Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer

NCT ID: NCT03993054

Last Updated: 2025-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2024-07-12

Brief Summary

This is a one year study to develop and test a culturally-tailored, web-based cognitive behavioral stress management (CBSM) intervention for Latino sexual minority men living with both HIV and cancer. Sexual minority Latino men living with HIV and cancer experience a variety of health disparities related to their diagnoses, including higher distress. The project will use a single-group pre-post design. The project will use a community-based participatory research approach, and the investigators have included (and will continue to include) LGBT-serving community partners in all phases of the research from study design to implementation and dissemination of findings. The proposed study will aid in attenuating health disparities among Latino sexual minority men living with HIV and cancer.

Conditions

HIV/AIDS; Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Culturally-tailored CBSM

Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 10 weeks.

Group Type: EXPERIMENTAL

Culturally-tailored cognitive behavioral stress management

Intervention Type: BEHAVIORAL

The SmartManage CBSM intervention includes content that is of clinical relevance to sexual minority men dually diagnosed with HIV and cancer. Intervention content includes: co-management of HIV and cancer, strategies for self-advocacy, partnering with the health system and health providers, intimacy and disclosure concerns regarding both conditions, and contextual stressors (e.g., racial/ethnic minority status), stigmatization, assertiveness and communication skills, and self-efficacy in care coordination. Participants receive weekly 1.5 hour interactive group sessions online that focus on stress and self-management skill-building, and also receive access to didactic information regarding intervention content via the intervention website. Intervention length is 10 weeks. This intervention will be a version of SmartManage that is culturally-tailored for Latino populations.

Interventions

Culturally-tailored cognitive behavioral stress management

The SmartManage CBSM intervention includes content that is of clinical relevance to sexual minority men dually diagnosed with HIV and cancer. Intervention content includes: co-management of HIV and cancer, strategies for self-advocacy, partnering with the health system and health providers, intimacy and disclosure concerns regarding both conditions, and contextual stressors (e.g., racial/ethnic minority status), stigmatization, assertiveness and communication skills, and self-efficacy in care coordination. Participants receive weekly 1.5 hour interactive group sessions online that focus on stress and self-management skill-building, and also receive access to didactic information regarding intervention content via the intervention website. Intervention length is 10 weeks. This intervention will be a version of SmartManage that is culturally-tailored for Latino populations.

Intervention Type: BEHAVIORAL

Other Intervention Names

C-SmartManage

Eligibility Criteria

Inclusion Criteria

1. Have been diagnosed with at least one form of non-metastatic solid tumor cancer,

2. Are ≥ 30 days post active primary treatment (i.e. surgery, radiation, and/or chemotherapy*) for their cancer. (Note: Adjuvant therapies, such as hormone therapy for prostate cancer, etc. are not considered exclusionary),

3. Self-identify as a sexual minority man,

4. have been diagnosed with HIV,

5. Have reliable access to a computer/device with internet accessibility, and

6. Are fluent English.

2. Have a history of advanced (metastatic) cancer of any type or are currently undergoing primary treatment for their cancer,

3. Have had inpatient treatment for severe mental illness in the past 12 months, or have overt signs of psychopathology (i.e. psychosis) and/or suicidality at the time of screening,

4. Are experiencing active alcohol dependence, or have had inpatient treatment for alcohol abuse within the past 12 months,

5. Are experiencing active substance dependence, or have had inpatient treatment for substance abuse within the past 12 months, and/or

6. Have any other medical conditions resulting in a predicted life expectancy <12 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Sara StGeorge

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara St. George, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U54MD002266

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20200127

Identifier Type: -

Identifier Source: org_study_id