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

Primary Purpose

Family Planning Services, Substance-Related Disorders, Opiate Substitution Treatment

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sexual Health Initiative for Navigation and Education (SHINE) Health Educator Intervention
Sponsored by
Denver Health and Hospital Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Family Planning Services focused on measuring family planning, opioid use disorder, patient navigation, reproductive health, sexual health, substance use disorder, health education

Eligibility Criteria

18 Years - 44 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Denver Health & Hospital Authority

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Health Educator Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Intervention sessions completed.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
November 11, 2019
Last Updated
November 29, 2022
Sponsor
Denver Health and Hospital Authority
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT04162184
Brief Title
Increasing Linkage to Family Planning Care for Individuals With Substance Use Disorder
Official Title
Increasing Linkage to Family Planning Care for Individuals With Substance Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Denver Health and Hospital Authority
Collaborators
Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Educator Intervention
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sexual Health Initiative for Navigation and Education (SHINE) Health Educator Intervention
Other Intervention Name(s)
SHINE Intervention
Intervention Description
a brief health educator-led behavioral intervention focused on educating, identifying reproductive health needs, and linking to services if desired
Primary Outcome Measure Information:
Title
Intervention sessions completed.
Description
Intervention acceptability will be measured by the number of sessions completed by the health educator among participants enrolled in the study.
Time Frame
up to 3 months
Title
Self-reported satisfaction with intervention.
Description
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).
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Rinehart, PhD, MA
Organizational Affiliation
Denver Health & Hospital Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health & Hospital Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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