Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 44 |
| Updated: | 11/4/2018 |
| Start Date: | March 2015 |
| End Date: | May 2019 |
| Contact: | Sarah H. Heil, Ph.D. |
| Email: | sarah.heil@uvm.edu |
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.
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.
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.
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.
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
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