Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection

NCT05833074 | Enrolling By Invitation DMC

• 2 other identifiers: R01 DA050508-S1R01DA050508-03S1
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Binge drinking

  6 months

• pre-exposure prophylaxis (PrEP) uptake

  6 months

• PrEP adherence

  6 months

• Drug use Frequency

  6 months

Study Arms (2)

Couples HIV testing and counseling retesting

EXPERIMENTAL

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

ACTIVE COMPARATOR

Individual HIV testing and counseling.

Behavioral: Individual HIV testing and counseling

Interventions

Couples HIV testing and counseling BEHAVIORAL

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

Couples HIV testing and counseling retesting

Individual HIV testing and counseling BEHAVIORAL

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

Individual HIV testing

Eligibility Criteria

• Age: 17 Years - 65 Years
• Gender Eligibility Details: cismale
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hunter College of City University of New York: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Michigan: collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Hunter College

New York, New York, 10018, United States

Location

Related Publications (1)

• Starks TJ, Kyre K, Castiblanco J, Parker JN, Kahle E, Stephenson R, Cain D. Comparing Repeated (Annual) Couples HIV Testing and Counseling to Individual HIV Testing and Counseling Among Male Couples at High Risk of HIV Infection: Protocol for a Randomized Control Trial. JMIR Res Protoc. 2024 Feb 13;13:e53023. doi: 10.2196/53023.

  PMID: 38349737 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Counseling; chitinase C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants are not given access to information about study condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are randomized (with equal allocation) to either couples HIV testing and counseling retesting or an individual HIV testing control.

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 27, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)