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NCT07101458
The Eswatini PRISM Study on Adolescents Living With HIV
Conditions: Human Immunodeficiency Virus, Psychological Stress
Sex: All
Ages: 10 Years – 19 Years
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: Eswatini Nazarene Health Institutions
Location: Raleigh Fitkin Memorial Hospital-Baylor College of Medicine Children's Foundation Clinic Manzini Manzini Region
Summary
Adolescents living with Human Immunodeficiency Virus (ALHIV) are at an increased risk of experiencing psychological distress and adverse mental health outcomes, particularly in low- to middle-income countries (LMICs). Although interventions aimed at promoting resilience have demonstrated potential in enhancing psychosocial outcomes among adolescents with chronic illnesses in high-income settings, there is a paucity of evidence from LMICs. This study protocol aims to outline a comprehensive framework for evaluating the feasibility, acceptability, and effectiveness of the Promoting Resilience in Stress Management (PRISM) intervention in comparison to standard psychosocial care among ALHIV in a LMIC, such as Eswatini (formerly known as Swaziland). Additionally, it seeks to gather qualitative insights from both participants and PRISM coaches regarding the PRISM program. Exploratory outcomes under investigation are psychological distress, resilience, and HIV health-related quality of life. We hypothesise that:
1. Participants in the PRISM intervention group will experience reduced psychological distress compared to those in the control arm.
2. Participants in the PRISM intervention group will report improved HIV health-related quality of life after receiving the intervention compared to the control group.
3. Participants in the intervention arm will have higher resilience scores after receiving the intervention compared to those receiving usual psychosocial care.
Eligibility Criteria
Inclusion Criteria for the Clinical Trial:
* Adolescents living with HIV aged 10-19 years.
* Adolescents living with HIV who are cognitively able to participate in interviews (based on their medical history).
* Adolescents living with HIV who will have a score \> 13 on the Kessler Screening Scale for Psychological Distress (K6).
Exclusion Criteria for the Clinical Trial:
* Adolescents who refuse to participate.
* Adolescents whose parents/caretakers (for \
Source: ClinicalTrials.gov (NCT07101458). StuddyBuddy aggregates publicly available trial information.