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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04227145
• Other study ID #: STUDY00001099
• Status: Completed
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: August 2022
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 30, 2022
• Est. primary completion date: September 13, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Contraceptive Usage

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Amethyst Place: Swope Health Services Partner	Kansas City	Missouri
United States	Healing House Inc.: Swope Health Services Partner	Kansas City	Missouri
United States	ReDiscover: Swope Health Services Partner	Kansas City	Missouri
United States	Swope Health Services	Kansas City	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	Swope Health Services, Kansas City Missouri, University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 month
Secondary	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	3 months