North Carolina A&T State University
Greensboro, North Carolina, 27611, United States
NCT Number: NCT06878755
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.
Trial opening soon.
Get Notified14 year–17 year
All sexes
Interventional
Not applicable
Greensboro, North Carolina, 27611, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
See Arm Description
See Arm Description
Time frame: Baseline, immediately post-intervention, 3 months, 9 months
Participants' likelihood of using a condom during sexual intercourse with a partner
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
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)
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)
Time frame: Baseline, 3 months, 9 months
Behavioral outcome measuring whether a condom was used for sexual intercourse
Time frame: Baseline, 3 months, 9 months
Behavioral outcome measuring discussion about condom use prior to sexual intercourse
Time frame: Baseline, 3 months, 9 months
Behavioral outcome measuring affirmative consent communication before and during sexual intercourse
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)
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)
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)
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)
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)
Time frame: Immediately post-intervention
How much of the intervention did participants complete?
Time frame: Baseline
How much does it cost to implement the intervention?
Contact information is provided by the study sponsor or research team.
Eric Walsh-Buhi, PhD, MPH
CONTACT
Hannah Javidi, PhD
CONTACT
North Carolina Agriculture & Technical State University
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT07475702
Behavior, Condomless Sex
San Francisco, California, United States
View Trial DetailsNCT06096324
Behavior, Behavioral Symptoms
Baltimore, Maryland, United States
View Trial DetailsNCT02974998
Access and Linkage to Healthcare, Acquired Immunodeficiency Syndrome
Cape Town, South Africa
View Trial DetailsNCT05620849
Alcohol Drinking, Behavior
Seattle, Washington, United States
View Trial Details