Clinical trial NCT04441294: The Evaluation of Achieving Condom Empowerment (ACE)-Plus in New York City
Official title: The Evaluation of Achieving Condom Empowerment (ACE)-Plus in New York City
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Teen Pregnancy
Lead sponsor: Philliber Research & Evaluation
Sponsor class: OTHER
Collaborators: name: The Office of Adolescent Health, HHS
First posted: 2020-06-22
Enrollment: 238
Sex: MALE
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Youth must have been born with a penis
2. Youth must be aged 16 to 20
3. Youth must have had vaginal intercourse at least once
4. Youth can not be currently participating in any other teen pregnancy prevention program
5. Youth must be in foster care or preventive services

Exclusion Criteria:

1. Lack of consent.

Primary outcomes:
measure: Condom use in the past 3 months
timeFrame: 3-month follow-up
measure: Condom use in the past 3 months
timeFrame: 9-month follow-up
Secondary outcomes:
measure: Use of hormonal birth control methods (birth control pills, shot, patch, ring, IUD, or implants) while having vaginal sex during the past 3 months.
timeFrame: 3-month follow-up
measure: Use of birth control by female partner(s)
timeFrame: 3-month follow-up
measure: Obtaining birth control
timeFrame: 3-month follow-up
measure: Communication with sexual partner(s) about birth control
timeFrame: 3-month follow-up
Other outcomes:
Locations:
Study officials:
References: