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

HIV Infections Clinical Trial

— 4Us Part B  

Official title:

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infections

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