The Eswatini PRISM Study on Adolescents Living With HIV

NCT ID: NCT07101458

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2026-12-30

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. 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.

Detailed Description

This study employs an explanatory sequential mixed-methods design to rigorously evaluate the Promoting Resilience in Stress Management (PRISM) intervention. In the initial quantitative phase, a single-site, single-blind, pilot randomized controlled trial (RCT) will be conducted. A sample of (n=140) ALHIV will be recruited and randomly assigned to either the PRISM intervention arm or a control arm receiving standard psychosocial care. The PRISM intervention, a manualized, skills-based training program, originally comprises six 30-60-minute, one-on-one sessions designed to enhance resilience resources, including stress management, goal-setting, cognitive reframing, and meaning-making, in adolescents and young adults (AYAs). For the purposes of this trial, the PRISM intervention will be adapted to consist of three 60-minute sessions, delivered at intervals of 1-2 weeks based on participant preference. Participants in both arms will complete validated survey instruments to assess exploratory outcomes, including psychological distress, resilience, and HIV-related quality of life. Data collection will occur at baseline (T0), and at 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4) post-enrollment. The researchers will then evaluate the feasibility, acceptability, and effectiveness of the PRISM intervention based on these outcomes.

In the second phase of the study, an Exploratory-Descriptive Qualitative (EDQ) research design will be employed to investigate the experiences and perceptions of participants engaged in the PRISM program. Data collection will involve the use of semi-structured interview guides administered to nurse PRISM coaches and a purposively selected sample of ALHIV from the intervention arm of the pilot clinical trial. The collected data will undergo rigorous thematic analysis to elucidate key insights into the participants' experiences and perceptions of the PRISM intervention, thereby contributing to a deeper understanding of its implementation and impact.

Conditions

Human Immunodeficiency Virus; Psychological Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment Arm

Promoting Resilience in Stress Management (PRISM)

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

Group Type: EXPERIMENTAL

Promoting Resilience in Stress Management intervention

Intervention Type: 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.

Standard Psychosocial Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Promoting Resilience in Stress Management intervention

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PRISM; PRISM intervention; PRISM program

Eligibility Criteria

Inclusion Criteria

• 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).

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.

• 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.

Exclusion Criteria

• Adolescents who refuse to participate.
• Adolescents whose parents/caretakers (for <18 years) will not consent to their participation.
• Adolescents who will report having suicidal thoughts (i.e., who will respond yes to one item asking if they thought of killing themselves in the last 30days). This exclusion is based on the understanding that the PRISM intervention was not designed to address suicidal ideation, as confirmed by its developers. Such individuals will be referred to a licensed psychologist following the study's established referral plan, thereby ensuring they receive the appropriate care and support.

• A parent or caretaker who refuses to participate.

Eligibility Criteria for Participation in Semi-Structured Interviews Post Intervention

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Foundation Eswatini

UNKNOWN

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

University of Eswatini

UNKNOWN

Sponsor Role: collaborator

Eswatini Nazarene Health Institutions

OTHER

Sponsor Role: lead

Responsible Party

Musa Lewis Nhlabatsi

Family Nurse Practitioner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Musa L. Nhlabatsi, MSc

Role: PRINCIPAL_INVESTIGATOR

Eswatini Nazarene Health Institutions

Mduduzi C. Shongwe, PhD

Role: STUDY_DIRECTOR

Department of Midwifery Science, University of Eswatini

Debrah Vambe, MD

Role: STUDY_DIRECTOR

Baylor Foundation Eswatini

Kay Alexander, MD

Role: STUDY_DIRECTOR

Baylor Foundation Eswatini

Nobuhle Mthethwa, MPH

Role: STUDY_DIRECTOR

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

Joyce Yi-Frazier, PhD

Role: STUDY_DIRECTOR

Dana-Farber Cancer Institute (DFCI)

Locations

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

Manzini, Manzini Region, Eswatini

Site Status: RECRUITING

Countries

Eswatini

Central Contacts

Musa L. Nhlabatsi, MSc

Role: CONTACT

lewienhlabatsi@gmail.com

+26876115197

Mduduzi C. Shongwe, PhD

Role: CONTACT

mduyaye@gmail.com

+26876180806/+26879280047

References

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.

Reference Type: BACKGROUND

PMID: 34817581 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30230531 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25678533 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39158914 (View on PubMed)

Other Identifiers

EHHRRB 075/2025

Identifier Type: -

Identifier Source: org_study_id