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Clinical Trials/NCT04441294
NCT04441294UnknownNot Applicable

The Evaluation of Achieving Condom Empowerment (ACE)-Plus in New York City

Philliber Research & Evaluation0 sites238 target enrollmentStarted: August 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
238
Primary Endpoint
Condom use in the past 3 months

Study Overview

Brief 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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
16 Years to 20 Years (Child, Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • Lack of consent.

Outcomes

Primary Outcomes

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?

Secondary Outcomes

  • Use of birth control by female partner(s)(3-month follow-up)
  • Use of hormonal birth control methods (birth control pills, shot, patch, ring, IUD, or implants) while having vaginal sex during the past 3 months.(3-month follow-up)
  • Obtaining birth control(3-month follow-up)
  • Communication with sexual partner(s) about birth control(3-month follow-up)

Investigators

Sponsor
Philliber Research & Evaluation
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Scott Herrling

Senior Research Associate

Philliber Research & Evaluation

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