Clinical trial NCT06564792: Contingency Management in HIV Care for Both Stimulant Use & ART Adherence
Official title: CoMBo Study: Contingency Management for Both HIV And Stimulant Use in Primary Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stimulant Use (Diagnosis)
Hiv
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: proportion of CM visits attended
timeFrame: Measured during intervention participation.
measure: Acceptability: in-depth interviews with participants, staff
timeFrame: Interviews performed within 6 months of intervention participation.
Secondary outcomes:
measure: Effectiveness (Urine)
timeFrame: Measured during intervention participation.
measure: Effectiveness (Hair)
timeFrame: Analyzed within 1 year following hair collection
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF at San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ayesha Appa, MD
role: PRINCIPAL_INVESTIGATOR
References: