Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03877757 |
| Other study ID # |
117213 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2019 |
| Est. completion date |
June 28, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
University of Utah |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
