Optimizing a Bio-behavioral Intervention for Sustained Viral Suppression
ConditionHIV Viremia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas, El Paso
About this trial
The study will test two behavioral intervention components to identify the combination of the two components that best supports people who inject drugs to achieve and sustain HIV viral load suppression.
The study design is a 2-to-the-2 factorial experiment. The 2 represents the level of each component: 0 (receive) or 1 (don't receive). The 2 represents the number of components being tested. The four components are: 1) receiving (or not receiving) peer support services for medication-assisted treatment (MAT) uptake and persistence and 2) behavioral activation therapy for depression (BAT). Therefore, in order to test which combination of components produce the best outcome, this factorial design randomizes people to 1 of 4 conditions. Each condition represents a possible combination of the 2 components above. All participants will receive patient navigation for care engagement.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
be at least 18 years of age
be able to provide informed consent
be eligible to receive free HIV care services in Mexico
be HIV positive
Disqualifiers
has not injected drugs in the last 30 days or do not have a verifiable opioid use disorder
is not HIV positive
is receiving methadone
is unwilling to discuss methadone uptake with a peer
Trial design
Design model
Factorial
Treatments tested in this trial
Peer support to promote uptake and persistence of medication assisted treatment (MAT)
BehavioralParticipants will be assigned to receive peer support to promote uptake of MAT and persistence. This component will consist of two informational sessions, a tailored recovery plan, and on-going support from a peer for the first 6 months.
Behavioral Activation Treatment (BAT) to reduce depression
BehavioralParticipants will be assigned to receive BAT treatment for depression. This component will consist of 8 sessions where participants will identify short and long-term goals, values, and the activities unrelated to substance use that were previously enjoyed or are likely to increase a feeling of well-being. This intervention component focuses on making a plan to troubleshoot barriers to re-engage in these activities. Sessions are delivered weekly. The content includes psycho-education about what depression is, the intervention rationale, and the activities and monitoring of activities, building social contracts to engage networks, and discussion of potential barriers to following through with activities.
No Intervention Components
BehavioralParticipants not assigned to components 1 and 2
Treatment groups
220 Participants
are divided into 4 treatment groupsGroup A: Condition 1: Component 1Experimental treatment 1 intervention
Group B: Condition 2: Component 2Experimental treatment 1 intervention
Group C: Condition 3: Components 1 and 2Experimental treatment 2 interventions
Group D: Condition 4: No ComponentsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Achievement of Viral Suppression
Viral suppression is defined as a laboratory test result showing HIV viral load as less than 400 copies per mL. To meet our definition of achieved viral suppression, viral load must be below 400 copiers per mL at 6-month follow-up.
Time frame
Viral load below or above 400 copiers per mL at the 6-month follow-up assessment2
Viral Suppression at 9-month follow-up
Viral suppression is defined as a laboratory test result showing HIV viral load as less than 400 copies per mL. To meet our definition of viral suppression, viral load must be below 400 copiers per mL at 6-month follow-up.
Time frame
Viral load below or above 400 copiers per mL at the 9-month follow-up assessment3
Viral Suppression at 12-month follow-up
Viral suppression is defined as a laboratory test result showing HIV viral load as less than 400 copies per mL. To meet our definition of viral suppression, viral load must be below 400 copiers per mL.
Time frame
Viral load below or above 400 copiers per mL at the 12-month follow-up assessmentSecondary outcomes
1
Drug use
Will be measured through urine analysis and participants will self-report the frequency (yes vs no), quantity (how much typically consumed when using), and duration of use (how may days in the last 30 days did the participant use and how many times did the participant use yesterday) of various drugs in last 30 days.
Time frame
3-,6-,9-, and 12-month follow-up assessments2
Methadone uptake and persistence
Information about date of first dose, current dosage, and number of days on Methadone will be extracted from the medical record.
Time frame
3-,6-,9-, and 12-month follow-up assessments3
Drug use frequency and severity of withdrawal and cravings
Opioid Withdrawal Scale - This is a clinician administered scale that assesses the extent opiate withdrawal symptoms based on 11 symptoms (resting pulse rate, sweating, restlessness, pupil size, bone or joint aches, runny nose, GI upset, tremors, yawning, anxiety or irritability, gooseflesh skin.
Time frame
3-,6-,9-, and 12-month follow-up assessments4
Depressive Symptoms (Clinician-assisted rating)
The Montgomery-Asberg Depression Rating Scale will be used, which is a 10-item scale and is clinician-assisted. interview participants and clinicians will rate their level of depression. Symptoms assessed include: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts
Time frame
3-,6-,9-, and 12-month follow-up assessmentsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas, El Paso
Lead sponsor
University of California, San Francisco
Collaborator
Centro de Integracion Juvenil
Collaborator
El Centro Ambulatorio para la Prevención y Atención en SIDA e Infecciones de Transmisión Sexual
Collaborator
Source ClinicalTrials.gov