Stimulant Use (Diagnosis)CoMBoNCT06564792
Contingency Management in HIV Care for Both Stimulant Use & ART Adherence
A study testing Contingency management in people with Stimulant Use (Diagnosis) and Hiv, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stimulant Use (Diagnosis), Hiv
- What is being tested?
- Contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2023to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stimulant use disorder
- Living with HIV or risk for HIV
- Suboptimal ART adherence (treatment or prevention)
Who cannot join
- Unable to provide urine testing weekly
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF at San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: CoMBo Study: Contingency Management for Both HIV And Stimulant Use in Primary Care
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.
Read the 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.
- Conditions
- Stimulant Use (Diagnosis), Hiv
- Being tested
- Contingency management
- Medical subject headings
- Disease, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Contingency management arm | Experimental | Participants are offered once weekly contingency management in clinic to support reduced stimulant use and HIV medication adherence. Receives: Behavioral: Contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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.
Measured: Interviews performed within 6 months of intervention participation.
Secondary outcomes (2)
Effectiveness (Urine)
The investigators will report proportion of urine tests negative for stimulants; proportion positive for tenofovir.
Measured: Measured during intervention participation.
Effectiveness (Hair)
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.
Measured: Analyzed within 1 year following hair collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start15 Sep 2023
- Primary completion30 May 2024
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stimulant Use (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Appa, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564792
- Sponsor's protocol ID
- 23-38747
- Acronym
- CoMBo
- Status last verified
- Oct 2025
- First submitted
- 19 Aug 2024
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Appa A, Steiner G, Baral S, Riley E, Suchman L, Roberts K, Knight K, Murphy M, Chamie G, Shoptaw S, Coffin PO, Gandhi M. Integrating HIV and Stimulant-Use Disorder Treatment: A Pilot Implementation Effectiveness Trial of Contingency Management in HIV Care. Clin Infect Dis. 2026 Apr 30;82(4):e728-e734. doi: 10.1093/cid/ciag006.
PubMed 41505433Steiner 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.
PubMed 40825537
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoMBo Study: Contingency Management for Both HIV And Stimulant Use in Primary Care
- ClinicalTrials.gov ID
- NCT06564792
- Acronym / sponsor ID
- CoMBo / 23-38747
- Conditions
- Stimulant Use (Diagnosis), Hiv
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contingency management arm | Experimental | Behavioral: Contingency managementParticipants are offered once weekly contingency management in clinic to support reduced stimulant use and HIV medication adherence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stimulant use disorder
- Living with HIV or risk for HIV
- Suboptimal ART adherence (treatment or prevention)
Key exclusion criteria (1 listed)
- Unable to provide urine testing weekly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency managementOnce 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. | Behavioural | Contingency management arm |
Primary outcome
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.
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.
2 secondary outcomes
Effectiveness (Urine)
Time frame: Measured during intervention participation.
Effectiveness (Hair)
Time frame: Analyzed within 1 year following hair collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Derived from this study: PubMed 41505433Appa A, Steiner G, Baral S, Riley E, Suchman L, Roberts K, Knight K, Murphy M, Chamie G, Shoptaw S, Coffin PO, Gandhi M. Integrating HIV and Stimulant-Use Disorder Treatment: A Pilot Implementation Effectiveness Trial of Contingency Management in HIV Care. Clin Infect Dis. 2026 Apr 30;82(4):e728-e734. doi: 10.1093/cid/ciag006.
- Derived from this study: PubMed 40825537Steiner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayesha Appa, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency management in people with Stimulant Use (Diagnosis) and Hiv, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: proportion of CM visits attended (time frame: Measured during intervention participation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06564792, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.