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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Couples HIV testing and counseling
* Behavioral: Individual HIV testing and counseling


Participation Criteria
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Eligibility Criteria
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Inclusion: enrolled previously in the parent study DA050508 (NCT05000866). in a relationship with the same main partner with whom they completed the baseline intervention session. both partners in the couple must consent to continue with activities specified in this revision. 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: serious psychiatric symptoms; current suicidal/homicidal ideation; gross cognitive impairment a history of severe physical or sexual Intimate Partner Violence (IPV) victimization in the current relationship.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomized (with equal allocation) to either couples HIV testing and counseling retesting or an individual HIV testing control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Couples HIV testing and counseling retesting<br>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<br>* 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)<br>* Other names: CHTC;|
| Active Comparator: Individual HIV testing<br>Individual HIV testing and counseling. | Behavioral: Individual HIV testing and counseling<br>* 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)<br>* Other names: HTC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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