CClinicalTrials.gg
Active, not recruitingNCT03877757Updated Dec 11, 2024

Family Planning Elevated: Initiative Evaluation

An observational study in Contraception, sponsored by University of Utah. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-12-11.

Sponsored by University of Utah · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
22
Ages
18 Years to 50 Years
Sex
All
01

Study summary

Family Planning Elevated (FPE) is a statewide contraceptive initiative with two primary aims: 1) supporting existing and proposed legislative policy that expands family planning services in Utah among low-income individuals covered by contraceptive legislation (currently individuals at ≤100% federal poverty) and 2) demonstrating additional existing service need among low-income individuals who currently fall in the contraceptive coverage gap (101%-250% federal poverty). Family Planning Elevated provides contraceptive grants, education and training, and technical assistance on comprehensive contraceptive care to participating clinics. The purpose of this evaluation is to assess the effect of FPE on clinic-level family planning service delivery among low-income women who fall in the contraceptive coverage gap compared to those receiving services from matched control clinics which did not receive the intervention. To assess these effects, FPE will collect monthly family planning service delivery data from both intervention and control clinics, beginning 12 months prior to the FPE intervention, and following for 12 months after the FPE intervention ends. A difference-in-difference analysis will compare trends and level-changes in family planning services provided to intervention and control groups.

Read the detailed description

Intervention clinics (FPE Contraceptive Access Program [FPE CAP]) receive a multifaceted contraceptive intervention, including:

  1. Training and technical assistance on contraceptive counseling and provision for FPE CAP providers, administrators, and health center support staff. FPE CAP staff will be required to attend an annual contraceptive training conference and receive additional remote and on-site technical support on counseling and provision of contraceptive methods. Methods include emergency contraception, oral contraceptive pills, contraceptive patch, vaginal ring, contraceptive injection, fertility awareness methods, condoms, contraceptive implant, hormonal IUDs, and non-hormonal IUD and other contraceptive methods, as feasible.
  2. FPE will provide FPE CAP members a cash grant to offset personnel and equipment costs associated with FPE CAP start-up and implementation.
  3. Monthly reimbursement for FPE CAP contraceptive services. As a result of the Medicaid Family Planning Waiver effective January 1, 2019, Utah health centers may claim Medicaid reimbursement for contraceptive services provided to Medicaid enrolled clients at ≤100% Federal Poverty Level. FPE CAP seeks to expand this coverage by providing reimbursement to FPE CAP health centers for contraceptive services provided to clients at 101% - 250% FPL (or 0% - 250% FPL for undocumented clients). Clients must be of reproductive age seeking female-user dependent methods and not be eligible for Medicaid/PCN.
  4. Contraceptive method stock. The high upfront cost of some contraceptive methods, particularly IUDs and implants, is often a barrier for health centers to maintain adequate contraceptive inventory. During the FPE CAP project period, members will be provided a stock of IUDs and implants to provide to eligible FPE CAP clients. Health centers will be also be reimbursed or provided vouchers for short-acting methods including oral contraceptive pills, vaginal rings, contraceptive injections, condoms, cycle beads, and emergency contraception. FPE will provide technical assistance to members to build a sustainable inventory of contraceptive methods for the post-FPE CAP project period. This will include training on drug forecasting and stocking, 340B Drug Discount Program, group purchasing organizations, and patient assistance programs.
  5. Evaluative Support: FPE CAP members will be responsible for providing routine data to FPE to help us assess the impact of the program. As part of this effort, FPE CAP members will receive evaluative support in developing and reporting data requirements both for the program and to fill existing clinical data needs around contraception. Additionally, data provided to the FPE team will be analyzed and returned back to the individual health centers as part of the dissemination strategy.
  6. Marketing campaign: FPE will produce a targeted media campaign to increase public awareness of expanded eligibility for contraceptive services, improve demand for contraceptive services at community health centers, and provide client education on available contraceptive options. FPE will support FPE CAP members by creating customized media campaigns for community outreach and education.

Control clinics are similar clinics (matched by clinic size, geography, and serving Medicaid clients) who are not interested in participating in Family Planning Elevated, but are willing to provide the monthly service delivery data for the same time periods as their matched intervention clinic.

02

Conditions studied

  • Contraception

Keywords

  • Family Planning
  • Implementation science
  • Evaluation
  • Contraceptive initiative
03

In context

Lead sponsor

University of Utah is the lead sponsor of 970 studies on the registry; 179 are open to participants now.

Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The intervention occurs at the clinic level. Participating clinics are Utah health systems and individual clinics across Utah.

Inclusion criteria

  • Women of reproductive age (age 18-50) who visited the intervention or control clinic within the allotted time frame.

Exclusion criteria

Exclusion Criteria:

  • Under age 18
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
22 participants (estimated)
Patient registry
No

Groups and cohorts

  • Family Planning Elevated Contraceptive Access Clinics Program

    This group consists of community clinics who apply and are accepted for FPE CAP membership during the Family Planning Elevated initiative. These clinics will receive the intervention and will provide monthly service delivery data to the FPE evaluation team.

  • Control Clinics

    This group consists of non-participating community clinics matched on clinic size, geography, and client populations who are not interested in participating in the initiative but are willing to provide monthly service delivery data to the FPE evaluation team.

06

What researchers measure

Primary outcomes

  1. Change in total family planning services provided to women ages 18-49, as measured by monthly service delivery report

    Family planning services are defined as all family planning-related E/M, CPT, and HCPC codes within the FPE monthly service delivery report

    Time frame: 12 months prior to FPE intervention start, for the 24-month intervention period, and for 12 months post-intervention

Secondary outcomes

  1. Changes in total long-acting reversible contraceptive services (LARC) provided to all women ages 18-49, as measured by monthly service delivery report

    Defined as all related E/M, CPT, and HCPC codes related to LARC methods within the FPE monthly service delivery report

    Time frame: 12 months prior to FPE intervention start, for the 24-month intervention period, and for 12 months post-intervention

07

Study locations

1 site
  • University of Utah, Department of Obstetrics & Gynecology
    Salt Lake City, Utah 84132, United States
08

References and documents

Publications

  • Cohen SR, Baayd J, Garcia G, Quade C, Gero A, Ekey M, Poggio C, Simmons R. Facility-based simulation as a programmatic tool for implementing a statewide contraceptive initiative. BMC Health Serv Res. 2022 Jul 29;22(1):965. doi: 10.1186/s12913-022-08332-4. PubMed 35906656 ↗
  • Baayd J, Simmons RG. Protocol for a process evaluation of Family Planning Elevated: a statewide initiative to improve contraceptive access in Utah (USA). BMJ Open. 2020 Oct 1;10(10):e038049. doi: 10.1136/bmjopen-2020-038049. PubMed 33004395 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03877757
Lead sponsor
University of Utah
Responsible party
Sponsor
First posted
Mar 18, 2019
Start date
Feb 1, 2019
Primary completion
Jun 14, 2024
Completion
Dec 28, 2025 (estimated)
Last update
Dec 11, 2024

Study contacts

Rebecca Simmons, PhD
principal investigator · University of Utah, Department of OBGYN

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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