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Evaluating a Digital Intervention to Improve Adolescent Condom Use and Communication

Evaluating a Digital Intervention to Improve Adolescent Condom Use and Communication

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06878755
Enrollment
300
Registered
2025-03-17
Start date
2026-06-01
Completion date
2028-01-01
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condomless Sex, Sexual Assault

Keywords

online intervention, digital health, sexual consent, condom use, condom negotiation, LGBTQ health, adolescents

Brief 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.

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.

Interventions

OTHERPromoting Assertive Communication among Teens (PACT)

See Arm Description

See Arm Description

Sponsors

North Carolina Agriculture & Technical State University
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

PACT (Promoting Assertive Communication among Teens) is a brief online (web-based) educational program that can be taken on participants' personal devices.

Eligibility

Sex/Gender
ALL
Age
14 Years to 17 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Condom negotiation intentionsBaseline, immediately post-intervention, 3 months, 9 monthsParticipants' likelihood of using a condom during sexual intercourse with a partner
Affirmative consent intentionsBaseline, immediately post-intervention, 3 months, 9 monthsParticipants' 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-efficacyBaseline, immediately post-intervention, 3 months, 9 monthsParticipants' 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-efficacyBaseline, immediately post-intervention, 3 months, 9 monthsParticipants' 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

MeasureTime frameDescription
Condom useBaseline, 3 months, 9 monthsBehavioral outcome measuring whether a condom was used for sexual intercourse
Condom negotiationBaseline, 3 months, 9 monthsBehavioral outcome measuring discussion about condom use prior to sexual intercourse
Affirmative consent communicationBaseline, 3 months, 9 monthsBehavioral outcome measuring affirmative consent communication before and during sexual intercourse
Condom attitudesBaseline, immediately post-intervention, 3 months, 9 monthsParticipants' beliefs about the importance of condom use (items from the Condom Attitudes scale, strongly disagree to strongly agree, higher scores = more positive attitudes)
Affirmative consent attitudesBaseline, immediately post-intervention, 3 months, 9 monthsParticipants' beliefs about the importance of affirmative consent (items from the Sexual Consent Scale-Revised, strongly disagree to strongly agree, higher scores = more positive attitudes)
Condom normsBaseline, immediately post-intervention, 3 months, 9 monthsParticipants' personal and perceived norms about condom use (condom norms items from the Psychosocial Scales, higher score = more positive norms)
Affirmative consent normsBaseline, immediately post-intervention, 3 months, 9 monthsParticipants' personal and perceived norms about affirmative consent (Norms items from Sexual Consent Scale-Revised, strongly disagree to strongly agree, higher scores = more positive norms)
AcceptabilityImmediately post-interventionParticipants' 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)

Countries

United States

Contacts

CONTACTHannah Javidi, PhD
hjavidi@ncat.edu7042807859
CONTACTEric Walsh-Buhi, PhD, MPH
erwals@iu.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026