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HIV/AIDSARTEMISNCT01926184

RCT of an Integrative Intervention for Non-Treatment-Seeking Meth Users

A study testing Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS) and Contingency Management (CM) in people with HIV/AIDS and Stimulant Use Disorders, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the era of HIV treatment as prevention (TasP), efforts are needed to identify evidence-based combination prevention approaches that achieve greater decreases HIV viral load among populations that are more likely to engage in HIV transmission risk behavior. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
HIV/AIDS, Stimulant Use Disorders
What is being tested?
Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS) and Contingency Management (CM)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
1 siteUnited States
Study dates
Jan 2013to 8 Oct 2018
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years old
  • Documentation of HIV-positive serostatus
  • Speak English
  • Biological verification of recent methamphetamine use
  • Completion of at least three contingency management (CM) visits
  • Self reported anal sex with a man (MSM) in the past 12 months

Who cannot join

  • Inability to provide informed consent, evidenced by cognitive impairment
  • HIV negative serostatus

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Alliance Health Project

    San Francisco, California, 94102

Other trials in United States

About this study

Official title: Randomized Controlled Trial of an Integrative Intervention for Non-Treatment-Seeking Meth Users

In the era of HIV treatment as prevention (TasP), efforts are needed to identify evidence-based combination prevention approaches that achieve greater decreases HIV viral load among populations that are more likely to engage in HIV transmission risk behavior. Because methamphetamine-using men who have sex with men (MSM) are at greater risk for acquiring and transmitting HIV, interventions targeting stimulant use in this population of high-risk men could boost the effectiveness of TasP. At present, only conditional cash transfer approaches such as contingency management (CM) have demonstrated short- term efficacy in reducing stimulant use among substance-using MSM who are not actively seeking formal treatment. The proposed RCT will examine the efficacy of a positive affect intervention that is designed to optimize the effectiveness of CM to achieve long-term reductions in stimulant use and HIV viral load in this population. the team will examine the efficacy of this integrative intervention in a randomized controlled trial (RCT) with 110 HIV-positive, methamphetamine-using MSM. After enrolling in CM, participants will be randomized to receive either: 1) the positive affect intervention; or 2) a attention-matched control condition. Follow-up data will be collected at 3, 6, 12, and 15 months post-randomization. This RCT will provide an opportunity to examine the efficacy of an integrative intervention designed to promote long-term reductions in HIV viral load as the primary outcome. Secondary outcomes that will be examined include: increases positive affect, reductions in stimulant use, improvements in T-helper (CD4+) count, unsuppressed viral load, and decreases HIV transmission risk behavior. Identifying an efficacious intervention approach to decrease HIV viral load among methamphetamine-using MSM would substantially support the goals of the National HIV/AIDS Strategy to reduce HIV incidence and mitigate HIV-related health disparities.

Being tested
Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS), Contingency Management (CM)
Keywords
HIV/AIDS, Treatment as Prevention, Methamphetamine, Cocaine, HIV viral Load
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS)Behavioural

    5-session integrative intervention to improve positive affect as well as boost and extend the effectiveness of contingency management (CM).

  • Contingency Management (CM)Behavioural

    Also called Positive Reinforcement Opportunity Project (PROP)

    12-week CM protocol that provides escalating monetary reinforcement for biological evidence of methamphetamine abstinence. Delivered as the standard of care for non-treatment-seeking methamphetamine-using MSM in San Francisco. Delivered to both the intervention and attention-control arms

Study groups in NCT01926184
Study groupRoleWhat they receive
ARTEMIS+CMExperimentalThis is a 5-session, individually delivered intervention that is designed to enhance positive affect. It is designed to boost and extend the effectiveness of contingency management (CM).
Receives: Behavioral: Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS); Behavioral: Contingency Management (CM)
Attention-Control+CMPlacebo comparatorAttention-matched, 5-session control condition consisting of brief-self report psychological measures and neutral writing exercises. Contingency management (CM) is also administered to this arm.
Receives: Behavioral: Contingency Management (CM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV Viral Load

    Log10 HIV viral load change and log10 viral load at 15 months

    Measured: 15 Months

Secondary outcomes (5)

  1. Unsuppressed HIV viral load

    Any unsuppressed viral load (>= 200 copies/mL) over the 15-month follow-up period.

    Measured: 15 Months

  2. T-helper Count

    Change in T-helper (CD4+) count

    Measured: 15 Months

  3. Methamphetamine and Cocaine Use (Stimulant Use)

    Changes in methamphetamine and cocaine use (assessed via self-report and urine toxicology screening) over the 15-month follow-up.

    Measured: 15 Months

  4. Psychological Adjustment

    Changes in positive affect, negative affect, and depressive symptoms over the 15-month follow-up.

    Measured: 15 Months

  5. Potentially Amplified Transmission (PAT) Risk Behavior

    Changes in self-reported HIV transmission risk behavior with an unsuppressed HIV viral load (>= 200 copies/mL) over the 15-month follow-up.

    Measured: 15 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2013 (estimated)
  2. Study startJan 2013
  3. Primary completion8 Oct 2018
  4. Study completion8 Oct 2018

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01926184
Sponsor's protocol ID
R01DA033854
Other IDs
R01DA033854
Acronym
ARTEMIS
Status last verified
Mar 2022
First submitted
16 Aug 2013
Last updated
21 Mar 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Foley J, Batchelder AW, Bernier L, Glynn T, Moskowitz J, Carrico A. Facets of mindfulness are associated with inflammation biomarkers in a sample of sexual minority men with HIV. Psychol Health Med. 2025 Feb;30(2):368-383. doi: 10.1080/13548506.2024.2407445. Epub 2024 Sep 24.

    PubMed 39315986

  • Carrico AW, Gomicronmez W, Jain J, Shoptaw S, Discepola MV, Olem D, Lagana-Jackson J, Andrews R, Neilands TB, Dilworth SE, Evans JL, Woods WJ, Moskowitz JT. Randomized controlled trial of a positive affect intervention for methamphetamine users. Drug Alcohol Depend. 2018 Nov 1;192:8-15. doi: 10.1016/j.drugalcdep.2018.07.029. Epub 2018 Sep 5.

    PubMed 30195243

  • Carrico AW, Jain J, Discepola MV, Olem D, Andrews R, Woods WJ, Neilands TB, Shoptaw S, Gomez W, Dilworth SE, Moskowitz JT. A community-engaged randomized controlled trial of an integrative intervention with HIV-positive, methamphetamine-using men who have sex with men. BMC Public Health. 2016 Jul 30;16:673. doi: 10.1186/s12889-016-3325-1.

    PubMed 27476110

Questions about this trial

What is this clinical trial studying?

A study testing Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS) and Contingency Management (CM) in people with HIV/AIDS and Stimulant Use Disorders, 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 6 inclusion and 2 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 21 Mar 2022. 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. Some participants in this study may receive a placebo. 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?

HIV Viral Load (time frame: 15 Months). 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 NCT01926184, which also lists 3 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 21 Mar 2022.

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