Suppression of HIV 1 RNA in People Living With HIV

NCT02363387 | Completed Results

• 2 other identifiers: IRB00044740R01AI117065
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; antiretroviral medications; incentives

Outcome Measures

Primary Outcomes (1)

• Undetectable Viral Loads During Treatment

  We will assess the percentage of blood samples that have undetectable viral loads (i.e., \<200 copies/mL) at the eight 3-month assessments conducted throughout the 2-year intervention evaluation period (Y/N at each assessment).

  2 years

Secondary Outcomes (5)

• Biologically-verified Adherence to Antiretroviral Medications

  2 years

• Self-reported Adherence to Antiretroviral Medications

  2 years

• Maintaining Prescriptions for Antiretroviral Medications

  2 years

• Retention in HIV Medical Care

  2 years

• Post-intervention Effects

  Year 3

Study Arms (2)

Incentive Group

EXPERIMENTAL

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.

Behavioral: Incentives for Viral Suppression; Behavioral: Standard HIV Medical Care

Usual Care Group

OTHER

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

Behavioral: Standard HIV Medical Care

Interventions

Incentives for Viral Suppression 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.

Incentive Group

Standard HIV Medical Care BEHAVIORAL

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

Incentive Group; Usual Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• living with HIV

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

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

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• 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.

  PMID: 38117449 DERIVED

Results Point of Contact

• Title: Kenneth Silverman
• Organization: Johns Hopkins University School of Medicine

ksilverm@jhmi.edu

443-617-6051

Study Officials

• Kenneth Silverman, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 16, 2015
• Study Start: November 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: March 1, 2021
• Last Updated: April 24, 2023
• Results First Posted: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)