Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings

Inclusion Criteria - For Youth Participants:

• At screening, 15-19 years old.

• If of legal age to provide independent informed consent as determined by site Standard Operating Procedures (SOPs) and consistent with site IRB/EC policies and procedures: potential youth participant is willing and able to provide written informed consent for study participation.

• If not of legal age to provide independent informed consent: Parent or guardian is willing and able to provide written informed consent for study participation and potential youth participant is willing and able to provide written informed assent for study participation.

• Confirmed HIV-infection based on documented testing of two samples collected at different time points as documented in medical records or by confirmatory testing.

• At screening, aware of his or her HIV infection, as confirmed by Investigator of Record or designee.

• At screening, has been prescribed ART for a minimum of 24 weeks prior to screening based on medical record documentation.

• At screening, meets at least one of the following indicators of moderate to severe mental health symptomology:

• Patient Health Questionnaire-9 (PHQ-9) score ≥ 10

• General Anxiety Disorder-7 (GAD-7) score ≥ 10

• UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA PTSD-RI) score > 35

Inclusion Criteria - For Caregiver Participants:

• Caregiver, defined as a biological parent, legal guardian, or person who provides emotional, psychological and/or informational care to a youth taking part in the Randomized Trial, as identified by the youth, and for whom the youth has provided written permission to participate in the study.

• Of legal age to provide independent consent and willing and able to provide written informed consent for study participation.

Exclusion Criteria - For Youth Participants:

• At entry, participating in a study delivering a mental health or ART adherence intervention.

• Has prior participation in an IMPAACT 2016 Focus Group or Pilot Test

• Any other condition, adverse social situation or cognitive impairment that, in the opinion of the site investigator, would preclude informed assent and informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Exclusion Criteria - For Caregiver Participants:

Has prior participation in an IMPAACT 2016 Focus Group or Pilot Test.