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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05833074
Other study ID # R01 DA050508-S1
Secondary ID R01DA050508-03S1
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date November 1, 2026

Study information

Verified date April 2024
Source Hunter College of City University of New York
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 384
Est. completion date November 1, 2026
Est. primary completion date November 1, 2026
Accepts healthy volunteers No
Gender Male
Age group 17 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)
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)

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Hunter College New York New York

Sponsors (3)

Lead Sponsor Collaborator
Hunter College of City University of New York National Institute on Drug Abuse (NIDA), University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

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