Human Immunodeficiency VirusPRISMNCT07101458

The Eswatini PRISM Study on Adolescents Living With HIV

A study testing Promoting Resilience in Stress Management intervention in people with Human Immunodeficiency Virus and Psychological Stress, run by Eswatini Nazarene Health Institutions at 1 site in Eswatini.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 10 to 19 years
Conditions the study is for: Human Immunodeficiency Virus, Psychological Stress
What is being tested?: Promoting Resilience in Stress Management intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 1 siteEswatini
Study dates: 30 Oct 2025to 30 Jun 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 19 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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
Participants who meet the inclusion criteria but are unwilling to provide informed consent or assent and/or parental consent.
PRISM coaches who meet the inclusion criteria but are unwilling to provide informed consent to participate.

Trial locations and contacts

1 site in 1 country.

Eswatini1 site

Raleigh Fitkin Memorial Hospital-Baylor College of Medicine Children's Foundation Clinic
Manzini, Manzini Region, M200

Other trials in Eswatini

About this study

Official title: Feasibility and Acceptability of the Promoting Resilience in Stress Management (PRISM) Intervention Among Adolescents (10 - 19 Years) Living With HIV in Eswatini: A Single Site, Single-Blind, Randomized Controlled Pilot Clinical Trial

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:

Participants in the PRISM intervention group will experience reduced psychological distress compared to those in the control arm.
Participants in the PRISM intervention group will report improved HIV health-related quality of life after receiving the intervention compared to the control group.
Participants in the intervention arm will have higher resilience scores after receiving the intervention compared to those receiving usual psychosocial care.

Read the 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
Being tested: Promoting Resilience in Stress Management intervention
Keywords: Adolescents, Health-related quality of life, Human immunodeficiency virus, Psychological distress, Promoting Resilience in Stress Management, Resilience
Medical subject headings: Acquired Immunodeficiency Syndrome, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Promoting Resilience in Stress Management interventionBehavioural
Also called PRISM, PRISM intervention, PRISM program
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.

Study groups in NCT07101458
Study group	Role	What they receive
Treatment Arm	Experimental	Promoting Resilience in Stress Management (PRISM) Individual, 1:1 version of the Promoting Resilience in Stress Management intervention. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 12 months outcome assessment point.

Secondary outcomes (4)

Effectiveness of the PRISM intervention
Effectiveness of the PRISM intervention will be determined by comparing the changes in psychological distress, resilience and HIV health-related quality of life mean scores pre- and post-intervention for both the treatment and usual care groups of the trial. A statistically significant reduction in mean scores of the above-mentioned outcomes in the treatment group compared to the control group will suggest that the PRISM intervention is effective.
Measured: At 12 months outcome assessment point.
Psychological distress
Psychological distress will be assessed by the Kessler Psychological Distress Scale (K6), a self-administered screening tool developed to screen for non-specific psychological distress and serious mental illness in various populations. Participants will be asked to rate how often they experienced symptoms in the past thirty days using the K6 questionnaire. They will rate their experiences on a 5-point Likert scale for each question, where 0 = none of the time, 1 = a little of the time, 2 = some of the time, 3 = most of the time, and 4 = all of the time. A total score of psychological distress will be computed by summing the scores for all six items. The K6 questionnaire has a total score ranging from 0 to 24 points, with higher scores indicating severe psychological distress.
Measured: At 3, 6, 9, and 12-months outcome assessment points.
Resilience
Resilience will be assessed with the Connor-Davidson Resilience Scale 10-Item (CD-RISC 10). The CD-RISC 10 consists of 10 items, and respondents rate each item on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). The total score for the CD-RISC 10 ranges from 0 to 40, with higher scores indicating greater resilience.
Measured: At 3, 6, 9, and 12-months outcome assessment points.
HIV health-related quality of life
The HIV health-related quality of life of adolescents living with HIV will be assessed using the World Health Organization Quality of Life Instrument-HIV (WHOQOL-HIV). Each item within the WHOQOL HIV BREF instrument is rated on a 5-point scale: 1 = not at all, 2 = a little, 3 = a moderate amount, 4 = very much, and 5 = an extreme amount. Participants in the study will score how they perceive the five domain items in the WHOQOL targeting HIV. An average score from each domain will be computed to have a total health quality of life for each participant. Then, higher scores reflect higher satisfaction or better functioning in these domains, suggesting a better overall quality of life.
Measured: At 3, 6, 9, and 12-months outcome assessment points.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 202530 Jun 2027

First posted3 Aug 2025
Study start30 Oct 2025
Primary completion30 Jun 2027 (estimated)
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single-site, single-blind, parallel randomized clinical trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07101458
Sponsor's protocol ID: EHHRRB 075/2025
Acronym: PRISM
Status last verified: Sep 2026
First submitted: 28 Jul 2025
Last updated: 2 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified data generated from this study will be securely uploaded to a dedicated Baylor Foundation Eswatini data server repository to facilitate data sharing in accordance with the foundation's data management policy. The study protocol and statistical analysis plan will be publicly accessible on ClinicalTrials.gov, in compliance with federal regulations or as stipulated by the conditions of awards and agreements supporting the research.

Publications

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.
PubMed 34817581
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.
PubMed 30230531
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.
PubMed 25678533
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.
PubMed 39158914

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility and Acceptability of the Promoting Resilience in Stress Management (PRISM) Intervention Among Adolescents (10 - 19 Years) Living With HIV in Eswatini: A Single Site, Single-Blind, Randomized Controlled Pilot Clinical Trial
ClinicalTrials.gov ID: NCT07101458
Acronym / sponsor ID: PRISM / EHHRRB 075/2025
Conditions: Human Immunodeficiency Virus, Psychological Stress
Keywords: Adolescents, Health-related quality of life, Human immunodeficiency virus, Psychological distress, Promoting Resilience in Stress Management, Resilience
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 140 participants (actual)
Lead sponsor: Eswatini Nazarene Health InstitutionsUniversity, hospital or other
Collaborators: Baylor College of Medicine Children's Foundation, Dana-Farber Cancer Institute, University of Eswatini
Study start: 30 Oct 2025 (actual)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 30 Jun 2027 (estimated)
First posted: 3 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Participants in the PRISM intervention group will experience reduced psychological distress compared to those in the control arm.
Participants in the PRISM intervention group will report improved HIV health-related quality of life after receiving the intervention compared to the control group.
Participants in the intervention arm will have higher resilience scores after receiving the intervention compared to those receiving usual psychosocial care.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Single-site, single-blind, parallel randomized clinical trial

Arm	Type	Receives
Treatment Arm	Experimental	Behavioral: Promoting Resilience in Stress Management interventionPromoting Resilience in Stress Management (PRISM) Individual, 1:1 version of the 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.

Who may qualify

Ages: 10 to 19 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Promoting Resilience in Stress Management interventionAlso: PRISM, PRISM intervention, PRISM programPRISM 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.	Behavioural	Treatment Arm

Primary outcome

Feasibility of the PRISM intervention
Time frame: 12 months outcome assessment point.
Feasibility of the PRISM intervention will be defined as priori >70% program completion of the three PRISM sessions among enrolled participants.
Acceptability of the PRISM
Time frame: 12 months outcome assessment point.
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.

4 secondary outcomes

Effectiveness of the PRISM intervention
Time frame: At 12 months outcome assessment point.
Psychological distress
Time frame: At 3, 6, 9, and 12-months outcome assessment points.
Resilience
Time frame: At 3, 6, 9, and 12-months outcome assessment points.
HIV health-related quality of life
Time frame: At 3, 6, 9, and 12-months outcome assessment points.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
Background: PubMed 34817581Rosenberg 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.
Background: PubMed 30230531Rosenberg 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.
Background: PubMed 25678533Rosenberg 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.
Background: PubMed 39158914Yi-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.
Individual participant dataSharing planned: Yes. De-identified data generated from this study will be securely uploaded to a dedicated Baylor Foundation Eswatini data server repository to facilitate data sharing in accordance with the foundation's data management policy. The study protocol and statistical analysis plan will be publicly accessible on ClinicalTrials.gov, in compliance with federal regulations or as stipulated by the conditions of awards and agreements supporting the research.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Musa L. Nhlabatsi, MSc principal investigator

Eswatini Nazarene Health Institutions

Mduduzi C. Shongwe, PhD study director

Department of Midwifery Science, University of Eswatini

Debrah Vambe, MD study director

Baylor College of Medicine Children's Foundation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Eswatini. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the PRISM intervention (time frame: 12 months outcome assessment point.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07101458, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.