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

Sponsor
Hunter College of City University of New York (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05833074
Collaborator
National Institute on Drug Abuse (NIDA) (NIH), University of Michigan (Other)
384
2
2
31.6
192
6.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Couples HIV testing and counseling
  • Behavioral: Individual HIV testing and counseling
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
384 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are randomized (with equal allocation) to either couples HIV testing and counseling retesting or an individual HIV testing control.Participants are randomized (with equal allocation) to either couples HIV testing and counseling retesting or an individual HIV testing control.
Masking:
Single (Outcomes Assessor)
Masking Description:
Research assistants are not given access to information about study condition.
Primary Purpose:
Health Services Research
Official Title:
Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection
Actual Study Start Date :
Jan 13, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. number of condomless anal sex acts with a casual partner in the absence of PrEP [6 months]

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

    Secondary Outcome Measures

    1. Binge drinking [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 [6 months]

      self-reported receipt of a PrEP-prescription

    3. PrEP adherence [6 months]

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

    4. Drug use Frequency [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 29 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    Inclusion: Participants in the activities proposed under this competitive revision must be enrolled previously in the parent study DA050508 (NCT05000866). In addition, all participants enrolled into activities specified in this revision must be in a relationship with the same main partner with whom they completed the baseline intervention session. To be eligible, both partners in the couple must consent to continue with activities specified in this revision. Finally, all participants must complete the 12-month assessment associated with participation in the parent study prior to consenting to participate in activities specified under this revision.

    Exclusion: The nature of CHTC retesting inherently implies re-engagement with the same couple over time. As such, participants will be excluded from participation in activities specified under this revision if they indicate that they are single or if they are in a relationship with a new main partner (different from the person with whom they completed their initial intervention session with following baseline). Consistent with baseline procedures, participants will be excluded if they report any of the following at the 12-month follow-up: a) serious psychiatric symptoms; b) current suicidal/homicidal ideation; c) gross cognitive impairment or d) a history of severe physical or sexual Intimate Partner Violence (IPV) victimization in the current relationship.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan Ann Arbor Michigan United States 48109
    2 Hunter College New York New York United States 10018

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tyrel Starks, Associate Professor, Hunter College of City University of New York
    ClinicalTrials.gov Identifier:
    NCT05833074
    Other Study ID Numbers:
    • R01 DA050508-S1
    First Posted:
    Apr 27, 2023
    Last Update Posted:
    Apr 27, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 27, 2023