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

Hunter College of City University of New York

Status: Invitation-only

Conditions: HIV Infections

Treatments: Behavioral: Individual HIV testing and counseling; Behavioral: Couples HIV testing and counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05833074

R01DA050508-03S1 (U.S. NIH Grant/Contract)

R01 DA050508-S1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 384 estimated patients

Sex: Male

Ages: 17 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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384 participants in 2 patient groups

Couples HIV testing and counseling retesting

Experimental group

Description:

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.

Treatment:

Behavioral: Couples HIV testing and counseling

Individual HIV testing

Active Comparator group

Description:

Individual HIV testing and counseling.

Treatment:

Behavioral: Individual HIV testing and counseling