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NCT Number: NCT06878755

Evaluating a Digital Intervention to Improve Adolescent Condom Use and Communication

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.

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Key information

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Carolina A&T State University

Greensboro, North Carolina, 27611, United States

Location contact

Hannah Javidi, PhD

CONTACT

[email protected]

704-280-7859

Hannah Javidi, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Promoting Assertive Communication among Teens (PACT)

Other

See Arm Description

Healthy Minds

Other

See Arm Description

Primary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

Secondary outcomes

  1. Condom use

    Time frame: Baseline, 3 months, 9 months

    Behavioral outcome measuring whether a condom was used for sexual intercourse

  2. Condom negotiation

    Time frame: Baseline, 3 months, 9 months

    Behavioral outcome measuring discussion about condom use prior to sexual intercourse

  3. Affirmative consent communication

    Time frame: Baseline, 3 months, 9 months

    Behavioral outcome measuring affirmative consent communication before and during sexual intercourse

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

Other outcomes

  1. Dose

    Time frame: Immediately post-intervention

    How much of the intervention did participants complete?

  2. Cost

    Time frame: Baseline

    How much does it cost to implement the intervention?

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Walsh-Buhi, PhD, MPH

CONTACT

[email protected]

Hannah Javidi, PhD

CONTACT

[email protected]

7042807859

Sponsors and collaborators

Lead sponsor

North Carolina Agriculture & Technical State University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Mar 17, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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