N/A
Completed N=254
Innovative Approaches for Minor Consent: Consent 2.0
Source: ClinicalTrials.gov NCT03242954 ↗Enrolled (actual)
254
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Mean Adolescent WTP Scores — 3.7; 3.7; 3.5 score on a scale — p=0.5148
Summary
The purpose of this study is to examine how the consent process affects the acceptability of participation in biomedical HIV prevention trials, from the perspective of behaviorally high-risk minors and the parents of minor adolescents.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Adolescent WTP Scores |
3.7; 3.7; 3.5 | 0.5148 |
| PRIMARY Mean Parent WTS Scores |
2.6; 3.1; 4.4 | <.0001 sig |
| PRIMARY Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores |
3.6; 3.7; 3.6; 3.8; 3.8; 3.4 | 0.4324 |
| PRIMARY Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores |
2.7; 3.1; 4.3; 2.6; 3.1; 4.4 | <.0001 sig |
Eligibility Criteria
Note: Age limits apply to adolescent participants and to the adolescent children of parent participants.
Adolescent Inclusion Criteria
- Age 14-17 inclusive
- Able to read and speak English
- HIV status is negative or unknown
- Engaged in high-risk sexual activity in the last six months
Adolescent Exclusion Criteria
- Child of a parent already enrolled in the study
Parent Inclusion Criteria
- Able to read and speak English
- Parent or guardian of an adolescent who is between ages 14-17
- The parent/guardian's adolescent's HIV status is either negative or unknown
Parent Exclusion Criteria
- Parent of a child already enrolled in the study
Data sourced from ClinicalTrials.gov (NCT03242954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.