What is the mechanism of action of this treatment?

Hormonal contraceptives, such as combined oral contraceptives (COCs) and progestin-only pills, are common birth control methods. COCs deliver synthetic estrogen and progestin to inhibit ovulation, thicken cervical mucus to block sperm, and thin the endometrial lining to prevent implantation. Progestin-only pills mainly thicken cervical mucus and thin the endometrial lining, with some ovulation suppression. These mechanisms are important for patients to understand as they influence the effectiveness, side effects, and suitability of the contraceptive method based on individual health needs.

What side effects are associated with this type of intervention?

Common side effects of combined estrogen-progestin oral contraceptives (COCPs) include an increased risk of thromboembolism, particularly in individuals with underlying thrombophilic disorders or a history of venous thromboembolic events. Users may also experience mood changes, unscheduled bleeding, and potential hyperkalemia with drospirenone-containing pills. Progestin-only pills (POPs) can lead to unscheduled bleeding, mood changes, and an increased risk of depression. Both types of contraceptives may require time for users to adjust to changes in bleeding patterns.

What prior FDA approvals exist?

The FDA has approved various combined estrogen-progestin oral contraceptives for birth control, which are relevant to increasing contraceptive use as studied in the Adapted CHOICES Program. These include formulations containing ethinyl estradiol combined with different progestins such as drospirenone, which has a potassium-sparing diuretic effect. These contraceptives are effective in reducing acne lesions and are also used for other indications like managing premenstrual dysphoric disorder. Notably, drospirenone-containing contraceptives require monitoring for hyperkalemia and are contraindicated in patients with renal impairment or adrenal insufficiency.

What other types of research exist?

Promising alternatives to the Adapted CHOICES Program for 2024 include: 1) Enhanced Care models that combine structured contraceptive counseling with healthcare provider education and cost support for long-acting reversible contraception (LARC), 2) Digital health interventions that provide personalized contraceptive counseling and behavioral support via mobile apps, and 3) Comprehensive preconception care programs that integrate lifestyle interventions, such as weight management and smoking cessation, with contraceptive counseling to improve overall reproductive health outcomes.

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Behavioral Intervention

Native-CHOICES for Preventing Alcohol Exposed Pregnancies (Native-CHOICES Trial)

N/A

Waitlist Available

Led By Dedra Buchwald, MD

Research Sponsored by Washington State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 3 months and 6 months post intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program called Native-CHOICES to help American Indian and Alaska Native women reduce the risk of alcohol-exposed pregnancies. It includes motivational talks, contraceptive advice, and supportive messages. The goal is to encourage safer drinking habits and better use of contraception. The Native-CHOICES program is a tailored version of the CHOICES program, which has shown promise in reducing the risk of alcohol-exposed pregnancies among American Indian and Alaska Native women.

Who is the study for?

This trial is for American Indian and Alaska Native women aged 18-44 who live on the Cheyenne River Sioux Reservation or in Rapid City, South Dakota. Participants should engage in high-risk drinking behaviors, be sexually active without effective birth control, and not currently pregnant or infertile.

What is being tested?

The study tests 'Native CHOICES', an adapted intervention aimed at reducing alcohol-exposed pregnancies among participants by addressing risky alcohol use and improving contraception effectiveness.

What are the potential side effects?

Since this trial focuses on behavioral intervention rather than medication, traditional drug side effects are not a concern. However, participants may experience emotional discomfort discussing personal habits like drinking and sexual activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 3 months and 6 months post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 3 months and 6 months post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 3 months and 6 months post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction in alcohol exposed pregnancy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Native CHOICES InterventionExperimental Treatment1 Intervention

Native-CHOICES will comprise usual care plus 2 MI sessions delivered over 4 weeks; a contraception counseling session at a local clinic; and 3 months of electronic messaging to boost the effects of MI and counseling by increasing perceptions of social connection and social support for behavior change. Contraception counseling will be completed within 2 weeks after the second MI session, so the maximum duration of MI and counseling for each participant will be 6 weeks. Electronic messaging will include positive motivational content consistent with alcohol and contraception use goals set in the MI sessions.

Group II: Wait-list Control GroupActive Control1 Intervention

The control condition will comprise usual care for the 6-month study period, with a wait-list design that offers women the Native- CHOICES program after they have completed the 6-month data collection.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hormonal contraceptives, such as combined oral contraceptives (COCs) and progestin-only pills, are common birth control methods. COCs deliver synthetic estrogen and progestin to inhibit ovulation, thicken cervical mucus to block sperm, and thin the endometrial lining to prevent implantation. Progestin-only pills mainly thicken cervical mucus and thin the endometrial lining, with some ovulation suppression. These mechanisms are important for patients to understand as they influence the effectiveness, side effects, and suitability of the contraceptive method based on individual health needs.

Long-acting reversible contraceptive acceptability and unintended pregnancy among women presenting for short-acting methods: a randomized patient preference trial.An Intervention Delivered by App Instant Messaging to Increase Acceptability and Use of Effective Contraception Among Young Women in Bolivia: Protocol of a Randomized Controlled Trial.Women's experiences with tailored use of a combined oral contraceptive: a qualitative study.