Optimizing a Bio-behavioral Intervention for Sustained Viral Suppression
NCT ID: NCT05377463
Last Updated: 2024-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2023-05-10
2026-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
The 2 intervention components are:
Component 1. Peer recovery coaching to promote uptake and persistence of medication assisted treatment in the form of methadone.
Component 2. Behavioral activation therapy to reduce depression.
Participants will be randomly assigned to receive a total of 0 or up to 2 components. There are 4 conditions because there are 4 possible combinations of the 2 components (e.g., Condition 1 = Delivery of 1 whereas Condition 3 = Delivery of 1 and 2). All participants will receive a standard of care package which will consist of referral and patient navigation to HIV treatment services, linkage to a peer support group, and harm reduction education and materials.
SUPPORTIVE_CARE
SINGLE
Study Groups
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Condition 1: Component 1
1\) Peer-Support for Medication-Assisted Treatment
Peer support to promote uptake and persistence of medication assisted treatment (MAT)
Participants 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.
Condition 2: Component 2
2\) Behavioral Activation Therapy
Behavioral Activation Treatment (BAT) to reduce depression
Participants 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.
Condition 3: Components 1 and 2
Participants assigned to a combination of:
1. Peer-Support for Medication-Assisted Treatment
2. Behavioral Activation Therap
Peer support to promote uptake and persistence of medication assisted treatment (MAT)
Participants 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
Participants 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.
Condition 4: No Components
Participants not assigned to any of the 2 components. They are placed on a wait list and will receive components after the primary data collection period.
No Intervention Components
Participants not assigned to components 1 and 2
Interventions
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Peer support to promote uptake and persistence of medication assisted treatment (MAT)
Participants 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
Participants 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
Participants not assigned to components 1 and 2
Eligibility Criteria
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Inclusion Criteria
* be able to provide informed consent
* be eligible to receive free HIV care services in Mexico
* be HIV positive
* have injected drugs in the last 30 days
* not be on methadone replacement therapy
* be willing to discuss MAT uptake with a peer
* sign a medical release form to have medical data abstracted
* agree to submit and describe locator information
* agree to return to follow-up visits
* able to communicate in Spanish
* screen positive for depression on the PHQ-2
* have no plans of moving outside the study area in the next 12-months
* meet one of the following:
1. not currently in possession of ART or not taking ART but prescribed ART or
2. sub-optimal ART adherence as at least one 4-day treatment interruption in the past 90 days or
3. sub-optimal retention in HIV care - never engaged or disengaged from HIV care as 2 or more missed clinic appointments in the last 9 months or
4. no viral load test done in the past six months or
5. self-reports a detectable viral load within the past 6 months
Exclusion Criteria
* is not HIV positive
* is receiving methadone
* is unwilling to discuss methadone uptake with a peer
* does not screen positive for depression
* is not able to provide informed consent
* does not speak Spanish
* has plans to move out of the city
* does not qualify to receive free HIV care services in Mexico
* has an appearance of psychological disturbance or severe cognitive impairment that could limit understanding of study procedures as determined by study staff
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Centro de Integracion Juvenil
UNKNOWN
El Centro Ambulatorio para la Prevención y Atención en SIDA e Infecciones de Transmisión Sexual
UNKNOWN
University of Texas, El Paso
OTHER
Responsible Party
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Principal Investigators
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Julia Lechuga
Role: PRINCIPAL_INVESTIGATOR
The University of Texas at El Paso
John A Sauceda
Role: PRINCIPAL_INVESTIGATOR
The University of California San Francisco
Locations
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Programa Compañeros
Ciudad Juárez, Chihuahua, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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Sauceda JA, Lechuga J, Ramos ME, Puentes J, Ludwig-Barron N, Salazar J, Christopoulos KA, Johnson MO, Gomez D, Covarrubias R, Hernandez J, Montelongo D, Ortiz A, Rojas J, Ramos L, Avila I, Gwadz MV, Neilands TB. A factorial experiment grounded in the multiphase optimization strategy to promote viral suppression among people who inject drugs on the Texas-Mexico border: a study protocol. BMC Public Health. 2023 Feb 10;23(1):307. doi: 10.1186/s12889-023-15172-2.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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1780619-1
Identifier Type: -
Identifier Source: org_study_id
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