The Eswatini PRISM Study on Adolescents Living With HIV

NCT07101458 | Recruiting DMC

• 1 other identifier: EHHRRB 075/2025
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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. 1.Participants in the PRISM intervention group will experience reduced psychological distress compared to those in the control arm.
2. 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. 3.Participants in the intervention arm will have higher resilience scores after receiving the intervention compared to those receiving usual psychosocial care.

Conditions

Human Immunodeficiency Virus; Psychological Stress

Keywords

Adolescents; Health-related quality of life; Human immunodeficiency virus; Psychological distress; Promoting Resilience in Stress Management; Resilience

Outcome Measures

Primary Outcomes (2)

• Feasibility of the PRISM intervention

  Feasibility of the PRISM intervention will be defined as priori \>70% program completion of the three PRISM sessions among enrolled participants.

  12 months outcome assessment point.

• Acceptability of the PRISM

  Acceptability of the PRISM intervention, which is a primary outcome, will be measured using the Client Satisfaction Questionnaire (CSQ-8), an 8-item measuring participant's opinions and assessments of the intervention. Each item is rated on a 4-point Likert scale, where responses range from 1 (indicating dissatisfaction) to 4 (indicating high satisfaction). The total score, which ranges from 8 to 32, is derived by summing the responses to all eight items. A higher score on the CSQ-8 reflects greater satisfaction with the PRISM intervention.

  12 months outcome assessment point.

Secondary Outcomes (4)

• Effectiveness of the PRISM intervention

  At 12 months outcome assessment point.

• Psychological distress

  At 3, 6, 9, and 12-months outcome assessment points.

• Resilience

  At 3, 6, 9, and 12-months outcome assessment points.

• HIV health-related quality of life

  At 3, 6, 9, and 12-months outcome assessment points.

Other Outcomes (1)

• Experiences and perceptions of ALHIV and PRISM coaches regarding the PRISM intervention.

  Within a month after completing the intervention.

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Promoting Resilience in Stress Management (PRISM) Individual, 1:1 version of the Promoting Resilience in Stress Management intervention.

Behavioral: Promoting Resilience in Stress Management intervention

Standard Psychosocial Care

NO INTERVENTION

Standard psychosocial care includes comprehensive psychosocial evaluations and referrals to behavioural health services, financial assistance, and various social support resources available at the health facility.

Interventions

Promoting Resilience in Stress Management intervention BEHAVIORAL

PRISM is a manualized, skills-based training program comprised of three 60-minute, one-on-one sessions designed to build resilience resources (stress management, goal-setting, cognitive-reframing, and meaning-making) in adolescents and young adults (AYAs). The sessions are scheduled every 1-2 weeks based on participant preference. In this study, the PRISM sessions will be facilitated by trained nurses who hold bachelor's degrees in Nursing Science with a specialisation in mental health.

Also known as: PRISM, PRISM intervention, PRISM program

Treatment Arm

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Adolescents who refuse to participate.
• Adolescents whose parents/caretakers (for \<18 years) will not consent to their participation.
• The PRISM intervention requires a caretaker or parent to be invited by the study participant to join the third session.
• Parent or caretaker should be ≥ 18 years of age and consent to participation.
• A parent or caretaker who refuses to participate.
• Eligibility Criteria for Participation in Semi-Structured Interviews Post Intervention
• Adolescents who have been in the treatment arm of the PRISM intervention pilot clinical trial.
• Adolescents who completed all sessions of the PRISM intervention.
• Adolescents who are willing to be audio taped.
• PRISM coaches who offered all sessions of the PRISM intervention and who will be willing to be audio-taped.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: collaborator
• University of Eswatini: collaborator
• Baylor Foundation Eswatini: collaborator
• Eswatini Nazarene Health Institutions: lead

Study Sites (1)

Raleigh Fitkin Memorial Hospital-Baylor College of Medicine Children's Foundation Clinic

Manzini, Manzini Region, M200, Eswatini

RECRUITING

Related Publications (4)

• Rosenberg AR, Zhou C, Bradford MC, Salsman JM, Sexton K, O'Daffer A, Yi-Frazier JP. Assessment of the Promoting Resilience in Stress Management Intervention for Adolescent and Young Adult Survivors of Cancer at 2 Years: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2136039. doi: 10.1001/jamanetworkopen.2021.36039.

  PMID: 34817581 BACKGROUND

• Rosenberg AR, Bradford MC, McCauley E, Curtis JR, Wolfe J, Baker KS, Yi-Frazier JP. Promoting resilience in adolescents and young adults with cancer: Results from the PRISM randomized controlled trial. Cancer. 2018 Oct 1;124(19):3909-3917. doi: 10.1002/cncr.31666. Epub 2018 Sep 19.

  PMID: 30230531 BACKGROUND

• Rosenberg AR, Yi-Frazier JP, Eaton L, Wharton C, Cochrane K, Pihoker C, Baker KS, McCauley E. Promoting Resilience in Stress Management: A Pilot Study of a Novel Resilience-Promoting Intervention for Adolescents and Young Adults With Serious Illness. J Pediatr Psychol. 2015 Oct;40(9):992-9. doi: 10.1093/jpepsy/jsv004. Epub 2015 Feb 11.

  PMID: 25678533 BACKGROUND

• Yi-Frazier JP, Hilliard ME, O'Donnell MB, Zhou C, Ellisor BM, Garcia Perez S, Duran B, Rojas Y, Malik FS, DeSalvo DJ, Pihoker C, Bradford MC, Scott S, Devaraj S, Rosenberg AR. Promoting Resilience in Stress Management for Adolescents With Type 1 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2428287. doi: 10.1001/jamanetworkopen.2024.28287.

  PMID: 39158914 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Stress, Psychological

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Musa L. Nhlabatsi, MSc

  Eswatini Nazarene Health Institutions

  PRINCIPAL INVESTIGATOR

• Mduduzi C. Shongwe, PhD

  Department of Midwifery Science, University of Eswatini

  STUDY DIRECTOR

• Debrah Vambe, MD

  Baylor Foundation Eswatini

  STUDY DIRECTOR

• Kay Alexander, MD

  Baylor Foundation Eswatini

  STUDY DIRECTOR

• Nobuhle Mthethwa, MPH

  Eswatini Ministry of Health (MOH)/Eswatini National Health AIDS

  STUDY DIRECTOR

• Joyce Yi-Frazier, PhD

  Dana-Farber Cancer Institute (DFCI)

  STUDY DIRECTOR

Central Study Contacts

Musa L. Nhlabatsi, MSc

CONTACT

+26876115197; lewienhlabatsi@gmail.com

Mduduzi C. Shongwe, PhD

CONTACT

+26876180806/+26879280047; mduyaye@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family Nurse Practitioner

Model Details: Single-site, single-blind, parallel randomized clinical trial

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months after publication for 10 years.
• Access Criteria: Anonymized participant data will be shared with the scientific community according to the Baylor Foundation Eswatini data sharing policy upon request.

Locations

ES (1)