Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

family planningopioid use disorderpatient navigationreproductive healthsexual healthsubstance use disorderhealth 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 InterventionBehavioral

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 44 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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:

Sponsors & Collaborators

Denver Health and Hospital Authority
Otherlead
Department of Health and Human Services
US federal agencycollaborator

Study Sites (1)

Denver Health & Hospital Authority

Denver, Colorado, 80204, United States

MeSH Terms

Conditions

Substance-Related DisordersOpioid-Related DisordersHealth Education

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNarcotic-Related DisordersAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

Deborah Rinehart, PhD, MA
Denver Health & Hospital Authority
PRINCIPAL INVESTIGATOR

Enrollment

199 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Health Educator Intervention

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Health Educator Intervention

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations