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

NCT04227145 | Completed Results

• 1 other identifier: STUDY00001099
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 4

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.

Conditions

Contraceptive Usage; Contraception

Keywords

contraception; sexhealth mobile; substance abuse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Current Use of Highly Effective Contraception

  3 months

Study Arms (2)

Usual Care

NO 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 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.

SexHealth Mobile

EXPERIMENTAL

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

Interventions

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.

SexHealth Mobile

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Participants will be ineligible if they:
• have previously enrolled in the study
• are unable to provide informed consent
• are pregnant at index (recruitment) visit

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• Swope Health Services: collaborator
• University of Kansas Medical Center: collaborator

Study Sites (4)

Swope Health Services

Kansas City, Missouri, 64108, United States

Location

Amethyst Place: Swope Health Services Partner

Kansas City, Missouri, 64109, United States

Location

ReDiscover: Swope Health Services Partner

Kansas City, Missouri, 64109, United States

Location

Healing House Inc.: Swope Health Services Partner

Kansas City, Missouri, 64123, United States

Location

Related Publications (5)

• 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.

  PMID: 26727196 RESULT

• 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.

  PMID: 21036512 RESULT

• 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.

  PMID: 25900803 RESULT

• 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.

  PMID: 30091969 RESULT

• Hurley EA, Goggin K, Pina-Brugman K, Noel-MacDonnell JR, Allen A, Finocchario-Kessler S, Miller MK. Contraception use among individuals with substance use disorder increases tenfold with patient-centered, mobile services: a quasi-experimental study. Harm Reduct J. 2023 Mar 6;20(1):28. doi: 10.1186/s12954-023-00760-7.

  PMID: 36879314 DERIVED

MeSH Terms

Conditions

Contraception Behavior; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Emily Hurley
• Organization: Children's Mercy Kansas City

eahurley@cmh.edu

(816) 731-7093

Study Officials

• Melissa Miller, MD

  Children's Mercy Emergency Department

  PRINCIPAL INVESTIGATOR

• Emily Hurley, PhD

  Children's Mercy Health Services and Outcomes Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 13, 2020
• Study Start: March 2, 2020
• Primary Completion: September 13, 2021
• Study Completion: January 30, 2022
• Last Updated: July 21, 2023
• Results First Posted: July 21, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

US (4)