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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an updated relationship education and HIV prevention program called all2GETHER. It focuses on gay, bisexual, queer, and transgender individuals with cisgender male partners. Participants will complete online surveys, undergo testing for Chlamydia, Gonorrhea, and HIV, and may join either the all2GETHER program or a control group without intervention. Those who have engaged in condomless anal sex with two or more male partners of different or unknown HIV status in the last six months might be suitable for this study. Participation is entirely remote, and the study lasts up to two years. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance HIV prevention strategies for diverse communities.

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 prior data suggests that this program is safe for participants?

Research shows that the all2GETHER program, which helps prevent HIV and improve relationship skills, is safe for participants. Similar programs, like 2GETHER, have been studied and found to be generally well-received. Participants in these programs did not report any major negative effects.

These programs typically include online lessons and video sessions that teach skills like communication and problem-solving. Without medications or medical procedures, there are no physical side effects. The focus remains on learning and building skills, which are safe activities.

In summary, the all2GETHER program is expected to be safe because it involves educational activities that similar studies have well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the all2GETHER program because it takes a fresh approach to HIV prevention by combining relationship education with practical skills development, tailored specifically for young men who have sex with men (MSM). Unlike traditional methods that often focus solely on individual behavior change, all2GETHER includes online modules and videoconference coaching that emphasize communication, problem-solving, and couple-based HIV prevention strategies. This personalized and interactive method aims to not only enhance individual knowledge but also strengthen relationship dynamics, making it a unique and promising tool in the fight against HIV.

What evidence suggests that the all2GETHER program is effective for HIV prevention?

Research shows that the all2GETHER program, an extension of the 2GETHER program, effectively reduces the risk of HIV. In this trial, participants in the experimental arm will engage in the all2GETHER program, which includes online lessons and coaching sessions focused on sexual health, relationship skills, and HIV prevention specifically for young men who have sex with men (MSM). Previous studies found that participants improved their communication and problem-solving skills, which are important for lowering HIV risk. Overall, the program supports both medical and behavioral prevention methods. ^{2 5 6 7 8}

Who Is on the Research Team?

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

Michael E Newcomb, Ph.D

Principal Investigator

Northwestern University

Jim Carey, MPH

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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, 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 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]

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]

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 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39992776/

Randomized controlled trial of a relationship education and ... This study evaluated the efficacy of the 2GETHER relationship education and HIV prevention program for young male couples in reducing the risk for HIV.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05678556

Effectiveness of Relationship Education for Reducing HIV ... all2GETHER is an HIV prevention and relationship education program designed for young MSM. all2GEHTER consists of 3 online didactic skills modules and 2 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37141032/

A randomized controlled trial of a telehealth HIV prevention ... Conclusions: 2GETHER is an efficacious intervention that has a significant impact on both biomedical and behavioral HIV prevention outcomes ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06457-9

Protocol for an attention-matched randomized controlled trial ... The purpose of this manuscript is to describe the protocol for a randomized controlled trial (RCT) of 2GETHER, a relationship education and HIV ...

5. researchprotocols.org researchprotocols.org/2020/1/e15883/

Relationship Education and HIV Prevention for Young ... 2GETHER is a relationship education and HIV prevention program for young male couples, and the 2GETHER USA randomized controlled trial (RCT) was launched.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9207885/

Protocol for an attention-matched randomized controlled trial ... The purpose of this manuscript is to describe the protocol for a randomized controlled trial (RCT) of 2GETHER, a relationship education and HIV ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5549448/

Integrating HIV Prevention and Relationship Education for ... This pilot study assessed the feasibility, acceptability and preliminary efficacy of the 2GETHER couples-based HIV prevention and relationship education ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03284541

Online HIV Prevention for Young Male Couples 2GETHER is an HIV prevention and relationship education program designed for young male couples. 2GETHER consists of 4 sessions (2 group sessions, 2 ...