Career and Sexual Health Education for Unsafe Sex Prevention

(MWB Trial)

Recruiting at 2 trial locations

Overseen By Jennifer Manlove, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Child Trends

Disqualifiers: Planning pregnancy, Other sexual health education, Others

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

Compensation: Varies

Number of Visits: 10

700 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized control trial is to clinical trial is to evaluate Many Ways of Being, an innovative sexual health promotion program focused on addressing rigid gender norms and promoting healthy relationships. The overall goal of the MWB program is to reduce incidence of sexually transmitted infections (STI) and unplanned pregnancy and promote healthy, consensual, and violence-free relationships among youth. The primary research question we aim to answer through this study is: Among youth ages 15-19, does the Many Ways of Being program reduce unprotected sex (through consistent and correct use of condoms and contraceptives) compared to the a career readiness program, which does not include sexual health components? As part of the study, participants will be asked to: * Attend approximately 14 hours and 40 minutes of programming completed over 4-8 weeks * Complete baseline, post-intervention, and 9-month follow-up surveys * For select participants who received the MWB program, participate in an optional focus group discussion The local evaluation will focus on the impact of the entire MWB intervention, as compared to a similar-length control program focused on career readiness.

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 focuses on sexual health education and does not mention any medication requirements.

What data supports the effectiveness of the treatment Many Ways of Being, MWB, Muchas Formas de Ser, Passport to Success for preventing unsafe sex?

Research shows that educational programs focusing on skills like condom use and communication can reduce sexually transmitted infections by up to 30%. This suggests that similar comprehensive education treatments, like Many Ways of Being, could be effective in preventing unsafe sex. ^{1 2 3 4 5}

How does the Career and Sexual Health Education treatment differ from other treatments for unsafe sex prevention?

This treatment is unique because it combines career and sexual health education to prevent unsafe sex, focusing on empowering individuals with knowledge and skills for safer sexual practices, unlike traditional methods that may only focus on contraceptive use or abstinence. ^{6 7 8 9 10}

Research Team

Jennifer Manlove, PhD

Principal Investigator

Child Trends

Eligibility Criteria

This trial is for English or Spanish-speaking youth aged 15-19 living in the greater Metropolitan DC area. It's not for those planning a pregnancy, who've had sexual health education from the Latin American Youth Center before, or are getting other sexual health education during the study.

Inclusion Criteria

I am between 15 and 19 years old and live in the greater Metropolitan DC area.

Exclusion Criteria

I am a young person planning to become pregnant.

Youth who have participated in other sexual health programming through the LAYC previously

Youth who are receiving other sexual health education during the implementation period

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants attend the Many Ways of Being program or a career readiness program for a total of 14 hours and 40 minutes over 4-8 weeks

4-8 weeks

8 sessions (in-person or virtual)

Follow-up

Participants complete post-intervention and 9-month follow-up surveys to assess outcomes

9 months

2 surveys (virtual)

Optional Focus Group

Select participants who received the MWB program participate in an optional focus group discussion

Treatment Details

Interventions

• Many Ways of Being
• Passport to Success

Trial Overview The 'Many Ways of Being' program aims to reduce STIs and unplanned pregnancies by promoting healthy relationships and challenging rigid gender norms. This will be compared with a career readiness program without sexual health components over 4-8 weeks.

Participant Groups

Group I: Many Ways of Being Experimental Treatment 1 Intervention

In the experimental arm, Equimundo's Many Ways of Being program will be implemented. Youth will receive eight two-hour sessions or 16 one-hour sessions over four to eight weeks for a total of 14 hours and 40 minutes of programming.

Group II: A career readiness program Active Control 1 Intervention

In the comparison arm, a curriculum focused on career readiness will be implemented. Youth will receive eight two-hour sessions or 16 one-hour sessions over four to eight weeks for a total of 14 hours and 40 minutes of programming.

Who Is Running the Clinical Trial?

Child Trends

Lead Sponsor

Trials

20

Recruited

208,000+

Latin American Youth Center

Collaborator

Trials

3

Recruited

2,200+

Equimundo:Center for Masculinities and Social Justice

Collaborator

Trials

1

Recruited

700+

Family and Youth Services Bureau

Collaborator

Trials

3

Recruited

2,100+

Findings from Research

The Sexual Health Empowerment Project was developed as a brief jail-based intervention aimed at improving cervical health knowledge and self-efficacy among incarcerated women, based on their specific health literacy needs.

Future evaluations are necessary to assess the long-term impact of this intervention on health behaviors and outcomes for women transitioning from jail to community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of a brief jail-based cervical health promotion intervention. Ramaswamy, M., Simmons, R., Kelly, PJ.[2023]

A systematic review of 15 randomized controlled trials (RCTs) found that school-based behavioral interventions for preventing sexually transmitted infections generally improved knowledge and self-efficacy among participants, but had limited effects on actual behavioral outcomes like condom use.

While about half of the studies reported some positive behavioral changes, these effects were often restricted to specific subgroups, indicating that while sexual health education is crucial, its impact on behavior may be influenced by various factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural interventions for the prevention of sexually transmitted infections in young people aged 13-19 years: a systematic review. Picot, J., Shepherd, J., Kavanagh, J., et al.[2022]

A new ten-page women's health and cancer prevention learning guide was developed specifically for women in the criminal justice system, covering important topics like cervical cancer, breast cancer, STIs, and unintended pregnancy prevention.

Feedback from a sample of 33 women indicated a strong interest in more information about birth control side effects and STI testing and treatment, while they expressed satisfaction with the cancer prevention content, highlighting the guide's relevance and potential impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Cancer Prevention Health Education Resource: a Primer of Process and Evaluation. Kelly, PJ., Driscoll, D., Lipnicky, A., et al.[2023]

A review of 73 studies identified four effective program types that can significantly delay sexual initiation and reduce teen pregnancy and sexually transmitted infections among adolescents.

These effective programs include specific sex and HIV education curricula, one-on-one clinician-patient interactions, service learning initiatives, and a comprehensive youth development program, all of which have shown strong evidence in improving sexual health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective approaches to reducing adolescent unprotected sex, pregnancy, and childbearing. Kirby, D.[2014]

A systematic review of 289 interventions aimed at reducing STIs in U.S. adolescents found that comprehensive education programs, which teach safe sexual practices and skills, can lead to a 30% reduction in STI incidence.

Interventions focused solely on abstinence showed no effectiveness, while those that improved condom use and communication skills reduced STI rates by 30-36%, highlighting the importance of practical skills in sexual health education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Evidence-Based Programs For Preventing Sexually-Transmitted Infections: A Meta-Analysis. Petrova, D., Garcia-Retamero, R.[2019]

Women diagnosed with viral sexually transmitted infections (STIs) often find it more challenging to negotiate condom use, as they face social pressures that conflict with safer sex education messages.

Most women in the study expressed a desire for clinicians to initiate discussions about safer sex, highlighting a gap in education and the need for nurses to understand the complexities of gender dynamics in sexual health negotiations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Nice girls don't': women and the condom conundrum. Cook, C.[2014]

Adolescent sexual activity poses significant risks to young women's health and quality of life, including early pregnancy and sexually transmitted diseases, highlighting the urgent need for comprehensive sexual education.

Effective sexual education should not only focus on contraceptive methods but also promote personal responsibility and citizenship, fostering respect and self-care among adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex education in school: preventing unwanted pregnancy in adolescents. Saito, MI.[2019]

A health education intervention for 341 college students led to increased sexual abstinence among men and improved consistent condom use among women after 3 months, indicating positive behavioral changes.

The intervention was effective in reducing sexual risk behaviors overall, but the impact varied by gender, highlighting the need for tailored approaches in sexual health education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in sexual risk behaviors among college students following a comprehensive health education intervention. Turner, JC., Korpita, E., Mohn, LA., et al.[2006]

Adolescents aged 12-16 in rural primary schools reported benefits from school-based sexuality education, indicating its potential effectiveness in promoting sexual health.

However, the implementation of these programs faced significant challenges due to various factors at national, institutional, community, family, and individual levels, highlighting the need for a collaborative approach among stakeholders to improve the effectiveness of sexuality education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of adolescents and teachers on school-based sexuality education in rural primary schools in Uganda. Achora, S., Thupayagale-Tshweneagae, G., Akpor, OA., et al.[2018]

A multi-country study is being conducted in Colombia, Ethiopia, Ghana, and Malawi to evaluate the feasibility and effectiveness of delivering comprehensive sexuality education (CSE) to young people who are out of school, addressing their unique needs.

The research aims to improve adolescent sexual and reproductive health by preparing facilitators to effectively deliver CSE in these contexts, contributing to global goals for health and gender equality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a multi-country implementation research study to assess the feasibility, acceptability, and effectiveness of context-specific actions to train and support facilitators to deliver sexuality education to young people in out-of-school settings. Plesons, M., De Meyer, S., Amo-Adjei, J., et al.[2023]

References

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

The development of a brief jail-based cervical health promotion intervention. [2023]

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

Behavioural interventions for the prevention of sexually transmitted infections in young people aged 13-19 years: a systematic review. [2022]

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

Developing a Cancer Prevention Health Education Resource: a Primer of Process and Evaluation. [2023]

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

Effective approaches to reducing adolescent unprotected sex, pregnancy, and childbearing. [2014]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effective Evidence-Based Programs For Preventing Sexually-Transmitted Infections: A Meta-Analysis. [2019]

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

'Nice girls don't': women and the condom conundrum. [2014]

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

Sex education in school: preventing unwanted pregnancy in adolescents. [2019]

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

Reduction in sexual risk behaviors among college students following a comprehensive health education intervention. [2006]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Perceptions of adolescents and teachers on school-based sexuality education in rural primary schools in Uganda. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Protocol for a multi-country implementation research study to assess the feasibility, acceptability, and effectiveness of context-specific actions to train and support facilitators to deliver sexuality education to young people in out-of-school settings. [2023]