Evaluating a Digital Intervention to Improve Adolescent Condom Use and Communication

NCT06878755 | Not Yet Recruiting

• 2 other identifiers: 207405K99MD019060-02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the effectiveness, likability, and implementation potential of PACT, an adapted digital program to teach non-heterosexual adolescent boys about sexual consent and condom negotiation in a randomized controlled trial over 9 months.

Conditions

Condomless Sex; Sexual Assault

Keywords

online intervention; digital health; sexual consent; condom use; condom negotiation; LGBTQ health; adolescents

Outcome Measures

Primary Outcomes (4)

• Condom negotiation intentions

  Participants' likelihood of using a condom during sexual intercourse with a partner

  Baseline, immediately post-intervention, 3 months, 9 months

• Affirmative consent intentions

  Participants' likelihood of 1) ensuring consent is obtained from a partner prior to sexual intercourse and 2) communicating their consent affirmatively to a partner prior to intercourse

  Baseline, immediately post-intervention, 3 months, 9 months

• Condom negotiation self-efficacy

  Participants' confidence in their ability to assert their desire to use a condom with a partner (5-point likert, strongly disagree to strongly agree, higher scores = higher self-efficacy)

  Baseline, immediately post-intervention, 3 months, 9 months

• Affirmative consent self-efficacy

  Participants' confidence in their ability to communicate sexual consent with a partner (4-point likert, "not at all confident" to "very confident", higher scores = higher self-efficacy)

  Baseline, immediately post-intervention, 3 months, 9 months

Secondary Outcomes (8)

• Condom use

  Baseline, 3 months, 9 months

• Condom negotiation

  Baseline, 3 months, 9 months

• Affirmative consent communication

  Baseline, 3 months, 9 months

• Condom attitudes

  Baseline, immediately post-intervention, 3 months, 9 months

• Affirmative consent attitudes

  Baseline, immediately post-intervention, 3 months, 9 months

Other Outcomes (2)

• Dose

  Immediately post-intervention

• Cost

  Baseline

Study Arms (2)

Promoting Assertive Communication among Teens (PACT)

EXPERIMENTAL

A 30-minute digital program designed to teach adolescent sexual minority males information and skills regarding two dimensions of sexual assertiveness: consent and condom negotiation.

Other: Promoting Assertive Communication among Teens (PACT)

Healthy Minds

ACTIVE COMPARATOR

An attention-matched digital program focused on growth mindsets and mental health, designed for a general population of adolescents.

Other: Healthy Minds

Interventions

Promoting Assertive Communication among Teens (PACT) OTHER

See Arm Description

Promoting Assertive Communication among Teens (PACT)

Healthy Minds OTHER

See Arm Description

Healthy Minds

Eligibility Criteria

• Age: 14 Years - 17 Years
• Gender Eligibility Details: Participants will be eligible if they consider themselves "queer teen guys." Although a large percentage of the sample will be male-assigned at birth, the investigators anticipate that the total sample will also include gender-diverse adolescents, including those who are trans boys, transmasculine, non-binary, agender, genderqueer, and gender nonconforming.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years old
• lives in the U.S.
• identifies as a queer teen guy or sexual minority male

You may not qualify if:

• younger than 14
• older than 17
• does not live in U.S.
• does not identify as a queer teen guy or sexual minority male

Sponsors & Collaborators

• North Carolina Agriculture & Technical State University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

North Carolina A&T State University

Greensboro, North Carolina, 27611, United States

Location

Related Publications (1)

• Javidi H, Widman L, Maheux AJ, McCrimmon J, Evans-Paulson R, Becker W. PACT: Developing and Evaluating a Digital Sexual Consent Program for Youth. J Sex Res. 2024 Mar-Apr;61(3):466-480. doi: 10.1080/00224499.2023.2208560. Epub 2023 May 15.

  PMID: 37186689 BACKGROUND

MeSH Terms

Conditions

Unsafe Sex

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Central Study Contacts

Hannah Javidi, PhD

CONTACT

7042807859; hjavidi@ncat.edu

Eric Walsh-Buhi, PhD, MPH

CONTACT

erwals@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Model Details: PACT (Promoting Assertive Communication among Teens) is a brief online (web-based) educational program that can be taken on participants' personal devices.

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: March 17, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)