Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Ayesha Appa, MD
Headshot of Ayesha Appa
Ayesha Appa

Description

Summary

Methamphetamine use and associated sequelae have been rising, and represent a major barrier to successful control of the HIV epidemic. Methamphetamine use is associated with poor adherence to antiretroviral therapy for HIV, and we propose a trial of contingency management (providing incentives for behavioral change) targeting both reduced methamphetamine use and improved adherence to HIV medications. We will utilize a real-time, point-of-care urine assay for both outcomes, aiming to evaluate feasibility, acceptability and preliminary effectiveness of HIV care-based contingency management. We will also study hair levels as a quantitative outcome for reduction in methamphetamine use.

Official Title

CoMBo Study: Contingency Management for Both HIV And Stimulant Use in Primary Care

Details

Methamphetamine (MA) use is increasing in the United States, along with a sharp rise in overdose deaths. MA use is particularly prevalent among people with HIV (PWH), which can contribute to non-adherence to antiretroviral therapy (ART) and progression to AIDS. Contingency management (CM) is an evidence-based intervention that has repeatedly demonstrated efficacy in stimulant use disorder treatment and has also proved efficacious in improving ART adherence for those in care. Since uptake of CM outside of formal drug treatment programs has been limited, incorporating CM into HIV primary care is an important opportunity to expand access to treatment for MA use disorder while also supporting ART adherence.

This study addresses two barriers that have each limited outward expansion of CM into HIV primary care: 1) feasibility challenges for CM in clinical practice settings; as CM is traditionally delivered 2-3x weekly, this study explores a de-intensified CM schedule (e.g., once weekly visits) in HIV primary care; and 2) CM for ART adherence has been previously limited by the inaccuracy of indirect or non-timely measures of adherence.

The study utilizes a novel point-of-care urine tenofovir assay to perform POC testing on the same urine specimen for both ART use and MA non-use, enabling a truly paired CM intervention that addresses the following aims: 1) a pilot RCT evaluating feasibility of de-intensified (once weekly) combined contingency management for reducing MA use and increasing ART adherence in HIV primary care, compared to conventional twice weekly CM; 2) in-depth interviews following RCT completion to qualitatively explore the acceptability of this intervention to participants and their primary care providers; and 3) given incomplete ability to detect cumulative MA use with only once weekly urine testing, we will study the correlation between monthly MA hair levels with monthly Timeline Followback interviews to validate use of hair MA levels to be able to quantitatively detect reduced use (in addition to abstinence) as a future study outcome.

Keywords

Stimulant Use (Diagnosis), Hiv, Contingency management

Eligibility

You can join if…

Open to people ages 18 years and up

  • Stimulant use disorder
  • Living with HIV or risk for HIV
  • Suboptimal ART adherence (treatment or prevention)

You CAN'T join if...

  • Unable to provide urine testing weekly

Location

  • UCSF at San Francisco General Hospital
    San Francisco California 94110 United States

Lead Scientist at UCSF

  • Ayesha Appa, MD
    Dr. Ayesha Appa is an Assistant Professor of Medicine in the Division of HIV, Infectious Diseases, and Global Medicine at San Francisco General Hospital and a clinician investigator triply board-certified in Infectious Diseases, Addiction Medicine, and Internal Medicine.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06564792
Study Type
Interventional
Participants
About 37 people participating
Last Updated