CompletedNCT02921841DSTARUpdated Jan 27, 2020Results posted

Digital Star: HIV Prevention for Youth in Mental Health Treatment

An interventional study of D*STAR and D*HEALTH in Human Immunodeficiency Virus and Mental Health, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to participants aged 13 Years to 20 Years. Per ClinicalTrials.gov, last updated 2020-01-27.

Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 125
Allocation: Randomized
Ages: 13 Years to 20 Years
Sex: All

Study 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).

Read the detailed description

Adolescents in mental health treatment are at greater risk for HIV and other STIs than their peers due to an earlier age of onset of sex, less protected sex, more sexual partners, and more frequent substance use. The numerous adolescents who receive mental health treatment do so in a variety of settings such as day hospital programs, therapeutic schools and residential centers. These programs offer a variety of health services but there is no efficacious HIV prevention program specifically tailored for the issues of youth in mental health treatment, other than the one described in this project. STAR ("Safe Thinking and Affect Regulation"). The goal of this SBIR (Small Business Innovation Research) Fast-Track project is to transform STAR into an engaging digital, multimedia format, Digital STAR (D*STAR), for easy and reliable use by care agencies that serve adolescents in mental health treatment. To transform this intervention, Virtually Better, a company with a successful history of production and distribution of cutting-edge technological interventions, has teamed with the research developers of STAR at Rhode Island Hospital and Brown University. During the two phases of this Fast-Track project, digital session development will be accomplished by an iterative process of feedback and refinement between Virtually Better, the developers of STAR, adolescents in mental health treatment, and a Community Advisory Board.

Phase 1: Specific Aims A. To develop and refine digital versions of core sessions of STAR that introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education. These sessions represent essential content areas and modalities of the D*STAR intervention.

B. To conduct focus groups of the feasibility, utility, and acceptability of the planned sessions. There will be focus groups with approximately 10 Community Advisory Board (CAB) members comprised of parents of youth in mental health treatment and mental health treatment staff. There will also be focus groups with approximately 15 adolescents in mental health treatment (13-18 years old) .

C. To conduct two qualitative interview sessions of approximately 15 youth with mental health treatment to determine the acceptability of the session's prototypes and revise based on feedback.

D. To conduct an open trial of D*STAR sessions with approximately 30 adolescents to determine its preliminary impact with self-report assessments at baseline and then 1 month post intervention.

Phase 2: Specific Aims A. To develop and refine digital versions the remaining sessions of STAR and a digital general health promotion (HP) intervention, building upon the essential content areas and refinements developed in Phase I.

B. To conduct qualitative evaluations of the feasibility, utility, and acceptability of D*STAR and the digital HP intervention with adolescents in mental health treatment, our Community Advisory Board (CAB), and mental health treatment center staff.

Hypothesis: Both digital interventions (HP and D*STAR) will be rated by youth, our CAB, and mental health treatment center staff as enjoyable, useful and easy to implement.

C. To conduct a randomized control trial of D*STAR compared to the time matched digital HP intervention among 120 adolescents ages 13 to 18 in mental health treatment.

Hypothesis: Participants in D*STAR will report safer sexual behaviors, greater HIV knowledge and greater self-efficacy for HIV prevention skills than participants in digital HP at three months follow-up.

Conditions studied

Human Immunodeficiency Virus
Mental Health

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Keywords

Adolescents
HIV prevention
computerized intervention
mental health treatment

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 125 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Rhode Island Hospital is the lead sponsor of 187 studies on the registry; 37 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 13 Years to 20 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 125 participants (actual)

Study arms

Experimental
DSTAR
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
Active comparator
DHEALTH
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

BehavioralD*STAR
BehavioralD*HEALTH
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.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 3 months post-intervention
Lifetime Sexual Intercourse
Lifetime oral, vaginal, and/or anal sex
Time frame: 3-months post-intervention
Recent Oral, Vaginal, and/or Anal Sex
Oral, vaginal, and/or anal sex in the past 3 months
Time frame: 3-months post-intervention
Frequency of Sexual Intercourse
Number of oral, vaginal, and/or anal sexual occurrences in the past 3 months.
Time frame: 3-months post-intervention
Number of Sexual Partners
Number of sexual partners in the past 3 months.
Time frame: 3-months post-intervention
Frequency of Condom Use
Number of times a condom was used during oral, vaginal, and/or anal sex
Time frame: 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.".
Time frame: 3-months post-intervention
Recent Alcohol Use
Alcohol use in the past 30 days (yes/no)
Time frame: 3-months post-intervention
Frequency of Recent Alcohol Use
Number of days alcohol was used in the past 30 days
Time frame: 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
Time frame: 3-months post-intervention
Recent Marijuana Use
Marijuana use in the past 30 days (yes/no)
Time frame: 3-months post-intervention
Frequency of Recent Marijuana Use
Number of days marijuana was used in the past 30 days
Time frame: 3-months post-intervention

Secondary outcomes

Affect Dysregulation Scale
A six-item scale assessing adolescents' perceived abilities to manage emotional upset (e.g., "In the past three months, I have had trouble controlling my feelings.") in sexual situations. Scores range from 6 to 24 with higher scores indicated poorer perceived ability to manage emotional upset in sexual situations.
Time frame: 3 months post-intervention (average 6 months)

Results

Posted Jan 27, 2020

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.

Participant flow

Participant flow — Overall Study
Milestone	DSTAR	DHEALTH
Started	68	57
Completed	52	44
Not completed	16	13

Outcome measures

PrimaryHIV 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.

Time frame:: 3 months post-intervention
Reported as:: Mean · score on a scale

HIV Knowledge
score on a scale	DSTAR	DHEALTH
HIV Knowledge	11.10 ± 3.32	10.98 ± 3.18

PrimarySelf-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.

Time frame:: 3 months post-intervention
Reported as:: Mean · score on a scale

Self-efficacy for HIV Prevention
score on a scale	DSTAR	DHEALTH
Self-efficacy for HIV Prevention	37.83 ± 9.76	37.37 ± 8.63

PrimaryLifetime Sexual Intercourse

Lifetime oral, vaginal, and/or anal sex

Time frame:: 3-months post-intervention
Reported as:: Count of participants · Participants

Lifetime Sexual Intercourse
Participants	DSTAR	DHEALTH
No	23	15
Yes	29	29

PrimaryRecent Oral, Vaginal, and/or Anal Sex

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

Time frame:: 3-months post-intervention
Reported as:: Count of participants · Participants

Recent Oral, Vaginal, and/or Anal Sex
Participants	DSTAR	DHEALTH
No	34	27
Yes	18	16

PrimaryFrequency of Sexual Intercourse

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

Time frame:: 3-months post-intervention
Reported as:: Mean · sexual acts

Frequency of Sexual Intercourse
sexual acts	DSTAR	DHEALTH
Frequency of Sexual Intercourse	13.75 ± 18.11	9.40 ± 15.61

PrimaryNumber of Sexual Partners

Number of sexual partners in the past 3 months.

Time frame:: 3-months post-intervention
Reported as:: Mean · sexual partners

Number of Sexual Partners
sexual partners	DSTAR	DHEALTH
Number of Sexual Partners	2.06 ± 1.48	2.00 ± 1.47

PrimaryFrequency of Condom Use

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

Time frame:: 3-months post-intervention
Reported as:: Mean · times a condom was used

Frequency of Condom Use
times a condom was used	DSTAR	DHEALTH
Frequency of Condom Use	3.33 ± 6.45	2.36 ± 3.23

PrimaryCondom 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.".

Time frame:: 3-months post-intervention
Reported as:: Mean · units on a scale

Condom Use Intention
units on a scale	DSTAR	DHEALTH
Condom Use Intention	58.75 ± 42.84	61.84 ± 45.47

PrimaryRecent Alcohol Use

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

Time frame:: 3-months post-intervention
Reported as:: Count of participants · Participants

Recent Alcohol Use
Participants	DSTAR	DHEALTH
No	42	36
Yes	10	8

PrimaryFrequency of Recent Alcohol Use

Number of days alcohol was used in the past 30 days

Time frame:: 3-months post-intervention
Reported as:: Mean · days

Frequency of Recent Alcohol Use
days	DSTAR	DHEALTH
Frequency of Recent Alcohol Use	5.71 ± 10.73	7.57 ± 10.34

PrimaryQuantity of Recent Alcohol Use

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

Time frame:: 3-months post-intervention
Reported as:: Mean · alcoholic drinks

Quantity of Recent Alcohol Use
alcoholic drinks	DSTAR	DHEALTH
Quantity of Recent Alcohol Use	3.14 ± 3.53	10.50 ± 6.44

PrimaryRecent Marijuana Use

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

Time frame:: 3-months post-intervention
Reported as:: Count of participants · Participants

Recent Marijuana Use
Participants	DSTAR	DHEALTH
No	35	32
Yes	12	10

PrimaryFrequency of Recent Marijuana Use

Number of days marijuana was used in the past 30 days

Time frame:: 3-months post-intervention
Reported as:: Mean · days

Frequency of Recent Marijuana Use
days	DSTAR	DHEALTH
Frequency of Recent Marijuana Use	15.83 ± 12.69	8.60 ± 7.51

SecondaryAffect Dysregulation Scale

A six-item scale assessing adolescents' perceived abilities to manage emotional upset (e.g., "In the past three months, I have had trouble controlling my feelings.") in sexual situations. Scores range from 6 to 24 with higher scores indicated poorer perceived ability to manage emotional upset in sexual situations.

Time frame:: 3 months post-intervention (average 6 months)
Reported as:: Mean · score on a scale

Affect Dysregulation Scale
score on a scale	DSTAR	DHEALTH
Affect Dysregulation Scale	9.39 ± 2.60	8.90 ± 2.97

Adverse events

Collected over Up to 5 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
DSTAR	0/68 (0%)	0/68 (0%)	0/68 (0%)
DHEALTH	0/57 (0%)	0/57 (0%)	0/57 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	DSTAR	DHEALTH	Total
Mean	15.9 ± 1.4	15.8 ± 1.3	15.8 ± 1.4

Sex/Gender, Customized
Sex/Gender, Customized(Participants)	DSTAR	DHEALTH	Total
Gender — Male	42	40	82
Gender — Female	23	17	40
Gender — Other	1	0	1
Gender — Unknown or Not Reported	2	0	2

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	DSTAR	DHEALTH	Total
Hispanic or Latino	24	20	44
Not Hispanic or Latino	43	36	79
Unknown or Not Reported	1	1	2

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	DSTAR	DHEALTH	Total
American Indian or Alaska Native	2	2	4
Asian	1	1	2
Native Hawaiian or Other Pacific Islander	6	6	12
Black or African American	1	1	2
White	27	24	51
More than one race	18	10	28
Unknown or Not Reported	13	13	26

Region of Enrollment
Region of Enrollment(participants)	DSTAR	DHEALTH	Total
United States	68	57	125

History of Arrest
History of Arrest(Participants)	DSTAR	DHEALTH	Total
No	35	26	61
Yes	33	31	64

Sexual Orientation
Sexual Orientation(Participants)	DSTAR	DHEALTH	Total
Heterosexual	50	41	91
Homosexual	5	3	8
Bisexual	9	8	17
Undecided/Questioning	3	4	7
Unknown or Not Reported	1	1	2

School Lunch Price
School Lunch Price(Participants)	DSTAR	DHEALTH	Total
Full Price	21	17	38
Reduced Price or Free	45	39	84
Unknown or Not Reported	2	1	3

Study locations

1 site

Rhode Island Hospital
Providence, Rhode Island 02903, United States

References and documents

Publications

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Study documents

Protocol and statistical analysis plan · Apr 16, 2019

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Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02921841
Lead sponsor: Rhode Island Hospital
Collaborators: Virtually Better, Inc.
Responsible party: Dr. Larry K. Brown (Director of Research, Rhode Island Hospital) — Principal investigator
First posted: Oct 3, 2016
Start date: Nov 2016
Primary completion: Mar 2019
Completion: Jul 2019
Results posted: Jan 27, 2020
Last update: Jan 27, 2020

Study contacts

Margo Adams Larsen, PhD

principal investigator · Virtually Better, Inc.

Oversight

Data monitoring committee: Yes

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