Human Immunodeficiency Virus, Mental Health
Conditions
Keywords
Adolescents, HIV prevention, computerized intervention, mental health treatment
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).
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.
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.
Sponsors
Virtually Better, Inc.
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 20 Years
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: 1. English speaking, 2. adolescent assent given to participate in the study, 3. consent of a parent/legal guardian and HIPAA research authorization permission and 4. attending an alternative / therapeutic school, mental health day treatment program, partial hospital program, or therapeutic group homes.
Exclusion criteria
1. self-report of HIV infection (STAR is not designed to address disclosure, stigma, and medical adherence issues), 2. recent or current pregnancy, 3. cognitive limitation that impairs consent capacity by judgment of clinical staff and 4. current participation in another psychosocial intervention that is addressing STI/HIV prevention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Recent Marijuana Use | 3-months post-intervention | Number of days marijuana was used in the past 30 days |
| Recent Alcohol Use | 3-months post-intervention | Alcohol use in the past 30 days (yes/no) |
| HIV Knowledge | 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. |
| Frequency of Recent Alcohol Use | 3-months post-intervention | Number of days alcohol was used in the past 30 days |
| Self-efficacy for HIV Prevention | 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 | 3-months post-intervention | Lifetime oral, vaginal, and/or anal sex |
| Recent Oral, Vaginal, and/or Anal Sex | 3-months post-intervention | Oral, vaginal, and/or anal sex in the past 3 months |
| Frequency of Sexual Intercourse | 3-months post-intervention | Number of oral, vaginal, and/or anal sexual occurrences in the past 3 months. |
| Number of Sexual Partners | 3-months post-intervention | Number of sexual partners in the past 3 months. |
| Frequency of Condom Use | 3-months post-intervention | Number of times a condom was used during oral, vaginal, and/or anal sex |
| Condom Use Intention | 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.. |
| Quantity of Recent Alcohol Use | 3-months post-intervention | Number of drinks reported on days that a participant drank alcohol in the past 30 days |
| Recent Marijuana Use | 3-months post-intervention | Marijuana use in the past 30 days (yes/no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Affect Dysregulation Scale | 3 months post-intervention (average 6 months) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 68 |
| 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. | 57 |
| Total | 125 |
Baseline characteristics
| Characteristic | DSTAR | Total | DHEALTH |
|---|---|---|---|
| Age, Continuous | 15.9 years STANDARD_DEVIATION 1.4 | 15.8 years STANDARD_DEVIATION 1.4 | 15.8 years STANDARD_DEVIATION 1.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 44 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 79 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| History of Arrest No | 35 Participants | 61 Participants | 26 Participants |
| History of Arrest Yes | 33 Participants | 64 Participants | 31 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 18 Participants | 28 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 26 Participants | 13 Participants |
| Race (NIH/OMB) White | 27 Participants | 51 Participants | 24 Participants |
| Region of Enrollment United States | 68 participants | 125 participants | 57 participants |
| School Lunch Price Full Price | 21 Participants | 38 Participants | 17 Participants |
| School Lunch Price Reduced Price or Free | 45 Participants | 84 Participants | 39 Participants |
| School Lunch Price Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Sex/Gender, Customized Gender Female | 23 Participants | 40 Participants | 17 Participants |
| Sex/Gender, Customized Gender Male | 42 Participants | 82 Participants | 40 Participants |
| Sex/Gender, Customized Gender Other | 1 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Gender Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Sexual Orientation Bisexual | 9 Participants | 17 Participants | 8 Participants |
| Sexual Orientation Heterosexual | 50 Participants | 91 Participants | 41 Participants |
| Sexual Orientation Homosexual | 5 Participants | 8 Participants | 3 Participants |
| Sexual Orientation Undecided/Questioning | 3 Participants | 7 Participants | 4 Participants |
| Sexual Orientation Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 57 |
| other Total, other adverse events | 0 / 68 | 0 / 57 |
| serious Total, serious adverse events | 0 / 68 | 0 / 57 |
Outcome results
Primary
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
Population: Missing data accounts for the discrepancy in the analytic sample for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DSTAR | Condom Use Intention | 58.75 units on a scale | Standard Deviation 42.84 |
| DHEALTH | Condom Use Intention | 61.84 units on a scale | Standard Deviation 45.47 |
Primary
Frequency of Condom Use
Number of times a condom was used during oral, vaginal, and/or anal sex
Time frame: 3-months post-intervention
Population: Restricted to those who were sexually active in the past three months at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DSTAR | Frequency of Condom Use | 3.33 times a condom was used | Standard Deviation 6.45 |
| DHEALTH | Frequency of Condom Use | 2.36 times a condom was used | Standard Deviation 3.23 |
Primary
Frequency of Recent Alcohol Use
Number of days alcohol was used in the past 30 days
Time frame: 3-months post-intervention
Population: Restricted to those that indicated alcohol use in the past 30 days at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DSTAR | Frequency of Recent Alcohol Use | 5.71 days | Standard Deviation 10.73 |
| DHEALTH | Frequency of Recent Alcohol Use | 7.57 days | Standard Deviation 10.34 |
Primary
Frequency of Recent Marijuana Use
Number of days marijuana was used in the past 30 days
Time frame: 3-months post-intervention
Population: Restricted to those that indicated marijuana use in the past 30 days at the 3-month post-intervention follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DSTAR | Frequency of Recent Marijuana Use | 15.83 days | Standard Deviation 12.69 |
| DHEALTH | Frequency of Recent Marijuana Use | 8.60 days | Standard Deviation 7.51 |
Primary
Frequency of Sexual Intercourse
Number of oral, vaginal, and/or anal sexual occurrences in the past 3 months.
Time frame: 3-months post-intervention
Population: Restricted to those that were sexually active in the past 3 months at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in analytic sample for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DSTAR | Frequency of Sexual Intercourse | 13.75 sexual acts | Standard Deviation 18.11 |
| DHEALTH | Frequency of Sexual Intercourse | 9.40 sexual acts | Standard Deviation 15.61 |
Primary
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
Population: Missing data accounts for the discrepancy in the analytic sample for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DSTAR | HIV Knowledge | 11.10 score on a scale | Standard Deviation 3.32 |
| DHEALTH | HIV Knowledge | 10.98 score on a scale | Standard Deviation 3.18 |
Primary
Lifetime Sexual Intercourse
Lifetime oral, vaginal, and/or anal sex
Time frame: 3-months post-intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSTAR | Lifetime Sexual Intercourse | No | 23 Participants |
| DSTAR | Lifetime Sexual Intercourse | Yes | 29 Participants |
| DHEALTH | Lifetime Sexual Intercourse | No | 15 Participants |
| DHEALTH | Lifetime Sexual Intercourse | Yes | 29 Participants |
Primary
Number of Sexual Partners
Number of sexual partners in the past 3 months.
Time frame: 3-months post-intervention
Population: Restricted to those that were sexually active in the past 3 months at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DSTAR | Number of Sexual Partners | 2.06 sexual partners | Standard Deviation 1.48 |
| DHEALTH | Number of Sexual Partners | 2.00 sexual partners | Standard Deviation 1.47 |
Primary
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
Population: Restricted to those that indicated alcohol use in the past 30 days at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DSTAR | Quantity of Recent Alcohol Use | 3.14 alcoholic drinks | Standard Deviation 3.53 |
| DHEALTH | Quantity of Recent Alcohol Use | 10.50 alcoholic drinks | Standard Deviation 6.44 |
Primary
Recent Alcohol Use
Alcohol use in the past 30 days (yes/no)
Time frame: 3-months post-intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSTAR | Recent Alcohol Use | No | 42 Participants |
| DSTAR | Recent Alcohol Use | Yes | 10 Participants |
| DHEALTH | Recent Alcohol Use | No | 36 Participants |
| DHEALTH | Recent Alcohol Use | Yes | 8 Participants |
Primary
Recent Marijuana Use
Marijuana use in the past 30 days (yes/no)
Time frame: 3-months post-intervention
Population: Missing data accounts for the discrepancy in analytic sample for this measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSTAR | Recent Marijuana Use | No | 35 Participants |
| DSTAR | Recent Marijuana Use | Yes | 12 Participants |
| DHEALTH | Recent Marijuana Use | Yes | 10 Participants |
| DHEALTH | Recent Marijuana Use | No | 32 Participants |
Primary
Recent Oral, Vaginal, and/or Anal Sex
Oral, vaginal, and/or anal sex in the past 3 months
Time frame: 3-months post-intervention
Population: Missing data accounts for the discrepancies in the analytic sample for this measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSTAR | Recent Oral, Vaginal, and/or Anal Sex | No | 34 Participants |
| DSTAR | Recent Oral, Vaginal, and/or Anal Sex | Yes | 18 Participants |
| DHEALTH | Recent Oral, Vaginal, and/or Anal Sex | No | 27 Participants |
| DHEALTH | Recent Oral, Vaginal, and/or Anal Sex | Yes | 16 Participants |
Primary
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
Population: Missing data accounts for the discrepancy in the analytic sample for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DSTAR | Self-efficacy for HIV Prevention | 37.83 score on a scale | Standard Deviation 9.76 |
| DHEALTH | Self-efficacy for HIV Prevention | 37.37 score on a scale | Standard Deviation 8.63 |
Secondary
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)
Population: Missing data accounts for the discrepancy in the analytic sample for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DSTAR | Affect Dysregulation Scale | 9.39 score on a scale | Standard Deviation 2.6 |
| DHEALTH | Affect Dysregulation Scale | 8.90 score on a scale | Standard Deviation 2.97 |