Adolescents and young adults living with HIV HIV
Conditions
Interventions
Integrated Music and Trotzer Group Counseling Program for 10 sessions, 90 minutes/ session, Music Program for 10 sessions, 90 minutes/ session,Trotzer Group Counseling Program for 10 sessions, 90 minu
Integrated Music and Counseling Program,Music Program,Trotzer Group Counseling Program,Control
Sponsors
Research Institute for Health Sciences, Chiang Mai University
Eligibility
Sex/Gender
All
Age
15 Years to 24 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion Criteria for Pilot Phase 1 At enrollment 15 to 24 years of age 2 Confirmed HIV-1 disease based on documented testing of two samples collected from two separate blood collection tubes per Sample 1 and Sample 2 requirements at different time points. Test results were obtained from medical records. 3 Having evidence of perinatal HIV infection. 4 At screening being aware of their HIV infection status as determined by the investigator. 5 Having at least one documented plasma HIV-1 RNA less than 50 copies per mL from a specimen collected within 12 months prior to entry. 6 Currently receiving Dolutegravir-based regimen. 7 At screening meets at least one of the following indicators of mild to moderate mental health symptomology The DASS-21 test result for depression ranges from 5 to 10 The DASS-21 test result for Anxiety ranges from 4 to 7 The DASS-21 test result for Stress ranges from 8 to 12 Self-esteem scores equal or less than 20 Thai Internalized HIV-related Stigma Scale scores equal or greater than 10 8 Parent or legal guardian of the potential participant age below 20 years is willing and able to provide written informed consent for study participation and potential participant is willing and able to provide written assent for participant age below 20 years or informed consent for participant age equal or above 20 years for study participation. 9 At enrollment, willing and able to comply with the study visit schedule and other study requirements, as determined by the investigator. 10 At enrollment, willing to disclose his-her HIV status to the investigator, study team, and other participants. 2. Inclusion Criteria for Phase 1 1 At enrollment, 15 to 24 years of age 2 Confirmed HIV-1 disease based on documented testing of two samples collected from two separate blood collection tubes per Sample 1 and Sample 2 requirements, at different time points. Test results will be obtained from medical records. 3 Having evidence of perinatally HIV infection. 4 At screening, being aware of their HIV infection status, as determined by the investigator. 5 Has at least one documented plasma HIV-1 RNA greater 50 copies per mL from a specimen collected within 12 months prior to entry. 6 The parent or legal guardian of a potential participant under the age of 20 is willing and able to provide written informed consent for the participant's participation in the study, and the potential participant is willing and able to provide written informed consent for the participant's participation in the study if the participant is 20 years of age or older. 7 At enrollment, willing and able to comply with the study visit schedule and other study requirements, as determined by the investigator. 3. Inclusion Criteria for Phase 2 1 Enrolled in phase 1 of the study. 2 Currently receive Dolutegravir-based regimen. 3 At screening, meets at least one of the following indicators of mild to moderate mental health symptomology: The DASS-21 test result for depression ranges from 5 to 10. The DASS-21 test result for Anxiety ranges from 4 to 7 The DASS-21 test result for Stress ranges from 8 to 12 Self-esteem scores equal or less than 25 Thai Internalized HIV-related Stigma Scale scores equal or greater than 10 4 Parent or legal guardian of the potential participant age below 20 years is willing and able to pr
Exclusion criteria
Exclusion criteria: 1. Exclusion Criteria for Pilot Phase and Phase 2 1 As determined by the investigator and based on available medical records, known or suspected psychosis, depression or other major psychological problems. 2 At screening, meets at least one of the following indicators of severe and very severe mental health symptomology Depression from the DASS-21 test score equal or greater than 11 Anxiety from the DASS-21 test score equal or greater than 8 Stress from the DASS-21 test score equal or greater than 13 3 Clinically significant disease, as determined by the investigator based on available medical records. 4 Any other condition or social circumstance situation that, in the opinion of the investigator, would make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. 2. Exclusion Criteria for Phase 1 1 As determined by the investigator and based on available medical records, known or suspected psychosis, depression or other major psychological problems. However, The AYA-PHIV with mental health diagnosis and on stable medication are eligible to participate in this study. 2 Clinically significant disease, as determined by the investigator based on available medical records. 3 Any other condition or social circumstance situation that, in the opinion of the investigator, would make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression Entry and Week 10 visits DASS-21 Score,Anxiety Entry and Week 10 visits DASS-21 Score,Stress Entry and Week 10 visits DASS-21 Score,Self-esteem Entry and Week 10 visits SES-10 Score,Thai Internalized HIV-related Stigma Entry and Week 10 visits Thai-IHSS Score,ART adherence questionnaires Entry and Week 10 visits ART adherence questionnaires Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Cortisol hormone in Saliva Entry, Week 10, and Week 24 Cortisol hormone in Saliva Test,Dolutegravir Concentration in Hair Entry, Week 10, and Week 24 Dolutegravir Concentration in Hair Test,Depression Week 24 DASS-21 Score,Anxiety Week 24 DASS-21 Score,Stress Week 24 DASS-21 Score,Self-esteem Week 24 SES-10 Score,Thai Internalized HIV-related Stigma Week 24 Thai-IHSS Score,ART adherence questionnaires Week 24 ART adherence questionnaires Score | — |
Countries
Thailand
Contacts
Public ContactChintana Khamrong
Research Institute for Health Sciences, Chiang Mai University
Outcome results
None listed