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Completed

NCT Number: NCT04227145

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Amethyst Place: Swope Health Services Partner, Kansas City, Missouri, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SexHealth Mobile

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Current Use of Highly Effective Contraception

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

  • Swope Health Services
  • University of Kansas Medical Center

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 13, 2020
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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