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Mental HealthGwanEnjoyLifeNCT07762612

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

A study testing Gwan Enjoy Life Interveniton in people with Mental Health and HIV, run by University of California, San Francisco at 1 site in Jamaica.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Mental Health, HIV, Pyschological Distress
What is being tested?
Gwan Enjoy Life Interveniton
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteJamaica
Study dates
25 Aug 2026to 30 Aug 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 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

415-476-9463

orlando.harris@ucsf.edu

Sheri Weiser, MD contact

Sheri.Weiser@ucsf.edu

Jamaica1 site

  • Jamaica AIDS Support for Life

    Kingston

    Kandasi Levermore-Walton, MPH, +1-876-925-0021, klevermore@jasforlife.org

    Xavier Biggs, MPH, +1-876-925-0021, xbiggs@jasforlife.org

Other trials in Jamaica

About this study

Official 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

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.

Read the 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.

Being tested
Gwan Enjoy Life Interveniton
Keywords
Mental Health, HIV, Engagement in Care, Jamaica, Sexual Minority Men, Psychological Distress
Medical subject headings
Psychological Well-Being, Suicidal Ideation

What participants receive

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

  • Gwan Enjoy Life IntervenitonOther

    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.

Study groups in NCT07762612
Study groupRoleWhat they receive
Gwan Enjoy Life InterventionExperimentalThe 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.
Receives: Other: Gwan Enjoy Life Interveniton
Control GroupNo interventionControl 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

What is being measured

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

  1. 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

    Measured: Baseline; 6 months; 12 months

  2. 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

    Measured: Baseline; 6 months; 12 months

  3. 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.

    Measured: Baseline; 6 months; 12 months

  4. 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

    Measured: Baseline; 6 months; 12 months

  5. 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.

    Measured: Baseline; 6 months; 12 months

Secondary outcomes (8)

  1. 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

    Measured: Baseline; 6 months; 12 months

  2. 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.

    Measured: Baseline; 6 months; 12 months

  3. 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.

    Measured: Baseline; 6 months; 12 months

  4. ART Adherence / Retention on ART

    Assessed via clinical records including prescription refill data and treatment status

    Measured: Baseline; 6 months; 12 months

  5. 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.

    Measured: Baseline; 6 months; 12 months

  6. CD4 Count

    Immune status measured via CD4 laboratory values from clinical records

    Measured: Baseline; 6 months; 12 months

  7. 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).

    Measured: Baseline; 6 months; 12 months

  8. Intervention Adherence

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

    Measured: Baseline; 6 months; 12 months

Timeline

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

  1. First posted13 Aug 2026
  2. Study start25 Aug 2026 (estimated)
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

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
The intervention will be conducted over six sessions. Sixty participants will be randomized in a 2:1 ratio to the intervention or control group (40 intervention; 20 control) and assessed at baseline, 24 weeks, and 12 months using structured surveys and clinical record abstraction.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07762612
Sponsor's protocol ID
26-46310
Other IDs
5K23MH130250-05
Acronym
GwanEnjoyLife
Status last verified
Aug 2026
First submitted
23 Jul 2026
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Johnson MO, Neilands TB, Dilworth SE, Morin SF, Remien RH, Chesney MA. The role of self-efficacy in HIV treatment adherence: validation of the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). J Behav Med. 2007 Oct;30(5):359-70. doi: 10.1007/s10865-007-9118-3. Epub 2007 Jun 23.

    PubMed 17588200

  • Beckford Jarrett S, De La Haye W, Miller Z, Figueroa JP, Duncan J, Harvey K. High prevalence of psychiatric and substance use disorders among persons seeking treatment for HIV and other STIs in Jamaica: a short report. AIDS Care. 2018 May;30(5):604-608. doi: 10.1080/09540121.2017.1384786. Epub 2017 Oct 3.

    PubMed 28971701

  • Logie CH, Lacombe-Duncan A, Wang Y, Levermore K, Jones N, Ellis T, Bryan N, Grace D. Adapting the psychological mediation framework for cisgender and transgender sexual minorities in Jamaica: Implications from latent versus observed variable approaches to sexual stigma. Soc Sci Med. 2020 Jan;245:112663. doi: 10.1016/j.socscimed.2019.112663. Epub 2019 Nov 5.

    PubMed 31734480

  • Logie CH, James L, Tharao W, Loutfy MR. HIV, gender, race, sexual orientation, and sex work: a qualitative study of intersectional stigma experienced by HIV-positive women in Ontario, Canada. PLoS Med. 2011 Nov;8(11):e1001124. doi: 10.1371/journal.pmed.1001124. Epub 2011 Nov 22.

    PubMed 22131907

  • Harris OO, Jarrett S. Beyond Homophobia: How Do Jamaican Men Who Have Sex with Men Build Communities, Affirm Identity, and Mitigate Homophobia? J Assoc Nurses AIDS Care. 2018 Sep-Oct;29(5):749-761. doi: 10.1016/j.jana.2018.03.003. Epub 2018 Mar 14.

    PubMed 29631931

  • Beckford Jarrett S, Flanagan R, Coriolan A, Harris O, Campbell A, Skyers N. Barriers and facilitators to participation of men who have sex with men and transgender women in HIV research in Jamaica. Cult Health Sex. 2020 Aug;22(8):887-903. doi: 10.1080/13691058.2019.1634222. Epub 2019 Aug 19.

    PubMed 31423952

  • Logie CH, Lacombe-Duncan A, Kenny KS, Levermore K, Jones N, Marshall A, Newman PA. Associations between Police Harassment and HIV Vulnerabilities among Men Who Have Sex with Men and Transgender Women in Jamaica. Health Hum Rights. 2017 Dec;19(2):147-154. No abstract available.

    PubMed 29302172

  • Harris OO. Social and cultural determinants of HIV risk among young Jamaican men who have sex with men. 2014. https://urresearch.rochester.edu/institutionalPublicationPublicView.action?institutionalItemId=28044.

  • Harris OO. Survival now versus survival later: immediate and delayed HIV risk assessment among young Jamaican men who have transactional sex with men. Cult Health Sex. 2019 Aug;21(8):883-897. doi: 10.1080/13691058.2018.1524079. Epub 2018 Nov 16.

    PubMed 30444450

  • Harris OO, Dunn LL. "I Kept It to Myself": Young Jamaican Men Who Have Sex with Men's Experiences with Childhood Sexual Abuse and Sexual Assault. Arch Sex Behav. 2019 May;48(4):1227-1238. doi: 10.1007/s10508-018-1219-2. Epub 2018 Jun 27.

    PubMed 29951864

Questions about this trial

What is this clinical trial studying?

A study testing Gwan Enjoy Life Interveniton in people with Mental Health and HIV, run by University of California, San Francisco at 1 site in Jamaica.

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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 13 Aug 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 Jamaica. 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?

Contact Orlando O Harris, PhD, RN, FNP, MPH, (415-476-9463, orlando.harris@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire-9 (time frame: Baseline; 6 months; 12 months). The study lists 5 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 NCT07762612, which also lists 10 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 13 Aug 2026.

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