SexHealth Mobile: Integrating a Mobile Clinic and a Point-of-care Contraception Counseling and Access
NCT ID: NCT04227145
Last Updated: 2023-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
98 participants
INTERVENTIONAL
2020-03-02
2022-01-30
Brief Summary
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Detailed Description
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"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
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Usual Care
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.
No interventions assigned to this group
SexHealth Mobile
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.
SexHealth Mobile
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.
Interventions
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SexHealth Mobile
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* have previously enrolled in the study
* are unable to provide informed consent
* are pregnant at index (recruitment) visit
18 Years
40 Years
FEMALE
No
Sponsors
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Swope Health Services
OTHER
University of Kansas Medical Center
OTHER
Children's Mercy Hospital Kansas City
OTHER
Responsible Party
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Principal Investigators
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Melissa Miller, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Mercy Emergency Department
Emily Hurley, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Mercy Health Services and Outcomes Research
Locations
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Swope Health Services
Kansas City, Missouri, United States
Amethyst Place: Swope Health Services Partner
Kansas City, Missouri, United States
ReDiscover: Swope Health Services Partner
Kansas City, Missouri, United States
Healing House Inc.: Swope Health Services Partner
Kansas City, Missouri, United States
Countries
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY00001099
Identifier Type: -
Identifier Source: org_study_id
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