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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Quasi-experimental, Interrupted Time Series Study to Evaluate the Effectiveness of SexHealth Mobile on Uptake of Contraception in Women With Substance Use Disorder

Conditions
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Contraceptive Usage, Contraception

Intervention / Treatment
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* Behavioral: SexHealth Mobile


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>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. | |
| Experimental: SexHealth Mobile<br>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. | Behavioral: SexHealth Mobile<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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substance abuse, contraception, sexhealth mobile