Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Connecticut
About this trial
The investigators will conduct an optimization trial among N=256 PWID newly started on medication for opioid use disorder and Pre-Exposure Prophylaxis (PrEP) to assess the performance of four intervention components (Attention, Executive Functioning, Memory, and Information Processing) aimed at enhancing the ability of PWID on MOUD to process and utilize HIV prevention content, leading to improvements in HIV prevention information, motivation, behavioral skills, and behaviors (IMB).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
being 18 years or older
meeting DSM-V criteria for opioid dependence and being newly prescribed and adherent to Medication for Opioid Use Disorder (e.g., methadone, buprenorphine) at the APT Foundation, Inc.
showing mild cognitive impairment based on the Montreal Cognitive Assessment (MoCA) screening
having initiated Pre-Exposure Prophylaxis (PrEP) within the past week
Disqualifiers
unable to provide consent
actively suicidal
actively homicidal
actively psychotic
Trial design
Design model
Factorial
Treatments tested in this trial
community-friendly health recovery program
BehavioralParticipants will receive 4 weekly 45 minute sessions HIV prevention sessions.
Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
DrugParticipants will be prescribed Pre-exposure prophylaxis (PrEP) is a biomedical intervention.
Treatment groups
256 Participants
are divided into 16 treatment groups16
Treatment groupsSee each treatment group below.
Group A: Condition 1Active comparator 2 interventions
Group B: Condition 2Experimental treatment 2 interventions
Group C: Condition 3Experimental treatment 2 interventions
Group D: Condition 4Experimental treatment 2 interventions
Group E: Condition 5Experimental treatment 2 interventions
Group F: Condition 6Experimental treatment 2 interventions
Group G: Condition 7Experimental treatment 2 interventions
Group H: Condition 8Experimental treatment 2 interventions
Group I: Condition 9Experimental treatment 2 interventions
Group J: Condition 10Experimental treatment 2 interventions
Group K: Condition 11Experimental treatment 2 interventions
Group L: Condition 12Experimental treatment 2 interventions
Group M: Condition 13Experimental treatment 2 interventions
Group N: Condition 14Experimental treatment 2 interventions
Group O: Condition 15Experimental treatment 2 interventions
Group P: Condition 16Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Time frame
PrEP adherence DBS measured at week 42
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Time frame
PrEP adherence DBS measured at the 3-month post-intervention follow-up3
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Time frame
PrEP adherence DBS measured at the 6-month post-intervention follow-up4
Pre-Exposure Prophylaxis Adherence via Dried Blood Spots (DBS)
Dried Blood Spots will test the amount of active PrEP components in the participants blood.
Time frame
PrEP adherence DBS measured at the 9-month post-intervention follow-upSecondary outcomes
1
HIV risk behaviors questionnaire
Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.
Time frame
HIV risk behaviors measured at Week 12
HIV risk behaviors questionnaire
Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.
Time frame
HIV risk behaviors measured at Week 43
HIV risk behaviors questionnaire
Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.
Time frame
HIV risk behaviors measured at the 3-month post-intervention follow-up4
HIV risk behaviors questionnaire
Self-report of "any" high-risk behavior (sexual or drug-related) as well as measurements of event-level (i.e., partner-by-partner) behaviors.
Time frame
HIV risk behaviors measured at the 6-month post-intervention follow-upOther outcomes
1
Drug Test via Urine toxicology
Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses
Time frame
conducted at Week 12
Drug Test via Urine toxicology
Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses
Time frame
conducted at twice weekly during the 4-week intervention phase3
Drug Test via Urine toxicology
Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses
Time frame
conducted at 3-month follow-up4
Drug Test via Urine toxicology
Four-panel (i.e., heroin, cocaine, oxycodone, and benzodiazepine) immunoassay (I/A) urinalyses
Time frame
conducted at 6-month follow-upSponsors and contacts
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Source ClinicalTrials.gov