NCT06564792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

October 14, 2025

Status Verified

October 1, 2025

Enrollment Period

9 months

First QC Date

August 19, 2024

Last Update Submit

October 9, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Feasibility: proportion of CM visits attended

    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.

    Measured during intervention participation.

  • Acceptability: in-depth interviews with participants, staff

    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.

    Interviews performed within 6 months of intervention participation.

Secondary Outcomes (2)

  • Effectiveness (Urine)

    Measured during intervention participation.

  • Effectiveness (Hair)

    Analyzed within 1 year following hair collection

Study Arms (1)

Contingency management arm

EXPERIMENTAL

Participants are offered once weekly contingency management in clinic to support reduced stimulant use and HIV medication adherence.

Behavioral: Contingency management

Interventions

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.

Contingency management arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unable to provide urine testing weekly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF at San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (1)

  • Steiner G, Baral S, Riley ED, Shoptaw S, Chamie G, Roberts K, Suchman L, Knight K, Gandhi M, Coffin P, Appa A. Harm Reduction Contingency Management for Stimulant Use Reduction and Antiretroviral Therapy Adherence in HIV Primary Care: Protocol for an Implementation Effectiveness Study. JMIR Res Protoc. 2025 Aug 18;14:e67292. doi: 10.2196/67292.

MeSH Terms

Conditions

DiseaseAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Ayesha Appa, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 21, 2024

Study Start

September 15, 2023

Primary Completion

May 30, 2024

Study Completion

October 1, 2025

Last Updated

October 14, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations