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

August 25, 2011
September 10, 2013
October 2011
June 2014   (final data collection date for primary outcome measure)
Point prevalence use of a prescription contraceptive [ Time Frame: 6 months after randomization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01425060 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Improving Effective Contraceptive Use Among Opioid-maintained Women
Improving Effective Contraceptive Use Among Opioid-maintained Women

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Contraceptive Usage
  • Opioid Dependence
  • 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.
  • 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.
  • Experimental: Contraceptive management program
    Intervention: Behavioral: Contraceptive management program
  • 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.
    Intervention: Other: Usual care
Heil SH, Jones HE, Arria A, Kaltenbach K, Coyle M, Fischer G, Stine S, Selby P, Martin PR. Unintended pregnancy in opioid-abusing women. J Subst Abuse Treat. 2011 Mar;40(2):199-202. doi: 10.1016/j.jsat.2010.08.011. Epub 2010 Oct 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 44 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01425060
R34DA030534
Yes
Sarah Heil, University of Vermont
University of Vermont
Not Provided
Principal Investigator: Sarah H. Heil, Ph.D. University of Vermont
University of Vermont
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP