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Enrolling by invitation NCT05833074

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

No phase Interventional HIV Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Couples HIV testing and counseling, Individual HIV testing and counseling.
Who it may be relevant to
Registry conditions: HIV Infections. Basic parameters: 17 years — 65 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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).

Interventions

  • 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)
  • 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)

Primary outcome measures

  • number of condomless anal sex acts with a casual partner in the absence of PrEP [Time frame: 6 months]
Secondary outcome measures (4)
  • Binge drinking [Time frame: 6 months]
  • pre-exposure prophylaxis (PrEP) uptake [Time frame: 6 months]
  • PrEP adherence [Time frame: 6 months]
  • Drug use Frequency [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 2 centers
  • University of Michigan — Ann Arbor
  • Hunter College — New York

Publications

  • 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

Identifiers

NCT: NCT05833074 · R01 DA050508-S1 · R01DA050508-03S1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗