Digital Star: HIV Prevention for Youth in Mental Health Treatment

NCT02921841 | Completed Results DMC

• 1 other identifier: R44MH102140
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Human Immunodeficiency Virus; Mental Health

Keywords

Adolescents; HIV prevention; computerized intervention; mental health treatment

Outcome Measures

Primary Outcomes (13)

• HIV Knowledge

  HIV Knowledge Questionnaire. A 18-item (true, false, uncertain) scale surveys routes of transmission, casual contact misconceptions, general information and course of illness. Scores range from 0-18 with higher scores indicating greater HIV knowledge.

  3 months post-intervention

• Self-efficacy for HIV Prevention

  The scale contains 13 items that reflect the context of condom use, such as "could use a condom when I'm very upset". Scores range from 13 to 52 with higher scores indicated lower self-efficacy for HIV prevention.

  3 months post-intervention

• Lifetime Sexual Intercourse

  Lifetime oral, vaginal, and/or anal sex

  3-months post-intervention

• Recent Oral, Vaginal, and/or Anal Sex

  Oral, vaginal, and/or anal sex in the past 3 months

  3-months post-intervention

• Frequency of Sexual Intercourse

  Number of oral, vaginal, and/or anal sexual occurrences in the past 3 months.

  3-months post-intervention

• Number of Sexual Partners

  Number of sexual partners in the past 3 months.

  3-months post-intervention

• Frequency of Condom Use

  Number of times a condom was used during oral, vaginal, and/or anal sex

  3-months post-intervention

• Condom Use Intention

  On a scale of 0 to 100, participants report how likely it is that they will use a condom when they have sex in the next 3 months. Zero represented "I will not use a condom", "50" represented "I will use a condom half the time.", and "100" represented "I will use a condom all the time.".

  3-months post-intervention

• Recent Alcohol Use

  Alcohol use in the past 30 days (yes/no)

  3-months post-intervention

• Frequency of Recent Alcohol Use

  Number of days alcohol was used in the past 30 days

  3-months post-intervention

• Quantity of Recent Alcohol Use

  Number of drinks reported on days that a participant drank alcohol in the past 30 days

  3-months post-intervention

• Recent Marijuana Use

  Marijuana use in the past 30 days (yes/no)

  3-months post-intervention

• Frequency of Recent Marijuana Use

  Number of days marijuana was used in the past 30 days

  3-months post-intervention

Secondary Outcomes (1)

• Affect Dysregulation Scale

  3 months post-intervention (average 6 months)

Study Arms (2)

DSTAR

EXPERIMENTAL

Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education.

Behavioral: D*STAR

DHEALTH

ACTIVE COMPARATOR

Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.

Behavioral: D*HEALTH

Interventions

D*STAR BEHAVIORAL

DSTAR

D*HEALTH BEHAVIORAL

Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.

DHEALTH

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Virtually Better, Inc.: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

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MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Psychological Well-Being

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Personal Satisfaction; Behavior

Limitations and Caveats

This study had a small sample. Participants were recruited from alternative schools across Rhode Island which may not be representative of all adolescents that attend alternative schools.

Results Point of Contact

• Title: Larry K. Brown, MD
• Organization: Rhode Island Hospital

lkbrown@lifespan.org

(401) 793 - 8808

Study Officials

• Margo Adams Larsen, PhD

  Virtually Better, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 3, 2016
• Study Start: November 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 27, 2020
• Results First Posted: January 27, 2020

Record last verified: 2020-01

Locations

US (1)