opportunity to attend 13 follow-up visits where vital signs and a urine pregnancy test will be administered. Side effects of any prescription contraception will also be assessed and participants will have the option to change their prescription contraceptive method at any time. Participants in the WHO + incentives condition will also receive the WHO contraceptive initiation protocol and their choice of prescription contraceptive in consultation with a nurse practitioner. These participants will also subsequently be offered the opportunity to attend 13 follow-up visits where vital signs and a urine pregnancy test will be administered. Side effects of any prescription contraception will be assessed and participants will have the option to change their prescription contraceptive method at any time. Participants in the WHO + incentives condition participants will also earn vouchers exchangeable for goods and services for attending these visits. Contraceptive use by all participants will be evaluated at assessments scheduled 1, 3, 6, and 12 months after trial intake.
- Conditions
- Contraceptive Usage, Opioid Dependence
- Being tested
- Treatment as usual, WHO contraception protocol, Incentives
- Keywords
- Contraception, Unintended pregnancy, HIV risk, Sexually transmitted infections, Women, Pregnancy, Neonatal health, Drug use, Drug treatment, Opioids
- Medical subject headings
- Contraception Behavior, Opioid-Related Disorders, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usualBehavioural
General information about contraceptive options and referral to contraceptive service providers
WHO contraception protocolBehavioural
World Health Organization's contraception protocol
IncentivesBehavioural
Financial incentives contingent on follow-up visit attendance
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | The usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services. Receives: Behavioral: Treatment as usual |
| WHO contraception protocol | Experimental | The WHO contraception protocol condition will receive the World Health Organization's contraception protocol and will be invited to attend follow-up visits. Receives: Behavioral: Treatment as usual; Behavioral: WHO contraception protocol |
| WHO contraception protocol + incentives | Experimental | The WHO + incentives condition will receive the World Health Organization's contraception protocol and will be invited to attend follow-up visits, but will also receive financial incentives contingent on attending those follow-up visits. Receives: Behavioral: Treatment as usual; Behavioral: WHO contraception protocol; Behavioral: Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study start5 May 2015
- Primary completion6 Mar 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Heil, University of Vermont
- Investigators
- Sarah H. Heil, Ph.D., Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411357
- Sponsor's protocol ID
- R01DA036670
- Status last verified
- Jan 2023
- First submitted
- 2 Apr 2015
- Last updated
- 10 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Heil SH, Melbostad HS, Matusiewicz AK, Rey CN, Badger GJ, Shepard DS, Sigmon SC, MacAfee LK, Higgins ST. Efficacy and Cost-Benefit of Onsite Contraceptive Services With and Without Incentives Among Women With Opioid Use Disorder at High Risk for Unintended Pregnancy: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Oct 1;78(10):1071-1078. doi: 10.1001/jamapsychiatry.2021.1715.
PubMed 34259798
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II
- ClinicalTrials.gov ID
- NCT02411357
- Acronym / sponsor ID
- R01DA036670
- Conditions
- Contraceptive Usage, Opioid Dependence
- Keywords
- Contraception, Unintended pregnancy, HIV risk, Sexually transmitted infections, Women, Pregnancy, Neonatal health, Drug use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 5 May 2015 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Posted 10 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended and the majority of non-pregnant opioid-maintained women do not use contraception or use less effective methods like condoms. This proposal aims to further test a novel contraceptive management program to increase use of more effective contraceptives among opioid-maintained women at risk of unintended pregnancy.
Detailed description
The rate of unintended pregnancy among opioid-dependent women is extremely high: nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended, a rate 2-3 times that of the general population. Despite these dire statistics, there is a dearth of scientific knowledge about contraceptive use in this population and about how to promote use of more effective contraceptives (e.g., birth control pills, intrauterine devices (IUDs), implants).
The aim of this Stage II Behavioral and Integrative Treatment Development Program application is to further test a novel contraceptive management program to increase use of more effective contraceptives among opioid-maintained (OM) women. OM women at risk for unintended pregnancy (N=195) will be randomly assigned to one of three conditions: (1) usual care, (2) the World Health Organization (WHO) contraception protocol, and (3) the WHO contraception protocol + financial incentives. Participants in the usual care condition will receive a referral to local contraceptive providers. Participants in the WHO alone condition will receive the WHO contraceptive initiation protocol and their choice of prescription contraceptive in consultation with a nurse practitioner. These participants will also subsequently be offered the opportunity to attend 13 follow-up visits where vital signs and a urine pregnancy test will be administered. Side effects of any prescription contraception will also be assessed and participants will have the option to change their prescription contraceptive method at any time. Participants in the WHO + incentives condition will also receive the WHO contraceptive initiation protocol and their choice of prescription contraceptive in consultation with a nurse practitioner. These participants will also subsequently be offered the opportunity to attend 13 follow-up visits where vital signs and a urine pregnancy test will be administered. Side effects of any prescription contraception will be assessed and participants will have the option to change their prescription contraceptive method at any time. Participants in the WHO + incentives condition participants will also earn vouchers exchangeable for goods and services for attending these visits. Contraceptive use by all participants will be evaluated at assessments scheduled 1, 3, 6, and 12 months after trial intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Behavioral: Treatment as usualThe usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services. |
| WHO contraception protocol | Experimental | Behavioral: Treatment as usual, Behavioral: WHO contraception protocolThe WHO contraception protocol condition will receive the World Health Organization's contraception protocol and will be invited to attend follow-up visits. |
| WHO contraception protocol + incentives | Experimental | Behavioral: Treatment as usual, Behavioral: WHO contraception protocol, Behavioral: IncentivesThe WHO + incentives condition will receive the World Health Organization's contraception protocol and will be invited to attend follow-up visits, but will also receive financial incentives contingent on attending those follow-up visits. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 18-44 years of age
- pre-menopausal and have no history of tubal ligation or hysterectomy
- have had heterosexual vaginal sex in the past 3 months
- have no plans to become pregnant in the next 6 months
- be medically eligible to use prescription contraceptives
Key exclusion criteria (2 listed)
- failure to meet the aforementioned inclusion criteria
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as usualGeneral information about contraceptive options and referral to contraceptive service providers | Behavioural | Treatment as usual, WHO contraception protocol, WHO contraception protocol + incentives |
| WHO contraception protocolWorld Health Organization's contraception protocol | Behavioural | WHO contraception protocol, WHO contraception protocol + incentives |
| IncentivesFinancial incentives contingent on follow-up visit attendance | Behavioural | WHO contraception protocol + incentives |
Primary outcome
Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment
Time frame: 6 months after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34259798Heil SH, Melbostad HS, Matusiewicz AK, Rey CN, Badger GJ, Shepard DS, Sigmon SC, MacAfee LK, Higgins ST. Efficacy and Cost-Benefit of Onsite Contraceptive Services With and Without Incentives Among Women With Opioid Use Disorder at High Risk for Unintended Pregnancy: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Oct 1;78(10):1071-1078. doi: 10.1001/jamapsychiatry.2021.1715.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah H. Heil, Ph.D. principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as usual, WHO contraception protocol and Incentives in people with Contraceptive Usage and Opioid Dependence, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02411357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.