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

Not Applicable

Completed

Conditions: Contraceptive Usage
Contraception

Registration Number: NCT04227145

Lead Sponsor: Children's Mercy Hospital Kansas City

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 98

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Current Use of Highly Effective Contraception	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

Secondary Outcome Measures

Name	Time	Method
Current Use of Highly Effective Contraception	3 months	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

Trial Locations

Locations (4): Swope Health Services
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Kansas City, Missouri, United States
Amethyst Place: Swope Health Services Partner
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Kansas City, Missouri, United States
ReDiscover: Swope Health Services Partner
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Kansas City, Missouri, United States
Healing House Inc.: Swope Health Services Partner
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Kansas City, Missouri, United States
Swope Health Services
🇺🇸Kansas City, Missouri, United States