Comprehensive Reproductive Support Program for Pregnancy Prevention

(PREVENT Trial)

Overseen By Joel Birkemeier, MD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Dr. Karen Yeates

Disqualifiers: Pregnancy, Long-term contraception, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new program to prevent unplanned pregnancies among teenage girls in Kilimanjaro, Tanzania. It aims to educate participants on reproductive health through text messages and connect them with local mentors for guidance and support. The trial includes two groups: one will receive educational messages and mentor support, while the other will also receive information on accessing contraception discreetly. Girls aged 15-19 who live in the study area, have a mobile phone, and can read texts in English or Swahili are suitable candidates. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance reproductive health education and support for teenagers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing contraceptive services and education, so it's best to discuss your specific medications with the study team.

What prior data suggests that this program is safe for adolescent girls?

Research has shown that learning about sexual health and birth control is generally safe and well-received. Programs designed to prevent unintended pregnancies help teenagers make informed choices without causing harm. Educational efforts, like those in this trial, have proven effective in preventing teen pregnancies and supporting overall well-being.

Studies find that using birth control is much safer than dealing with unintended pregnancies. While some side effects can occur, they are usually mild and uncommon. The World Health Organization supports the safe use of birth control, highlighting it as a basic right for individuals to plan their families.

Helping teenagers with decisions about reproductive health has not been linked to any major safety issues. Providing access to community mentors and counseling is seen as supportive rather than medical treatment, so it is not expected to pose any safety risks.

Overall, the components of this trial—education, access to birth control, and personal support—are supported by research as safe and helpful strategies for teenagers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it takes a comprehensive and personalized approach to pregnancy prevention. Unlike typical methods that focus solely on contraception, this program integrates education through SMS about reproductive health, offers personal support from community peer mentors, and provides access to a mobile reproductive health team for contraception and counseling. This holistic support system aims to empower individuals with knowledge and resources, potentially leading to more effective and sustainable pregnancy prevention compared to traditional standalone methods.

What evidence suggests that this trial's treatments could be effective for preventing unplanned pregnancies?

Research has shown that teaching young people about reproductive health can change their sexual behaviors and improve their reproductive health. One study found that reproductive health improved after educational programs. In this trial, participants in the Case Intervention arm will receive education, access to reliable birth control, and personal support, which together can greatly reduce unintended pregnancies. Specifically, one study reported that about 51.6% of people used effective birth control methods after gaining access. Personal support through contraceptive counseling increased birth control use by 39% within a few months. Meanwhile, participants in the Control Intervention arm will receive education and personal support, but not direct access to contraception. Combining education, access to birth control, and personal support appears effective in reducing unplanned pregnancies. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

The PREVENT Project is for girls aged 15-19 living in Kilimanjaro, Tanzania who can read SMS texts in English or Swahili. They must have a mobile phone, be willing to participate for 12 months, and not be pregnant nor planning pregnancy within the year. Girls using long-term contraception or with cognitive delays are excluded.

Inclusion Criteria

Be able and willing to return for follow-up after 12 months

Have a personal mobile phone and be willing to provide the phone number to the researchers to receive the intervention messages

I am a woman between 15 and 19 years old.

Exclusion Criteria

Be pregnant or planning pregnancy within 12 months (assessed when obtaining consent using HCG (human chorionic gonadotropin) urine dipstick)

Already utilizing a long-term form of contraception such as intra-uterine device, or implantable or inject-able contraception

Participation in another study or intervention that may affect the outcome of this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive educational SMS messages, access to interactive voice response services, and personal support from community peer mentors. The case group also receives access to contraception and counseling services.

12 months

Follow-up

Participants are monitored for changes in SRH knowledge, contraceptive use, and pregnancy outcomes.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Access to contraception
• Education
• Personal Support

Trial Overview

This study tests an educational program on reproductive health via text messages and voice services. It connects participants to local support and discreet contraceptive access points. The case group receives additional personal support and access to contraceptives through the program.

How Is the Trial Designed?

Group I: Control Intervention Experimental Treatment 2 Interventions

1. Education about contraceptive use, reproductive health and family planning services through SMS messages on SRH. 2. Personal Support from community peer mentor to access counselling services through SRH

Group II: Case Intervention Experimental Treatment 3 Interventions

1. Education about contraceptive use, reproductive health and family planning services through SMS messages on SRH. 2. Personal Support from community peer mentor to access counselling services through SRH 3. Access to Contraception and counselling and service provision will be provided by the mobile reproductive health team at contraceptive access points.

Who Is Running the Clinical Trial?

Dr. Karen Yeates

Lead Sponsor

Trials

2

Recruited

3,200+

Dr. Karen Yeates

Lead Sponsor

Trials

2

Recruited

3,200+

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Published Research Related to This Trial

All five reviewed adolescent pregnancy prevention programs effectively emphasized abstinence, decision-making skills, and education on sexuality and contraception, with four providing access to contraceptive services.

Programs targeting younger adolescents were particularly successful, reducing sexual initiation by up to 15 percentage points and increasing contraceptive use by as much as 22 percentage points, with the most effective programs also significantly decreasing pregnancy rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the impact of effective teenage pregnancy prevention programs. Frost, JJ., Forrest, JD.[2022]

A quality improvement project involving 124 psychiatric patients showed that individualized safety plans created during inpatient treatment were well-tailored, scoring an average of 32.85 out of 44 on a customization rubric.

Postdischarge, 96.1% of patients retained their safety plans, and 36.8% reported using them, with 67.9% of those users finding the plans helpful, indicating that these plans can support recovery after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the Gap Between Individualized Inpatient Safety Planning and Postdischarge Efficacy. Leonard, J., Chiappetta, L., Stark, S., et al.[2023]

Citations

1.

publichealth.jmir.org

publichealth.jmir.org/2024/1/e58009

Integrating Sexual and Reproductive Health Equity Into Public ...

Approximately half (51.6%) were using a contraceptive method rated as most or moderately effective for pregnancy prevention. More than a quarter ...

2.

odphp.health.gov

odphp.health.gov/healthypeople/objectives-and-data/browse-objectives/family-planning

Family Planning - Healthy People 2030 | odphp.health.gov

Birth control and family planning services can also help increase the length of time between pregnancies, which can improve health for women and their infants.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10228284/

Increasing Access to Contraception in the United States

Increasing access to the most effective forms of contraception is a strategy to reduce unintended pregnancies and rapid repeat pregnancies. Long-acting ...

4.

opa.hhs.gov

opa.hhs.gov/research-evaluation/title-x-services-research/contraceptive-care-measures

Contraceptive Care Measures - HHS Office of Population Affairs

The contraceptive care measures use claims data and are intended to encourage providers to screen for pregnancy preferences, offer the full range of most and ...

5.

who.int

who.int/news-room/fact-sheets/detail/family-planning-contraception

Family planning/contraception methods

It also provides significant health benefits by preventing unintended pregnancies and reducing related health risks.

6.

cdc.gov

cdc.gov/reproductive-health/hcp/unintended-pregnancy/index.html

Unintended Pregnancy | Reproductive Health

Overview of what CDC is doing to increase equitable access to contraception and useful resources.

7.

kffhealthnews.org

kffhealthnews.org/news/article/title-x-family-planning-hhs-opa-trump-cuts-reproductive-health-maine/

The Quiet Collapse of America's Reproductive Health ...

Each pregnancy averted through Title X saves about $15,000 in public spending on medical and social services, according to an analysis by Power ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11163908/

Removing Barriers to Contraceptive Access for Adolescents

Contraception is significantly safer than the condition it is intended to prevent. There are side effects and rare adverse events associated ...