Clinical trial NCT06878755: Evaluating a Digital Sexual Assertiveness Intervention for ASMM
Official title: A Randomized Controlled Trial to Evaluate a Digital Sexual Assertiveness Intervention for Adolescent Sexual Minority Males
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Condomless Sex
Sexual Assault
Keywords: online intervention
digital health
sexual consent
condom use
condom negotiation
LGBTQ health
adolescents
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 300
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Condom negotiation intentions
timeFrame: Baseline, immediately post-intervention, 3 months, 9 months
measure: Affirmative consent intentions
timeFrame: Baseline, immediately post-intervention, 3 months, 9 months
measure: Condom negotiation self-efficacy
timeFrame: Baseline, immediately post-intervention, 3 months, 9 months
measure: Affirmative consent self-efficacy
timeFrame: Baseline, immediately post-intervention, 3 months, 9 months
Secondary outcomes:
measure: Condom use
timeFrame: Baseline, 3 months, 9 months
measure: Condom negotiation
timeFrame: Baseline, 3 months, 9 months
measure: Affirmative consent communication
timeFrame: Baseline, 3 months, 9 months
measure: Condom attitudes
timeFrame: Baseline, immediately post-intervention, 3 months, 9 months
measure: Affirmative consent attitudes
timeFrame: Baseline, immediately post-intervention, 3 months, 9 months
measure: Condom norms
timeFrame: Baseline, immediately post-intervention, 3 months, 9 months
measure: Affirmative consent norms
timeFrame: Baseline, immediately post-intervention, 3 months, 9 months
measure: Acceptability
timeFrame: Immediately post-intervention
Other outcomes:
measure: Dose
timeFrame: Immediately post-intervention
measure: Cost
timeFrame: Baseline
Locations:
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
Study officials:
References:
citation: 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.