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

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.
    

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, intrauterine devices
      (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 opioid-maintained (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.
    

Intervention name(s): Treatment as usual; WHO contraception protocol; Incentives
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): General information about contraceptive options and referral to contraceptive service providers; World Health Organization's contraception protocol; Financial incentives contingent on follow-up visit attendance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception; Unintended pregnancy; HIV risk; Sexually transmitted infections; Women; Pregnancy; Neonatal health; Drug use; Drug treatment; Opioids