CClinicalTrials.gg
Not yet recruitingNCT06878755Updated Mar 30, 2026

Evaluating a Digital Intervention to Improve Adolescent Condom Use and Communication

An interventional study of Promoting Assertive Communication among Teens (PACT) and Healthy Minds in Condomless Sex and Sexual Assault, sponsored by North Carolina Agriculture & Technical State University. Not yet recruiting at 1 site in United States. Open to participants aged 14 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by North Carolina Agriculture & Technical State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
14 Years to 17 Years
Sex
All
01

Study 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.

Read the detailed description

Because the PACT (Promoting Affirmative Consent among Teens) digital health intervention showed evidence of effectiveness at improving sexual consent cognitions in its first trial, and was found generally likable among adolescents, the research team has adapted the program to serve as sexual assertiveness (consent and condom negotiation) training. This adapted version is tailored to the specific needs of adolescent sexual minority males (ASMM), a population that has been historically underserved by traditional sex education while also experiencing disproportionately high rates of both sexual violence victimization and condom non-use. The evaluation of the adapted PACT program (now titled Promoting Assertive Communication among Teens) will take place in an RCT with a Type 1 effectiveness-implementation hybrid design. Surveys will be administered at pre-intervention, post-intervention, 3-month follow-up, and 9-month follow-up. The investigators will assess acceptability, implementation factors, and main and secondary outcomes related to consent and condom negotiation/use.

02

Conditions studied

  • Condomless Sex
  • Sexual Assault

Keywords

  • online intervention
  • digital health
  • sexual consent
  • condom use
  • condom negotiation
  • LGBTQ health
  • adolescents
03

In context

Lead sponsor

North Carolina Agriculture & Technical State University is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 14-17 years old
  • lives in the U.S.
  • identifies as a queer teen guy or sexual minority male

Exclusion criteria

Exclusion Criteria:

  • younger than 14
  • older than 17
  • does not live in U.S.
  • does not identify as a queer teen guy or sexual minority male
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Promoting Assertive Communication among Teens (PACT)

    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)

  • Active comparator
    Healthy Minds

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

    Other: Healthy Minds

Interventions

  • OtherPromoting Assertive Communication among Teens (PACT)

    See Arm Description

  • OtherHealthy Minds

    See Arm Description

06

What researchers measure

Primary outcomes

  1. Condom negotiation intentions

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

    Time frame: Baseline, immediately post-intervention, 3 months, 9 months

  2. 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

    Time frame: Baseline, immediately post-intervention, 3 months, 9 months

  3. 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)

    Time frame: Baseline, immediately post-intervention, 3 months, 9 months

  4. 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)

    Time frame: Baseline, immediately post-intervention, 3 months, 9 months

Secondary outcomes

  1. Condom use

    Behavioral outcome measuring whether a condom was used for sexual intercourse

    Time frame: Baseline, 3 months, 9 months

  2. Condom negotiation

    Behavioral outcome measuring discussion about condom use prior to sexual intercourse

    Time frame: Baseline, 3 months, 9 months

  3. Affirmative consent communication

    Behavioral outcome measuring affirmative consent communication before and during sexual intercourse

    Time frame: Baseline, 3 months, 9 months

  4. Condom attitudes

    Participants' beliefs about the importance of condom use (items from the Condom Attitudes scale, strongly disagree to strongly agree, higher scores = more positive attitudes)

    Time frame: Baseline, immediately post-intervention, 3 months, 9 months

  5. Affirmative consent attitudes

    Participants' beliefs about the importance of affirmative consent (items from the Sexual Consent Scale-Revised, strongly disagree to strongly agree, higher scores = more positive attitudes)

    Time frame: Baseline, immediately post-intervention, 3 months, 9 months

  6. Condom norms

    Participants' personal and perceived norms about condom use (condom norms items from the Psychosocial Scales, higher score = more positive norms)

    Time frame: Baseline, immediately post-intervention, 3 months, 9 months

  7. Affirmative consent norms

    Participants' personal and perceived norms about affirmative consent (Norms items from Sexual Consent Scale-Revised, strongly disagree to strongly agree, higher scores = more positive norms)

    Time frame: Baseline, immediately post-intervention, 3 months, 9 months

  8. Acceptability

    Participants' perceptions of the likability and usefulness of the program (items adapted from Acceptability of Intervention measure, "not at all" to "a lot", higher scores = higher acceptability)

    Time frame: Immediately post-intervention

Other outcomes

  1. Dose

    How much of the intervention did participants complete?

    Time frame: Immediately post-intervention

  2. Cost

    How much does it cost to implement the intervention?

    Time frame: Baseline

07

Study locations

1 site
  • North Carolina A&T State University
    Greensboro, North Carolina 27611, United States
    • Hannah Javidi, PhD · Contact · hjavidi@ncat.edu · 704-280-7859
    • Hannah Javidi, PhD · Principal investigator
08

References and documents

Publications

  • 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. PubMed 37186689 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06878755
Lead sponsor
North Carolina Agriculture & Technical State University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Responsible party
Hannah Javidi (Assistant Professor of Psychology, North Carolina Agriculture & Technical State University) — Principal investigator
First posted
Mar 17, 2025
Start date
Jun 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Jan 2028 (estimated)
Last update
Mar 30, 2026

Study contacts

Hannah Javidi, PhD
Contact
hjavidi@ncat.edu
7042807859
Eric Walsh-Buhi, PhD, MPH
Contact
erwals@iu.edu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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