Contraceptive UsageNCT04227145

SexHealth Mobile: Integrating a Mobile Clinic and a Point-of-care Contraception Counseling and Access

A study testing SexHealth Mobile in people with Contraceptive Usage and Contraception, run by Children's Mercy Hospital Kansas City at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 years, women only
Conditions the study is for: Contraceptive Usage, Contraception
What is being tested?: SexHealth Mobile
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 98 participants
Where: 4 sitesUnited States
Study dates: 2 Mar 2020to 30 Jan 2022
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 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

Participants will be eligible if they:
are between the ages of 18-40 years
are biological females
have an unmet need for contraception (sexually active, able to become pregnant, not consistently/currently using these contraception methods [sterilization, subdermal implant, intrauterine device, injectable, pill, patch, or ring]
have current or recent (within the past year) problematic patterns of substance use (according to the CAGE-AID self-assessment

Who cannot join

Participants will be ineligible if they:
have previously enrolled in the study
are unable to provide informed consent
are pregnant at index (recruitment) visit

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Swope Health Services
Kansas City, Missouri, 64108
Amethyst Place: Swope Health Services Partner
Kansas City, Missouri, 64109
ReDiscover: Swope Health Services Partner
Kansas City, Missouri, 64109
Healing House Inc.: Swope Health Services Partner
Kansas City, Missouri, 64123

Other trials in United States

About this study

Official title: A Quasi-experimental, Interrupted Time Series Study to Evaluate the Effectiveness of "SexHealth Mobile" on Uptake of Contraception in Women With Substance Use Disorder

Pilot study aims to evaluate the effectiveness of "SexHealth Mobile" and improve access to highly effective contraception among women with substance use disorder (SUD) with "SexHealth Mobile" intervention. This intervention will consist of two existing services that will help reach women with or recovering from SUD and provide access to contraception, as well as counseling.

Read the detailed description

Pilot study aims to evaluate the effectiveness of "SexHealth Mobile" and improve access to highly effective contraception among women with substance use disorder (SUD) with "SexHealth Mobile." Our study will follow a quasi-experimental design that uses an interrupted time series (i.e., usual care [control] then intervention care) to compare the uptake of contraception before and after implementing the "SexHealth Mobile" intervention.

"SexHealth Mobile" integrates two existing services in our community: a mobile medical unit (MMU) operated by Swope Health Services and "SexHealth" a point-of-care contraception counseling service that our research team developed for Children's Mercy Hospital's emergency department (ED) for adolescents. Using a menu of adaptive services, "SexHealth Mobile" will bring contraceptive care to women with SUD (including the subset with opioid use disorder [OUD]) at recovery centers in the Kansas City community.

Our primary hypothesis is that the current use of highly effective contraception will be greater at 1-month post-enrollment among women recruited during the intervention period (i.e., "SexHealth Mobile") compared to those recruited during the usual care period. The current use and discontinuation of contraception will also be compared at 2-weeks and 3-months.

Our approach consists of enrolling (n=170) eligible women are accessing health, recovery, or community services at a site we identified in our formative research work. We will aim to recruit up to 85 women during the usual care period and 85 during the intervention period. We will follow-up with participants at 2-weeks, 1-month, and 3-months after the enrollment date.

Conditions: Contraceptive Usage, Contraception
Being tested: SexHealth Mobile
Keywords: contraception, sexhealth mobile, substance abuse
Medical subject headings: Contraception Behavior, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SexHealth MobileBehavioural
It will integrate two existing services in our community: a mobile medical unit (MMU) operated by Swope Health Services, and "SexHealth" a point-of-care contraception counseling service that our research team developed for Children's Mercy Hospital's emergency department (ED). Using a menu of adaptive services, "SexHealth Mobile" will bring contraceptive care to women with SUD (including a subset of women with OUD), if they wish to receive it, at targeted recovery sites Swope currently partners with.

Study groups in NCT04227145
Study group	Role	What they receive
Usual Care	No intervention	We will recruit up to 85 women with substance abuse disorder (or opioid abuse disorder) from recovery centers. Eligible women will complete a baseline survey and study staff will provide a referral for participants to seek more information on contraception and services. Study staff will record whether the participant accepted the referral. Follow-up will occur via phone call at 2-weeks, 1-month and 3-months post-enrollment to determine if they accessed contraceptive referral services if they initiated any contraceptive method, and if so: if they continued, changed, or discontinued this contraception method. We will recruit, complete baseline and usual care referral at recovery sites on a timely rotation that mirrors the intervention period (e.g., every fourth Friday morning at Site 1), in order to increase the chance of recruiting a comparable population.
SexHealth Mobile	Experimental	We will train Swope providers in contraceptive counseling before intervention. We will recruit up to 85 women with substance abuse disorder (or opioid abuse disorder) from recovery centers. Eligible women will complete a baseline survey. Study staff will provide a referral for participants to seek more information on contraception and services. Women will have direct access to contraceptive counseling and services on-site via the mobile medical unit if they choose to use it. Counseling will focus on presenting the most effective contraceptive methods first (i.e., LARC). If women participate in contraceptive counseling, study staff will record the uptake of contraceptive medication and clinic referral at the time of enrollment and conduct follow-up surveys at 2-weeks, 1-month, and 3-months post-enrollment. If the participant refuses contraceptive counseling on MMU, a referral will be given. Receives: Behavioral: SexHealth Mobile

What is being measured

The primary outcome is the main question the study is designed to answer.

Current Use of Highly Effective Contraception
Participants will be asked if they acquired birth control and their current use of it at 1-month period following the recruitment visit.
Did participant initiate hormonal contraception or contraceptive device at initial visit or referral? Yes/No
If yes, which contraception or contraceptive device was initiated? Implant/Depo-Provera/Birth control patch/Birth control pills/Birth control ring/Emergency contraception/ Intrauterine device
If participant started using hormonal contraception or contraceptive device at 2-week follow-up time, are they still using hormonal contraception or contraceptive device at 1-month? Yes/No
Measured: 1 month

Secondary outcomes (1)

Current Use of Highly Effective Contraception
Participants will be asked if they acquired birth control and their current use of it at 2-weeks and 3-months after recruitment visit
Did participant initiate hormonal contraception or contraceptive device at initial visit or referral? Yes/No
If yes, which contraception or contraceptive device was initiated? Implant/Depo-Provera/Birth control patch/Birth control pills/Birth control ring/Emergency contraception/ Intrauterine device
If participant started using hormonal contraception or contraceptive device at 2-week follow-up time, are they still using hormonal contraception or contraceptive device at 3-month? Yes/No
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 202030 Jan 2022

First posted13 Jan 2020
Study start2 Mar 2020
Primary completion13 Sep 2021
Study completion30 Jan 2022

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 (5)Papers the sponsor has linked to this study.
Other trials for Contraceptive UsageStudies 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: Non-randomised
Intervention model: Sequential
Masking: Single blind
Who is masked: Participant
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04227145
Sponsor's protocol ID: STUDY00001099
Status last verified: Aug 2022
First submitted: 10 Jan 2020
Last updated: 21 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After analysis, we will draft a de-identified results summary to be given to all partnering sites to share with their staff and clients.

Publications

Miller MK, Champassak S, Goggin K, Kelly P, Dowd MD, Mollen CJ, Humiston SG, Linebarger J, Apodaca T. Brief Behavioral Intervention to Improve Adolescent Sexual Health: A Feasibility Study in the Emergency Department. Pediatr Emerg Care. 2016 Jan;32(1):17-9. doi: 10.1097/PEC.0000000000000285.
PubMed 26727196
Heil SH, Jones HE, Arria A, Kaltenbach K, Coyle M, Fischer G, Stine S, Selby P, Martin PR. Unintended pregnancy in opioid-abusing women. J Subst Abuse Treat. 2011 Mar;40(2):199-202. doi: 10.1016/j.jsat.2010.08.011. Epub 2010 Oct 30.
PubMed 21036512
Terplan M, Hand DJ, Hutchinson M, Salisbury-Afshar E, Heil SH. Contraceptive use and method choice among women with opioid and other substance use disorders: A systematic review. Prev Med. 2015 Nov;80:23-31. doi: 10.1016/j.ypmed.2015.04.008. Epub 2015 Apr 18.
PubMed 25900803
Haight SC, Ko JY, Tong VT, Bohm MK, Callaghan WM. Opioid Use Disorder Documented at Delivery Hospitalization - United States, 1999-2014. MMWR Morb Mortal Wkly Rep. 2018 Aug 10;67(31):845-849. doi: 10.15585/mmwr.mm6731a1.
PubMed 30091969
Hurley EA, Goggin K, Pina-Brugman K, Noel-MacDonnell JR, Allen A, Finocchario-Kessler S, Miller MK. Contraception use among individuals with substance use disorder increases tenfold with patient-centered, mobile services: a quasi-experimental study. Harm Reduct J. 2023 Mar 6;20(1):28. doi: 10.1186/s12954-023-00760-7.
PubMed 36879314

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Contraceptive Usage trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Quasi-experimental, Interrupted Time Series Study to Evaluate the Effectiveness of "SexHealth Mobile" on Uptake of Contraception in Women With Substance Use Disorder
ClinicalTrials.gov ID: NCT04227145
Acronym / sponsor ID: STUDY00001099
Conditions: Contraceptive Usage, Contraception
Keywords: contraception, sexhealth mobile, substance abuse
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: Children's Mercy Hospital Kansas CityUniversity, hospital or other
Collaborators: Swope Health Services, University of Kansas Medical Center
Study start: 2 Mar 2020 (actual)
Primary completion: 13 Sep 2021 (actual)
Study completion: 30 Jan 2022 (actual)
First posted: 13 Jan 2020 (actual)
Results: Posted 21 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Pilot study aims to evaluate the effectiveness of "SexHealth Mobile" and improve access to highly effective contraception among women with substance use disorder (SUD) with "SexHealth Mobile." Our study will follow a quasi-experimental design that uses an interrupted time series (i.e., usual care [control] then intervention care) to compare the uptake of contraception before and after implementing the "SexHealth Mobile" intervention.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Sequential
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Usual Care	No intervention	–We will recruit up to 85 women with substance abuse disorder (or opioid abuse disorder) from recovery centers. Eligible women will complete a baseline survey and study staff will provide a referral for participants to seek more information on contraception and services. Study staff will record whether the participant accepted the referral. Follow-up will occur via phone call at 2-weeks, 1-month and 3-months post-enrollment to determine if they accessed contraceptive referral services if they initiated any contraceptive method, and if so: if they continued, changed, or discontinued this contraception method. We will recruit, complete baseline and usual care referral at recovery sites on a timely rotation that mirrors the intervention period (e.g., every fourth Friday morning at Site 1), in order to increase the chance of recruiting a comparable population.
SexHealth Mobile	Experimental	Behavioral: SexHealth MobileWe will train Swope providers in contraceptive counseling before intervention. We will recruit up to 85 women with substance abuse disorder (or opioid abuse disorder) from recovery centers. Eligible women will complete a baseline survey. Study staff will provide a referral for participants to seek more information on contraception and services. Women will have direct access to contraceptive counseling and services on-site via the mobile medical unit if they choose to use it. Counseling will focus on presenting the most effective contraceptive methods first (i.e., LARC). If women participate in contraceptive counseling, study staff will record the uptake of contraceptive medication and clinic referral at the time of enrollment and conduct follow-up surveys at 2-weeks, 1-month, and 3-months post-enrollment. If the participant refuses contraceptive counseling on MMU, a referral will be given.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

are between the ages of 18-40 years
are biological females
have an unmet need for contraception (sexually active, able to become pregnant, not consistently/currently using these contraception methods [sterilization, subdermal implant, intrauterine device, injectable, pill, patch, or ring]
have current or recent (within the past year) problematic patterns of substance use (according to the CAGE-AID self-assessment

Key exclusion criteria (4 listed)

have previously enrolled in the study
are unable to provide informed consent
are pregnant at index (recruitment) visit

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
SexHealth MobileIt will integrate two existing services in our community: a mobile medical unit (MMU) operated by Swope Health Services, and "SexHealth" a point-of-care contraception counseling service that our research team developed for Children's Mercy Hospital's emergency department (ED). Using a menu of adaptive services, "SexHealth Mobile" will bring contraceptive care to women with SUD (including a subset of women with OUD), if they wish to receive it, at targeted recovery sites Swope currently partners with.	Behavioural	SexHealth Mobile

Primary outcome

Current Use of Highly Effective Contraception
Time frame: 1 month
Participants will be asked if they acquired birth control and their current use of it at 1-month period following the recruitment visit. Did participant initiate hormonal contraception or contraceptive device at initial visit or referral? Yes/No If yes, which contraception or contraceptive device was initiated? Implant/Depo-Provera/Birth control patch/Birth control pills/Birth control ring/Emergency contraception/ Intrauterine device If participant started using hormonal contraception or contraceptive device at 2-week follow-up time, are they still using hormonal contraception or contraceptive device at 1-month? Yes/No

1 secondary outcome

Current Use of Highly Effective Contraception
Time frame: 3 months

Results and safety

Results posted to the registry on 21 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	48	48
SexHealth Mobile	50	50

Primary outcome: Current Use of Highly Effective Contraception

Time frame: 1 month. Count of participants. Unit: Participants

Measure	Usual Care n = 37	SexHealth Mobile n = 33
Value	2	17

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 48 (0%)	0 of 48 (0%)	0 of 48
SexHealth Mobile	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26727196Miller MK, Champassak S, Goggin K, Kelly P, Dowd MD, Mollen CJ, Humiston SG, Linebarger J, Apodaca T. Brief Behavioral Intervention to Improve Adolescent Sexual Health: A Feasibility Study in the Emergency Department. Pediatr Emerg Care. 2016 Jan;32(1):17-9. doi: 10.1097/PEC.0000000000000285.
Results publication: PubMed 21036512Heil SH, Jones HE, Arria A, Kaltenbach K, Coyle M, Fischer G, Stine S, Selby P, Martin PR. Unintended pregnancy in opioid-abusing women. J Subst Abuse Treat. 2011 Mar;40(2):199-202. doi: 10.1016/j.jsat.2010.08.011. Epub 2010 Oct 30.
Results publication: PubMed 25900803Terplan M, Hand DJ, Hutchinson M, Salisbury-Afshar E, Heil SH. Contraceptive use and method choice among women with opioid and other substance use disorders: A systematic review. Prev Med. 2015 Nov;80:23-31. doi: 10.1016/j.ypmed.2015.04.008. Epub 2015 Apr 18.
Results publication: PubMed 30091969Haight SC, Ko JY, Tong VT, Bohm MK, Callaghan WM. Opioid Use Disorder Documented at Delivery Hospitalization - United States, 1999-2014. MMWR Morb Mortal Wkly Rep. 2018 Aug 10;67(31):845-849. doi: 10.15585/mmwr.mm6731a1.
Derived from this study: PubMed 36879314Hurley EA, Goggin K, Pina-Brugman K, Noel-MacDonnell JR, Allen A, Finocchario-Kessler S, Miller MK. Contraception use among individuals with substance use disorder increases tenfold with patient-centered, mobile services: a quasi-experimental study. Harm Reduct J. 2023 Mar 6;20(1):28. doi: 10.1186/s12954-023-00760-7.
Individual participant dataSharing planned: Yes. After analysis, we will draft a de-identified results summary to be given to all partnering sites to share with their staff and clients.

Related trials for Contraceptive Usage

Enrolling by invitation
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FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
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Not yet recruiting
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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.

Melissa Miller, MD principal investigator

Children's Mercy Emergency Department

Emily Hurley, PhD principal investigator

Children's Mercy Health Services and Outcomes Research

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SexHealth Mobile in people with Contraceptive Usage and Contraception, run by Children's Mercy Hospital Kansas City at 4 sites 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 5 inclusion and 4 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 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 21 Jul 2023). 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?

Current Use of Highly Effective Contraception (time frame: 1 month). 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 NCT04227145, which also lists 5 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 21 Jul 2023.