Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 384
- Locations
- 3
- Primary Endpoint
- number of condomless anal sex acts with a casual partner in the absence of PrEP
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Research assistants are not given access to information about study condition.
Eligibility Criteria
- Ages
- 17 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Couples HIV testing and counseling retesting
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.
Intervention: Couples HIV testing and counseling (Behavioral)
Individual HIV testing
Individual HIV testing and counseling.
Intervention: Individual HIV testing and counseling (Behavioral)
Outcomes
Primary Outcomes
number of condomless anal sex acts with a casual partner in the absence of PrEP
Time Frame: 6 months
Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments
Secondary Outcomes
- Binge drinking(6 months)
- PrEP adherence(6 months)
- pre-exposure prophylaxis (PrEP) uptake(6 months)
- Drug use Frequency(6 months)
Investigators
Tyrel Starks
Professor
Hunter College of City University of New York