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Trial record 10 of 101 for:    Recruiting, Not yet recruiting, Available Studies | contraception

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

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ClinicalTrials.gov Identifier: NCT02411357
Recruitment Status : Recruiting
First Posted : April 8, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Sarah Heil, University of Vermont

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.

Condition or disease Intervention/treatment Phase
Contraceptive Usage Opioid Dependence Behavioral: Treatment as usual Behavioral: WHO contraception protocol Behavioral: Incentives Not Applicable

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, 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 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II
Study Start Date : March 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Active Comparator: Treatment as usual
The usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services.
Behavioral: Treatment as usual
General information about contraceptive options and referral to contraceptive service providers

Experimental: WHO contraception protocol
The WHO contraception protocol condition will receive the World Health Organization's contraception protocol and will be invited to attend follow-up visits.
Behavioral: Treatment as usual
General information about contraceptive options and referral to contraceptive service providers

Behavioral: WHO contraception protocol
World Health Organization's contraception protocol

Experimental: WHO contraception protocol + incentives
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.
Behavioral: Treatment as usual
General information about contraceptive options and referral to contraceptive service providers

Behavioral: WHO contraception protocol
World Health Organization's contraception protocol

Behavioral: Incentives
Financial incentives contingent on follow-up visit attendance




Primary Outcome Measures :
  1. Period prevalence use of a prescription contraceptive [ Time Frame: 6 months after randomization ]
    Period prevalence use of a prescription contraceptive



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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411357


Contacts
Contact: Sarah H. Heil, Ph.D. sarah.heil@uvm.edu

Locations
United States, Vermont
Vermont Center on Behavior and Health Recruiting
Burlington, Vermont, United States, 05401
Contact: Sarah H. Heil, Ph.D.         
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Sarah H. Heil, Ph.D. University of Vermont

Responsible Party: Sarah Heil, Associate Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT02411357     History of Changes
Other Study ID Numbers: R01DA036670 ( U.S. NIH Grant/Contract )
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by Sarah Heil, University of Vermont:
Contraception
Unintended pregnancy
HIV risk
Sexually transmitted infections
Women
Pregnancy
Neonatal health
Drug use
Drug treatment
Opioids

Additional relevant MeSH terms:
Analgesics, Opioid
Contraceptive Agents
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Reproductive Control Agents