Family Planning ServicesNCT04162184
Increasing Linkage to Family Planning Care for Individuals With Substance Use Disorder
A study testing Sexual Health Initiative for Navigation and Education (SHINE) Health Educator Intervention in people with Family Planning Services and Substance-Related Disorders, run by Denver Health and Hospital Authority at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Family Planning Services, Substance-Related Disorders, Opiate Substitution Treatment
- What is being tested?
- Sexual Health Initiative for Navigation and Education (SHINE) Health Educator Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2019to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Denver Health & Hospital Authority
Denver, Colorado, 80204
About this study
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.
Read the 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.
- Conditions
- Family Planning Services, Substance-Related Disorders, Opiate Substitution Treatment, Sexual Health
- Being tested
- Sexual Health Initiative for Navigation and Education (SHINE) Health Educator Intervention
- Keywords
- family planning, opioid use disorder, patient navigation, reproductive health, sexual health, substance use disorder, health education
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual Health Initiative for Navigation and Education (SHINE) Health Educator InterventionBehavioural
Also called SHINE Intervention
a brief health educator-led behavioral intervention focused on educating, identifying reproductive health needs, and linking to services if desired
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sexual Health Initiative for Navigation and Education (SHINE) Health Educator Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention sessions completed.
Intervention acceptability will be measured by the number of sessions completed by the health educator among participants enrolled in the study.
Measured: 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).
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start16 Dec 2019
- Primary completion30 Jan 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Planning ServicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Deborah Rinehart, Denver Health and Hospital Authority
- Investigators
- Deborah Rinehart, PhD, MA, Principal investigator, Denver Health & Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162184
- Sponsor's protocol ID
- 19-2621
- Other IDs
- 1 FPRPA006064-01-00
- Status last verified
- Aug 2024
- First submitted
- 11 Nov 2019
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Linkage to Family Planning Care for Individuals With Substance Use Disorder
- ClinicalTrials.gov ID
- NCT04162184
- Acronym / sponsor ID
- 19-2621
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Educator Intervention | Other | Behavioral: Sexual Health Initiative for Navigation and Education (SHINE) Health Educator InterventionAs 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- currently pregnant; intoxicated or mentally impaired to the point that one is unable to voluntarily consent to participate and/or respond to the surveys.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexual Health Initiative for Navigation and Education (SHINE) Health Educator InterventionAlso: SHINE Interventiona brief health educator-led behavioral intervention focused on educating, identifying reproductive health needs, and linking to services if desired | Behavioural | Health Educator Intervention |
Primary outcome
Intervention sessions completed.
Time frame: up to 3 months
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.
Time frame: up to 3 months
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Rinehart, PhD, MA principal investigator
Denver Health & Hospital Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual Health Initiative for Navigation and Education (SHINE) Health Educator Intervention in people with Family Planning Services and Substance-Related Disorders, run by Denver Health and Hospital Authority at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention sessions completed. (time frame: up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.