NCT05678556 Effectiveness of Relationship Education for Reducing HIV Incidence Among Men Who Have Sex With Men
| NCT ID | NCT05678556 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Hiv |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2022-12-15 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5,000 participants in total. It began in 2022-12-15 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Cisgender men, transgender women and men, non-binary individuals * Had condomless anal sex with 2 or more serodiscordant/unknown-status cisgender male partners in the last 6 months * Aged 16-34 years * Lab-test confirmed HIV-negative * Read and speak English at 8th grade level or better * Internet access * Agree to audio recording of intervention sessions * Provides address to receive HIV/STI test supplies * 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 Exclusion Criteria: -Participants assigned female at birth who identify as women are not eligible
Contact & Investigator
Michael E Newcomb, Ph.D
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT05678556 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 34 Years, studying Hiv. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05678556 currently recruiting?
Yes, NCT05678556 is actively recruiting participants. Contact the research team at newcomb@northwestern.edu for enrollment information.
Where is the NCT05678556 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05678556 clinical trial?
NCT05678556 is sponsored by Northwestern University. The principal investigator is Michael E Newcomb, Ph.D at Northwestern University. The trial plans to enroll 5,000 participants.
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