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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual | Active Comparator | The usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services. |
|
| WHO contraception protocol | Experimental | The WHO contraception protocol condition will receive the World Health Organization's contraception protocol and will be invited to attend follow-up visits. |
|
| WHO contraception protocol + incentives | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment as usual | Behavioral | General information about contraceptive options and referral to contraceptive service providers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment | 6 months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah H. Heil, Ph.D. | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vermont Center on Behavior and Health | Burlington | Vermont | 05401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34259798 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Contraceptive Services |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment | Posted | Count of Participants | Participants | 6 months after randomization |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse events not categorized by organ system | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah H. Heil, PhD | University of Vermont | 802-656-8712 | sarah.heil@uvm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2023 | Jan 19, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| D009293 | Opioid-Related Disorders |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D005298 | Fertility |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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| WHO contraception protocol | Behavioral | World Health Organization's contraception protocol |
|
| Incentives | Behavioral | Financial incentives contingent on follow-up visit attendance |
|
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.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| One or more unintended pregnancies in lifetime | Count of Participants | Participants |
|
| 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. |
|
|
|
| 0 |
| 48 |
| 1 |
| 48 |
| 26 |
| 48 |
| EG001 | 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. | 0 | 48 | 3 | 48 | 42 | 48 |
| EG002 | 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. | 0 | 42 | 1 | 42 | 36 | 42 |
| Infection secondary to surgical incision | Surgical and medical procedures | Systematic Assessment |
|
| Opioid overdose | Psychiatric disorders | Systematic Assessment |
|
| Bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Cardiac arrest secondary to probable bupropion overdose | Psychiatric disorders | Systematic Assessment |
|
| Hospitalization for depression/suicidality | Psychiatric disorders | Systematic Assessment |
|
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| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |