Condomless SexNCT06878755
Evaluating a Digital Intervention to Improve Adolescent Condom Use and Communication
A study testing Promoting Assertive Communication among Teens (PACT) and Healthy Minds in people with Condomless Sex and Sexual Assault, run by North Carolina Agriculture & Technical State University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Condomless Sex, Sexual Assault
- What is being tested?
- Promoting Assertive Communication among Teens (PACT) and Healthy Minds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 14-17 years old
- lives in the U.S.
- identifies as a queer teen guy or sexual minority male
Who cannot join
- younger than 14
- older than 17
- does not live in U.S.
- does not identify as a queer teen guy or sexual minority male
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eric Walsh-Buhi, PhD, MPH contact
United States1 site
North Carolina A&T State University
Greensboro, North Carolina, 27611
Hannah Javidi, PhD, 704-280-7859, hjavidi@ncat.edu
Hannah Javidi, PhD
About this study
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.
- Conditions
- Condomless Sex, Sexual Assault
- Being tested
- Promoting Assertive Communication among Teens (PACT), Healthy Minds
- Keywords
- online intervention, digital health, sexual consent, condom use, condom negotiation, LGBTQ health, adolescents
- Medical subject headings
- Unsafe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting Assertive Communication among Teens (PACT)Other
See Arm Description
Healthy MindsOther
See Arm Description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Healthy Minds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condom negotiation intentions
Participants' likelihood of using a condom during sexual intercourse with a partner
Measured: 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
Measured: 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)
Measured: 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)
Measured: Baseline, immediately post-intervention, 3 months, 9 months
Secondary outcomes (8)
Condom use
Behavioral outcome measuring whether a condom was used for sexual intercourse
Measured: Baseline, 3 months, 9 months
Condom negotiation
Behavioral outcome measuring discussion about condom use prior to sexual intercourse
Measured: Baseline, 3 months, 9 months
Affirmative consent communication
Behavioral outcome measuring affirmative consent communication before and during sexual intercourse
Measured: Baseline, 3 months, 9 months
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)
Measured: Baseline, immediately post-intervention, 3 months, 9 months
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)
Measured: Baseline, immediately post-intervention, 3 months, 9 months
Condom norms
Participants' personal and perceived norms about condom use (condom norms items from the Psychosocial Scales, higher score = more positive norms)
Measured: Baseline, immediately post-intervention, 3 months, 9 months
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)
Measured: Baseline, immediately post-intervention, 3 months, 9 months
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)
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Condomless SexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PACT (Promoting Assertive Communication among Teens) is a brief online (web-based) educational program that can be taken on participants' personal devices.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Carolina Agriculture & Technical State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Hannah Javidi, North Carolina Agriculture & Technical State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878755
- Sponsor's protocol ID
- 20740
- Other IDs
- 5K99MD019060-02
- Status last verified
- Mar 2026
- First submitted
- 23 Dec 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Digital Intervention to Improve Adolescent Condom Use and Communication
- ClinicalTrials.gov ID
- NCT06878755
- Acronym / sponsor ID
- 20740
- Conditions
- Condomless Sex, Sexual Assault
- Keywords
- online intervention, digital health, sexual consent, condom use, condom negotiation, LGBTQ health, adolescents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- North Carolina Agriculture & Technical State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- PACT (Promoting Assertive Communication among Teens) is a brief online (web-based) educational program that can be taken on participants' personal devices.
| Arm | Type | Receives |
|---|---|---|
| Promoting Assertive Communication among Teens (PACT) | Experimental | Other: 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. |
| Healthy Minds | Active comparator | Other: Healthy MindsAn attention-matched digital program focused on growth mindsets and mental health, designed for a general population of adolescents. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 14-17 years old
- lives in the U.S.
- identifies as a queer teen guy or sexual minority male
Key exclusion criteria (4 listed)
- younger than 14
- older than 17
- does not live in U.S.
- does not identify as a queer teen guy or sexual minority male
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promoting Assertive Communication among Teens (PACT)See Arm Description | Other | Promoting Assertive Communication among Teens (PACT) |
| Healthy MindsSee Arm Description | Other | Healthy Minds |
Primary outcome
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
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
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)
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)
8 secondary outcomes
Condom use
Time frame: Baseline, 3 months, 9 months
Condom negotiation
Time frame: Baseline, 3 months, 9 months
Affirmative consent communication
Time frame: Baseline, 3 months, 9 months
Condom attitudes
Time frame: Baseline, immediately post-intervention, 3 months, 9 months
Affirmative consent attitudes
Time frame: Baseline, immediately post-intervention, 3 months, 9 months
Condom norms
Time frame: Baseline, immediately post-intervention, 3 months, 9 months
Affirmative consent norms
Time frame: Baseline, immediately post-intervention, 3 months, 9 months
Acceptability
Time frame: Immediately post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 37186689Javidi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Walsh-Buhi, PhD, MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting Assertive Communication among Teens (PACT) and Healthy Minds in people with Condomless Sex and Sexual Assault, run by North Carolina Agriculture & Technical State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Javidi, PhD (7042807859, hjavidi@ncat.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Condom negotiation intentions (time frame: Baseline, immediately post-intervention, 3 months, 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06878755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.