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Couples-Based Intervention for HIV Infection (T2 Trial)

N/A

Waitlist Available

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

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

Must have

Both partners must have engaged in condomless sex within the past 6 months with any partner

Age 18 or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes in cr-hiv at 12-month follow-up

Awards & highlights

T2 Trial Summary

This trial will test a couples-based HIV prevention program to see if it can reduce the risk of HIV transmission for transgender women and their partners.

Who is the study for?

This trial is for English-speaking couples aged 18 or older, where one partner is a transgender woman (assigned male at birth but identifies as female) and they've been in an emotional/sexual relationship for over three months. They must have had unprotected sex within the last six months and be able to consent. Couples can't join if either person is currently psychotic, suicidal, manic, or fears physical harm from participating.Check my eligibility

What is being tested?

The study tests a couples-based HIV prevention program against an enhanced standard of care control. It's a large-scale randomized controlled trial involving diverse transgender women and their partners who will be followed quarterly over a year to measure HIV transmission risk through behavior and biomedical indicators like viral suppression and PrEP adherence.See study design

What are the potential side effects?

Since this intervention involves education and behavioral strategies rather than medication, typical drug side effects are not expected. However, participants may experience emotional or psychological discomfort discussing personal topics during sessions.

T2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My partner and I have had unprotected sex in the last 6 months.

Select...

I am 18 years old or older.

T2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes in cr-hiv at 12-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes in cr-hiv at 12-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes in cr-hiv at 12-month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Composite Risk for HIV

T2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Participants and their partners will complete four couples counseling sessions focused on developing and enhancing relationship skills to decrease HIV risk behaviors.

Group II: ControlActive Control1 Intervention

Participants and their partners will receive information and referrals on HIV risk and prevention strategies.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brown UniversityOTHER

456 Previous Clinical Trials

562,963 Total Patients Enrolled

Emory UniversityOTHER

1,636 Previous Clinical Trials

2,560,455 Total Patients Enrolled

University of MichiganLead Sponsor

1,795 Previous Clinical Trials

6,373,818 Total Patients Enrolled

Media Library

Couples-based Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04067661 — N/A

Human Immunodeficiency Virus Infection Research Study Groups: Intervention, Control

Human Immunodeficiency Virus Infection Clinical Trial 2023: Couples-based Intervention Highlights & Side Effects. Trial Name: NCT04067661 — N/A

Couples-based Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04067661 — N/A

Frequently Asked Questions

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

What is the aggregate figure of participants in this research project?

"Affirmative. Clinicaltrials.gov attests that this medical experiment, incepted on November 1st 2019 and recently revised on February 28th 2022, is actively recruiting volunteers. The investigators have set their sights on 240 patients from a single site."

Answered by AI

Is the enrollment process for this trial still open?

"Affirmative. According to the clinicaltrials.gov website, this trial is seeking subjects for participation and was initially posted on November 1st 2019 with its most recent edit falling on February 28th 2022. The study requires 240 patients from a single site in order to be successful."

Answered by AI

Recent research and studies

AIDS and BehaviorJournal

Research with Marginalized Communities: Challenges to Continuity During the COVID-19 Pandemic

Sevelius, Jae M., Luis Gutierrez-Mock, Sophia Zamudio-Haas, Breonna McCree, Azize Ngo, Akira Jackson, Carla Clynes, et al.. 2020. “Research with Marginalized Communities: Challenges to Continuity During the COVID-19 Pandemic”. AIDS and Behavior. Springer Science and Business Media LLC. doi:10.1007/s10461-020-02920-3.

BMJ OpenJournal

Couples-based Approach to HIV Prevention for Transgender Women and Their Partners: Study Protocol for a Randomised Controlled Trial Testing the Efficacy of the ‘it Takes Two’ Intervention

Gamarel, Kristi E, Jae M Sevelius, Torsten B Neilands, Rachel L Kaplan, Mallory O Johnson, Tooru Nemoto, Lynae A Darbes, and Don Operario. 2020. “Couples-based Approach to HIV Prevention for Transgender Women and Their Partners: Study Protocol for a Randomised Controlled Trial Testing the Efficacy of the ‘it Takes Two’ Intervention”. BMJ Open. BMJ. doi:10.1136/bmjopen-2020-038723.

AIDS and BehaviorJournal

Composite Risk for HIV: A New Approach Towards Integrating Biomedical and Behavioral Strategies in Couples-based HIV Prevention Research

Gamarel, Kristi E., Deepalika Chakravarty, Torsten B. Neilands, Colleen C. Hoff, James Lykens, and Lynae A. Darbes. 2018. “Composite Risk for HIV: A New Approach Towards Integrating Biomedical and Behavioral Strategies in Couples-based HIV Prevention Research”. AIDS and Behavior. Springer Science and Business Media LLC. doi:10.1007/s10461-018-2229-8.

clinicaltrials.govStudy