"Gwan Enjoy Life:" Protocol for a Randomized Controlled Trial to Test a Peer-Supported Mental Health Intervention to Improve Engagement in Care for High-Priority Sexual Minority Men Living With HIV
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Patient Health Questionnaire-9
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Self-identified as a cisgender man who have sex with men
- •Age 18 and older,
- •Living in one of the 14 parishes
- •Able to offer informed consent
- •Living with HIV (currently engaged, marginally engaged, and not engaged in care)
- •Provide consent to clinic staff to review medical records.
Exclusion Criteria
- •Self-reported participation in another HIV care engagement study
- •Unable to understand the consent process
- •Planning on relocating out of Jamaica over the next 12 months.
Arms & Interventions
Gwan Enjoy Life Intervention
The Gwan Enjoy Life intervention is a 6-session choice-based program.
- Session 1: Introduction, identity, and risk
- Session 2: Understanding HIV and Engagement in Care
- Session 3: Mental Health, Trauma, and HIV
- Session 4: Stigma, Violence, and Human Rights
- Resilient Coping, Social Support, and HIV Disclosure
- 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.
Intervention: Gwan Enjoy Life Interveniton (Other)
Control Group
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
Outcomes
Primary Outcomes
Patient Health Questionnaire-9
Time Frame: Baseline; 6 months; 12 months
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
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline; 6 months; 12 months
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
UCLA Loneliness Scale: Loneliness
Time Frame: Baseline; 6 months; 12 months
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.
Kessler Psychological Distress Scale (K10)
Time Frame: Baseline; 6 months; 12 months
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
Columbia Suicide Severity Risk Scale (C-SSRS)
Time Frame: Baseline; 6 months; 12 months
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.
Secondary Outcomes
- The Brief Resilient Coping Scale (BRCS)(Baseline; 6 months; 12 months)
- The Medical Outcomes Study (MOS) Social Support Survey(Baseline; 6 months; 12 months)
- Retention in Care(Baseline; 6 months; 12 months)
- ART Adherence / Retention on ART(Baseline; 6 months; 12 months)
- Viral Suppression(Baseline; 6 months; 12 months)
- CD4 Count(Baseline; 6 months; 12 months)
- Theoretical Framework of Acceptability (TFA)(Baseline; 6 months; 12 months)
- Intervention Adherence(Baseline; 6 months; 12 months)