Opioid Dependence Clinical Trial
Official title:
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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