Optimizing a Bio-behavioral Intervention for Sustained Viral Suppression

Official title

Optimizing a Bio-behavioral Intervention to Promote Viral Suppression Among HIV+ People Who Inject Drugs on the U.S.-Mexico Border

Overview

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.

Detailed description

Participants will be randomly assigned to one of 4 experimental conditions. Each condition will represents every possible combination of 2 components (e.g., 1 only, 2 only, 1-2, none). Participants complete a survey assessment at baseline, complete their assigned intervention components, and then return to complete follow-up assessment surveys at 3-, 6-,9-, and 12-months. The primary outcome is sustained viral suppression defined as viral load test results of \<400 copies per mL on all 6-,9-, and 12-month follow-up visits. Results of Aim 1 will yield estimates of the unique impact of each intervention component, as well as each combination of components, on sustained viral suppression. The research team and partners will make decisions about what constitutes the optimized intervention by judging the observed effect sizes and statistical significance against real-world constraints that go into the delivery of the interventions. The secondary aims are to test mediators to explain component 1-2 and its relationship to viral suppression. We will also test moderators of these relationship between each component and outcome of viral suppression.

Interventions

• Behavioral 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 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 d
• Behavioral No Intervention Components
  Participants not assigned to components 1 and 2

Primary outcome measures

• Achievement of Viral Suppression [Time frame: Viral load below or above 400 copiers per mL at the 6-month follow-up assessment]
• Viral Suppression at 9-month follow-up [Time frame: Viral load below or above 400 copiers per mL at the 9-month follow-up assessment]
• Viral Suppression at 12-month follow-up [Time frame: Viral load below or above 400 copiers per mL at the 12-month follow-up assessment]

Secondary outcome measures (12)

• Drug use [Time frame: 3-,6-,9-, and 12-month follow-up assessments]
• Methadone uptake and persistence [Time frame: 3-,6-,9-, and 12-month follow-up assessments]
• Drug use frequency and severity of withdrawal and cravings [Time frame: 3-,6-,9-, and 12-month follow-up assessments]
• Depressive Symptoms (Clinician-assisted rating) [Time frame: 3-,6-,9-, and 12-month follow-up assessments]
• Depressive Symptoms (Self-report) [Time frame: 3-,6-,9-, and 12-month follow-up assessments]
• Behavioral activation for depression [Time frame: 3-,6-,9-, and 12-month follow-up assessments]
• Adherence to antiretroviral medication (ART) [Time frame: 3-,6-,9-, and 12-month follow-up assessments]
• Non-adherence to antiretroviral medication (ART) [Time frame: 3-,6-,9-, and 12-month follow-up assessments]
• Information, motivation, and behavioral skills to adhere to ART [Time frame: 3-,6-,9-, and 12-month follow-up assessments]
• Self-efficacy to adhere to ART [Time frame: 3-,6-,9-, and 12-month follow-up assessments]
• Retention in HIV care [Time frame: 3-,6-,9-, and 12-month follow-up assessments]
• Logistical barriers to HIV care [Time frame: 3-,6-,9-, and 12-month follow-up assessments]

Eligibility criteria

Inclusion criteria

• 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
• 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:

• not currently in possession of ART or not taking ART but prescribed ART or
• sub-optimal ART adherence as at least one 4-day treatment interruption in the past 90 days or
• 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
• no viral load test done in the past six months or
• self-reports a detectable viral load within the past 6 months

Exclusion criteria

• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Single blind

Primary purpose

Supportive care

Study locations

Mexico · 1 center

• Programa Compañeros — Ciudad Juárez

Publications

• 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 PMID 36765309

Identifiers

NCT: NCT05377463 · 1780619-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗