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

NCT04441294 | Unknown

• 1 other identifier: PhiiliberCAI
• Study Type: interventional
• Target: 238
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Teen Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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?

  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?

  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.

  3-month follow-up

• Use of birth control by female partner(s)

  3-month follow-up

• Obtaining birth control

  3-month follow-up

• Communication with sexual partner(s) about birth control

  3-month follow-up

Study Arms (2)

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.

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.

Interventions

ACE-Plus BEHAVIORAL

ACE-Plus

Eligibility Criteria

• Age: 16 Years - 20 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \. Lack of consent.

Sponsors & Collaborators

• Philliber Research & Evaluation: lead
• The Office of Adolescent Health, HHS: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Associate

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 22, 2020
• Study Start: August 1, 2016
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share