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Relationship Education Program for HIV Prevention (all2GETHER Trial)

N/A

Recruiting

Led By Michael E Newcomb, Ph.D

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24-months

Awards & highlights

all2GETHER Trial Summary

This trial tests a program to help gay, bisexual, queer, transgender, and non-binary people reduce their risk of HIV infection, by using online surveys & testing for Chlamydia and Gonorrhea and at-home point-of-care HIV testing. Participants randomized into one of two conditions & monitored for 2 yrs. Participation is remote.

Who is the study for?

This trial is for gay, bisexual, queer, transgender and non-binary individuals aged 16-34 who have had condomless sex with multiple partners of unknown or different HIV status in the past 6 months. They must be HIV-negative, speak English well, have internet access and agree to audio recordings during sessions.Check my eligibility

What is being tested?

The study tests an updated relationship education and HIV prevention program called all2GETHER. Participants will either receive this program or no program at all by random assignment. The effectiveness will be measured through online surveys and home testing for HIV, Chlamydia, and Gonorrhea over two years.See study design

What are the potential side effects?

Since this trial involves educational intervention rather than medication, there are no direct medical side effects. However, participants may experience discomfort discussing personal topics during the education sessions.

all2GETHER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HIV infection

Secondary outcome measures

Condomless Anal Sex

Pre-Exposure Prophylaxis Use

Relationship Functioning

+1 more

all2GETHER Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental ArmExperimental Treatment1 Intervention

all2GETHER is an HIV prevention and relationship education program designed for young MSM. all2GEHTER consists of 3 online didactic skills modules and 2 videoconference-based skills coaching sessions The 3 online modules focus on developmental skills related to sexual health and relationship functioning, including HIV prevention in couples, communication skills, coping skills, problem-solving and acceptance. Individualized couple sessions focus on implementation of skills specific to the needs of each couple.

Group II: Control ArmActive Control1 Intervention

Participants will receive no intervention, but have access to HIV prevention resources from the CDC website and national databases. We will also assess exposure to other interventions that may be naturally occurring in participants' local context, which can be used to describe the sample and as a covariate (as necessary).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

912,251 Total Patients Enrolled

4 Trials studying Gonorrhea

3,682 Patients Enrolled for Gonorrhea

University of CincinnatiOTHER

428 Previous Clinical Trials

629,394 Total Patients Enrolled

2 Trials studying Gonorrhea

70,256 Patients Enrolled for Gonorrhea

Medical University of South CarolinaOTHER

933 Previous Clinical Trials

7,389,635 Total Patients Enrolled

Media Library

all2GETHER Clinical Trial Eligibility Overview. Trial Name: NCT05678556 — N/A

Gonorrhea Research Study Groups: Experimental Arm, Control Arm

Gonorrhea Clinical Trial 2023: all2GETHER Highlights & Side Effects. Trial Name: NCT05678556 — N/A

all2GETHER 2023 Treatment Timeline for Medical Study. Trial Name: NCT05678556 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available slots for volunteers in this clinical investigation?

"As evidenced by clinicaltrials.gov, this medical experiment is presently recruiting participants. This trial was initially uploaded to the database on December 15th 2022 and the most recent update came out January 4th 2023."

Answered by AI

Does this research project permit geriatric individuals to enroll?

"The age range for participants of this medical experiment is 16 to 34. There are 29 clinical trials designed for minors, and 75 specifically targeting geriatric populations."

Answered by AI

What is the scope of individuals being enrolled in this trial?

"Affirmative. Clinicaltrials.gov details that this experimental research, which was initially publicized on December 15th 2022, is seeking to enroll participants currently. Approximately 5000 people are needed from 1 medical facility."

Answered by AI

Is participation in this research endeavor open to me?

"This study is recruiting 5000 gender diverse individuals between 16 and 34 years old who have had unprotected anal intercourse with at least two different cisgender men in the past 6 months. Criteria for eligibility include: laboratory-verified HIV negativity, 8th grade English reading/speaking skills or better, access to the internet, agreement to audio recording of intervention sessions, availability of a mailing address for receiving STI tests supplies; additionally dyad partners aged 35+ and/or identified as being HIV positive may enrol but with some restricted parameters."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effectiveness of Relationship Education for Reducing HIV Incidence Among SGM

Michael E. Newcomb 2022. "Effectiveness of Relationship Education for Reducing HIV Incidence Among SGM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05678556.