Human Immunodeficiency VirusDSTARNCT02921841

Digital Star: HIV Prevention for Youth in Mental Health Treatment

A study testing D*STAR and D*HEALTH in people with Human Immunodeficiency Virus and Mental Health, run by Rhode Island Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 to 20 years
Conditions the study is for: Human Immunodeficiency Virus, Mental Health
What is being tested?: D*STAR and D*HEALTH
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 125 participants
Where: 1 siteUnited States
Study dates: Nov 2016to Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 20 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Rhode Island Hospital
Providence, Rhode Island, 02903

Other trials in United States

About this study

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.

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) .
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.
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.

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.

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: Human Immunodeficiency Virus, Mental Health
Being tested: D*STAR, D*HEALTH
Keywords: Adolescents, HIV prevention, computerized intervention, mental health treatment
Medical subject headings: Acquired Immunodeficiency Syndrome, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

D*STARBehavioural
D*HEALTHBehavioural
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.

Study groups in NCT02921841
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: D*HEALTH

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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.
Measured: 3 months post-intervention (average 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Jul 2019

First posted3 Oct 2016 (estimated)
Study startNov 2016
Primary completionMar 2019
Study completionJul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (96)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02921841
Sponsor's protocol ID: R44MH102140
Acronym: DSTAR
Status last verified: Jan 2020
First submitted: 29 Sep 2016
Last updated: 27 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Brown LK, Nugent NR, Houck CD, Lescano CM, Whiteley LB, Barker D, Viau L, Zlotnick C. Safe Thinking and Affect Regulation (STAR): human immunodeficiency virus prevention in alternative/therapeutic schools. J Am Acad Child Adolesc Psychiatry. 2011 Oct;50(10):1065-74. doi: 10.1016/j.jaac.2011.06.018. Epub 2011 Aug 27.
PubMed 21961780
CDC. Estimated HIV incidence in the United States, 2007-2010, HIV Surveillance Supplemental Report, 2012. Accessed from: http://www.cdc.gov/hiv/topics/surveillance/resources/reports/#supplemental.
UNAIDS. UNAIDS World AIDS Day Report, 2011, Accessed from: http://www.unaids.org/en/resources/documents/2011/20111121_JC2216_WordAIDSday_report_2011
CDC. 2008 Sexually Transmitted Disease Surveillance. 2009. Accessed from: http://www.cdc.gov/std/stats08/default.htm
Martinez G, Copen CE, Abma JC. Teenagers in the United States: sexual activity, contraceptive use, and childbearing, 2006-2010 national survey of family growth. Vital Health Stat 23. 2011 Oct;(31):1-35.
PubMed 22256688
Kaiser Family Foundation. Medicare and HIV/AIDS Fact Sheet. February, 2009. Accessed from: http://www.kff.org/hivaids/7171.cfm
Schackman BR, Gebo KA, Walensky RP, Losina E, Muccio T, Sax PE, Weinstein MC, Seage GR 3rd, Moore RD, Freedberg KA. The lifetime cost of current human immunodeficiency virus care in the United States. Med Care. 2006 Nov;44(11):990-7. doi: 10.1097/01.mlr.0000228021.89490.2a.
PubMed 17063130
CDC. Projecting Possible Future Courses of the HIV Epidemic in the United States. 2010. Accessed from: https://npin.cdc.gov/publication/projecting-possible-future-courses-hiv-epidemic-united-states
Brown LK, Barone VJ, Fritz GK, Cebollero P, Nassau JH. AIDS education: the Rhode Island experience. Health Educ Q. 1991 Summer;18(2):195-206. doi: 10.1177/109019819101800205.
PubMed 2055777
Santelli JS, Kaiser J, Hirsch L, Radosh A, Simkin L, Middlestadt S. Initiation of sexual intercourse among middle school adolescents: the influence of psychosocial factors. J Adolesc Health. 2004 Mar;34(3):200-8. doi: 10.1016/j.jadohealth.2003.06.004.
PubMed 14967343
Houck CD, Lescano CM, Brown LK, Tolou-Shams M, Thompson J, Diclemente R, Fernandez MI, Pugatch D, Schlenger WE, Silver BJ. "Islands of Risk": subgroups of adolescents at risk for HIV. J Pediatr Psychol. 2006 Jul;31(6):619-29. doi: 10.1093/jpepsy/jsj067. Epub 2005 Aug 24.
PubMed 16120764
Jessor R, Jessor S. Problem behavior and psychosocial development: A longitudinal study of youth. New York: Academic Press; 1977.
Raffaelli M, Crockett LJ. Sexual risk taking in adolescence: the role of self-regulation and attraction to risk. Dev Psychol. 2003 Nov;39(6):1036-46. doi: 10.1037/0012-1649.39.6.1036.
PubMed 14584983
DiClemente RJ, Wingood GM, Crosby RA, Sionean C, Brown LK, Rothbaum B, Zimand E, Cobb BK, Harrington K, Davies S. A prospective study of psychological distress and sexual risk behavior among black adolescent females. Pediatrics. 2001 Nov;108(5):E85. doi: 10.1542/peds.108.5.e85.
PubMed 11694669
Brown LK, Tolou-Shams M, Lescano C, Houck C, Zeidman J, Pugatch D, Lourie KJ; Project SHIELD Study Group. Depressive symptoms as a predictor of sexual risk among African American adolescents and young adults. J Adolesc Health. 2006 Sep;39(3):444.e1-8. doi: 10.1016/j.jadohealth.2006.01.015. Epub 2006 Jul 10.
PubMed 16919811

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Digital Star: HIV Prevention for Youth in Mental Health Treatment
ClinicalTrials.gov ID: NCT02921841
Acronym / sponsor ID: DSTAR / R44MH102140
Conditions: Human Immunodeficiency Virus, Mental Health
Keywords: Adolescents, HIV prevention, computerized intervention, mental health treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: Rhode Island HospitalUniversity, hospital or other
Collaborators: Virtually Better, Inc.
Study start: Nov 2016
Primary completion: Mar 2019 (actual)
Study completion: Jul 2019 (actual)
First posted: 3 Oct 2016 (estimated)
Results: Posted 27 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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) .
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.
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.

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.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DSTAR	Experimental	Behavioral: D*STARDigital 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.
DHEALTH	Active comparator	Behavioral: D*HEALTHDigital 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.

Who may qualify

Ages: 13 to 20 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
D*STAR	Behavioural	DSTAR
D*HEALTHDigital 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.	Behavioural	DHEALTH

Primary outcome

HIV Knowledge
Time frame: 3 months post-intervention
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.
Self-efficacy for HIV Prevention
Time frame: 3 months post-intervention
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.
Lifetime Sexual Intercourse
Time frame: 3-months post-intervention
Lifetime oral, vaginal, and/or anal sex
Recent Oral, Vaginal, and/or Anal Sex
Time frame: 3-months post-intervention
Oral, vaginal, and/or anal sex in the past 3 months
Frequency of Sexual Intercourse
Time frame: 3-months post-intervention
Number of oral, vaginal, and/or anal sexual occurrences in the past 3 months.
Number of Sexual Partners
Time frame: 3-months post-intervention
Number of sexual partners in the past 3 months.
Frequency of Condom Use
Time frame: 3-months post-intervention
Number of times a condom was used during oral, vaginal, and/or anal sex
Condom Use Intention
Time frame: 3-months post-intervention
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.".
Recent Alcohol Use
Time frame: 3-months post-intervention
Alcohol use in the past 30 days (yes/no)
Frequency of Recent Alcohol Use
Time frame: 3-months post-intervention
Number of days alcohol was used in the past 30 days
Quantity of Recent Alcohol Use
Time frame: 3-months post-intervention
Number of drinks reported on days that a participant drank alcohol in the past 30 days
Recent Marijuana Use
Time frame: 3-months post-intervention
Marijuana use in the past 30 days (yes/no)
Frequency of Recent Marijuana Use
Time frame: 3-months post-intervention
Number of days marijuana was used in the past 30 days

1 secondary outcome

Affect Dysregulation Scale
Time frame: 3 months post-intervention (average 6 months)

Results and safety

Results posted to the registry on 27 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DSTAR	68	52
DHEALTH	57	44

Primary outcome: HIV Knowledge

Time frame: 3 months post-intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	DSTAR n = 52	DHEALTH n = 43
Value	11.10 (3.32)	10.98 (3.18)

Population analysed: Missing data accounts for the discrepancy in the analytic sample for this measure.

Primary outcome: Self-efficacy for HIV Prevention

Time frame: 3 months post-intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	DSTAR n = 52	DHEALTH n = 43
Value	37.83 (9.76)	37.37 (8.63)

Population analysed: Missing data accounts for the discrepancy in the analytic sample for this measure.

Primary outcome: Lifetime Sexual Intercourse

Time frame: 3-months post-intervention. Count of participants. Unit: Participants

Measure	DSTAR n = 52	DHEALTH n = 44
No	23	15
Yes	29	29

Primary outcome: Recent Oral, Vaginal, and/or Anal Sex

Time frame: 3-months post-intervention. Count of participants. Unit: Participants

Measure	DSTAR n = 52	DHEALTH n = 43
No	34	27
Yes	18	16

Population analysed: Missing data accounts for the discrepancies in the analytic sample for this measure.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DSTAR	0 of 68 (0%)	0 of 68 (0%)	0 of 68
DHEALTH	0 of 57 (0%)	0 of 57 (0%)	0 of 57

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21961780Brown LK, Nugent NR, Houck CD, Lescano CM, Whiteley LB, Barker D, Viau L, Zlotnick C. Safe Thinking and Affect Regulation (STAR): human immunodeficiency virus prevention in alternative/therapeutic schools. J Am Acad Child Adolesc Psychiatry. 2011 Oct;50(10):1065-74. doi: 10.1016/j.jaac.2011.06.018. Epub 2011 Aug 27.
BackgroundCDC. Estimated HIV incidence in the United States, 2007-2010, HIV Surveillance Supplemental Report, 2012. Accessed from: http://www.cdc.gov/hiv/topics/surveillance/resources/reports/#supplemental.
BackgroundUNAIDS. UNAIDS World AIDS Day Report, 2011, Accessed from: http://www.unaids.org/en/resources/documents/2011/20111121_JC2216_WordAIDSday_report_2011
BackgroundCDC. 2008 Sexually Transmitted Disease Surveillance. 2009. Accessed from: http://www.cdc.gov/std/stats08/default.htm
Background: PubMed 22256688Martinez G, Copen CE, Abma JC. Teenagers in the United States: sexual activity, contraceptive use, and childbearing, 2006-2010 national survey of family growth. Vital Health Stat 23. 2011 Oct;(31):1-35.
BackgroundKaiser Family Foundation. Medicare and HIV/AIDS Fact Sheet. February, 2009. Accessed from: http://www.kff.org/hivaids/7171.cfm
Background: PubMed 17063130Schackman BR, Gebo KA, Walensky RP, Losina E, Muccio T, Sax PE, Weinstein MC, Seage GR 3rd, Moore RD, Freedberg KA. The lifetime cost of current human immunodeficiency virus care in the United States. Med Care. 2006 Nov;44(11):990-7. doi: 10.1097/01.mlr.0000228021.89490.2a.
BackgroundCDC. Projecting Possible Future Courses of the HIV Epidemic in the United States. 2010. Accessed from: https://npin.cdc.gov/publication/projecting-possible-future-courses-hiv-epidemic-united-states
Background: PubMed 2055777Brown LK, Barone VJ, Fritz GK, Cebollero P, Nassau JH. AIDS education: the Rhode Island experience. Health Educ Q. 1991 Summer;18(2):195-206. doi: 10.1177/109019819101800205.
Background: PubMed 14967343Santelli JS, Kaiser J, Hirsch L, Radosh A, Simkin L, Middlestadt S. Initiation of sexual intercourse among middle school adolescents: the influence of psychosocial factors. J Adolesc Health. 2004 Mar;34(3):200-8. doi: 10.1016/j.jadohealth.2003.06.004.
Background: PubMed 16120764Houck CD, Lescano CM, Brown LK, Tolou-Shams M, Thompson J, Diclemente R, Fernandez MI, Pugatch D, Schlenger WE, Silver BJ. "Islands of Risk": subgroups of adolescents at risk for HIV. J Pediatr Psychol. 2006 Jul;31(6):619-29. doi: 10.1093/jpepsy/jsj067. Epub 2005 Aug 24.
BackgroundJessor R, Jessor S. Problem behavior and psychosocial development: A longitudinal study of youth. New York: Academic Press; 1977.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Margo Adams Larsen, PhD principal investigator

Virtually Better, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing D*STAR and D*HEALTH in people with Human Immunodeficiency Virus and Mental Health, run by Rhode Island Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV Knowledge (time frame: 3 months post-intervention). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02921841, which also lists 96 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.