Increasing Linkage to Family Planning Care for Individuals With Substance Use Disorder

Not Applicable

Completed

• Conditions: Opiate Substitution Treatment; Family Planning Services; Sexual Health; Substance-Related Disorders

• Registration Number: NCT04162184
• Lead Sponsor: Denver Health and Hospital Authority

Brief Summary

This study will utilize mixed methods to develop and assess the feasibility and acceptability of a health educator intervention designed to connect patients in recovery from substance use disorder to reproductive health education and services.

Detailed Description

Developing effective reproductive health interventions for individuals in treatment for substance use disorder is an important public health priority. In the US nearly half (45%) of all pregnancies are unplanned and studies have consistently found this rate to be much higher among individuals in substance treatment, almost 90%. There is a paucity of research on interventions to support the family planning care of this population. The primary goal of this project is to identify an innovative delivery model to address the family planning needs of individuals of reproductive age in treatment for substance use disorder at an urban integrated safety-net health system. Through the use of mixed methods this study will address the following objectives: 1) To describe the family planning experiences and needs of individuals in treatment for substance use disorders (SUD) in a representative sample of patients and 2) To assess the feasibility and acceptability of the intervention among study participants. If found to be acceptable, efficacy should be assessed in a randomized controlled trial. A navigator model such as this is generalizable and could be easily integrated into a variety of settings.

Study Timeline

• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-14
• Study Start: 2019-12-16
• Primary Completion: 2023-01-30
• Study Completion: 2023-09-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

• In treatment for substance use disorder at one of the participating clinics; 18-44 years of age; English-speaking; not currently pregnant; able to become pregnant (e.g., no history of hysterectomy, tubal ligation, hysterectomy, menopause); not planning to leave the Denver area in the next 3 months.

Exclusion Criteria

• currently pregnant; intoxicated or mentally impaired to the point that one is unable to voluntarily consent to participate and/or respond to the surveys.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Intervention sessions completed.	up to 3 months	Intervention acceptability will be measured by the number of sessions completed by the health educator among participants enrolled in the study.
Self-reported satisfaction with intervention.	up to 3 months	Intervention acceptability will be assessed by participant self-reported satisfaction with the intervention (via surveys) among those who complete the intervention sessions. Satisfaction will be assessed with 8 items on a 4-point scale describing how strongly participants agree with each statement. The response scale is coded so that a higher score reflects higher satisfaction and therefore a better outcome. Reported as mean overall score (range 1-32).

Trial Locations

Locations (1)

Denver Health & Hospital Authority; 🇺🇸 Denver, Colorado, United States