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Completed Not applicable Interventional Results available

Digital Star: HIV Prevention for Youth in Mental Health Treatment

ClinicalTrials.gov ID: NCT02921841

Public ClinicalTrials.gov record NCT02921841. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 10:03 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Teenagers in mental health treatment are at greater risk for HIV and other sexually transmitted infections. This greater risk comes from many factors, some of which are related to poor emotion regulation and low self-confidence. There is a need for an HIV prevention program specifically for these at-risk teens. The goal of this study is to develop a computerized HIV prevention study tailored to adolescents in mental health treatment. The first part of the study will develop core sessions of D\*STAR. It will do this by using focus group feedback from approximately 15 adolescents in mental health treatment, and approximately 10 parents of youth in mental health treatment and mental health treatment center staff. Feedback on D\*STAR prototype sessions will also be collected from two individual interviews with approximately 15 youth in mental health treatment. Core sessions will then be reviewed in an open trial with approximately 30 adolescents. The second part of the study will develop and refine digital versions of the remaining sessions of STAR and a digital general health promotion intervention. It will do this by using focus group feedback from approximately 20 adolescents in mental health treatment, and approximately 10 community advisory board members which include variety of staff from mental health treatment settings such as administrators, supervisors, therapists, health teachers at therapeutic schools, clinicians at day hospitals and day treatment programs, parents of youth in mental health treatment and from relevant community organizations, such as those serving lesbian, gay, bisexual, transgender, and questioning youth. Feedback on D\*STAR prototype sessions will also be collected from two individual interviews with approximately 20 youth in mental health treatment. All developed sessions (from both Phase I and Phase II) will then be reviewed in an open trial with approximately 20 adolescents. A randomized control trial (RCT) will then be conducted to compare D\*STAR to a time matched digital general health promotion intervention among approximately 120 adolescents. For the pilot and RCT phases, assessments will be administered prior to randomization, immediately following the last intervention session, and at one month post-intervention (pilot study) or at three month post-intervention (RCT).

Study identification

NCT ID
NCT02921841
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Rhode Island Hospital
Other
Enrollment
125 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
13 Years to 20 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2016
Primary completion
Feb 28, 2019
Completion
Jun 30, 2019
Last update posted
Jan 26, 2020

2016 – 2019

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Rhode Island Hospital Providence Rhode Island 02903

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02921841, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 26, 2020 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02921841 live on ClinicalTrials.gov.

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