Evaluating a Digital Intervention to Improve Adolescent Condom Use and Communication

March 24, 2026 updated by: Hannah Javidi, North Carolina Agriculture & Technical State University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Greensboro, North Carolina, United States, 27611
        • North Carolina A&T State University
        • Contact:
        • Principal Investigator:
          • Hannah Javidi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
See Arm Description
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
See Arm Description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Condom negotiation intentions
Time Frame: Baseline, immediately post-intervention, 3 months, 9 months
Participants' likelihood of using a condom during sexual intercourse with a partner
Baseline, immediately post-intervention, 3 months, 9 months
Affirmative consent intentions
Time Frame: Baseline, immediately post-intervention, 3 months, 9 months
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
Time Frame: Baseline, immediately post-intervention, 3 months, 9 months
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
Time Frame: Baseline, immediately post-intervention, 3 months, 9 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Condom use
Time Frame: Baseline, 3 months, 9 months
Behavioral outcome measuring whether a condom was used for sexual intercourse
Baseline, 3 months, 9 months
Condom negotiation
Time Frame: Baseline, 3 months, 9 months
Behavioral outcome measuring discussion about condom use prior to sexual intercourse
Baseline, 3 months, 9 months
Affirmative consent communication
Time Frame: Baseline, 3 months, 9 months
Behavioral outcome measuring affirmative consent communication before and during sexual intercourse
Baseline, 3 months, 9 months
Condom attitudes
Time Frame: Baseline, immediately post-intervention, 3 months, 9 months
Participants' beliefs about the importance of condom use (items from the Condom Attitudes scale, strongly disagree to strongly agree, higher scores = more positive attitudes)
Baseline, immediately post-intervention, 3 months, 9 months
Affirmative consent attitudes
Time Frame: Baseline, immediately post-intervention, 3 months, 9 months
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)
Baseline, immediately post-intervention, 3 months, 9 months
Condom norms
Time Frame: Baseline, immediately post-intervention, 3 months, 9 months
Participants' personal and perceived norms about condom use (condom norms items from the Psychosocial Scales, higher score = more positive norms)
Baseline, immediately post-intervention, 3 months, 9 months
Affirmative consent norms
Time Frame: Baseline, immediately post-intervention, 3 months, 9 months
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)
Baseline, immediately post-intervention, 3 months, 9 months
Acceptability
Time Frame: Immediately post-intervention
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)
Immediately post-intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose
Time Frame: Immediately post-intervention
How much of the intervention did participants complete?
Immediately post-intervention
Cost
Time Frame: Baseline
How much does it cost to implement the intervention?
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Carolina Agriculture & Technical State University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20740
  • 5K99MD019060-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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