CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 119 enrolled
Drug / intervention
SHINE intervention groupbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02794597
NCT02794597N/ACompleted

Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)

Denver Health and Hospital Authority·interventional·Posted Jun 9, 2016·Updated Nov 16, 2020

In Brief

A clinical study evaluating SHINE intervention group for Contraception. Completed, enrolled 119 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 9, 2016
Enrollment StartAug 1, 2016
Primary CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 10.1 years ago

Interventions

SHINE intervention groupbehavioral

Includes all substance treatment services as well as the brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing: Sexual Health Initiative for Navigation and Empowerment (SHINE).