Contraceptive Usage, Opioid Dependence
Conditions
Keywords
Contraception, Unintended pregnancy, HIV risk, Sexually transmitted infections, Women, Pregnancy, Neonatal health, Drug use, Drug treatment, Opioids
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.
Interventions
BEHAVIORALTreatment as usual
General information about contraceptive options and referral to contraceptive service providers
BEHAVIORALWHO contraception protocol
World Health Organization's contraception protocol
BEHAVIORALIncentives
Financial incentives contingent on follow-up visit attendance
Sponsors
University of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment | 6 months after randomization |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care The usual care condition received usual care consisting of a general information brochure about contraceptive methods and contact information for community contraceptive service facilities. | 48 |
| Contraceptive Services The contraceptive services condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visits to assess method satisfaction. | 48 |
| Contraceptive Services + Incentives The contraceptive services + incentives condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visit to assess method satisfaction plus financial incentives for attending follow-up visits. | 42 |
| Total | 138 |
Baseline characteristics
| Characteristic | Usual Care | Contraceptive Services | Contraceptive Services + Incentives | Total |
|---|---|---|---|---|
| Age, Continuous | 30.6 years STANDARD_DEVIATION 6 | 32.0 years STANDARD_DEVIATION 5.2 | 31.6 years STANDARD_DEVIATION 4.9 | 31.4 years STANDARD_DEVIATION 5.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 48 Participants | 42 Participants | 138 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| One or more unintended pregnancies in lifetime | 41 Participants | 42 Participants | 39 Participants | 122 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 43 Participants | 45 Participants | 40 Participants | 128 Participants |
| Sex: Female, Male Female | 48 Participants | 48 Participants | 42 Participants | 138 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 | 0 / 42 |
| other Total, other adverse events | 26 / 48 | 42 / 48 | 36 / 42 |
| serious Total, serious adverse events | 1 / 48 | 3 / 48 | 1 / 42 |
Outcome results
Primary
Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment
Time frame: 6 months after randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment | 5 Participants |
| Contraceptive Services | Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment | 14 Participants |
| Contraceptive Services + Incentives | Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment | 23 Participants |
p-value: <0.001Cochran-Armitage Chi-square trend test