N/A
N=125
Digital Star: HIV Prevention for Youth in Mental Health Treatment
Human Immunodeficiency Virus · Mental Health
Bottom Line
View on ClinicalTrials.gov: NCT02921841 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: HIV Knowledge — 11.10; 10.98 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- D*STAR (Behavioral); D*HEALTH (Behavioral)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Rhode Island Hospital
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HIV Knowledge |
11.10; 10.98 | — |
| PRIMARY Self-efficacy for HIV Prevention |
37.83; 37.37 | — |
| PRIMARY Lifetime Sexual Intercourse |
23; 15; 29; 29 | — |
| PRIMARY Recent Oral, Vaginal, and/or Anal Sex |
34; 27; 18; 16 | — |
| PRIMARY Frequency of Sexual Intercourse |
13.75; 9.40 | — |
| PRIMARY Number of Sexual Partners |
2.06; 2.00 | — |
| PRIMARY Frequency of Condom Use |
3.33; 2.36 | — |
| PRIMARY Condom Use Intention |
58.75; 61.84 | — |
| PRIMARY Recent Alcohol Use |
42; 36; 10; 8 | — |
| PRIMARY Frequency of Recent Alcohol Use |
5.71; 7.57 | — |
| PRIMARY Quantity of Recent Alcohol Use |
3.14; 10.50 | — |
| PRIMARY Recent Marijuana Use |
35; 32; 12; 10 | — |
| PRIMARY Frequency of Recent Marijuana Use |
15.83; 8.60 | — |
| SECONDARY Affect Dysregulation Scale |
9.39; 8.90 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
Adolescent males and females ages 13 to 20 years who are in mental health treatment will be eligible for enrollment in each phase of study according to the following criteria:
- English speaking,
- adolescent assent given to participate in the study,
- consent of a parent/legal guardian and HIPAA research authorization permission and
- attending an alternative / therapeutic school, mental health day treatment program, partial hospital program, or therapeutic group homes.
Exclusion Criteria
- self-report of HIV infection (STAR is not designed to address disclosure, stigma, and medical adherence issues),
- recent or current pregnancy,
- cognitive limitation that impairs consent capacity by judgment of clinical staff and
- current participation in another psychosocial intervention that is addressing STI/HIV prevention.
Data sourced from ClinicalTrials.gov (NCT02921841). 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.