Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II
1 other identifier
interventional
138
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2015
CompletedFirst Posted
Study publicly available on registry
April 8, 2015
CompletedStudy Start
First participant enrolled
May 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2019
CompletedResults Posted
Study results publicly available
February 10, 2023
CompletedFebruary 10, 2023
January 1, 2023
3.8 years
April 2, 2015
December 2, 2022
January 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment
6 months after randomization
Study Arms (3)
Treatment as usual
ACTIVE COMPARATORThe 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
EXPERIMENTALThe 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
EXPERIMENTALThe 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.
Interventions
General information about contraceptive options and referral to contraceptive service providers
World Health Organization's contraception protocol
Financial incentives contingent on follow-up visit attendance
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vermont Center on Behavior and Health
Burlington, Vermont, 05401, United States
Related Publications (1)
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.
PMID: 34259798DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sarah H. Heil, PhD
- Organization
- University of Vermont
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah H. Heil, Ph.D.
University of Vermont
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 2, 2015
First Posted
April 8, 2015
Study Start
May 5, 2015
Primary Completion
March 6, 2019
Study Completion
September 9, 2019
Last Updated
February 10, 2023
Results First Posted
February 10, 2023
Record last verified: 2023-01