Financial Incentives for Contraceptive Use

(M-CARES Trial)

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

4633 Participants Needed

Trial Summary

What is the purpose of this trial?

M-CARES will use large-scale administrative data complemented by follow-up surveys and a randomized control trial (RCT) to estimate the causal impact of greater financial access to contraception on a comprehensive set of outcomes. Outcomes include contraceptive use, pregnancy, childbearing, and parenting strategies; partnership decisions and relationship quality; health and health care use; education, labor market success, and public assistance receipt; financial security; neighborhood quality; mental health and stress; and life plans. The resulting estimates will inform a more complete understanding of the costs and benefits of financial access to contraception and, therefore, the investment value of related policies and programs.

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 data supports the effectiveness of the treatment involving financial incentives for contraceptive use?

The research suggests that reducing the cost of intrauterine contraception (IUC) can increase its use, as seen in the Kaiser Permanente study where removing cost barriers led to greater IUC utilization. This implies that financial incentives, like gift cards covering contraceptive costs, could similarly encourage more women to use IUC. ^{1 2 3 4 5}

Is it safe to use financial incentives for contraceptive use, specifically IUDs?

The safety of using financial incentives for contraceptive use, like IUDs, isn't directly addressed in the research, but IUDs themselves have known risks such as increased blood loss, uterine perforation, and infection. These risks are associated with the IUDs, not the financial incentives. ^{6 7 8 9 10}

How does the treatment of financial incentives for contraceptive use differ from other treatments?

This treatment is unique because it uses financial incentives, specifically gift cards, to encourage the use of contraceptives like IUDs, making them more accessible by covering their full or partial cost. Unlike traditional methods that focus on education or direct provision, this approach leverages financial motivation to increase contraceptive uptake. ^{2 5 6 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Intrauterine contraception: evaluation of clinician practice patterns in Kaiser Permanente Northern California. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Reaching providers is not enough to increase IUD use: a factorial experiment of 'academic detailing' in Kenya. [2018]

3. England pubmed.ncbi.nlm.nih.gov

FFPRHC Guidance (July 2005): The use of contraception outside the terms of the product licence. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

The need for quasi-experimental methodology to evaluate pricing effects. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

IUD use in France: women's and physician's perspectives. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Young women's attitudes towards, and experiences of, long-acting reversible contraceptives. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Intrauterine devices: medicated and nonmedicated. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Intrauterine Device Outcomes in Young Women with Heavy Menstrual Bleeding: Comparing Patients with and without Inherited Bleeding Disorders. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Copper IUD continuation, unwanted effects and cost consequences at 1 year in users aged under 30 - a secondary analysis of the EURAS-IUD study. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

[Bleeding patterns important factor in choosing an IUD]. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Study protocol: incentives for increased access to comprehensive family planning for urban youth using a benefits card in Uganda. A quasi-experimental study. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Increasing Contraceptive Access for Hard-to-Reach Populations With Vouchers and Social Franchising in Uganda. [2022]