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Enrolling by Invitation

NCT Number: NCT05833074

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

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.

Enrolling by Invitation

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Key information

Age range

17 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • 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.

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

  • 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.

Treatment and study plan

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)

Other names: CHTC

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)

Other names: HTC

Primary outcomes

  1. number of condomless anal sex acts with a casual partner in the absence of PrEP

    Time frame: 6 months

    Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments

Secondary outcomes

  1. Binge drinking

    Time frame: 6 months

    Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview

  2. pre-exposure prophylaxis (PrEP) uptake

    Time frame: 6 months

    self-reported receipt of a PrEP-prescription

  3. PrEP adherence

    Time frame: 6 months

    taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments

  4. Drug use Frequency

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

Hunter College of City University of New York

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Michigan

Registry information

Acronym: 4Us Part B

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2023
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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