Suppression of HIV 1 RNA in People Living With HIV

NCT ID: NCT02363387

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2021-03-31

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Incentive Group

Incentive group participants will receive the standard HIV medical care offered in their clinic. In addition, Incentive group participants will receive incentives for viral suppression. These incentives will be presented if the participants maintain 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.

Group Type: EXPERIMENTAL

Incentives for Viral Suppression

Intervention Type: BEHAVIORAL

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.

Standard HIV Medical Care

Intervention Type: BEHAVIORAL

The best HIV medical care available in each participant's medical clinic.

Usual Care Group

Usual Care Control participants will receive the standard HIV medical care offered in their clinic.

Group Type: OTHER

Standard HIV Medical Care

Intervention Type: BEHAVIORAL

The best HIV medical care available in each participant's medical clinic.

Interventions

Incentives for Viral Suppression

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.

Intervention Type: BEHAVIORAL

Standard HIV Medical Care

The best HIV medical care available in each participant's medical clinic.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• living with HIV

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Silverman, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142

Baltimore, Maryland, United States

Countries

United States

References

Novak MD, Holtyn AF, Toegel F, Rodewald AM, Leoutsakos JM, Fingerhood M, Silverman K. Long-Term Effects of Incentives for HIV Viral Suppression: A Randomized Clinical Trial. AIDS Behav. 2024 Feb;28(2):625-635. doi: 10.1007/s10461-023-04249-z. Epub 2023 Dec 20.

Reference Type: DERIVED

PMID: 38117449 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01AI117065

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00044740

Identifier Type: -

Identifier Source: org_study_id