Clinical trial NCT02411357: Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II
Official title: Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraceptive Usage
Opioid Dependence
Keywords: Contraception
Unintended pregnancy
HIV risk
Sexually transmitted infections
Women
Pregnancy
Neonatal health
Drug use
Drug treatment
Opioids
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment
timeFrame: 6 months after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Vermont Center on Behavior and Health
state: Vermont
Study officials:
affiliation: University of Vermont
name: Sarah H. Heil, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heil SH, Melbostad HS, Matusiewicz AK, Rey CN, Badger GJ, Shepard DS, Sigmon SC, MacAfee LK, Higgins ST. Efficacy and Cost-Benefit of Onsite Contraceptive Services With and Without Incentives Among Women With Opioid Use Disorder at High Risk for Unintended Pregnancy: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Oct 1;78(10):1071-1078. doi: 10.1001/jamapsychiatry.2021.1715.