Sexual BehaviorMWBNCT05801601
Evaluating the Many Ways of Being Program
A study testing Many Ways of Being, an innovative sexual health promotion program focused on addressing rigid gender norms and promoting healthy relationships and A career readiness program in people with Sexual Behavior and Unprotected Sex, run by Child Trends at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Sexual Behavior, Unprotected Sex
- What is being tested?
- Many Ways of Being, an innovative sexual health promotion program focused on addressing rigid gender norms and promoting healthy relationships and A career readiness program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Youth age 15-19 in the greater Metropolitan DC area
Who cannot join
- Youth who are actively planning a pregnancy, have participated in the other sexual health programming through the LAYC previously, or are receiving other sexual health education during the implementation period. Youth who do not speak English and/or Spanish will also not be eligible to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
LAYC's Teen Center
Washington D.C., District of Columbia, 20009
Lauren LaPointe
About this study
Official title: Evaluating Many Ways of Being, an Innovative Gender-synchronized and Gender-transformative Sexual Health Program
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?
Read more
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.
- Conditions
- Sexual Behavior, Unprotected Sex
- Being tested
- Many Ways of Being, an innovative sexual health promotion program focused on addressing rigid gender norms and promoting healthy relationships, A career readiness program
- Medical subject headings
- Sexual Behavior, Unsafe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Many Ways of Being, an innovative sexual health promotion program focused on addressing rigid gender norms and promoting healthy relationshipsBehavioural
Also called Many Ways of Being
The Many Ways of Being program is a gender-synchronous program informed by Equimundo's existing single-gender Manhood 2.0 and Sisterhood 2.0 programs. The curriculum is designed to shift unequal gender attitudes and behaviors and provide skill-building on maintaining healthy relationships, making healthy and informed decisions around sex, and avoiding risky sexual behaviors.
A career readiness programBehavioural
Youth enrolled in the control condition will receive a career readiness curriculum, either International Youth Foundation's Passport to Success, LAYC's Next Generation program or LAYC's Career Readiness Curriculum, depending on the site and implementation period. These programs equip young people with a range of professional, employment readiness, and practical skills that will help them stay in school and acquire the education, professional skills, employment
| Study group | Role | What they receive |
|---|---|---|
| Many Ways of Being | Experimental | 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. Receives: Behavioral: Many Ways of Being, an innovative sexual health promotion program focused on addressing rigid gender norms and promoting healthy relationships |
| A career readiness program | Active comparator | 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. Receives: Behavioral: A career readiness program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condomless sex (measure 1)
Vaginal or anal sex without a condom in the past 3 months (yes/no). Yes if had vaginal or anal sex in the past 3 months and did not use a condom "all the time". No if did not have sex or used a condom "all the time".
Measured: 9 months following program completion
Unprotected vaginal sex (measure 2)
Vaginal sex without any contraception (including condom) in the past 3 months (yes/no) Yes if had sex in the past 3 months and did not use a contraceptive "all the time". No if did not have sex or used a contraceptive "all the time".
Measured: 9 months following program completion
Secondary outcomes (15)
Sexual agency
The respondent reported that they communicated what they "liked, disliked, or wanted to try" "all" or "most" of the time and that they asked what their partner "liked, disliked, or wanted to try" "all" or "most" of the time when participating in any sexual activity (including sexual touching) in the past 3 months OR respondent was not sexually active in the past 3 months. (yes/no)
Measured: 9 months following program completion
Knowledge related to healthy relationships
Able to identify healthy and unhealthy relationship scenarios (% correct out of 7 items)
Measured: Immediately post-program and 9 months following program completion
Knowledge related to sexual and reproductive health (measure 1)
Knowledge of contraceptive methods (% correct out of 4 items)
Measured: Immediately post-program and 9 months following program completion
Knowledge related to sexual and reproductive health (measure 2)
Knowledge of STIs (% correct out of 5 items)
Measured: Immediately post-program and 9 months following program completion
Knowledge related to sexual and reproductive health (measure 3)
Able to identify sexual consent (% correct out of 4 items)
Measured: Immediately post-program and 9 months following program completion
Intentions to practice sexual health promoting behaviors (measure 1)
Intends to use contraception ("Yes, definitely") if chooses to have sex in the future
Measured: Immediately post-program and 9 months following program completion
Intentions to practice sexual health promoting behaviors (measure 2)
Intends to use condoms ("Yes, definitely") if chooses to have sex in the future
Measured: Immediately post-program and 9 months following program completion
Intentions to practice sexual health promoting behaviors (measure 3)
Intends to visit a health care provider for SRH services in the next 12 months (yes/no "Yes, definitely" vs other responses)
Measured: Immediately post-program and 9 months following program completion
Self-efficacy to practice sexual health promoting behaviors (measure 1)
Know where to go to get birth control (yes/no "Yes, definitely" vs other responses)
Measured: Immediately post-program and 9 months following program completion
Self-efficacy to practice sexual health promoting behaviors (measure 2)
Know where to go to get STI testing/ treatment (yes/no "Yes, definitely" versus other responses)
Measured: Immediately post-program and 9 months following program completion
Self-efficacy to practice sexual health promoting behaviors (measure 3)
Level of comfort going to a provider for services or approaching a trusted adult for information about SRH (4-item Likert scale).
Measured: Immediately post-program and 9 months following program completion
Self-efficacy to practice sexual health promoting behaviors (measure 4)
Self-reported ability to communicate with partners about consent, sex, and contraception (5-item Likert scale). Three items draw from Upadhyay UD et al. Development and Validation of the Sexual and Reproductive Empowerment Scale for Adolescents and Young Adults. J Adolesc Health. 2021 Jan;68(1):86-94.
Measured: Immediately post-program and 9 months following program completion
Positive attitudes around gender
Gender-equitable attitudes scale (7-item Likert scale)
Measured: Immediately post-program and 9 months following program completion
Positive attitudes around sexual health (measure 1)
Self-love subscale from Sexual and Reproductive Empowerment Scale (4-item Likert scale). Citation: Upadhyay UD et al. Development and Validation of the Sexual and Reproductive Empowerment Scale for Adolescents and Young Adults. J Adolesc Health. 2021 Jan;68(1):86-94.
Measured: Immediately post-program and 9 months following program completion
Positive attitudes around sexual health (measure 2)
Sexual pleasure subscale from Sexual Reproductive Empowerment Scale (3-item Likert scale). Citation: Upadhyay UD et al. Development and Validation of the Sexual and Reproductive Empowerment Scale for Adolescents and Young Adults. J Adolesc Health. 2021 Jan;68(1):86-94.
Measured: Immediately post-program and 9 months following program completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Mar 2023
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research project will used an individual randomized controlled trial design in which youth at each intervention site will be randomized 1:1 into the experimental condition (Many Ways of Being) or the comparison condition (a career readiness program).
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Child Trends
- Sponsor type
- University, hospital or other
- Collaborators
- Latin American Youth Center, Equimundo:Center for Masculinities and Social Justice, Family and Youth Services Bureau
- Responsible party
- Sponsor
- Investigators
- Jennifer Manlove, PhD, Principal investigator, Child Trends
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801601
- Sponsor's protocol ID
- 90AP2693
- Acronym
- MWB
- Status last verified
- Nov 2023
- First submitted
- 23 Feb 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Many Ways of Being, an Innovative Gender-synchronized and Gender-transformative Sexual Health Program
- ClinicalTrials.gov ID
- NCT05801601
- Acronym / sponsor ID
- MWB / 90AP2693
- Conditions
- Sexual Behavior, Unprotected Sex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Child TrendsUniversity, hospital or other
- Collaborators
- Latin American Youth Center, Equimundo:Center for Masculinities and Social Justice, Family and Youth Services Bureau
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research project will used an individual randomized controlled trial design in which youth at each intervention site will be randomized 1:1 into the experimental condition (Many Ways of Being) or the comparison condition (a career readiness program).
| Arm | Type | Receives |
|---|---|---|
| Many Ways of Being | Experimental | Behavioral: Many Ways of Being, an innovative sexual health promotion program focused on addressing rigid gender norms and promoting healthy relationshipsIn 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. |
| A career readiness program | Active comparator | Behavioral: A career readiness programIn 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 may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Youth age 15-19 in the greater Metropolitan DC area
Key exclusion criteria (1 listed)
- Youth who are actively planning a pregnancy, have participated in the other sexual health programming through the LAYC previously, or are receiving other sexual health education during the implementation period. Youth who do not speak English and/or Spanish will also not be eligible to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Many Ways of Being, an innovative sexual health promotion program focused on addressing rigid gender norms and promoting healthy relationshipsAlso: Many Ways of BeingThe Many Ways of Being program is a gender-synchronous program informed by Equimundo's existing single-gender Manhood 2.0 and Sisterhood 2.0 programs. The curriculum is designed to shift unequal gender attitudes and behaviors and provide skill-building on maintaining healthy relationships, making healthy and informed decisions around sex, and avoiding risky sexual behaviors. | Behavioural | Many Ways of Being |
| A career readiness programYouth enrolled in the control condition will receive a career readiness curriculum, either International Youth Foundation's Passport to Success, LAYC's Next Generation program or LAYC's Career Readiness Curriculum, depending on the site and implementation period. These programs equip young people with a range of professional, employment readiness, and practical skills that will help them stay in school and acquire the education, professional skills, employment | Behavioural | A career readiness program |
Primary outcome
Condomless sex (measure 1)
Time frame: 9 months following program completion
Vaginal or anal sex without a condom in the past 3 months (yes/no). Yes if had vaginal or anal sex in the past 3 months and did not use a condom "all the time". No if did not have sex or used a condom "all the time".
Unprotected vaginal sex (measure 2)
Time frame: 9 months following program completion
Vaginal sex without any contraception (including condom) in the past 3 months (yes/no) Yes if had sex in the past 3 months and did not use a contraceptive "all the time". No if did not have sex or used a contraceptive "all the time".
15 secondary outcomes
Sexual agency
Time frame: 9 months following program completion
Knowledge related to healthy relationships
Time frame: Immediately post-program and 9 months following program completion
Knowledge related to sexual and reproductive health (measure 1)
Time frame: Immediately post-program and 9 months following program completion
Knowledge related to sexual and reproductive health (measure 2)
Time frame: Immediately post-program and 9 months following program completion
Knowledge related to sexual and reproductive health (measure 3)
Time frame: Immediately post-program and 9 months following program completion
Intentions to practice sexual health promoting behaviors (measure 1)
Time frame: Immediately post-program and 9 months following program completion
Intentions to practice sexual health promoting behaviors (measure 2)
Time frame: Immediately post-program and 9 months following program completion
Intentions to practice sexual health promoting behaviors (measure 3)
Time frame: Immediately post-program and 9 months following program completion
Self-efficacy to practice sexual health promoting behaviors (measure 1)
Time frame: Immediately post-program and 9 months following program completion
Self-efficacy to practice sexual health promoting behaviors (measure 2)
Time frame: Immediately post-program and 9 months following program completion
Self-efficacy to practice sexual health promoting behaviors (measure 3)
Time frame: Immediately post-program and 9 months following program completion
Self-efficacy to practice sexual health promoting behaviors (measure 4)
Time frame: Immediately post-program and 9 months following program completion
Positive attitudes around gender
Time frame: Immediately post-program and 9 months following program completion
Positive attitudes around sexual health (measure 1)
Time frame: Immediately post-program and 9 months following program completion
Positive attitudes around sexual health (measure 2)
Time frame: Immediately post-program and 9 months following program completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Manlove, PhD principal investigator
Child Trends
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Many Ways of Being, an innovative sexual health promotion program focused on addressing rigid gender norms and promoting healthy relationships and A career readiness program in people with Sexual Behavior and Unprotected Sex, run by Child Trends at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Manlove, PhD (240-223-9262, jmanlove@childtrends.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Condomless sex (measure 1) (time frame: 9 months following program completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.