HIV/AIDSC-SmartManageNCT03993054
Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer
A study testing Culturally-tailored cognitive behavioral stress management in people with HIV/AIDS and Cancer, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- What is being tested?
- Culturally-tailored cognitive behavioral stress management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with at least one form of non-metastatic solid tumor cancer,
- 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),
- Self-identify as a sexual minority man,
- have been diagnosed with HIV,
- Have reliable access to a computer/device with internet accessibility, and
- Are fluent English.
Who cannot join
- Have had one of the following exclusionary cancer types: Leukemia (or other cancers of the blood), Non-melanoma skin cancer only (not in combination with another type listed in the inclusion criteria above), Brain cancer, Eye cancer, a form of pediatric cancer (if the pediatric cancer is the only cancer diagnosis the patient has had),
- Have a history of advanced (metastatic) cancer of any type or are currently undergoing primary treatment for their cancer,
- 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,
- Are experiencing active alcohol dependence, or have had inpatient treatment for alcohol abuse within the past 12 months,
- Are experiencing active substance dependence, or have had inpatient treatment for substance abuse within the past 12 months, and/or
- Have any other medical conditions resulting in a predicted life expectancy <12 months.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Culturally-tailored cognitive behavioral stress management
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally-tailored cognitive behavioral stress managementBehavioural
Also called C-SmartManage
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.
| Study group | Role | What they receive |
|---|---|---|
| Culturally-tailored CBSM | Experimental | Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 10 weeks. Receives: Behavioral: Culturally-tailored cognitive behavioral stress management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in General Stress
The Perceived Stress Scale (PSS) consists of 10 items, which are summed to create a total score ranging from 0 to 40. Higher scores indicate greater levels of perceived stress. The outcome was analyzed as the change from baseline.
Measured: 10 weeks
Change in Disease-Related Distress
The Impact of Events Scale-Revised (IES-R) measures the psychological impact of traumatic events. It consists of three subscales: intrusion (eight items), avoidance (eight items), and hyperarousal (six items). Each subscale score is calculated by summing the items within that subscale. The maximum possible score for intrusion and avoidance is 32 each, while hyperarousal has a maximum score of 24. The scores from these subscales are summed to create a total score, which ranges from 0 to 88. Higher scores indicate a greater negative impact of the traumatic event. The outcome was analyzed as the change from baseline.
Measured: 10 weeks
Change in Health-Related Quality of Life (FACT-G)
The Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire was used to assess quality of life. It comprises four sub-scales: physical well-being (7 items, score range 0-28), social/family well-being (7 items, score range 0-28), emotional well-being (6 items, score range 0-24), and functional well-being (7 items, score range 0-28). The overall score is calculated by summing the scores of these four sub-scales, resulting in a total possible score range of 0-108. Higher scores on the FACT-G indicate a better quality of life. The outcome was analyzed as the change from baseline.
Measured: 10 weeks
Change in Health-Related Quality of Life (MOS-HIV)
The Medical Outcomes Study HIV Survey (MOS-HIV) assesses 10 health dimensions (i.e., health perceptions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy, health distress, and quality of life). Subscales are scored on a 0-100 scale, with a higher score indicating better health. The outcome was analyzed as the change from baseline.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start9 Jan 2023
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Sara StGeorge, University of Miami
- Investigators
- Sara St. George, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993054
- Sponsor's protocol ID
- 20200127
- Other IDs
- U54MD002266
- Acronym
- C-SmartManage
- Status last verified
- May 2025
- First submitted
- 19 Jun 2019
- Last updated
- 2 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer
- ClinicalTrials.gov ID
- NCT03993054
- Acronym / sponsor ID
- C-SmartManage / 20200127
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Posted 2 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Culturally-tailored CBSM | Experimental | Behavioral: Culturally-tailored cognitive behavioral stress managementParticipants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have been diagnosed with at least one form of non-metastatic solid tumor cancer,
- 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),
- Self-identify as a sexual minority man,
- have been diagnosed with HIV,
- Have reliable access to a computer/device with internet accessibility, and
Key exclusion criteria (6 listed)
- Have had one of the following exclusionary cancer types: Leukemia (or other cancers of the blood), Non-melanoma skin cancer only (not in combination with another type listed in the inclusion criteria above), Brain cancer, Eye cancer, a form of pediatric cancer (if the pediatric cancer is the only cancer diagnosis the patient has had),
- Have a history of advanced (metastatic) cancer of any type or are currently undergoing primary treatment for their cancer,
- 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,
- Are experiencing active alcohol dependence, or have had inpatient treatment for alcohol abuse within the past 12 months,
- Are experiencing active substance dependence, or have had inpatient treatment for substance abuse within the past 12 months, and/or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally-tailored cognitive behavioral stress managementAlso: C-SmartManageThe 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. | Behavioural | Culturally-tailored CBSM |
Primary outcome
Change in General Stress
Time frame: 10 weeks
The Perceived Stress Scale (PSS) consists of 10 items, which are summed to create a total score ranging from 0 to 40. Higher scores indicate greater levels of perceived stress. The outcome was analyzed as the change from baseline.
Change in Disease-Related Distress
Time frame: 10 weeks
The Impact of Events Scale-Revised (IES-R) measures the psychological impact of traumatic events. It consists of three subscales: intrusion (eight items), avoidance (eight items), and hyperarousal (six items). Each subscale score is calculated by summing the items within that subscale. The maximum possible score for intrusion and avoidance is 32 each, while hyperarousal has a maximum score of 24. The scores from these subscales are summed to create a total score, which ranges from 0 to 88. Higher scores indicate a greater negative impact of the traumatic event. The outcome was analyzed as the change from baseline.
Change in Health-Related Quality of Life (FACT-G)
Time frame: 10 weeks
The Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire was used to assess quality of life. It comprises four sub-scales: physical well-being (7 items, score range 0-28), social/family well-being (7 items, score range 0-28), emotional well-being (6 items, score range 0-24), and functional well-being (7 items, score range 0-28). The overall score is calculated by summing the scores of these four sub-scales, resulting in a total possible score range of 0-108. Higher scores on the FACT-G indicate a better quality of life. The outcome was analyzed as the change from baseline.
Change in Health-Related Quality of Life (MOS-HIV)
Time frame: 10 weeks
The Medical Outcomes Study HIV Survey (MOS-HIV) assesses 10 health dimensions (i.e., health perceptions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy, health distress, and quality of life). Subscales are scored on a 0-100 scale, with a higher score indicating better health. The outcome was analyzed as the change from baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara St. George, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally-tailored cognitive behavioral stress management in people with HIV/AIDS and Cancer, run by University of Miami at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 2 Jun 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 2 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in General Stress (time frame: 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2025.