Improving Effective Contraceptive Use Among Opioid-maintained Women

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sarah Heil, University of Vermont
ClinicalTrials.gov Identifier:
NCT01425060
First received: August 25, 2011
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Contraceptive Usage
Opioid Dependence
Behavioral: Contraceptive management program
Other: Usual care
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Improving Effective Contraceptive Use Among Opioid-maintained Women

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Point prevalence use of a prescription contraceptive [ Time Frame: 6 months after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Contraceptive management program Behavioral: Contraceptive management program
The contraceptive management program will consist of two components: (1) the World Health Organization's contraception protocol and (2) reinforced follow-up visits.
Active Comparator: Usual care
The usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services.
Other: Usual care
The usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services.

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 I Behavioral and Integrative Treatment Development Program application is to develop and pilot test a novel contraceptive management program to increase use of more effective contraceptives among OM women. OM women (N=100) at risk for unintended pregnancy will be randomly assigned to a 6-month contraceptive management program or to usual care. The contraceptive management program will consist of two components: (1) the World Health Organization's contraception protocol and (2) reinforced follow-up visits. At their first visit, participants assigned to the contraceptive management program will complete the WHO's contraception protocol, which consists of assistance choosing a contraceptive method, structured educational counseling about their chosen method, a free supply of this method, and the option of initiating this method immediately. Subsequently, contraceptive management program participants will earn voucher-based incentives to reinforce attendance at follow-up visits where they will receive support to manage side effects and problem-solve compliance problems, refills of their chosen method, and assistance switching methods when indicated. At each visit, contraceptive management program participants will also be counseled about the risks of sexually transmitted infections (STIs), including HIV/AIDS, the need for dual protection (i.e., protection from both pregnancy and STIs), and provided with a supply of condoms. Participants assigned to the usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services. Contraceptive use by all participants will be evaluated at assessments scheduled 1, 3, and 6 months after trial intake. The impact of prescription contraceptive use on condom use will also be assessed. It is hypothesized that the contraceptive management program will increase effective contraceptive use without decreasing condom use.

The proposed project will be the seminal study of an intervention to increase more effective contraceptive use in OM women and the first step towards our overarching goal of developing an efficacious, empirically based contraceptive management program that can be disseminated to drug treatment facilities throughout the country. The proposed research also holds significant potential for impacting public health in general, as development of efficacious programs will help reduce the vast economic and societal costs associated with unintended pregnancy among drug-dependent and non-drug-dependent women alike.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-44 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.

Exclusion Criteria:

  • failure to meet the aforementioned inclusion criteria
  • refusal to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425060

Locations
United States, Vermont
University of Vermont Substance Abuse Treatment Center
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Sarah H. Heil, Ph.D. University of Vermont
  More Information

Publications:
Responsible Party: Sarah Heil, Associate Professor of Psychiatry and Psychology, University of Vermont
ClinicalTrials.gov Identifier: NCT01425060     History of Changes
Other Study ID Numbers: R34DA030534
Study First Received: August 25, 2011
Last Updated: September 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
Contraception
Unintended pregnancy
HIV
HIV Risk
Sexually Transmitted Infections
Women
Pregnancy
Neonatal Health
Drug Use
Drug Treatment
Opioids

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Contraceptive Agents
Analgesics, Opioid
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 26, 2014