Clinical trial NCT04162184: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2019-11-14
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Intervention sessions completed.
timeFrame: up to 3 months
measure: Self-reported satisfaction with intervention.
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health & Hospital Authority
state: Colorado
Study officials:
affiliation: Denver Health & Hospital Authority
name: Deborah Rinehart, PhD, MA
role: PRINCIPAL_INVESTIGATOR
References: