Improving Effective Contraceptive Use Among Opioid-maintained Women
Condition: Contraceptive Usage; Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): Contraceptive management program; Usual care
Intervention type(s): Behavioral; Other
Intervention description(s): 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.
Intervention MeSH terms: Contraceptive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception; Unintended pregnancy; HIV; HIV Risk; Sexually Transmitted Infections; Women; Pregnancy; Neonatal Health; Drug Use; Drug Treatment; Opioids