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OpenTrials
Completed

NCT Number: NCT06564792

Contingency Management in HIV Care for Both Stimulant Use & ART Adherence

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 the investigators propose a trial of contingency management (providing incentives for behavioral change) targeting both reduced methamphetamine use and improved adherence to HIV medications. The investigators 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. Hair levels will also be studied as a quantitative outcome for reduction in methamphetamine use.

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Key information

Conditions

Stimulant Use (Diagnosis) Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Disease Genital Diseases HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF at San Francisco General Hospital

San Francisco, California, 94110, United States

About this study

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, the investigators 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unable to provide urine testing weekly

Treatment and study plan

Contingency Management

Behavioral

Once weekly contingency management visit involving 15 minutes+ of motivational interviewing and provision of incentives for stimulant-negative urine tests and/or tenofovir-positive urine tests.

Primary outcomes

  1. Feasibility: proportion of CM visits attended

    Time frame: Measured during intervention participation.

    The investigators will report multiple process measures as feasibility outcomes, though primary outcome is the number and proportion of contingency management visits attended (of 12). It is expected that 50% of participants will attend at least 6 or more CM visits, which is defined as minimum engagement suggesting feasibility of this HIV primary care-based CM intervention.

  2. Acceptability: in-depth interviews with participants, staff

    Time frame: Interviews performed within 6 months of intervention participation.

    The investigators will conduct in-depth qualitative interviews to understand factors and circumstances that influence CM engagement among PWH with stimulant use disorder and suboptimal ART adherence. These findings will also help elucidate mechanisms contributing to stimulant use reduction and ART adherence when once weekly CM is delivered to PWH in a designated primary care setting.

Secondary outcomes

  1. Effectiveness (Urine)

    Time frame: Measured during intervention participation.

    The investigators will report proportion of urine tests negative for stimulants; proportion positive for tenofovir.

  2. Effectiveness (Hair)

    Time frame: Analyzed within 1 year following hair collection

    The investigators will correlate within-person changes in cumulative stimulant hair levels with the days free of stimulant use performed pre- vs. post-intervention using mixed effects Poisson regression with random effects for individual.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: CoMBo

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 21, 2024
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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