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

NCT04162184 | Completed

• 2 other identifiers: 19-26211 FPRPA006064-01-00
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

family planning; opioid use disorder; patient navigation; reproductive health; sexual health; substance use disorder; health education

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Health Educator Intervention

OTHER

As the population of focus in this study is diverse, including men and women regardless of pregnancy desire, the primary focus for the intervention for this study will be education, particularly for men. All participants that enroll in the study will be offered the intervention. The study health educator will use the PATH (Parenthood/Pregnancy Attitude, Timing, and How) framework questions to initially guide the conversation. Depending on the participant's desires, the educator will provide education on other topics such as sexually transmitted infections (STIs) and we will also navigate to clinical services as needed. The health educator will use a study manual to guide all intervention activities including engagement. Additionally, the health educator will collect data on intervention outreach, engagement, topics discussed, participant needs and outcomes.

Behavioral: Sexual Health Initiative for Navigation and Education (SHINE) Health Educator Intervention

Interventions

Sexual Health Initiative for Navigation and Education (SHINE) Health Educator Intervention BEHAVIORAL

a brief health educator-led behavioral intervention focused on educating, identifying reproductive health needs, and linking to services if desired

Also known as: SHINE Intervention

Health Educator Intervention

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Denver Health & Hospital Authority

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders; Health Education

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Deborah Rinehart, PhD, MA

  Denver Health & Hospital Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: December 16, 2019
• Primary Completion: January 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

US (1)