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NCT Number: NCT07762612

"Gwan Enjoy Life:" A Peer-Supported Mental Health Mentoring Intervention to Improve Engagement in Care Among Sexual Minority Men Living With HIV in Jamaica

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gwan Enjoy Life Interveniton

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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

  1. The Brief Resilient Coping Scale (BRCS)

    Time frame: Baseline; 6 months; 12 months

    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

  2. The Medical Outcomes Study (MOS) Social Support Survey

    Time frame: Baseline; 6 months; 12 months

    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.

  3. Retention in Care

    Time frame: Baseline; 6 months; 12 months

    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.
  4. ART Adherence / Retention on ART

    Time frame: Baseline; 6 months; 12 months

    Assessed via clinical records including prescription refill data and treatment status

  5. Viral Suppression

    Time frame: Baseline; 6 months; 12 months

    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.
  6. CD4 Count

    Time frame: Baseline; 6 months; 12 months

    Immune status measured via CD4 laboratory values from clinical records

  7. Theoretical Framework of Acceptability (TFA)

    Time frame: Baseline; 6 months; 12 months

    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).

  8. Intervention Adherence

    Time frame: Baseline; 6 months; 12 months

    Participation in core intervention components (e.g., number of peer-support sessions completed)

Study contacts

Contact information is provided by the study sponsor or research team.

Orlando O Harris, PhD, RN, FNP, MPH,

CONTACT

[email protected]

415-476-9463

Sheri Weiser, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

"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

Acronym: GwanEnjoyLife

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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