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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
North Carolina Agriculture & Technical State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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