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Clinical Trials/NCT05013710
NCT05013710Enrolling By InvitationNot Applicable

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

Plan A Health, Inc3 sites in 1 country10,000 target enrollmentStarted: January 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
10,000
Locations
3
Primary Endpoint
Vaccinations

Study Overview

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.

Detailed Description

The purpose of this prospective/retrospective cohort study is to evaluate the effectiveness of each individual participating mobile health clinic in improving their community's health and access to care, and to compare each clinic's performance and reach within their respective communities. This Institutional Review Board (IRB)-exempt study is a descriptive review of de-identified evaluation, clinical, and operations data, including staff and patient surveys, patient metrics, and clinic operations metrics. The investigators anticipate that additional mobile clinic programs will submit de-identified data from evaluations done under local IRB exemption. The study will utilize data already collected or to be collected by each mobile health clinic as a part of its clinical and operational activities. Each mobile health clinic will decide which indicators from the evaluation instrument it will use for its own evaluation, and which will be reported to the shared database, depending on the specific services provided and population served. Data will be tracked on a per-patient-visit level or per-operational day, whichever is more relevant to the variable at hand. Data will be sourced from each mobile health clinic's current evaluation sources, including patient intake records (for demographic information, clinic visit dates, clinic procedures done), time and budget tracking software (for hours/patient and cost/patient spent), patient questionnaires (for patient satisfaction and attitudes about their mobile health clinic visit), patient post-visit follow-up questionnaires (for simple referral or prescription follow-up), and clinic operational records (for distance traveled).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patient at a participating mobile clinic

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Vaccinations

Time Frame: 1 Day

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).

Reproductive Health

Time Frame: 1 Day

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.

Coronavirus Disease 2019 (COVID-19)

Time Frame: 1 Day

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.

Patient screening and referrals

Time Frame: 1 Day

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.

Sexual Health

Time Frame: 1 Day

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.

Secondary Outcomes

  • Patient Satisfaction on Visit(1 Day)
  • Patient Visit(1 Day)
  • Patient Demographics(1 Day)
  • Patients Assets, Risks, and Experiences(1 Day)

Investigators

Sponsor
Plan A Health, Inc
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Caroline Weinberg

Executive Director

Plan A Health, Inc

Study Sites (3)

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