Systematic review of couple-based HIV intervention and prevention studies: advantages, gaps, and future directions.
Tina Jiwatram-Negrón, Nabila El-Bassel
https://pubmed.ncbi.nlm.nih.gov/24980246/Actively Recruiting
Led by Northwestern University · Updated on 2026-05-08
5000
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating an updated relationship education and HIV prevention program designed specifically for gay, bisexual, queer, transgender, and non-binary individuals who partner with cisgender men. This program aims to test its effectiveness in reducing HIV incidence among these groups by conducting a randomized controlled trial involving 5,000 HIV-negative participants, including couples and single individuals. The study will explore the impact of this program on HIV prevention and relationship functioning over a 24-month period. Participants are randomly assigned to one of two groups the all2GETHER intervention or a control group receiving no intervention. The all2GETHER program includes a web app offering interactive multimedia modules on relationship skills and HIV prevention, and for couples, additional videoconference coaching sessions focusing on communication, conflict resolution, and sexual health. The control group receives access to standard HIV prevention resources but no formal intervention. Participants will complete online surveys and self-collect specimens for HIV and STI testing at multiple points during the study, including baseline, 12 months, and 24 months. Follow-up assessments will occur at 6, 12, 18, and 24 months, with questionnaires and biological testing to measure HIV infection rates and other health outcomes. The entire study is conducted remotely, allowing participants to remain at home while being monitored and supported for up to two years.
CONDITIONS
Effectiveness of Relationship Education for Reducing HIV Incidence Among Men Who Have Sex With Men
M
Michael E Newcomb, Ph.D.
K
Kathryn Macapagal, Ph.D.
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Northwestern University
Lead Sponsor
University of Cincinnati
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | all2GETHER Education & Skills Program | Standard Health Information (Control) |
|---|---|---|
| What is it? | A digital HIV prevention and relationship education program for young MSM and gender-diverse individuals, including three online self-paced modules and two facilitator-led couple sessions covering sexual health, relationship skills, and coping strategies. | Access to standard HIV prevention and sexual health information, as typically provided outside of structured behavioral intervention programs. |
| Role in the trial | Investigational intervention tested to determine whether relationship education plus HIV prevention skills can lower HIV incidence and improve relationship outcomes. | Serves as the comparison group, receiving baseline HIV prevention and health information without further behavioral skills training. |
| Primary use or purpose | Aims to reduce HIV incidence and risky sexual behaviors by building communication, problem-solving, and coping skills in same-sex couples and individuals at higher risk. | To provide basic HIV prevention and sexual health information, reflecting usual care outside specialized behavioral interventions. |
| How is it given or performed? | Participants complete three online education modules (videos, activities, self-paced lessons) and two video-based facilitator coaching sessions tailored to relationship and sexual health needs. | Participants receive standard HIV prevention and sexual health information online, without additional training or facilitator sessions. |
| Evidence status | Couple-based and relationship-focused HIV prevention interventions for young MSM show promise in reducing risky behaviors and improving relationship functioning, but large-scale efficacy data for programs like all2GETHER are still under investigation. | Basic information-only approaches are widely offered, but evidence suggests they are less effective at reducing HIV risk behaviors in young MSM compared to more interactive or couple-based behavioral interventions. |
| Important limitations | The effectiveness of the all2GETHER program in reducing HIV incidence has not been established in large, diverse populations, and sustained behavior change requires ongoing engagement. | Standard information alone may not be sufficient for risk reduction, and lacks individualized skill-building or relationship-focused support that could promote enduring behavioral change. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Online screening via an eligibility questionnaire
Duration - Approximately 1 week
Eligible participants complete an online informed consent and baseline self-report questionnaire, followed by self-collection of HIV/STI specimens using mailed testing kits.
1 baseline visit (online consent and survey) and specimen collection at home
Duration - Varied; intervention delivery over several weeks post-baseline
Participants are randomized to either the all2GETHER intervention or follow-up only control. The all2GETHER intervention includes access to an online relationship education and HIV prevention web app. Participants enrolled as couples also receive two videoconference dyadic skills coaching sessions focused on communication and sexual health.
2 videoconference coaching sessions for couples; web app access is self-paced
Duration - 24 months post-intervention
Participants complete follow-up surveys and self-collection of HIV/STI specimens at multiple timepoints to monitor HIV incidence and other outcomes.
Assessments at 6, 12, 18, and 24 months; 12- and 24-month visits include specimen collection
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Tina Jiwatram-Negrón, Nabila El-Bassel
https://pubmed.ncbi.nlm.nih.gov/24980246/Michael E Newcomb
https://pubmed.ncbi.nlm.nih.gov/33002795/Michael E Newcomb, Kathryn R Macapagal, Brian A Feinstein...
https://pubmed.ncbi.nlm.nih.gov/28083833/Patrick S Sullivan, Laura Salazar, Susan Buchbinder...
https://pubmed.ncbi.nlm.nih.gov/19417579/Howard J Markman, Galena K Rhoades
https://pubmed.ncbi.nlm.nih.gov/22283386/George J Greene, Kimberly A Fisher, Laura Kuper...
https://pubmed.ncbi.nlm.nih.gov/25678895/Michael E Newcomb, Elissa L Sarno, Emily Bettin...
https://pubmed.ncbi.nlm.nih.gov/35725624/George J Greene, Rebecca Andrews, Laura Kuper...
https://pubmed.ncbi.nlm.nih.gov/24202113/Northwestern University
Lead Sponsor
University of Cincinnati
Collaborating Sponsor