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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04162184
Enrollment
199
Registered
2019-11-14
Start date
2019-12-16
Completion date
2023-09-30
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

BEHAVIORALSexual 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

Sponsors

Department of Health and Human Services
CollaboratorFED
Denver Health and Hospital Authority
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Intervention sessions completed.up to 3 monthsIntervention 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 monthsIntervention 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026