An interventional study of Gwan Enjoy Life Interveniton in Mental Health, HIV and Pyschological Distress, sponsored by University of California, San Francisco. Not yet recruiting at 1 site in Jamaica. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
Sexual minority men (SMM) in Jamaica face many challenges that affect their health and well-being. Although they make up a relatively small part of the population, they are much more likely to be living with HIV than the general public. Many also experience discrimination because of their sexual orientation, HIV-related stigma, violence, poverty, unstable housing, limited educational opportunities, and barriers created by laws and social attitudes. These experiences can have a serious impact on mental health, leading to problems such as depression, anxiety, trauma, and thoughts of suicide. Many people also face barriers to getting mental health care because of stigma or a lack of services that are welcoming and appropriate for their needs. These challenges can make it difficult for people living with HIV to stay connected to medical care and take their HIV medications consistently. Missing appointments or stopping treatment can make it harder to keep the virus under control and can lead to poorer health over time. While researchers know that stigma, discrimination, and violence affect health, we still do not fully understand how these experiences work together to influence HIV care among sexual minority men in Jamaica.
To help address these challenges, we developed the Gwan Enjoy Life program, a culturally relevant program designed specifically for sexual minority men living with HIV in Jamaica. The program combines practical coping skills, emotional support, and strategies for managing the effects of trauma and stress. It is led by trained peer mentors who are also living with HIV, allowing participants to learn from people who understand their experiences. The six-session program gives participants the option of meeting one-on-one with a peer mentor or participating in a small group, depending on what they find most comfortable. The program will be tested in partnership with Jamaica AIDS Support for Life (JASL), one of Jamaica's leading HIV service organizations. Sixty participants from JASL clinics in Kingston and St. Andrew, St. James, and St. Ann will take part in the intervention. Participants will be randomly assigned to either receive the Gwan Enjoy Life program or continue with their usual care, and they will be followed for one year. Researchers will examine whether the program improves mental health, strengthens social support, helps participants stay engaged in HIV care, and improves medication adherence.
The goal of the intervention is to determine whether the Gwan Enjoy Life intervention is a practical and effective program that can be expanded to reach more people across Jamaica. The findings will help researchers, healthcare providers, and policymakers better understand how stigma, violence, and mental health affect HIV care and will support the development of programs that improve the health and well-being of sexual minority men living with HIV.
In Jamaica, an estimated 27,000 to 33,000 adult men who report same-sex sexual behavior are living with or face elevated likelihood of acquiring HIV infection. HIV prevalence in this group is estimated at approximately 33%, substantially higher than the 1.8% observed in the overall population. The parishes of Kingston and St. Andrew, St. James, and St. Ann account for some of the highest HIV case concentrations in the country. Psychological distress, social isolation, and exposure to interpersonal violence are associated with reduced engagement in HIV medical care and suboptimal treatment outcomes. Individuals experiencing these stressors demonstrate higher rates of depressive and anxiety symptoms, reduced adherence to antiretroviral therapy (ART), lower retention in care, and decreased rates of viral suppression. Interventions addressing psychological well-being have demonstrated improvements in emotional functioning; however, prior studies have shown inconsistent effects on HIV treatment outcomes, limited integration of stress-related care components, and minimal adaptation to local service delivery environments. There remains a need to develop and evaluate a sustainable peer-delivered behavioral intervention designed to strengthen psychological functioning and improve HIV care engagement outcomes, including social isolation, depressive symptoms, ART adherence, appointment adherence, and viral suppression. This proposal will develop and implement a structured peer-delivered behavioral support program to improve care engagement among adult men living with HIV in Jamaica. The study has the following aim: Aim 1. Assess feasibility, acceptability, and preliminary clinical impact (depressive symptoms, anxiety symptoms, social isolation, ART adherence, clinic attendance, and viral suppression) of the intervention. Guided by the Information-Motivation-Behavioral Skills (IMB) model and incorporating evidence-based stress-response management strategies, the Gwan Enjoy Life program will be a multi-session intervention delivered by trained peer community health workers (peers) living with HIV. The program is designed to strengthen coping skills, improve treatment adherence behaviors, and increase sustained engagement in care. Feasibility will be evaluated using predefined recruitment, retention, and implementation benchmarks. Acceptability will be assessed through structured exit interviews. Clinical impact will be evaluated through survey measures and medical records review, including virologic and immunologic indicators. The intervention will be conducted in partnership with Jamaica AIDS Support for Life (JASL), a community-based HIV service organization. Sixty participants will be randomized in a 2:1 ratio (40 intervention; 20 control) and assessed at baseline, 24 weeks, and 12 months using structured surveys and clinical record abstraction. The overall objective is to pilot and evaluate a scalable peer-delivered behavioral support program that improves clinical outcomes and strengthens long-term HIV treatment engagement in a high-burden setting, consistent with national and international HIV control priorities.
569 studies on the registry are indexed under Suicidal Ideation; 203 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 469 interventional studies indexed under Suicidal Ideation.
Browse Suicidal Ideation studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Compared within Suicidal Ideation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psychological Well-Being. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Gwan Enjoy Life intervention is a 6-session choice-based program. 1. Session 1: Introduction, identity, and risk 2. Session 2: Understanding HIV and Engagement in Care 3. Session 3: Mental Health, Trauma, and HIV 4. Session 4: Stigma, Violence, and Human Rights 5. Resilient Coping, Social Support, and HIV Disclosure 6. Session 6: Integration and Moving Forward Participants can self-select to either participate with the intervention content 1-1 with a peer facilitator (PMHM) or as part of group with other sexual minority men (SMM) living with HIV.
Other: Gwan Enjoy Life Interveniton
Control participants will have access to usual care services available at all three clinic sites. They will have the opportunity to recieve the full intervention at the conclusion of data collection
The Gwan Enjoy Life intervention is a 6-session choice-based program. 1. Session 1: Introduction, identity, and risk 2. Session 2: Understanding HIV and Engagement in Care 3. Session 3: Mental Health, Trauma, and HIV 4. Session 4: Stigma, Violence, and Human Rights 5. Resilient Coping, Social Support, and HIV Disclosure 6. Session 6: Integration and Moving Forward Participants can self-select to either participate with the intervention content 1-1 with a peer facilitator (PMHM) or as part of group with other sexual minority men (SMM) living with HIV.
Patient Health Questionnaire-9
Assessed using the Patient Health Questionnaire-9 (PHQ-9) to measure severity of depressive symptoms over the past two weeks. It scores symptoms experienced over the past two weeks on a scale from 0 to 27. Scoring and Severity 0-4 points: Minimal or no depression 5-9 points: Mild depression 10-14 points: Moderate depression 15-19 points: Moderately severe depression 20-27 points: Severe depression
Time frame: Baseline; 6 months; 12 months
Generalized Anxiety Disorder-7 (GAD-7)
Measured using the Generalized Anxiety Disorder-7 (GAD-7) to assess symptoms of anxiety. The GAD-7 is a brief, seven-item self-report questionnaire used to screen for generalized anxiety disorder and measure symptom severity. Patients rate how often they experienced specific anxiety symptoms over the past two weeks on a scale from 0 to 3, yielding a total score between 0 and 21. Score Interpretation: 0-4: Minimal anxiety; 5-9: Mild anxiety; 10-14: Moderate anxiety (a score of 10 or higher is typically the cut-off point where further clinical evaluation is recommended); 15-21: Severe anxiety
Time frame: Baseline; 6 months; 12 months
UCLA Loneliness Scale: Loneliness
Assessed using the UCLA Loneliness Scale (8-item short form) to measure perceived social isolation The scale features 20 statements (e.g., "I lack companionship", "I feel isolated from others"). Participants rate each statement using a 4-point scale: Never (1), Rarely (2), Sometimes (3), and Often (4). Positive items are reverse-scored. Total scores range from 20 to 80, with higher numbers showing higher levels of loneliness.
Time frame: Baseline; 6 months; 12 months
Kessler Psychological Distress Scale (K10)
The Kessler Psychological Distress Scale (K10) is a quick questionnaire used to measure recent signs of anxiety and depression, which asks 10 simple questions (nervousness, agitation, fatigue, and depression) about how a person felt over the past 30 days. Answers are ratedf rom 1 ("none of the time") to 5 ("all of the time"). Total scores range from 10 to 50 by adding up all the answers. The scores mean: 10-15: Low or no distress (likely well); 16-21 (or up to 24): Mild distress or mild mental disorder; 22-29 (or 25-29): Moderate distress or moderate disorder; 30-50: High or severe distress requiring help
Time frame: Baseline; 6 months; 12 months
Columbia Suicide Severity Risk Scale (C-SSRS)
The Columbia Suicide Severity Risk Scale (C-SSRS) is is a brief, evidence-based screening tool used to evaluate suicide risk. It relies on simple, plain-language questions to assess the severity of suicidal ideation, preparation, and behavior without requiring formal mental health training to administer. The scale does not yield a single total score, but rather categorizes risk levels using specific subscales: suicidal ideation severity (scored 1 to 5), ideation intensity (scored 2 to 25), and suicidal behavior (binary yes/no ratings). The highest possible score on the Intensity of Ideation subscale is 25.
Time frame: Baseline; 6 months; 12 months
The Brief Resilient Coping Scale (BRCS)
The Brief Resilient Coping Scale (BRCS) is a short, four-item questionnaire use to measure how well a person uses adaptive strategies to cope with stress. The total score ranges from 4 to 20, with higher numbers showing a stronger ability to handle tough situations. Participants rate four items on a 5-point scale, ranging from 1 ("does not describe me at all") to 5 ("describes me very well"). The items focus on proactive, positive, and creative approaches to managing difficult situations, controlling reactions, and addressing losses. Score Interpretation: 4 to 13: Low resilient coper; 14 to 16: Medium resilient coper; 17 to 20: High resilient coper
Time frame: Baseline; 6 months; 12 months
The Medical Outcomes Study (MOS) Social Support Survey
The Medical Outcomes Study (MOS) Social Support Survey is a 18-item, self-administered questionnaire measuring functional social support across four key domains: emotional/informational support, tangible support, affectionate support, and positive social interaction. The scale is structured around 4 domains: 1) Emotional/Informational Support (8 items): Expressions of empathy, guidance, or feedback; 2) Tangible Support (4 items): Provision of material aid or instrumental assistance; 3) Affectionate Support (3 items): Expressions of love and affection; and 4) Positive Social Interaction (3 items): Availability of others to do fun things with. Responses are recorded on a 5-point Likert scale ranging from 1 ("none of the time") to 5 ("all of the time"). Higher Scores indicates higher perceived availability of functional social support.
Time frame: Baseline; 6 months; 12 months
Retention in Care
Measured via medical chart review: clinic attendance, missed visits, and visit constancy. Retention in care will be measured using objective clinical indicators derived from medical records, supplemented where necessary by participant self-report: * Clinic attendance: Number and proportion of scheduled HIV care appointments attended over the study period, abstracted from clinic records. * Missed visits: Number of missed or delayed appointments (e.g., no-shows or visits outside recommended intervals). * Visit constancy: Presence of at least one completed visit within each predefined interval (e.g., quarterly), consistent with standard retention metrics in HIV care research.
Time frame: Baseline; 6 months; 12 months
ART Adherence / Retention on ART
Assessed via clinical records including prescription refill data and treatment status
Time frame: Baseline; 6 months; 12 months
Viral Suppression
HIV viral load (\<200 copies/mL) extracted from medical records to determine suppression status. Viral suppression will be assessed using laboratory-confirmed HIV viral load data extracted from medical records: * Primary indicator: Proportion of participants achieving viral suppression, defined as HIV RNA \<200 copies/mL, consistent with international clinical guidelines. * Secondary indicator: Maintenance of viral suppression across consecutive measurements, where available.
Time frame: Baseline; 6 months; 12 months
CD4 Count
Immune status measured via CD4 laboratory values from clinical records
Time frame: Baseline; 6 months; 12 months
Theoretical Framework of Acceptability (TFA)
The Theoretical Framework of Acceptability (TFA) comprises of seven core domains used to construct evaluation surveys for measuring how recipients perceive a healthcare or behavioral intervention. Acceptability is assessed using a Likert-scale (strongly agree to strongly disagree) items mapped to each of the domains (affective attitude, burden, perceived effectiveness, self-efficacy, ethicality, opportunity costs, and intervention coherence).
Time frame: Baseline; 6 months; 12 months
Intervention Adherence
Participation in core intervention components (e.g., number of peer-support sessions completed)
Time frame: Baseline; 6 months; 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The investigators will share individual participant data (IPD) in The National Institute of Mental Health Data Archive (NDA) and the SAP and source code will be available in GitHub repository.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be available by September 2028
Access criteria: The investigators will share IPD and supporting information upon reasonable request from the scientific community. Source code will be available on a GitHub repository along with a codebook and description of the SAP. A link to the repository will be available after requests are reviewed and approved by the investigator team.
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