Clinical trial NCT05833074: Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection
Official title: Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: HIV Infections
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Michigan
First posted: 2023-04-27
Enrollment: 384
Sex: MALE
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized (with equal allocation) to either couples HIV testing and counseling retesting or an individual HIV testing control.
Primary purpose: PREVENTION

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.

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).

Eligibility 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.

Primary outcomes:
measure: number of condomless anal sex acts with a casual partner in the absence of PrEP
timeFrame: 6 months
Secondary outcomes:
measure: Binge drinking
timeFrame: 6 months
measure: pre-exposure prophylaxis (PrEP) uptake
timeFrame: 6 months
measure: PrEP adherence
timeFrame: 6 months
measure: Drug use Frequency
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: Hunter College
state: New York
Study officials:
References: