Evaluating the Mobile Clinic Model as a Means of Increasing Access to Reproductive and Sexual Health

NCT05013710 | Unknown

• 1 other identifier: 01
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 3

Brief Summary

The mobile health clinic evaluation study examines the impact of mobile health clinics on access reproductive and sexual healthcare services in underserved communities. Multiple mobile clinics operating throughout the U.S. are participating by implementing the same evaluation plan for their programs and contributing de-identified data into a shared database. This allows the investigators to both determine the impact of individual programs and to compare and contrast their impact across different programs, states, population densities (rural, urban, suburban), and populations.

Conditions

Healthcare Disparities; Reproductive Health; Sexual Health; Program Evaluation; Health Care Quality, Access, and Evaluation

Outcome Measures

Primary Outcomes (5)

• Sexual Health

  Completed if patient received human immunodeficiency virus (HIV) status, HIV testing, education, and/or Pre-exposure prophylaxis (PrEP) AND/OR if patient received Sexually transmitted disease (STD) status, STD testing, education, and/or medication.

  1 Day

• Vaccinations

  Completed if patient received human papilloma virus (HPV) vaccine or if HPV vaccination status was recorded AND/OR if the patient received any other routine, non-COVID-19 vaccine(s).

  1 Day

• Reproductive Health

  Completed if patient received a pregnancy test AND/OR reported patient pregnancy status and history, prior pregnancy information, and provision of pregnancy and related referrals by the Mobile Health Clinic AND/OR if the patient received a pap smear during the visit or provided their pap smear history AND/OR if the mobile health clinic offered and provided contraception counseling and collected patient's current contraception status and contraception history AND/OR if patient requested for specific contraception or change in method AND/OR if patient received condoms AND/OR if patient received emergency contraception.

  1 Day

• Patient screening and referrals

  Completed if mobile health clinic collected patient's self-reported level of health AND/OR if the patient received primary care screenings (Chol, BP, Blood sugar, A1C) AND/OR if the patient was screened for sexual assault, depression, domestic violence, and drug use, AND/OR if the patient received referrals for social services, additional health services (including specialty services), AND/OR financial or health insurance-related assistance AND/OR if the patient attended ther referral appointment AND/OR if the patient received any prescription(s) for medication, AND/OR if the mobile health clinic registered the patient to vote, AND/OR if the patient used any of the telehealth hotspot to connect with alternate providers AND/OR if the mobile health clinic staff supported the telehealth visit.

  1 Day

• Coronavirus Disease 2019 (COVID-19)

  Completed if the mobile health clinic collected the patient's history on COVID-19 testing and history of COVID-19 AND/OR if the patient has been able to access COVID-19 testing AND/OR if the patient has been able to access the COVID-19 vaccination(s) and their vaccination status.

  1 Day

Secondary Outcomes (4)

• Patient Demographics

  1 Day

• Patient Visit

  1 Day

• Patients Assets, Risks, and Experiences

  1 Day

• Patient Satisfaction on Visit

  1 Day

Study Arms (3)

Plan A Health

Founded in 2018, Plan A Health, Inc seeks to address health care disparities in rural communities by improving access to reproductive and sexual care. Beginning April 2021, the first Plan A mobile health clinic opened, serving five counties in the Mississippi Delta. The care team in the clinic includes a community health worker, nurse practitioner, volunteer providers, residents, and a collaborating physician.

Other: Complete Clinical Interaction

Just the Pill

Just The Pill offers telemedicine appointments by phone or online for sexual and reproductive health needs that is delivered to the patient's home. The organization is also opening a mobile health clinic that will deliver care directly to communities.

Other: Complete Clinical Interaction

University of Florida Mobile Outreach Clinic

The mission of the Mobile Outreach Clinic is to reduce health disparities by providing best practice, flexible, low-barrier primary care at no cost to patients unable to access the healthcare system. They focus on addressing the social barriers that drive health inequities and educating health professions students in an environment that equips them to become the socially conscious medical providers of the future.

Other: Complete Clinical Interaction

Interventions

Complete Clinical Interaction OTHER

The intervention consists of a completed interaction with the mobile health clinic during the study periods, on which adequate evaluative data was collected on the patient visit (e.g. staff was able to note their visit and reason for visit, the patient met with an healthcare professional, etc)

Just the Pill; Plan A Health; University of Florida Mobile Outreach Clinic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient data included in the study will be from those who: 1. Presented to mobile health clinic during the study periods AND, 2. Completed an interaction with the mobile health clinic during the study periods, on which adequate evaluative data was collected on the patient visit (e.g. staff was able to note their visit and reason for visit, the patient met with a healthcare professional, etc)

You may qualify if:

• Patient at a participating mobile clinic

You may not qualify if:

• None

Sponsors & Collaborators

• Plan A Health, Inc: lead
• Organon: collaborator

Study Sites (3)

University of Florida Mobile Outreach Clinic

Gainesville, Florida, 32610, United States

Location

Just the Pill

Saint Paul, Minnesota, 55116, United States

Location

Plan A Health, Inc

Louise, Mississippi, 39097, United States

Location

Related Publications (4)

• Choi H, Steptoe A, Heisler M, Clarke P, Schoeni RF, Jivraj S, Cho TC, Langa KM. Comparison of Health Outcomes Among High- and Low-Income Adults Aged 55 to 64 Years in the US vs England. JAMA Intern Med. 2020 Sep 1;180(9):1185-1193. doi: 10.1001/jamainternmed.2020.2802.

  PMID: 32897385 BACKGROUND

• Rosenblatt RA, Hart LG. Physicians and rural America. West J Med. 2000 Nov;173(5):348-51. doi: 10.1136/ewjm.173.5.348. No abstract available.

  PMID: 11069878 BACKGROUND

• Hill CF, Powers BW, Jain SH, Bennet J, Vavasis A, Oriol NE. Mobile health clinics in the era of reform. Am J Manag Care. 2014 Mar;20(3):261-4.

  PMID: 24884754 BACKGROUND

• Yu SWY, Hill C, Ricks ML, Bennet J, Oriol NE. The scope and impact of mobile health clinics in the United States: a literature review. Int J Equity Health. 2017 Oct 5;16(1):178. doi: 10.1186/s12939-017-0671-2.

  PMID: 28982362 BACKGROUND

Related Links

• National Healthcare Quality and Disparities Report
• Mobile Clinic Delivers Culturally Competent Services to Underserved Neighborhoods, Leading to Identification of Untreated Chronic Conditions, Better Blood Pressure Control, and Significant Return on Investment \| AHRQ Health Care Innovations Exchange

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 19, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (3)