Improving Effective Contraceptive Use Among Opioid-maintained Women
1 other identifier
interventional
31
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 develop and test a novel contraceptive management program to increase use of more effective contraceptives among opioid-maintained women and to examine the impact of more effective contraceptive use on condom use. The proposed research may reduce unintended pregnancy among opioid-dependent women without increasing their risk of sexually transmitted infections and the knowledge gained will also have implications for addressing high rates of unintended pregnancy in the general population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2011
Typical duration for phase_1
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
August 25, 2011
CompletedFirst Posted
Study publicly available on registry
August 29, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 17, 2015
March 1, 2015
2.7 years
August 25, 2011
March 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Point prevalence use of a prescription contraceptive
6 months after randomization
Study Arms (2)
Contraceptive management program
EXPERIMENTALUsual care
ACTIVE COMPARATORThe usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services.
Interventions
The contraceptive management program will consist of two components: (1) the World Health Organization's contraception protocol and (2) reinforced follow-up visits.
The usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services.
Eligibility Criteria
You may qualify if:
- years of age
- pre-menopausal and have no history of a tubal ligation or hysterectomy
- have had heterosexual vaginal sex in the past 12 months
- have no plans to become pregnant in the next 6 months
- be medically eligible to use prescription contraceptives
- report no prescription contraceptive method use (i.e., no use of pills, patch, ring in the past 7 days or depot injections, implants, or IUD in the past 3 months) OR report primary use of a non-prescription method (i.e., condoms, sponge, diaphragm, withdrawal, or rhythm method)
- have been in opioid maintenance treatment for at least the past 30 days
- be English-speaking.
You may not qualify if:
- refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Vermont Substance Abuse Treatment Center
Burlington, Vermont, 05401, United States
Related Publications (5)
Heil SH, Higgins ST. The scientific and ethical rationale for using incentives to promote contraceptive use among drug-abusing women. Addiction. 2012 Jun;107(6):1044-6. doi: 10.1111/j.1360-0443.2012.03798.x. No abstract available.
PMID: 22563830BACKGROUNDHeil SH, Gaalema DE, Johnston AM, Sigmon SC, Badger GJ, Higgins ST. Infant pupillary response to methadone administration during treatment for neonatal abstinence syndrome: a feasibility study. Drug Alcohol Depend. 2012 Nov 1;126(1-2):268-71. doi: 10.1016/j.drugalcdep.2012.05.006. Epub 2012 Jun 8.
PMID: 22682657BACKGROUNDHand DJ, Heil SH, Sigmon SC, Higgins ST. Improving medicaid health incentives programs: lessons from substance abuse treatment research. Prev Med. 2014 Jun;63:87-9. doi: 10.1016/j.ypmed.2014.03.001. Epub 2014 Mar 12.
PMID: 24613792BACKGROUNDHerrmann ES, Hand DJ, Johnson MW, Badger GJ, Heil SH. Examining delay discounting of condom-protected sex among opioid-dependent women and non-drug-using control women. Drug Alcohol Depend. 2014 Nov 1;144:53-60. doi: 10.1016/j.drugalcdep.2014.07.026. Epub 2014 Jul 30.
PMID: 25190049BACKGROUNDMeyer MC, Johnston AM, Crocker AM, Heil SH. Methadone and buprenorphine for opioid dependence during pregnancy: a retrospective cohort study. J Addict Med. 2015 Mar-Apr;9(2):81-6. doi: 10.1097/ADM.0000000000000092.
PMID: 25622120BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah H. Heil, Ph.D.
University of Vermont
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry and Psychology
Study Record Dates
First Submitted
August 25, 2011
First Posted
August 29, 2011
Study Start
October 1, 2011
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
March 17, 2015
Record last verified: 2015-03