Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II

Opioid Dependence Clinical Trial

Official title:

Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411357
• Other study ID #: R01DA036670
• Status: Completed
• Phase: N/A
• Start date: May 5, 2015
• Est. completion date: September 9, 2019

Study information

• Verified date: January 2023
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: September 9, 2019
• Est. primary completion date: March 6, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• 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)
• 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

Exclusion Criteria:

• failure to meet the aforementioned inclusion criteria
• refusal to participate

Related Conditions & MeSH terms

• Contraceptive Usage
• Opioid Dependence
• Opioid-Related Disorders

Intervention

Behavioral:
• Treatment as usual
General information about contraceptive options and referral to contraceptive service providers
• WHO contraception protocol
World Health Organization's contraception protocol
• Incentives
Financial incentives contingent on follow-up visit attendance

Locations

Country	Name	City	State
United States	Vermont Center on Behavior and Health	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment		6 months after randomization