Financial Incentives for Contraceptive Use

(M-CARES Trial)

Not currently recruiting at 8 trial locations

Overseen By Vanessa Lang, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Pregnancy, Not female, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how financial incentives might affect contraceptive use and related life outcomes. Participants in the experimental group receive a gift card covering the full or partial cost of an IUD (a long-acting contraceptive device) to determine its impact on their choices and life decisions. Researchers will compare these outcomes to those of a control group that does not receive a voucher but continues with standard care. Women eligible for this trial include those using Planned Parenthood in Michigan, who face significant out-of-pocket costs for contraceptives and do not wish to become pregnant in the next year.

As an unphased trial, this study offers a unique opportunity to contribute to research that could improve access to contraceptives for many women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that financial incentives for contraceptive use are safe?

Research has shown that using financial incentives, such as vouchers, to encourage contraceptive use is generally safe. Studies have found that these vouchers help people access birth control without causing harm. In fact, a review found that financial incentives in healthcare improve outcomes, particularly in areas like substance use, without leading to major negative effects.

The gift card approach in these trials simply makes contraception more affordable. This method has been tested in similar situations and is well-accepted. No reports have directly linked problems to using these incentives. The main goal is to make contraception more accessible, and current findings support that it does so safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the role of financial incentives in contraceptive use. Unlike standard options, such as direct provision of contraceptives or counseling, this approach uses gift cards valued at up to 100% of the cost of a name-brand IUD to encourage women to obtain contraception. This method not only removes financial barriers but also empowers women to make informed choices about their reproductive health. By potentially increasing contraceptive uptake, this approach could lead to broader access and better health outcomes.

What evidence suggests that this trial's treatments could be effective for contraceptive use?

This trial will compare the effects of financial incentives on contraceptive use. Research has shown that offering financial incentives can encourage more people to use long-lasting birth control methods like IUDs (intrauterine devices). Studies have found that these long-lasting methods are much more reliable than options like pills, patches, or rings. For example, the failure rate for pills, patches, or rings is 4.55 per 100 participant-years, while it's only 0.22 for long-lasting methods. Additionally, people using long-lasting birth control tend to continue using it longer, with 86% sticking with it compared to 55% of those using the pill. This evidence suggests that financial incentives might help more people access and continue using effective birth control options. Participants in the treatment group of this trial will receive a voucher for contraceptives, while those in the control group will not receive a voucher. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

The trial is for individuals aged 18-35 who are not pregnant, do not wish to become pregnant in the next year, are biologically female and fertile, sexually active with men, and face out-of-pocket costs for contraceptives at PPMI.

Inclusion Criteria

I am a woman who could become pregnant.

I will have to pay some costs for contraceptives.

. not pregnant at the time of enrollment and not wishing to become pregnant in the next 12 months,

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a voucher for contraception and related services or standard care

Up to 1 year

Follow-up

Participants are monitored for outcomes such as pregnancy, childbirth, and contraceptive use

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Gift card to be used for contraceptives that is valued at 100% of cost of name-brand IUD (March 4, 2019-December 31, 2021)
• Gift card to be used for contraceptives that is valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023)
• Gift card to be used for contraceptives that is valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019)

Trial Overview M-CARES is testing the impact of financial access to contraception. Participants will receive gift cards covering either 50% or 100% of a name-brand IUD's cost. The study aims to understand how this affects various life aspects.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 2 Interventions

Women in this arm of the study receive a voucher which can be used to buy contraception and related services at Planned Parenthood

Group II: Control Group Active Control 1 Intervention

Women in this arm of the study DO NOT receive a voucher for contraceptives. Women in this arm receive the Planned Parenthood standard of care priced according to the Planned Parenthood sliding scale.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Opinion Research Center

Collaborator

Trials

15

Recruited

251,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3548669/

Continuation and Satisfaction of Reversible Contraception Long-acting reversible contraception users had higher 12-month continuation rates (86%) than OCP users (55%).

2. withpower.com withpower.com/trial/phase-7-2018-cad82

Financial Incentives for Contraceptive Use (M-CARES Trial) Outcomes include contraceptive use, pregnancy, childbearing, and parenting strategies; partnership decisions and relationship quality; health and health care ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1110855

Effectiveness of Long-Acting Reversible Contraception The failure rate among participants who used pills, patch, or ring was 4.55 per 100 participant-years, as compared with 0.22 for those who used ...

4. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2781882

Efficacy and Cost-Benefit of Onsite Contraceptive Services ... Results of this study suggest that onsite contraceptive services exceeded usual care, but that the combination of contraceptive services with incentives for ...

5. clinicaltrial.be clinicaltrial.be/en/details/67196?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Michigan Contraceptive Access, Research, and Evaluation ... The resulting estimates will inform a more complete understanding of the costs and benefits of financial access to contraception and, therefore, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8280955/

Efficacy and Cost-Benefit of Onsite Contraceptive Services ... Results of this study suggest that onsite contraceptive services exceeded usual care, but that the combination of contraceptive services with incentives for ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7956068/

Systematic Review on Use of Health Incentives in U.S. to ... The review showed that incentives such as vouchers and other financial incentives were effective in improving outcomes especially related to substance use, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0010782425004743

Mixed-methods outcomes from a statewide contraceptive ... In this descriptive evaluation of TRT, we measure availability of contraceptive methods and same-day contraceptive services at health centers, ...