Clinical trial NCT05377463: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Viremia
Keywords: HIV viral suppression
Lead sponsor: University of Texas, El Paso
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Centro de Integracion Juvenil
name: El Centro Ambulatorio para la Prevención y Atención en SIDA e Infecciones de Transmisión Sexual
First posted: 2022-05-17
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The factorial experiment is guided by the Multiphase Optimization Strategy (MOST).

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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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:

  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:

* 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

Primary outcomes:
measure: Achievement of Viral Suppression
timeFrame: Viral load below or above 400 copiers per mL at the 6-month follow-up assessment
measure: Viral Suppression at 9-month follow-up
timeFrame: Viral load below or above 400 copiers per mL at the 9-month follow-up assessment
measure: Viral Suppression at 12-month follow-up
timeFrame: Viral load below or above 400 copiers per mL at the 12-month follow-up assessment
Secondary outcomes:
measure: Drug use
timeFrame: 3-,6-,9-, and 12-month follow-up assessments
measure: Methadone uptake and persistence
timeFrame: 3-,6-,9-, and 12-month follow-up assessments
measure: Drug use frequency and severity of withdrawal and cravings
timeFrame: 3-,6-,9-, and 12-month follow-up assessments
measure: Depressive Symptoms (Clinician-assisted rating)
timeFrame: 3-,6-,9-, and 12-month follow-up assessments
measure: Depressive Symptoms (Self-report)
timeFrame: 3-,6-,9-, and 12-month follow-up assessments
measure: Behavioral activation for depression
timeFrame: 3-,6-,9-, and 12-month follow-up assessments
measure: Adherence to antiretroviral medication (ART)
timeFrame: 3-,6-,9-, and 12-month follow-up assessments
measure: Non-adherence to antiretroviral medication (ART)
timeFrame: 3-,6-,9-, and 12-month follow-up assessments
measure: Information, motivation, and behavioral skills to adhere to ART
timeFrame: 3-,6-,9-, and 12-month follow-up assessments
measure: Self-efficacy to adhere to ART
timeFrame: 3-,6-,9-, and 12-month follow-up assessments
measure: Retention in HIV care
timeFrame: 3-,6-,9-, and 12-month follow-up assessments
measure: Logistical barriers to HIV care
timeFrame: 3-,6-,9-, and 12-month follow-up assessments
measure: Perceived engagement in HIV care
timeFrame: 3-,6-,9-, and 12-month follow-up assessments
Other outcomes:
Locations:
city: Ciudad Juárez
country: Mexico
facility: Programa Compañeros
state: Chihuahua
Study officials:
affiliation: The University of Texas at El Paso
name: Julia Lechuga
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of California San Francisco
name: John A Sauceda
role: PRINCIPAL_INVESTIGATOR
References: