Relationship Education Program for HIV Prevention

(all2GETHER Trial)

Overseen By Kathryn Macapagal, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Assigned female at birth women

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

5000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on relationship education and HIV prevention, so it's unlikely that your medications will be affected.

What data supports the effectiveness of the treatment all2GETHER, 2GETHER for HIV prevention?

Research shows that the 2GETHER program, which combines relationship education and HIV prevention, is effective in reducing HIV risk behaviors and improving relationship investment among young male couples. Participants reported positive experiences and improvements in HIV prevention skills after participating in the program. ^{1 2 3 4 5}

Is the 2GETHER program safe for participants?

The 2GETHER program has been found to be feasible and acceptable, with participants reporting positive impressions and no safety concerns in the studies conducted. ^{1 2 3 4 6}

How is the 2GETHER treatment unique for HIV prevention?

The 2GETHER treatment is unique because it combines relationship education with HIV prevention specifically for young male couples, focusing on improving communication and relationship satisfaction while reducing HIV risk behaviors. It is delivered through both group and individual sessions, and can be administered face-to-face or online, making it flexible and tailored to the needs of young male couples. ^{1 2 3 4 7}

What is the purpose of this trial?

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.

Research Team

Michael E Newcomb, Ph.D

Principal Investigator

Northwestern University

Kathryn Macapagal, Ph.D

Principal Investigator

Northwestern University

Elissa Sarno, Ph.D

Principal Investigator

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

Principal Investigator

Northwestern University

Eligibility Criteria

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.

Inclusion Criteria

I am between 16 and 34 years old.

Internet access

Provides address to receive HIV/STI test supplies

Exclusion Criteria

I am not a woman assigned female at birth.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete online informed consent and baseline survey, and are mailed HIV/STI testing kits for self-collection

1-2 weeks

Intervention

Participants are randomized to either the all2GETHER intervention package or follow-up only control. The intervention includes the all2GETHER web app and dyadic skills coaching sessions for couples.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention with follow-up assessments at 6, 12, 18, and 24 months post-intervention.

24 months

Treatment Details

Interventions

• all2GETHER

Trial Overview 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.

Participant Groups

Group I: Experimental Arm Experimental Treatment 1 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 Arm Active Control 1 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).

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Drexel University

Collaborator

Trials

160

Recruited

48,600+

Findings from Research

The 2GETHER program, a five-session relationship education and HIV prevention intervention delivered via videoconference, significantly reduced the risk of rectal STIs and condomless anal sex among 200 young male couples over a 12-month period.

Participants in the 2GETHER program showed greater declines in risky sexual behaviors compared to those receiving a single-session counseling, highlighting the effectiveness of couple-based interventions in HIV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomedical and behavioral outcomes of 2GETHER: A randomized controlled trial of a telehealth HIV prevention program for young male couples. Newcomb, ME., Swann, G., Macapagal, K., et al.[2023]

The 2GETHER program, designed for young male couples, combines relationship education with HIV prevention and has shown strong feasibility and acceptability in a pilot trial, indicating it could be an effective intervention.

In a randomized controlled trial involving 128 couples (256 individuals), the program's efficacy will be assessed over 12 months, focusing on reducing sexually transmitted infections, highlighting its potential impact on both relationship skills and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for an attention-matched randomized controlled trial of 2GETHER: a relationship education and HIV prevention program for young male couples. Newcomb, ME., Sarno, EL., Bettin, E., et al.[2023]

The 2GETHER intervention, which combines HIV prevention and relationship education, was well-received by 57 young male couples, with 93% reporting positive impressions and high ratings for all components.

Participants showed significant improvements in HIV risk behaviors, knowledge, motivation, and relationship investment after the intervention, suggesting that integrating relationship education with sexual health programming can effectively reduce HIV transmission risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating HIV Prevention and Relationship Education for Young Same-Sex Male Couples: A Pilot Trial of the 2GETHER Intervention. Newcomb, ME., Macapagal, KR., Feinstein, BA., et al.[2019]

The 2GETHER USA trial is testing an innovative online relationship education and HIV prevention program for young male couples, aiming to improve communication about sexual risk behaviors and reduce HIV transmission, with 140 dyads enrolled so far and a target of 200.

The program is designed to be accessible to couples from diverse backgrounds and geographic locations, potentially improving health outcomes and reducing barriers to care for sexual minority individuals, especially in rural or under-resourced areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship Education and HIV Prevention for Young Male Couples Administered Online via Videoconference: Protocol for a National Randomized Controlled Trial of 2GETHER. Newcomb, ME., Sarno, EL., Bettin, E., et al.[2020]

A couples-based intervention significantly increased the uptake of couples HIV testing and counseling (CHTC) from 12% in the control group to 42% in the intervention group, demonstrating its efficacy in promoting mutual disclosure and linkage to care.

The intervention also reduced the time it took for couples to participate in CHTC, highlighting its potential to enhance public health efforts in communities heavily affected by HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a Couples-Based Randomized Controlled Trial Aimed to Increase Testing for HIV. Darbes, LA., McGrath, NM., Hosegood, V., et al.[2023]

The Healthy Love Workshop (HLW) significantly increased condom use among sexually active black women at both 3- and 6-month follow-ups, indicating its effectiveness as an HIV prevention intervention.

The study highlights the success of a community-based organization in delivering a culturally tailored intervention, demonstrating that single-session workshops can lead to meaningful behavioral changes in HIV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a single-session HIV prevention intervention for black women: a group randomized controlled trial. Diallo, DD., Moore, TW., Ngalame, PM., et al.[2022]

The 2GETHER program is a couple-based intervention designed specifically for young male couples, integrating HIV risk reduction with relationship education to improve both sexual health and relationship satisfaction.

This program utilizes cognitive-behavioral strategies and requires supportive environments and culturally competent facilitators, highlighting the importance of addressing both individual and societal factors in HIV prevention for sexual-minority couples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Young Male Couples' Sexual and Relationship Health in the 2GETHER Program: Intervention Techniques, Environments of Care, and Societal Considerations. Macapagal, K., Feinstein, BA., Puckett, JA., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Biomedical and behavioral outcomes of 2GETHER: A randomized controlled trial of a telehealth HIV prevention program for young male couples. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Protocol for an attention-matched randomized controlled trial of 2GETHER: a relationship education and HIV prevention program for young male couples. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Integrating HIV Prevention and Relationship Education for Young Same-Sex Male Couples: A Pilot Trial of the 2GETHER Intervention. [2019]

4. Canada pubmed.ncbi.nlm.nih.gov

Relationship Education and HIV Prevention for Young Male Couples Administered Online via Videoconference: Protocol for a National Randomized Controlled Trial of 2GETHER. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Results of a Couples-Based Randomized Controlled Trial Aimed to Increase Testing for HIV. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a single-session HIV prevention intervention for black women: a group randomized controlled trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Improving Young Male Couples' Sexual and Relationship Health in the 2GETHER Program: Intervention Techniques, Environments of Care, and Societal Considerations. [2021]