Effectiveness of Relationship Education for Reducing HIV Incidence Among SGM

NCT05678556 | Recruiting DMC

• 1 other identifier: U01AI156874-01
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv; Chlamydia; Gonorrhea

Outcome Measures

Primary Outcomes (1)

• HIV infection

  Incidence of HIV confirmed via lab processed but self-administered collection

  24-months

Secondary Outcomes (4)

• Condomless Anal Sex

  24-months

• Pre-Exposure Prophylaxis Use

  24-months

• Relationship Functioning

  24-months

• Sexually transmitted infections

  24-months

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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.

Behavioral: all2GETHER

Control Arm

NO 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).

Interventions

all2GETHER BEHAVIORAL

all2GETHER is an HIV prevention and relationship education program designed for young MSM and other individuals who have sex, date, and are in relationships with MSM. all2GEHTER consists of 3 online didactic skills modules that include videos, activities, and other self-paced education components and 2 videoconference-based skills coaching sessions The 3 online modules focus on developmental skills related to sexual health and relationship functioning, including HIV and STI prevention in couples, effective communication skills, coping skills for LGBTQ and relationship stress, problem-solving and acceptance. Individualized couple sessions led by facilitators focus on implementation of skills specific to the needs of each couple.

Experimental Arm

Eligibility Criteria

• Age: 16 Years - 34 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity. Participants assigned female at birth who identify as women are not eligible
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Participants assigned female at birth who identify as women are not eligible

Sponsors & Collaborators

• Northwestern University: lead
• University of Cincinnati: collaborator
• Medical University of South Carolina: collaborator
• Drexel University: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (8)

• Sullivan PS, Salazar L, Buchbinder S, Sanchez TH. Estimating the proportion of HIV transmissions from main sex partners among men who have sex with men in five US cities. AIDS. 2009 Jun 1;23(9):1153-62. doi: 10.1097/QAD.0b013e32832baa34.

  PMID: 19417579 BACKGROUND

• Greene GJ, Fisher KA, Kuper L, Andrews R, Mustanski B. "Is this normal? Is this not normal? There's no set example": Sexual Health Intervention Preferences of LGBT Youth in Romantic Relationships. Sex Res Social Policy. 2015 Mar;12(1):1-14. doi: 10.1007/s13178-014-0169-2.

  PMID: 25678895 BACKGROUND

• Greene GJ, Andrews R, Kuper L, Mustanski B. Intimacy, monogamy, and condom problems drive unprotected sex among young men in serious relationships with other men: a mixed methods dyadic study. Arch Sex Behav. 2014 Jan;43(1):73-87. doi: 10.1007/s10508-013-0210-1.

  PMID: 24202113 BACKGROUND

• Jiwatram-Negron T, El-Bassel N. Systematic review of couple-based HIV intervention and prevention studies: advantages, gaps, and future directions. AIDS Behav. 2014 Oct;18(10):1864-87. doi: 10.1007/s10461-014-0827-7.

  PMID: 24980246 BACKGROUND

• Markman HJ, Rhoades GK. Relationship education research: current status and future directions. J Marital Fam Ther. 2012 Jan;38(1):169-200. doi: 10.1111/j.1752-0606.2011.00247.x.

  PMID: 22283386 BACKGROUND

• Newcomb ME, Macapagal KR, Feinstein BA, Bettin E, Swann G, Whitton SW. Integrating HIV Prevention and Relationship Education for Young Same-Sex Male Couples: A Pilot Trial of the 2GETHER Intervention. AIDS Behav. 2017 Aug;21(8):2464-2478. doi: 10.1007/s10461-017-1674-0.

  PMID: 28083833 BACKGROUND

• Newcomb ME, Sarno EL, Bettin E, Conway A, Carey J, Garcia C, Hill R, Jozsa K, Swann G, Addington EL, Ciolino JD, Macapagal K, Moskowitz JT, Mustanski B, Whitton SW. Protocol for an attention-matched randomized controlled trial of 2GETHER: a relationship education and HIV prevention program for young male couples. Trials. 2022 Jun 20;23(1):514. doi: 10.1186/s13063-022-06457-9.

  PMID: 35725624 BACKGROUND

• Newcomb ME. Romantic relationships and sexual minority health: A review and description of the Dyadic Health Model. Clin Psychol Rev. 2020 Dec;82:101924. doi: 10.1016/j.cpr.2020.101924. Epub 2020 Sep 23.

  PMID: 33002795 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Chlamydia Infections; Gonorrhea

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections

Study Officials

• Michael E Newcomb, Ph.D

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Kathryn Macapagal, Ph.D

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Elissa Sarno, Ph.D

  Northwestern University

  STUDY DIRECTOR

• Brian Mustanski, Ph.D

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Dennis Li, Ph.D

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Jody Ciolino, Ph.D

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Jim Carey, MPH

  Northwestern University

  STUDY DIRECTOR

Central Study Contacts

Michael E Newcomb, Ph.D.

CONTACT

312-503-0702; newcomb@northwestern.edu

Kathryn Macapagal, Ph.D.

CONTACT

312-503-3605; kathryn.macapagal@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Experimental Arm: 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. Control Arm: 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).

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 10, 2023
• Study Start: December 15, 2022
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)