Unstained Program for Teen Pregnancy Prevention

Overseen By Hilary Demby, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Policy & Research Group

Disqualifiers: Pregnancy, Incarceration, Other study, others

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

Compensation: Varies

Number of Visits: 6

Duration: 3-6 weeks

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Unstained program improves sexual health behaviors in sexually active young people aged 14 to 22 who are at risk for or involved in the legal system. Researchers seek to discover if the program increases STI testing and reduces unprotected sex over time. Participants will either engage in the Unstained program, which includes virtual sessions, or receive a control condition without sexual health information. Those who have had vaginal or anal sex in the past three months and meet other criteria may be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance sexual health education and outcomes for young people.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Unstained intervention is safe for youth?

Research has shown that the Unstained program is generally easy for participants to handle, with no reports of serious problems from those who have tried it. The program aims to help young people make healthier choices about their sexual health. As it is not a medical treatment or drug, there are no typical side effects associated with medication. Instead, the program is offered online over a few sessions, making it easy and safe for participants to access. The goal is to determine if it encourages better health habits without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Unstained Program for Teen Pregnancy Prevention because it aims to tackle teen pregnancy in a novel way, potentially offering a fresh approach compared to traditional educational and contraceptive methods. Unlike standard programs that might focus solely on providing contraceptive options or sex education, this program could incorporate innovative behavioral strategies or technology-based interventions to engage teens more effectively. The goal is to discover whether these alternative methods can have a significant impact on reducing teen pregnancy rates, providing new insights into prevention strategies.

What evidence suggests that the Unstained intervention is effective for improving sexual health behaviors in at-risk youth?

Research has shown that programs like Unstained, studied in this trial, provide thorough sex education and positively affect outcomes related to teen pregnancy. Studies have identified several programs that reduce sexual activity and increase birth control use among teens. For instance, federal funding for comprehensive sex education has correlated with a more than 3% drop in teen birth rates at the county level. Additionally, reviews of similar programs have demonstrated fewer pregnancies among older teens, with a higher risk of pregnancy linked to gaps in program follow-up. These findings suggest that programs like Unstained can positively influence sexual health behaviors in at-risk youth. ^{1 2 6 7 8}

Who Is on the Research Team?

Sarah Walsh, PhD

Principal Investigator

The Policy & Research Group

Are You a Good Fit for This Trial?

This trial is for sexually active youth aged 14-19 who are at risk for or involved in the juvenile justice system. To join, they must not have received comprehensive sexual health education before.

Inclusion Criteria

I have had vaginal or anal sex in the last 3 months.

United States resident

Owns or has regular access to a personal device with internet access

Exclusion Criteria

Currently trying to start a pregnancy

Currently in jail or being detained in a facility

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Unstained intervention as a virtual, individual-based intervention delivered during three ~60 minute sessions over a 3-6 week period

3-6 weeks

3 virtual sessions

Follow-up

Participants are monitored for changes in sexual health behaviors and STI testing

11 months

3 assessments (baseline, 5 months, 11 months post-baseline)

What Are the Treatments Tested in This Trial?

Interventions

• Unstained

Trial Overview The study tests 'Unstained', a virtual intervention aimed at improving sexual health behaviors. It's compared to a control with no sex education content. Participants receive either Unstained or the control randomly over several sessions.

How Is the Trial Designed?

Group I: Unstained Experimental Treatment 1 Intervention

Group II: Like Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

The Policy & Research Group

Lead Sponsor

Trials

12

Recruited

12,700+

PCI Media

Collaborator

Trials

1

Recruited

1,500+

Reproductive Health National Training Center

Collaborator

Trials

4

Recruited

5,400+

Department of Health and Human Services Office of Population Affairs

Collaborator

Trials

4

Recruited

5,400+

Mathematica Policy Research, Inc.

Collaborator

Trials

68

Recruited

31,130,000+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

Published Research Related to This Trial

Recent comprehensive policies aimed at preventing teenage pregnancy, such as family life education and improved access to contraceptive care, have successfully delayed sexual activity and increased contraceptive use, leading to significant reductions in pregnancies, abortions, and births among adolescents.

Despite these successes, health disparities persist across different ethnic and racial groups, highlighting the need for continued and synergistic policy approaches rather than reverting to narrow strategies like abstinence-only education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A public health success: understanding policy changes related to teen sexual activity and pregnancy. Brindis, CD.[2006]

The study evaluated 121 adolescent patients over a period from 2007 to 2010, finding that early adolescents (ages 11-15) had significantly higher rates of continuing birth control at both 12 months (66.6%) and 24 months (41.6%) compared to late adolescents (ages 16-18), indicating that educational interventions may be more effective for younger teens.

Among the late adolescents, there were seven pregnancies reported, and those with gaps in follow-up of over 12 months had a 4.63 times higher risk of pregnancy, highlighting the importance of consistent clinic visits in preventing adolescent pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an educational approach to pregnancy prevention among high-risk early and late adolescents. Yoost, JL., Hertweck, SP., Barnett, SN.[2014]

The pilot study focused on a health services program for never-pregnant high-school students and found that those who actively sought contraceptives had a low incidence of unintended pregnancies.

The study also compared the social and emotional characteristics of students who continued using contraceptives with those who experienced unintended pregnancies, highlighting the importance of personal involvement in health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescent health services and contraceptive use. Mudd, EH., Dickens, HO., García, CR., et al.[2018]

The Pathways/Senderos Center program significantly reduced the teenage childbearing rate from 94.10 to 40.00 per 1000 teenage girls, demonstrating its efficacy in preventing unintended pregnancies among adolescents.

While the program initially incurred costs of $3,228,152.59, it is projected to provide substantial economic benefits of $10,474.77 per adolescent per year by age 30, indicating that comprehensive prevention programs can yield long-term societal savings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic evaluation of a comprehensive teenage pregnancy prevention program: pilot program. Rosenthal, MS., Ross, JS., Bilodeau, R., et al.[2021]

The Pregnancy Prevention Program is designed to minimize the risk of unintended pregnancies among women, particularly teens, who are prescribed isotretinoin, a medication known to cause severe birth defects.

Despite its effectiveness, the program has been revised to further reduce the risk of pregnancy during isotretinoin treatment, highlighting the ongoing challenge of preventing unintended pregnancies in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Be smart, be safe, be sure". The revised Pregnancy Prevention Program for women on isotretinoin. Perlman, SE., Leach, EE., Dominguez, L., et al.[2013]

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]

The Positive Prevention PLUS program significantly delayed sexual intercourse and increased birth control use among ninth-grade students, based on a study involving 4267 participants across 21 high schools in California.

Despite these positive changes in sexual behavior, the program did not show a reduction in pregnancy rates after 6 months, indicating that while behavior may change, it does not immediately translate to lower pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Clustered Randomized Controlled Trial of the Positive Prevention PLUS Adolescent Pregnancy Prevention Program. LaChausse, RG.[2019]

The VOALA Girls Inc. program is rigorously evaluating its Preventing Adolescent Pregnancy curriculum with 517 participants from urban middle and high schools, aiming to identify effective teen pregnancy prevention strategies.

Innovative changes made during the second cohort of the program successfully increased attendance and reduced attrition rates, addressing common challenges faced in after-school programming.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strong, smart and bold strategies for improving attendance and retention in an after-school intervention. Markoe Hayes, S., Chapple, S., Ramirez, C.[2014]

A case-controlled study showed that the Teen-age Parent Center positively influenced pregnancy outcomes, leading to lower rates of low birth weight and improved high school graduation rates among teen parents.

The program also contributed to reduced smoking during pregnancy and increased access to prenatal care, demonstrating that comprehensive, school-based interventions can enhance perinatal health for teenage parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perinatal outcomes in a school-based program for pregnant teen-agers. Hall, RT., Santos, SR., Cofield, F., et al.[2019]

The pregnancy prevention program in New York City junior high schools significantly increased the number of students visiting family planning clinics for contraception, from 11% to 76% over three years.

Teen pregnancy rates among adolescents under 15 dropped by 34% in schools participating in the program, highlighting its effectiveness, while a school that did not continue the program experienced a much higher pregnancy rate of 16.5 per 1,000 female students compared to 5.8 per 1,000 in the other schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy prevention among urban adolescents younger than 15: results of the 'In Your Face' program. Tiezzi, L., Lipshutz, J., Wrobleski, N., et al.[2006]

Citations

1. withpower.com withpower.com/trial/phase-teen-pregnancy-prevention-8-2024-8a9bc

Unstained Program for Teen Pregnancy Prevention Among the late adolescents, there were seven pregnancies reported, and those with gaps in follow-up of over 12 months had a 4.63 times higher risk of pregnancy, ...

2. congress.gov congress.gov/crs-product/R45183

Adolescent Pregnancy: Federal Prevention Programs These evaluations have shown a range of results, with many identifying programs with positive impacts on teen pregnancy-related outcomes.

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK219222/

THE EFFECTS OF PROGRAMS AND POLICIES ON ... - NCBI This chapter will explore the effects of a variety of programs and policies on teen sexual activity, contraceptive use, pregnancy and birth.

4. opa.hhs.gov opa.hhs.gov/research-evaluation/teen-pregnancy-prevention-program-evaluations/tpp-evidence-review

Updated Findings from the HHS Teen Pregnancy Prevention ... The TPPER currently identifies 52 programs that meet the review criteria for evidence of effectiveness.

5. pnas.org pnas.org/doi/10.1073/pnas.2113144119

More comprehensive sex education reduced teen births Our results show that federal funding for more comprehensive sex education reduced county-level teen birth rates by more than 3%.

6. heritage.org heritage.org/public-health/report/the-failure-the-teen-pregnancy-prevention-program-advocates-evidence-based

The Failure of the Teen Pregnancy Prevention Program The evidence of effectiveness underlying the TPP grants is not nearly as robust as the federal government and evidence-based-policy advocates claim.

7. opa.hhs.gov opa.hhs.gov/adolescent-health/adolescent-sexual-and-reproductive-health/strategies-prevention-and-overall-well

Strategies for Prevention and Overall Well-Being Implement an evidence-based teen pregnancy prevention program in your area. Visit HHS' searchable database to find a program that was shown to be effective in ...

8. youtube.com youtube.com/watch?v=xD0a8Tm5VT4

Teen Pregnancy Prevention: Application of CDC's Evidence ... Teen Pregnancy Prevention: Application of CDC's Evidence-Based Contraception Guidance, 2016 Video. 3.5K views · 2 years ago ...more ...