Clinical trial NCT02363387: Suppression of HIV 1 RNA in People Living With HIV
Official title: Suppression of HIV 1 RNA in People Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
antiretroviral medications
incentives
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2015-02-16
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators propose to evaluate a novel incentive intervention to promote suppression of viral load in people living with HIV that will employ empirically-based parameters that have been proven critical to the effectiveness of incentive interventions. Participants (N = 200) from medical clinics that serve adults living with HIV in Baltimore will be randomly assigned to an Incentive or a Usual Care Control group. Incentive group participants will receive incentives for maintaining suppressed and undetectable viral loads. The incentive program will employ high magnitude incentives, provide incentives for decreases in viral load early in treatment before a patient's viral load has reached undetectable levels, arrange frequent incentives early in treatment and reduce the frequency of incentives as participants achieve progressively longer periods of viral load suppression, arrange a schedule of escalating incentives for sustained suppression of viral load, and the intervention will be maintained for two years. Usual Care Control participants will only receive the standard HIV medical care offered in their clinic. Assessments will be conducted every 3 months throughout the two years of treatment and every 6 months throughout the year following treatment. The primary outcome measure will be the percentage of participants that have undetectable viral loads at the 3-month assessments conducted throughout the 2-year intervention period. Secondary measures will include adherence to HIV care and post-treatment outcomes. The investigators will also assess moderators and mediators of the effects of the incentives on the suppression of viral load, and conduct cost-effectiveness and cost-benefit analyses. If the incentive intervention maintains suppressed viral load and is economically sound, it could be used to improve the health of adults living with HIV, reduce health care costs, and reduce HIV transmission in the community.

Detailed description: Experimental Design. Participants (N = 200) will be randomly assigned to a Usual Care Control group or the Incentive group. A computerized urn randomization procedure (Wei \& Lachin, 1988) will be used to balance groups on five baseline characteristics that may influence outcome: (1) Diagnostic and Statistical Manual (DSM) V dependence on cocaine or opiates assessed on the Composite International Diagnostic Interview (CIDI) (Y/N); (2) DSM V alcohol dependence assessed on the CIDI (Y/N); (3) health literacy as assessed on the Test of Functional Health Literacy in Adults (TOFHLA) (score ≤ the rolling median, Y/N); (4) impulsivity as assessed by delay discounting (k value from the raw discounting data for each participant, which is an index of impulsivity (≤ the rolling median of k, Y/N); and (5) depression as assessed by the Beck Depression Inventory (score ≤ the rolling median, Y/N). Participants will be stratified by DSM V cocaine, opiate and alcohol dependence, health literacy, and depression at intake because drug use, health literacy, and depression has each been associated with poor Anti-Retroviral Therapy (ART) adherence. Participants will be stratified based on measures of impulsivity because high levels of impulsivity have been associated with poor health decision making and adverse health behaviors.

Standard HIV Medical Care.

Upon enrollment, participants will be taught about the benefits of ART adherence and the need to maintain nearly perfect adherence. All participants will receive their HIV medical care in their clinic.

Incentive Group.

The Incentive group will receive the novel empirically-based incentive intervention to promote long term suppression of HIV-1 RNA (viral load) being evaluated in this study. The incentive intervention will employ features and parameters that have been shown critically important to promote therapeutic behavior change in drug users and other populations. participants will be taught the details of the incentive program with written instructions and quizzes.

Usual Care Control Group.

Usual Care Control Only participants will receive the standard HIV medical care described above offered in their medical clinic. Participants in this group will not receive added viral load testing, feedback or incentives, beyond the viral load testing conducted as a routine part of their medical care.

Eligibility criteria: Inclusion Criteria:

* living with HIV

Exclusion Criteria:

* report current suicidal or homicidal ideation;
* have a severe psychiatric disorder

Primary outcomes:
measure: Undetectable Viral Loads During Treatment
timeFrame: 2 years
Secondary outcomes:
measure: Biologically-verified Adherence to Antiretroviral Medications
timeFrame: 2 years
measure: Self-reported Adherence to Antiretroviral Medications
timeFrame: 2 years
measure: Maintaining Prescriptions for Antiretroviral Medications
timeFrame: 2 years
measure: Retention in HIV Medical Care
timeFrame: 2 years
measure: Post-intervention Effects
timeFrame: Year 3
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kenneth Silverman, PhD
role: PRINCIPAL_INVESTIGATOR
References: