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

Substance-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04162184
• Other study ID #: 19-2621
• Secondary ID: 1 FPRPA006064-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 199
• Est. completion date: June 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Sexual Health Initiative for Navigation and Education (SHINE) Health Educator Intervention
a brief health educator-led behavioral intervention focused on educating, identifying reproductive health needs, and linking to services if desired

Locations

Country	Name	City	State
United States	Denver Health & Hospital Authority	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention sessions completed.	Intervention acceptability will be measured by the number of sessions completed by the health educator among participants enrolled in the study.	up to 3 months
Primary	Self-reported satisfaction with intervention.	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).	up to 3 months