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

Denver Health and Hospital Authority

Status: Completed

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

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04162184

19-2621

1 FPRPA006064-01-00 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 199 patients

Sex: All

Ages: 18 to 44 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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199 participants in 1 patient group

Health Educator Intervention

Other group

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.

Treatment:

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