An interventional study of Couples HIV testing and counseling and Individual HIV testing and counseling in HIV Infections, sponsored by Hunter College of City University of New York. Enrolling by invitation at 2 sites in United States. Open to male participants aged 17 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Hunter College of City University of New York · Not applicable, Interventional, and Prevention
This randomized controlled trial evaluates the efficacy of couples HIV testing and counseling retesting. Eligible couples previously enrolled in NCT05000866 are invited to participate. Those who do are randomized to either couples HIV testing and counseling (CHTC) retesting or an individual HIV testing control. Follow-ups occur 3 and 6 months post intervention.
The purpose of this study is to evaluate the benefits associated with couples HIV testing and counseling (CHTC) resting. After their 12-month follow-up, those participants who remain in the same relationship they were in at the time of their baseline will be offered the opportunity to continue in the components proposed in this revision. Those who consent will be randomized to either complete a second session of CHTC or to a comparison condition in which both partners receive a routine individual HIV test. HIV positive partners in serodiscordant couples randomized to the control condition will receive information about anti-retroviral treatment adherence and U=U (undetectable = untransmissible). Given potential attrition and rates of relationship dissolution, we anticipate randomizing 200 couples (80% of the original sample). Follow-up assessments will be conducted 3 and 6 months after retesting (15 and 18 months after the participants' original baseline appointment).
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 384 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Hunter College of City University of New York is the lead sponsor of 36 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion:
Exclusion: any of the following at the 12-month follow-up:
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.
Behavioral: Couples HIV testing and counseling
Individual HIV testing and counseling.
Behavioral: Individual HIV testing and counseling
Couples HIV testing follows a CDC published protocol for delivery of HIV testing to relationship partners. HIV test results are obtained from Oraquick (FDA approved for at home HIV testing)
Also known as: CHTC
Individual HIV testing and counseling uses a counseling protocol based on the standard of care for routine HIV pre- and post-test counseling. HIV test results are obtained from Oraquick (FDA approved for at home testing)
Also known as: HTC
number of condomless anal sex acts with a casual partner in the absence of PrEP
Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments
Time frame: 6 months
Binge drinking
Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview
Time frame: 6 months
pre-exposure prophylaxis (PrEP) uptake
self-reported receipt of a PrEP-prescription
Time frame: 6 months
PrEP adherence
taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments
Time frame: 6 months
Drug use Frequency
Number of reported days of illicit drug use (amphetamines, cocaine/crack, gama hydroxybutyric acid (GHB), ketamine or ecstasy) reported on quarterly timeline follow-back assessments
Time frame: 6 months
Plan to share: No — Participant-level data will be shared upon request and at the discretion of the study PI under the terms of a memorandum of understanding signed by officials at the transmitting and receiving institutions.
Started Oct 2021 (actual). Primary completion is estimated for Nov 2026, 60 months after the start.
Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 60 months is above that.
Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
Start moved once since we started tracking on Sep 25, 2026: Apr 2023 → Oct 2021, on Nov 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Hunter College of City University of New York