Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II

Conditions
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Contraceptive Usage, Opioid Dependence

Intervention / Treatment
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* Behavioral: Treatment as usual
* Behavioral: WHO contraception protocol
* Behavioral: Incentives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-44 years of age pre-menopausal and have no history of tubal ligation or hysterectomy have had heterosexual vaginal sex in the past 3 months have no plans to become pregnant in the next 6 months be medically eligible to use prescription contraceptives report no prescription contraceptive use (i.e., no use of pill, patch, ring, implants, or IUDs in the past 7 days or injections in the past 3 months) be in opioid maintenance treatment at least 8 weeks postpartum not be facing imminent incarceration have no plans to leave the area in the next 12 months be English-speaking Exclusion Criteria: failure to meet the aforementioned inclusion criteria refusal to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as usual<br>The usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services. | Behavioral: Treatment as usual<br>* General information about contraceptive options and referral to contraceptive service providers<br>|
| Experimental: WHO contraception protocol<br>The WHO contraception protocol condition will receive the World Health Organization's contraception protocol and will be invited to attend follow-up visits. | Behavioral: Treatment as usual<br>* General information about contraceptive options and referral to contraceptive service providers<br>Behavioral: WHO contraception protocol<br>* World Health Organization's contraception protocol<br>|
| Experimental: WHO contraception protocol + incentives<br>The WHO + incentives condition will receive the World Health Organization's contraception protocol and will be invited to attend follow-up visits, but will also receive financial incentives contingent on attending those follow-up visits. | Behavioral: Treatment as usual<br>* General information about contraceptive options and referral to contraceptive service providers<br>Behavioral: WHO contraception protocol<br>* World Health Organization's contraception protocol<br>Behavioral: Incentives<br>* Financial incentives contingent on follow-up visit attendance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment |  | 6 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV risk, Contraception, Unintended pregnancy, Sexually transmitted infections, Women, Pregnancy, Neonatal health, Drug use, Drug treatment, Opioids