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N/A N=102 Randomized Treatment

Suppression of HIV 1 RNA in People Living With HIV

HIV

Enrolled (actual)
102
Serious AEs
10.8%
Results posted
Apr 2023
Primary outcome: Primary: Undetectable Viral Loads During Treatment — 70.4; 42.5 percentage of blood samples undetectable — p=<0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Incentives for Viral Suppression (Behavioral); Standard HIV Medical Care (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Johns Hopkins University
Primary completion
Oct 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Undetectable Viral Loads During Treatment
70.4; 42.5 <0.001 sig
SECONDARY
Biologically-verified Adherence to Antiretroviral Medications
SECONDARY
Self-reported Adherence to Antiretroviral Medications
SECONDARY
Maintaining Prescriptions for Antiretroviral Medications
SECONDARY
Retention in HIV Medical Care
SECONDARY
Post-intervention Effects

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.

Eligibility Criteria

Inclusion Criteria

  • living with HIV

Exclusion Criteria

  • report current suicidal or homicidal ideation;
  • have a severe psychiatric disorder
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02363387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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