Teen PregnancyNCT04441294
The Evaluation of Achieving Condom Empowerment (ACE)-Plus in New York City
A study testing ACE-Plus in people with Teen Pregnancy, run by Philliber Research & Evaluation.
Trial summary
To test a new curriculum - the ACE-Plus curriculum - a two-session program that teaches males in foster care and/or preventive services about correct and consistent condom use as well as engagement with female partners to obtain and use contraception. Read more about this study
- Who is it for?
- Ages 16 to 20 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Teen Pregnancy
- What is being tested?
- ACE-Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 31 Aug 2020
- 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 16 to 20 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Youth must have been born with a penis
- Youth must be aged 16 to 20
- Youth must have had vaginal intercourse at least once
- Youth can not be currently participating in any other teen pregnancy prevention program
- Youth must be in foster care or preventive services
Who cannot join
- 1. Lack of consent.
About this study
To test a new curriculum - the ACE-Plus curriculum - a two-session program that teaches males in foster care and/or preventive services about correct and consistent condom use as well as engagement with female partners to obtain and use contraception.
Read the detailed description
ACE-Plus is a one-on-one dual-session intervention for males aged 16 to 20 within foster care or preventive services settings which promotes condom use and knowledge of dual methods of contraception. The goal of ACE-Plus is to promote correct and consistent condom use of male latex condoms during penile-vaginal sex and to promote male engagement (e.g., discussion, decision-making) with their female partners in the use of female-centered contraception methods.
Over 200 males aged 16 to 20 were recruited into this study (called My Plan) by 9 foster care agencies in New York City from June 2016 through November 2019. The foster care agencies were selected by Cicatelli Associates, Inc. in New York City, a non-profit organization which oversaw the implementation of the study. These agencies represent a convenience sample which agreed to participate and deliver either the treatment condition (Ace-Plus) or a benign control condition (On Track). Agency staff received a five-day training regarding the implementation of both programs prior to youth engagement and also received additional refresher trainings and technical assistance as needed.
Agency staff screened potential study youth to ascertain eligibility. To be eligible for inclusion in this study, interested youth must have been born with a penis, been aged 16 to 20, have had vaginal intercourse at least once, and could not be currently participating in any other teen pregnancy prevention program. Targeted youth were either in foster care or preventive services. Screening occurred until 238 males were enrolled and completed a baseline assessment.
After youth met the screening criteria and agreed to participate, agency staff obtained written parental consent (from biological parents) and youth assent for each male age 16 or 17 to participate in the study. Participants who were 18 to 20 years old provided their own written consent. Staff obtained written consent for freed minors from the Commissioner of Administration for Children's Services in New York City. Consent forms included consent for both program participation and participation in the evaluation. Both English and Spanish consent forms were utilized.
All study procedures were approved by three Institutional Review Boards: the Administration for Children's Services in New York City, the New York State Office of Children and Family Services, and Advarra® - a national IRB.
After a youth was deemed eligible to participate and had proper written consent and assent, he completed a baseline survey via SurveyMonkey at the foster care agency. Randomization occurred at the time of the final question on the baseline survey, which prompted the youth to draw a chip from a bag. The color of the chip determined group assignment. Trained agency staff oversaw this process to ensure accuracy.
Assigned youth then received the first of two one-hour sessions, with the second session occurring 10 to 14 days after the first. This is an intent-to-treat randomized controlled trial which includes all randomized youth regardless of dosage.
Follow-up assessments were completed 3- and 9-months after the end of session two. The evaluators followed-up with participants via email, text, phone, and regular mail to have them complete the 3- and 9-month follow-up surveys. A $50 stipend was provided to youth at the end of session two, for completion of the 3-month follow-up survey, and for completion of the 9-month follow-up survey.
- Conditions
- Teen Pregnancy
- Being tested
- ACE-Plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE-PlusBehavioural
| Study group | Role | What they receive |
|---|---|---|
| ACE-Plus | Experimental | ACE-Plus is a one-on-one dual-session intervention for males aged 16 to 20 within foster care or preventive services settings which promotes condom use and knowledge of dual methods of contraception. The goal of ACE-Plus is to promote correct and consistent condom use of male latex condoms during penile-vaginal sex and to promote male engagement (e.g., discussion, decision-making) with their female partners in the use of female-centered contraception methods.
Session one focuses on correct and consistent condom use for purposes of HIV/STD prevention including information and activities that address teen pregnancy prevention. Session two, which occurs within 10 to 14 days of the first session, promotes dual-method contraceptive use. Both sessions are one hour. Receives: Behavioral: ACE-Plus |
| On Track | No intervention | On Track was the alternative program provided to males randomly assigned to the control group. On Track seeks to assist participants in identifying their aptitudes and preferences regarding their careers and their values associated with employment, and to provide tools to prepare them for the work setting and future job interviews. Participants learn how to identify attitudes, values, preferences, and challenges surrounding a career path, receive an understanding of the documents required for employment, and develop an initial employment strategy and action plan. Trained foster care agency staff deliver the curriculum to participating youth in two one-on-one sessions at agencies. Each session is one hour in length. Session two occurs 10 to 14 days after session one. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condom use in the past 3 months
The primary outcome of interest focused on condom use in the past three months at 3-month follow-up. On all surveys, youth were asked the following question:
In the past three months, how many times have you had vaginal sex without using a condom?
Measured: 3-month follow-up
Condom use in the past 3 months
The primary outcome of interest focused on condom use in the past three months at 9-month follow-up. On all surveys, youth were asked the following question:
In the past three months, how many times have you had vaginal sex without using a condom?
Measured: 9-month follow-up
Secondary outcomes (4)
Use of hormonal birth control methods (birth control pills, shot, patch, ring, IUD, or implants) while having vaginal sex during the past 3 months.
The first secondary research question focused on use of hormonal birth control methods (birth control pills, shot, patch, ring, IUD, or implants) while having vaginal sex during the past three months. On all surveys, youth were asked the following question:
In the past three months, how many times have you had vaginal sex without using an effective method of birth control (birth control pills, shot, patch, ring, IUD, or implants)?
Measured: 3-month follow-up
Use of birth control by female partner(s)
The second secondary research question involved use of birth control by female partner(s). On all surveys, youth were asked:
In the past 3 months, how often do you think your female sex partner(s) were using birth control?
Measured: 3-month follow-up
Obtaining birth control
The third secondary research question involved obtaining birth control with sexual partner(s). On all surveys, youth were asked:
In the past 3 months, have you been to a clinic or doctor with your sexual partner(s) to obtain birth control?
Measured: 3-month follow-up
Communication with sexual partner(s) about birth control
The fourth secondary research question involved communication with sexual partner(s) about birth control. On all surveys, youth were asked:
In the past 3 months, how often have you spoken with your sexual partner(s) about the type of birth control they are using?
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Aug 2016
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teen PregnancyStudies 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
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philliber Research & Evaluation
- Sponsor type
- University, hospital or other
- Collaborators
- The Office of Adolescent Health, HHS
- Responsible party
- Principal investigator, Scott Herrling, Philliber Research & Evaluation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441294
- Sponsor's protocol ID
- PhiiliberCAI
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Achieving Condom Empowerment (ACE)-Plus in New York City
- ClinicalTrials.gov ID
- NCT04441294
- Acronym / sponsor ID
- PhiiliberCAI
- Conditions
- Teen Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Philliber Research & EvaluationUniversity, hospital or other
- Collaborators
- The Office of Adolescent Health, HHS
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 22 Jun 2020 (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.
To test a new curriculum - the ACE-Plus curriculum - a two-session program that teaches males in foster care and/or preventive services about correct and consistent condom use as well as engagement with female partners to obtain and use contraception.
Detailed description
ACE-Plus is a one-on-one dual-session intervention for males aged 16 to 20 within foster care or preventive services settings which promotes condom use and knowledge of dual methods of contraception. The goal of ACE-Plus is to promote correct and consistent condom use of male latex condoms during penile-vaginal sex and to promote male engagement (e.g., discussion, decision-making) with their female partners in the use of female-centered contraception methods.
Over 200 males aged 16 to 20 were recruited into this study (called My Plan) by 9 foster care agencies in New York City from June 2016 through November 2019. The foster care agencies were selected by Cicatelli Associates, Inc. in New York City, a non-profit organization which oversaw the implementation of the study. These agencies represent a convenience sample which agreed to participate and deliver either the treatment condition (Ace-Plus) or a benign control condition (On Track). Agency staff received a five-day training regarding the implementation of both programs prior to youth engagement and also received additional refresher trainings and technical assistance as needed.
Agency staff screened potential study youth to ascertain eligibility. To be eligible for inclusion in this study, interested youth must have been born with a penis, been aged 16 to 20, have had vaginal intercourse at least once, and could not be currently participating in any other teen pregnancy prevention program. Targeted youth were either in foster care or preventive services. Screening occurred until 238 males were enrolled and completed a baseline assessment.
After youth met the screening criteria and agreed to participate, agency staff obtained written parental consent (from biological parents) and youth assent for each male age 16 or 17 to participate in the study. Participants who were 18 to 20 years old provided their own written consent. Staff obtained written consent for freed minors from the Commissioner of Administration for Children's Services in New York City. Consent forms included consent for both program participation and participation in the evaluation. Both English and Spanish consent forms were utilized.
All study procedures were approved by three Institutional Review Boards: the Administration for Children's Services in New York City, the New York State Office of Children and Family Services, and Advarra® - a national IRB.
After a youth was deemed eligible to participate and had proper written consent and assent, he completed a baseline survey via SurveyMonkey at the foster care agency. Randomization occurred at the time of the final question on the baseline survey, which prompted the youth to draw a chip from a bag. The color of the chip determined group assignment. Trained agency staff oversaw this process to ensure accuracy.
Assigned youth then received the first of two one-hour sessions, with the second session occurring 10 to 14 days after the first. This is an intent-to-treat randomized controlled trial which includes all randomized youth regardless of dosage.
Follow-up assessments were completed 3- and 9-months after the end of session two. The evaluators followed-up with participants via email, text, phone, and regular mail to have them complete the 3- and 9-month follow-up surveys. A $50 stipend was provided to youth at the end of session two, for completion of the 3-month follow-up survey, and for completion of the 9-month follow-up survey.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACE-Plus | Experimental | Behavioral: ACE-PlusACE-Plus is a one-on-one dual-session intervention for males aged 16 to 20 within foster care or preventive services settings which promotes condom use and knowledge of dual methods of contraception. The goal of ACE-Plus is to promote correct and consistent condom use of male latex condoms during penile-vaginal sex and to promote male engagement (e.g., discussion, decision-making) with their female partners in the use of female-centered contraception methods. Session one focuses on correct and consistent condom use for purposes of HIV/STD prevention including information and activities that address teen pregnancy prevention. Session two, which occurs within 10 to 14 days of the first session, promotes dual-method contraceptive use. Both sessions are one hour. |
| On Track | No intervention | –On Track was the alternative program provided to males randomly assigned to the control group. On Track seeks to assist participants in identifying their aptitudes and preferences regarding their careers and their values associated with employment, and to provide tools to prepare them for the work setting and future job interviews. Participants learn how to identify attitudes, values, preferences, and challenges surrounding a career path, receive an understanding of the documents required for employment, and develop an initial employment strategy and action plan. Trained foster care agency staff deliver the curriculum to participating youth in two one-on-one sessions at agencies. Each session is one hour in length. Session two occurs 10 to 14 days after session one. |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Youth must have been born with a penis
- Youth must be aged 16 to 20
- Youth must have had vaginal intercourse at least once
- Youth can not be currently participating in any other teen pregnancy prevention program
- Youth must be in foster care or preventive services
Key exclusion criteria (1 listed)
- 1. Lack of consent.
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 |
|---|---|---|
| ACE-Plus | Behavioural | ACE-Plus |
Primary outcome
Condom use in the past 3 months
Time frame: 3-month follow-up
The primary outcome of interest focused on condom use in the past three months at 3-month follow-up. On all surveys, youth were asked the following question: In the past three months, how many times have you had vaginal sex without using a condom?
Condom use in the past 3 months
Time frame: 9-month follow-up
The primary outcome of interest focused on condom use in the past three months at 9-month follow-up. On all surveys, youth were asked the following question: In the past three months, how many times have you had vaginal sex without using a condom?
4 secondary outcomes
Use of hormonal birth control methods (birth control pills, shot, patch, ring, IUD, or implants) while having vaginal sex during the past 3 months.
Time frame: 3-month follow-up
Use of birth control by female partner(s)
Time frame: 3-month follow-up
Obtaining birth control
Time frame: 3-month follow-up
Communication with sexual partner(s) about birth control
Time frame: 3-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ACE-Plus in people with Teen Pregnancy, run by Philliber Research & Evaluation.
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 5 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 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Condom use in the past 3 months (time frame: 3-month follow-up). 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 22 Jun 2020.