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Couples HIV Testing and Counseling for HIV Retesting (4Us Part B Trial)

N/A
Waitlist Available
Research Sponsored by Hunter College of City University of New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests how effective couples HIV testing and counseling is at retesting. Eligible couples are invited to participate and will be randomly assigned to either the intervention or control group. Follow-up visits occur after 3 and 6 months.

Who is the study for?
This trial is for male couples at high risk of HIV who completed a previous study (NCT05000866) and its 12-month assessment. Both partners must consent to participate, be in the same relationship as before, and not have serious psychiatric symptoms, suicidal/homicidal thoughts, cognitive impairments or severe IPV history.
What is being tested?
The study compares annual Couples HIV Testing and Counseling (CHTC) retesting with individual testing among high-risk male couples. Participants are randomly assigned to one of these two groups and followed up after 3 and 6 months to evaluate efficacy.
What are the potential side effects?
Since this trial involves counseling rather than medication, there aren't typical drug side effects. However, participants may experience emotional or psychological distress related to discussing sensitive topics during counseling sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
number of condomless anal sex acts with a casual partner in the absence of PrEP
Secondary study objectives
Binge drinking
Drug use Frequency
PrEP adherence
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Couples HIV testing and counseling retestingExperimental Treatment1 Intervention
Couples HIV testing and counseling is completed following Centers for Disease Control and Prevention (CDC) standard protocol. Participants also complete any adjunct CHTC components associated with their originally assigned condition in NCT05000866.
Group II: Individual HIV testingActive Control1 Intervention
Individual HIV testing and counseling.

Find a Location

Who is running the clinical trial?

Hunter College of City University of New YorkLead Sponsor
40 Previous Clinical Trials
8,530 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,595 Previous Clinical Trials
3,328,359 Total Patients Enrolled
University of MichiganOTHER
1,860 Previous Clinical Trials
6,440,618 Total Patients Enrolled

Media Library

Couples HIV testing and counseling Clinical Trial Eligibility Overview. Trial Name: NCT05833074 — N/A
~196 spots leftby Nov 2026
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