Clinical trial NCT04227145: SexHealth Mobile: Integrating a Mobile Clinic and a Point-of-care Contraception Counseling and Access
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraceptive Usage
Contraception
Keywords: contraception
sexhealth mobile
substance abuse
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: Swope Health Services
name: University of Kansas Medical Center
First posted: 2020-01-13
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Participants will be ineligible if they:

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

Primary outcomes:
measure: Current Use of Highly Effective Contraception
timeFrame: 1 month
Secondary outcomes:
measure: Current Use of Highly Effective Contraception
timeFrame: 3 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Swope Health Services
state: Missouri
city: Kansas City
country: United States
facility: Amethyst Place: Swope Health Services Partner
state: Missouri
city: Kansas City
country: United States
facility: ReDiscover: Swope Health Services Partner
state: Missouri
city: Kansas City
country: United States
facility: Healing House Inc.: Swope Health Services Partner
state: Missouri
Study officials:
affiliation: Children's Mercy Emergency Department
name: Melissa Miller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Mercy Health Services and Outcomes Research
name: Emily Hurley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.