NCT04544917

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

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

September 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2024

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

3.6 years

First QC Date

September 3, 2020

Last Update Submit

August 11, 2025

Conditions

CancerHivStress

Keywords

Symptom burdenCognitive behavioral stress managementIntervention development

Outcome Measures

Primary Outcomes (1)

  • Proportion of eligible SMM that agree to participate

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

    Up to one year

Secondary Outcomes (1)

  • USE Questionnaire Scores

    Week 10

Study Arms (2)

SmartManage Group

EXPERIMENTAL

Participants in this group will receive ten 90-minute weekly therapist delivered SmartManage group sessions via video conference. Participants will have access to the SmartManage web platform, which will also guide the live intervention sessions.

Behavioral: SmartManage for HIV+ cancer survivors

Educational Control Group

ACTIVE COMPARATOR

Participants in this group will view ten weekly control content video recorded sessions.

Behavioral: Educational Control

Interventions

SmartManage for HIV+ cancer survivorsBEHAVIORAL

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.

SmartManage Group
Educational ControlBEHAVIORAL

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

Educational Control Group

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale sex assigned at birth and self-identify as male.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

NeoplasmsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Frank J Penedo, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 10, 2020

Study Start

February 15, 2021

Primary Completion

September 3, 2024

Study Completion

September 3, 2024

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)