ContraceptionNCT02794597
Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)
A study testing SHINE intervention group in people with Contraception, run by Denver Health and Hospital Authority at 1 site in United States.
Trial summary
Recent research suggests that women with substance use disorders may be at a higher risk of unintended pregnancy. There is a paucity of interventions specifically focused on this population. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- SHINE intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Biologically female
- 18-44 years of age
- receiving medications for opioid use disorder at one of two clinic sites
- not currently pregnant or trying to become pregnant and having no known medical reason that could prevent pregnancy
- having sex or intending to have sex with a biological male
- not currently using a LARC method.
Who cannot join
- Being too intoxicated at the time of the interview or impaired mentally due to physical or psychological problems to the point that they cannot voluntarily consent to participate in the study and/or respond to the interview
- Have a known reason why they will not be available for the intervention or the follow-up interview.
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health and Hospital Authority
Denver, Colorado, 80204
About this study
Recent research suggests that women with substance use disorders may be at a higher risk of unintended pregnancy. There is a paucity of interventions specifically focused on this population. Through using mixed methods, this study proposes to develop a brief peer-led intervention (based on the Health Belief Model) to prevent unintended pregnancies among women entering opioid medication-assisted treatment; to assess acceptability, feasibility and the initial efficacy of the behavioral intervention; and to conduct exploratory analyses to identify the Health Belief Model constructs that are most influential on use of long-acting reversible contraception methods. Future research would include testing the intervention in a larger scale trial and with other populations.
Read the detailed description
This study aims to develop a reproductive health intervention to prevent unintended pregnancy for women of child-bearing age in opioid medication-assisted treatment (OMAT). It will be conducted in two phases. The first formative phase will employ individual interviews and focus groups with women between the ages of 18 and 44 and in opioid medication-assisted treatment to better understand: pregnancy desires/motivation and perceived susceptibility and severity, contraceptive knowledge, perceived benefits/barriers, self-efficacy, social norms, behaviors, and access to contraception and family planning services, especially related to long-acting reversible contraception. This information, coupled with prior evidence and theory, will be used to develop a brief peer-led behavioral intervention.
In the second phase, we will conduct a randomized controlled trial to assess the acceptability, feasibility and the initial efficacy of the developed intervention. Women will be recruited from two opioid medication-assisted treatment facilities and once they have consented and the baseline survey is completed they will be randomized to either the behavioral intervention or usual care. Participants will complete a baseline, three and six-month post-baseline follow up survey.
For those randomized to the intervention arm, the first session will occur immediately post-consent and baseline, and the second will occur 2-4 weeks post-baseline. A trained peer-educator will deliver the behavioral intervention that will provide accurate, unbiased information about Long Acting Reversible Contraception (intrauterine devices and subdermal implants) and all other contraceptive methods (including effectiveness, advantages, and disadvantages), help women assess their needs (pregnancy desires compared to behavior), and utilize motivational interviewing to empower them to make an informed decision regarding their sexual health. For those that are interested, the peer-educator will connect women to a Denver Health Community Health Clinic or a clinic of their choosing to further explore appropriate birth control methods. The medical clinic will assess the woman and determine and dispense the most appropriate method.
- Conditions
- Contraception
- Being tested
- SHINE intervention group
- Keywords
- Unplanned Pregnancy, long-acting reversible contraception (LARC), medications for opioid use disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHINE intervention groupBehavioural
Includes all substance treatment services as well as the brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing: Sexual Health Initiative for Navigation and Empowerment (SHINE).
| Study group | Role | What they receive |
|---|---|---|
| Opioid Medication-Assisted Treatment only | No intervention | Usual care - Opioid Medication Assisted Treatment |
| Intervention | Experimental | Peer led, behavioral sexual health intervention: Sexual Health Initiative for Navigation and Empowerment (SHINE). Receives: Behavioral: SHINE intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition.
Assess initial efficacy (family planning/clinical visits and uptake of birth control, specifically long-acting reversible contraceptives (LARCs) of the SHINE intervention, using baseline/follow up surveys and review of medical records at three and six months. Specifically, the number of participants that were using LARCs and the number of participants who had attended family visits at each time point.
Measured: 3 and 6 months
Secondary outcomes (9)
Sexual Health Knowledge at Baseline by Intervention Condition.
Assess the impact of the SHINE intervention on overall sexual and reproductive health knowledge at baseline (based on participants who completed the baseline survey). Reported as percentage of questions answered correctly by participants.
Measured: Baseline
Sexual Health Knowledge at 3 Month Follow-up by Intervention Condition.
Assess the impact of the SHINE intervention on overall sexual and reproductive health knowledge at 3 month follow-up (based on participants who completed the 3 month follow-up survey). Reported as percentage of questions answered correctly by participants.
Measured: 3 months
Sexual Health Knowledge at 6 Month Follow-up by Intervention Condition.
Assess the impact of the SHINE intervention on overall sexual and reproductive health knowledge at 6 month follow-up (based on participants who completed the 6 month follow-up survey). Reported as percentage of questions answered correctly by participants.
Measured: 6 months
Health Belief Model Constructs (Perceived Threat of Pregnancy) at Baseline by Intervention Condition.
Assess the impact of the SHINE intervention on perceived threat of pregnancy at baseline (based on participants who completed the baseline survey). Reported as number of participants who indicated agreement with the statement, "If I do not use birth control and have unprotected sex, I could get pregnant."
Measured: Baseline
Health Belief Model Constructs (Perceived Threat of Pregnancy) at 3 Month Follow-up by Intervention Condition.
Assess the impact of the SHINE intervention on perceived threat of pregnancy at 3 month follow-up (based on participants who completed the 3 month follow-up survey). Reported as number of participants who indicated agreement with the statement, "If I do not use birth control and have unprotected sex, I could get pregnant."
Measured: 3 months
Health Belief Model Constructs (Perceived Threat of Pregnancy) at 6 Month Follow-up by Intervention Condition.
Assess the impact of the SHINE intervention on perceived threat of pregnancy at 6 month follow-up (based on participants who completed the 6 month follow-up survey). Reported as the number of participants who indicated agreement with the statement, "If I do not use birth control and have unprotected sex, I could get pregnant."
Measured: 6 months
Health Belief Model Constructs (Contraceptive Cost-benefit) at Baseline by Intervention Condition.
Assess the impact of the SHINE intervention on contraceptive cost-benefit at baseline (based on participants who completed the baseline survey). Perceived contraceptive costs and benefits were assessed with 14 items on a five-point scale describing how strongly participants agreed to each statement. The response scale was coded so that a higher score reflected higher benefits and lower costs and was the desired direction over time. Reported as mean overall score (range 0-56).
Measured: baseline
Health Belief Model Constructs (Contraceptive Cost-benefit) at 3 Month Follow-up by Intervention Condition.
Assess the impact of the SHINE intervention on contraceptive cost-benefit at 3 month follow-up (based on participants who completed the 3 month follow-up survey). Perceived contraceptive costs and benefits were assessed with 14 items on a five-point scale describing how strongly participants agreed to each statement. The response scale was coded so that a higher score reflected higher benefits and lower costs and was the desired direction over time. Reported as mean overall score (range 0-56).
Measured: 3 months
Health Belief Model Constructs (Contraceptive Cost-benefit) at 6 Month Follow-up by Intervention Condition.
Assess the impact of the SHINE intervention on contraceptive cost-benefit at 6 month follow-up (based on participants who completed the 6 month follow-up survey). Perceived contraceptive costs and benefits were assessed with 14 items on a five-point scale describing how strongly participants agreed to each statement. The response scale was coded so that a higher score reflected higher benefits and lower costs and was the desired direction over time. Reported as mean overall score (range 0-56).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Deborah Rinehart, PhD, Principal investigator, Denver Health and Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794597
- Sponsor's protocol ID
- 15-1236
- Other IDs
- 1R34DA039381-01A1
- Status last verified
- Oct 2020
- First submitted
- 31 May 2016
- Last updated
- 16 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Stowell MA, Thomas-Gale T, Jones HE, Binswanger I, Rinehart DJ. Perspectives among women receiving medications for opioid use disorder: Implications for development of a peer navigation intervention to improve access to family planning services. Subst Abus. 2022;43(1):722-732. doi: 10.1080/08897077.2021.2007514.
PubMed 35100081Rinehart DJ, Stowell M, Collings A, Durfee MJ, Thomas-Gale T, Jones HE, Binswanger I. Increasing access to family planning services among women receiving medications for opioid use disorder: A pilot randomized trial examining a peer-led navigation intervention. J Subst Abuse Treat. 2021 Jul;126:108318. doi: 10.1016/j.jsat.2021.108318. Epub 2021 Feb 4.
PubMed 34116817
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)
- ClinicalTrials.gov ID
- NCT02794597
- Acronym / sponsor ID
- 15-1236
- Conditions
- Contraception
- Keywords
- Unplanned Pregnancy, long-acting reversible contraception (LARC), medications for opioid use disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2016
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Posted 16 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent research suggests that women with substance use disorders may be at a higher risk of unintended pregnancy. There is a paucity of interventions specifically focused on this population. Through using mixed methods, this study proposes to develop a brief peer-led intervention (based on the Health Belief Model) to prevent unintended pregnancies among women entering opioid medication-assisted treatment; to assess acceptability, feasibility and the initial efficacy of the behavioral intervention; and to conduct exploratory analyses to identify the Health Belief Model constructs that are most influential on use of long-acting reversible contraception methods. Future research would include testing the intervention in a larger scale trial and with other populations.
Detailed description
This study aims to develop a reproductive health intervention to prevent unintended pregnancy for women of child-bearing age in opioid medication-assisted treatment (OMAT). It will be conducted in two phases. The first formative phase will employ individual interviews and focus groups with women between the ages of 18 and 44 and in opioid medication-assisted treatment to better understand: pregnancy desires/motivation and perceived susceptibility and severity, contraceptive knowledge, perceived benefits/barriers, self-efficacy, social norms, behaviors, and access to contraception and family planning services, especially related to long-acting reversible contraception. This information, coupled with prior evidence and theory, will be used to develop a brief peer-led behavioral intervention.
In the second phase, we will conduct a randomized controlled trial to assess the acceptability, feasibility and the initial efficacy of the developed intervention. Women will be recruited from two opioid medication-assisted treatment facilities and once they have consented and the baseline survey is completed they will be randomized to either the behavioral intervention or usual care. Participants will complete a baseline, three and six-month post-baseline follow up survey.
For those randomized to the intervention arm, the first session will occur immediately post-consent and baseline, and the second will occur 2-4 weeks post-baseline. A trained peer-educator will deliver the behavioral intervention that will provide accurate, unbiased information about Long Acting Reversible Contraception (intrauterine devices and subdermal implants) and all other contraceptive methods (including effectiveness, advantages, and disadvantages), help women assess their needs (pregnancy desires compared to behavior), and utilize motivational interviewing to empower them to make an informed decision regarding their sexual health. For those that are interested, the peer-educator will connect women to a Denver Health Community Health Clinic or a clinic of their choosing to further explore appropriate birth control methods. The medical clinic will assess the woman and determine and dispense the most appropriate method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid Medication-Assisted Treatment only | No intervention | –Usual care - Opioid Medication Assisted Treatment |
| Intervention | Experimental | Behavioral: SHINE intervention groupPeer led, behavioral sexual health intervention: Sexual Health Initiative for Navigation and Empowerment (SHINE). |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Biologically female
- 18-44 years of age
- receiving medications for opioid use disorder at one of two clinic sites
- not currently pregnant or trying to become pregnant and having no known medical reason that could prevent pregnancy
- having sex or intending to have sex with a biological male
Key exclusion criteria (2 listed)
- Being too intoxicated at the time of the interview or impaired mentally due to physical or psychological problems to the point that they cannot voluntarily consent to participate in the study and/or respond to the interview
- Have a known reason why they will not be available for the intervention or the follow-up interview.
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 |
|---|---|---|
| SHINE intervention groupIncludes all substance treatment services as well as the brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing: Sexual Health Initiative for Navigation and Empowerment (SHINE). | Behavioural | Intervention |
Primary outcome
Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition.
Time frame: 3 and 6 months
Assess initial efficacy (family planning/clinical visits and uptake of birth control, specifically long-acting reversible contraceptives (LARCs) of the SHINE intervention, using baseline/follow up surveys and review of medical records at three and six months. Specifically, the number of participants that were using LARCs and the number of participants who had attended family visits at each time point.
9 secondary outcomes
Sexual Health Knowledge at Baseline by Intervention Condition.
Time frame: Baseline
Sexual Health Knowledge at 3 Month Follow-up by Intervention Condition.
Time frame: 3 months
Sexual Health Knowledge at 6 Month Follow-up by Intervention Condition.
Time frame: 6 months
Health Belief Model Constructs (Perceived Threat of Pregnancy) at Baseline by Intervention Condition.
Time frame: Baseline
Health Belief Model Constructs (Perceived Threat of Pregnancy) at 3 Month Follow-up by Intervention Condition.
Time frame: 3 months
Health Belief Model Constructs (Perceived Threat of Pregnancy) at 6 Month Follow-up by Intervention Condition.
Time frame: 6 months
Health Belief Model Constructs (Contraceptive Cost-benefit) at Baseline by Intervention Condition.
Time frame: baseline
Health Belief Model Constructs (Contraceptive Cost-benefit) at 3 Month Follow-up by Intervention Condition.
Time frame: 3 months
Health Belief Model Constructs (Contraceptive Cost-benefit) at 6 Month Follow-up by Intervention Condition.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35100081Stowell MA, Thomas-Gale T, Jones HE, Binswanger I, Rinehart DJ. Perspectives among women receiving medications for opioid use disorder: Implications for development of a peer navigation intervention to improve access to family planning services. Subst Abus. 2022;43(1):722-732. doi: 10.1080/08897077.2021.2007514.
- Derived from this study: PubMed 34116817Rinehart DJ, Stowell M, Collings A, Durfee MJ, Thomas-Gale T, Jones HE, Binswanger I. Increasing access to family planning services among women receiving medications for opioid use disorder: A pilot randomized trial examining a peer-led navigation intervention. J Subst Abuse Treat. 2021 Jul;126:108318. doi: 10.1016/j.jsat.2021.108318. Epub 2021 Feb 4.
- Individual participant dataSharing planned: No
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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 principal investigator
Denver Health and 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 SHINE intervention group in people with Contraception, 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 6 inclusion and 2 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 16 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 16 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition. (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794597, which also lists 2 linked publications.
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 16 Nov 2020.