Ignite Creation Date:
2024-05-06 @ 2:52 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04441294
Status:
UNKNOWN
Last Update Posted:
2020-06-22
First Post:
2020-06-15
Brief Title:
The Evaluation of Achieving Condom Empowerment ACE-Plus in New York City
Sponsor:
Philliber Research Evaluation
Organization:
Philliber Research Evaluation
Study Overview
Official Title:
The Evaluation of Achieving Condom Empowerment ACE-Plus in New York City
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To test a new curriculum - the ACE-Plus curriculum - a two-session program that teaches males in foster care andor 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 eg 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 Childrens 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 Childrens 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
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 Childrens 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 Childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None