Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection (4Us Part B)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Couples HIV testing and counseling; Behavioral: Individual HIV testing and counseling

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 384
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New York
    • New York, New York, United States, 10018
      • Hunter College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion:

1. enrolled previously in the parent study DA050508 (NCT05000866).
2. in a relationship with the same main partner with whom they completed the baseline intervention session.
3. both partners in the couple must consent to continue with activities specified in this revision.
4. completion of the 12-month assessment associated with participation in the parent study prior to consenting to participate in activities specified under this revision.

Exclusion: any of the following at the 12-month follow-up:

1. serious psychiatric symptoms;
2. current suicidal/homicidal ideation;
3. gross cognitive impairment
4. a history of severe physical or sexual Intimate Partner Violence (IPV) victimization in the current relationship.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Couples HIV testing and counseling retesting; 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; 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); Other Names: CHTC
Active Comparator: Individual HIV testing; Individual HIV testing and counseling.	Behavioral: Individual HIV testing and counseling; 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); Other Names: HTC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binge drinking	Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview	6 months
pre-exposure prophylaxis (PrEP) uptake	self-reported receipt of a PrEP-prescription	6 months
PrEP adherence	taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments	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	6 months

Collaborators and Investigators

• Sponsor: Hunter College of City University of New York
• Collaborators: National Institute on Drug Abuse (NIDA); University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R01 DA050508-S1; R01DA050508-03S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No