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OpenTrials
Completed

NCT Number: NCT04544917

SmartManage Stress Management for HIV+ Cancer Survivors

The purpose of this study is to design and refine a web-based platform developed for managing symptom burden in men who have sex who are HIV+ cancer survivors.

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Key information

Conditions

Cancer Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neoplasms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Stress Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 18 years or older
  • Fluent in English
  • Have evidence of at least one form of non-metastatic solid tumor cancer or blood cancer
  • Be at least 30 days post active primary cancer treatment
  • Self identify as a sexual minority cisgender man
  • Self-report having been diagnosed with HIV
  • Have reliable access to a computer/device with internet accessibility

Exclusion criteria

  • Have had one of the following exclusionary cancer types: Non-melanoma skin cancer, brain cancer, eye cancer, history of some form of pediatric cancer (if that is participant's only cancer diagnosis)
  • History of advanced (metastatic) cancer of any type
  • Inpatient treatment for severe mental illness in the past 12 months and/or suicidality of moderate or greater risk
  • Appears actively intoxicated or otherwise unable to provide full informed consent
  • Have any other medical condition resulting in predicted live expectancy of less than 12 months

Treatment and study plan

SmartManage for HIV+ cancer survivors

Behavioral

Ten weekly therapist delivered group sessions delivered via web conference. Sessions focus on cognitive behavioral stress management, psychoeducation, and management strategies for dual diagnosis of HIV and cancer. Participants will have access to the SmartManage web platform which has all intervention material, resources, and exercises.

Educational Control

Behavioral

Participants in the control condition will view ten videos over ten weeks, consisting of informational and educational material relevant to cancer and HIV.

Primary outcomes

  1. Proportion of eligible SMM that agree to participate

    Time frame: Up to one year

    Feasibility of the intervention will be reported as the proportion of eligible sexual minority men (SMM) who agree to participate versus decline

Secondary outcomes

  1. USE Questionnaire Scores

    Time frame: Week 10

    Acceptability of the intervention will be reported as Usefulness, Satisfaction and Ease of Use (USE) Questionnaire Scores. USE is a 30-item questionnaire with a total score ranging from 30-240 with the higher score indicating greater acceptability of the intervention.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

Development of an eHealth-based Cognitive Behavioral Stress and Self-Management Intervention to Reduce Symptom Burden in HIV+ Gay and Bisexual Men Who Have Sex With Men (MSM) Treated for Non-Metastatic Cancer

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 10, 2020
Registry last updated
Aug 13, 2025

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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