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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
384
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 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)
University of Michigan
Ann Arbor, Michigan, United States
Hunter College
New York, New York, United States
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
Time frame: 6 months
Binge drinking
Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview
Time frame: 6 months
pre-exposure prophylaxis (PrEP) uptake
self-reported receipt of a PrEP-prescription
Time frame: 6 months
PrEP adherence
taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments
Time frame: 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
Time frame: 6 months
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