N/A
N=119
Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT02794597 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition. — 2; 7; 2; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SHINE intervention group (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Denver Health and Hospital Authority
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition. |
2; 7; 2; 7; 8; 17 | — |
| SECONDARY Sexual Health Knowledge at Baseline by Intervention Condition. |
78.4; 76.2 | — |
| SECONDARY Sexual Health Knowledge at 3 Month Follow-up by Intervention Condition. |
81.6; 81.9 | — |
| SECONDARY Sexual Health Knowledge at 6 Month Follow-up by Intervention Condition. |
81.8; 83.5 | — |
| SECONDARY Health Belief Model Constructs (Perceived Threat of Pregnancy) at Baseline by Intervention Condition. |
59; 52 | — |
| SECONDARY Health Belief Model Constructs (Perceived Threat of Pregnancy) at 3 Month Follow-up by Intervention Condition. |
42; 34 | — |
| SECONDARY Health Belief Model Constructs (Perceived Threat of Pregnancy) at 6 Month Follow-up by Intervention Condition. |
44; 37 | — |
| SECONDARY Health Belief Model Constructs (Contraceptive Cost-benefit) at Baseline by Intervention Condition. |
37.6; 35.6 | — |
| SECONDARY Health Belief Model Constructs (Contraceptive Cost-benefit) at 3 Month Follow-up by Intervention Condition. |
37.9; 40.1 | — |
| SECONDARY Health Belief Model Constructs (Contraceptive Cost-benefit) at 6 Month Follow-up by Intervention Condition. |
38.7; 41.5 | — |
Summary
Recent research suggests that women with substance use disorders may be at a higher risk of unintended pregnancy. There is a paucity of interventions specifically focused on this population. Through using mixed methods, this study proposes to develop a brief peer-led intervention (based on the Health Belief Model) to prevent unintended pregnancies among women entering opioid medication-assisted treatment; to assess acceptability, feasibility and the initial efficacy of the behavioral intervention; and to conduct exploratory analyses to identify the Health Belief Model constructs that are most influential on use of long-acting reversible contraception methods. Future research would include testing the intervention in a larger scale trial and with other populations.
Eligibility Criteria
Inclusion Criteria
- Biologically female
- 18-44 years of age
- receiving medications for opioid use disorder at one of two clinic sites
- not currently pregnant or trying to become pregnant and having no known medical reason that could prevent pregnancy
- having sex or intending to have sex with a biological male
- not currently using a LARC method.
Exclusion Criteria
- Being too intoxicated at the time of the interview or impaired mentally due to physical or psychological problems to the point that they cannot voluntarily consent to participate in the study and/or respond to the interview
- Have a known reason why they will not be available for the intervention or the follow-up interview.
Data sourced from ClinicalTrials.gov (NCT02794597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.