NCT07762612

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

August 25, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

July 23, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

Mental HealthHIVEngagement in CareJamaicaSexual Minority MenPsychological Distress

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    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.

    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

    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.

    Baseline; 6 months; 12 months

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Gwan Enjoy Life Intervention

EXPERIMENTAL

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 Group

NO INTERVENTION

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

Interventions

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.

Gwan Enjoy Life Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jamaica AIDS Support for Life

Kingston, Jamaica

Location

Related Publications (10)

  • 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.

    PMID: 17588200BACKGROUND
  • 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.

    PMID: 28971701BACKGROUND
  • 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.

    PMID: 31734480BACKGROUND
  • 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.

    PMID: 22131907BACKGROUND
  • 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.

    PMID: 29631931BACKGROUND
  • 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.

    PMID: 31423952BACKGROUND
  • 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.

    PMID: 29302172BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 30444450BACKGROUND
  • 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.

    PMID: 29951864BACKGROUND

MeSH Terms

Conditions

Psychological Well-BeingSuicidal Ideation

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorSuicideSelf-Injurious BehaviorBehavioral Symptoms

Study Officials

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

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

Sheri Weiser, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2026

First Posted

August 13, 2026

Study Start (Estimated)

August 25, 2026

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.

Locations