Evaluating a Digital Intervention to Improve Adolescent Condom Use and Communication
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Promoting Assertive Communication among Teens (PACT), Healthy Minds.
- Who it may be relevant to
- Registry conditions: Condomless Sex, Sexual Assault. Basic parameters: 14 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Promoting Assertive Communication among Teens (PACT)
See Arm Description - Other Healthy Minds
See Arm Description
Primary outcome measures
- Condom negotiation intentions [Time frame: Baseline, immediately post-intervention, 3 months, 9 months]
- Affirmative consent intentions [Time frame: Baseline, immediately post-intervention, 3 months, 9 months]
- Condom negotiation self-efficacy [Time frame: Baseline, immediately post-intervention, 3 months, 9 months]
- Affirmative consent self-efficacy [Time frame: Baseline, immediately post-intervention, 3 months, 9 months]
Secondary outcome measures (8)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- North Carolina A&T State University — Greensboro
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. PMID 37186689
Identifiers
NCT: NCT06878755 · 20740 · 5K99MD019060-02