RECRUITING

Effectiveness of Relationship Education for Reducing HIV Incidence Among SGM

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to upgrade an existing relationship education and HIV prevention program. This program is designed for gay, bisexual, queer, and transgender and non-binary people who partner with cisgender men. This means the program is designed for gay, bisexual and queer men, including both cisgender and transgender men. It is also designed for transgender and non-binary people who partner with cisgender men, including both transfeminine and transmasculine people. The investigators aim to test the effectiveness of this updated program among couples and single people. Participants will complete online surveys and get tested for Chlamydia and Gonorrhea. Participants will be tested for urethral and rectal Chlamydia and Gonorrhea. Participants will also complete at-home point-of-care HIV testing, with confirmatory testing for preliminary positive results. They will also participate in our program on relationship education and HIV prevention. Study staff will follow up with participants for up to 2 years. All participants will be randomized into one of two different conditions: the all2GETHER program or no program. "Randomized" means that it is completely up to chance which condition participants will be put into. Participants have a 50% chance of being assigned to either condition, similar to a coin toss. Participants should expect that they will be in this research study for 2 years. Participation in this study will be done remotely - participants will never need to come into a research lab.

Official Title

Effectiveness of Relationship Education for Reducing HIV Incidence in Men Who Have Sex With Men

Quick Facts

Study Start:2022-12-15
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05678556

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 34 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Cisgender men, transgender women and men, non-binary individuals
  2. * Had condomless anal sex with 2 or more serodiscordant/unknown-status cisgender male partners in the last 6 months
  3. * Aged 16-34 years
  4. * Lab-test confirmed HIV-negative
  5. * Read and speak English at 8th grade level or better
  6. * Internet access
  7. * Agree to audio recording of intervention sessions
  8. * Provides address to receive HIV/STI test supplies
  9. * For dyads, both partners may enroll if they meet the above criteria- partners who are aged 35+ and/or HIV-positive may enroll in a more limited capacity
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Michael E Newcomb, Ph.D.
CONTACT
312-503-0702
newcomb@northwestern.edu
Kathryn Macapagal, Ph.D.
CONTACT
312-503-3605
kathryn.macapagal@northwestern.edu

Principal Investigator

Michael E Newcomb, Ph.D
PRINCIPAL_INVESTIGATOR
Northwestern University
Kathryn Macapagal, Ph.D
PRINCIPAL_INVESTIGATOR
Northwestern University
Elissa Sarno, Ph.D
STUDY_DIRECTOR
Northwestern University
Brian Mustanski, Ph.D
PRINCIPAL_INVESTIGATOR
Northwestern University
Dennis Li, Ph.D
PRINCIPAL_INVESTIGATOR
Northwestern University
Jody Ciolino, Ph.D
PRINCIPAL_INVESTIGATOR
Northwestern University
Jim Carey, MPH
STUDY_DIRECTOR
Northwestern University

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Michael E Newcomb, Ph.D, PRINCIPAL_INVESTIGATOR, Northwestern University
  • Kathryn Macapagal, Ph.D, PRINCIPAL_INVESTIGATOR, Northwestern University
  • Elissa Sarno, Ph.D, STUDY_DIRECTOR, Northwestern University
  • Brian Mustanski, Ph.D, PRINCIPAL_INVESTIGATOR, Northwestern University
  • Dennis Li, Ph.D, PRINCIPAL_INVESTIGATOR, Northwestern University
  • Jody Ciolino, Ph.D, PRINCIPAL_INVESTIGATOR, Northwestern University
  • Jim Carey, MPH, STUDY_DIRECTOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-15
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2022-12-15
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Hiv
  • Chlamydia
  • Gonorrhea