Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04563962 |
| Other study ID # |
IRB#19-001996 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2021 |
| Est. completion date |
August 31, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
University of California, Los Angeles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Use of crystal methamphetamine (MA) leads to changes in sexual risk behavior, adherence to
HIV prevention tools, immune response to infection, and tissue inflammation that collectively
increase risk for HIV transmission among MA-using men who have sex with men (MSM), their
sexual partners, and their networks. Contingency Management (CM) offers a behavioral
modification tool helpful for reducing frequency of MA use, but the effects of CM on the
behavioral and biological factors that promote HIV transmission in MSM networks have only
been partially evaluated. The intersection of substance use, sexual risk behavior, and HIV
transmission in MSM networks presents a critical problem for contemporary HIV prevention as
HIV-uninfected MSM who use MA have a 16%-33% greater risk for HIV infection, while only
approximately 50% of HIV-infected MA-using MSM achieve and maintain an undetectable viral
load. The investigators propose to compare two different CM models to integrate substance use
treatment with HIV prevention among MA-using MSM: 1) Traditional CM targeted to MA abstinence
and 2) Allternative CM based on ARV adherence.
Description:
Background
The intersection of substance use, sexual behavior, and HIV transmission in the social and
sexual networks of crystal methamphetamine (MA)-using men who have sex with men (MSM)
presents a critical public health problem. MA use increases risk for HIV acquisition and
transmission in an interwoven series of behavioral, biological, and social mechanisms.
Behaviorally, MA use stimulates pleasure-seeking behavior, increasing the likelihood of
high-risk sexual contacts and impairing adherence to tools like condoms, pre-exposure
prophylaxis (PrEP), and Treatment as Prevention (TasP). Biologically, MA affects immunologic
factors associated with HIV-1 transmission, including viral replication, inflammatory
cytokine production, T-cell activation, and recruitment of CD4+ T-cells to rectal mucosa.
Socially, MA use negatively impacts the perceptions of interpersonal commitment and social
cohesion central to community norms of HIV prevention, while elevating the incidence of
untreated HIV/STIs in the population and increasing risks of exposure for sexual network
contacts. Efforts to address these problems have typically prioritized either reducing MA use
or controlling HIV transmission, without targeting the overlapping space between the two
problems and exploring how individual-level interventions targeted to high-risk networks can
transform community-scale outcomes.
Contingency Management (CM) has been shown to control MA use among habitual users. Adapting
principles of behavioral economics, CM addresses the prioritization of short-term rewards and
the devaluation of long-term risks commonly seen with MA use. While behavioral approaches
like Cognitive Behavioral Therapy have been evaluated as strategies to manage stimulant
abuse, these methods have not shown independent benefit in modifying patterns of drug use,
presumably because they do not intervene in the cognitive risk-reward feedback loop that
underlies stimulant abuse and that is replaced by CM incentives. Analysis of previous
clinical trial data suggests that the small financial incentives provided in exchange for
stimulant-free urine may substitute for the short-term feedback loops that structure the
cognitive processes of habitual MA users, and serve as an essential component in CM's
success.
The potential indirect effects of CM on HIV transmission have been evaluated in several
studies. In conjunction with reduced MA use, MSM often report a corresponding reduction in
frequency of condomless intercourse. However, efforts to implement CM as a harm reduction
strategy in sexually transmitted infection (STI) clinics have been unsuccessful, leading to
questions about how it can be applied to real world settings. In these contexts, incremental
improvements among individual MA users are often insufficient in modifying problems like
frequency of condomless intercourse, adherence to antiretroviral therapy (ART), and
network-level patterns of HIV and STI transmission. The goal of the current research is to
use CM as a platform to integrate HIV prevention with substance use treatment among MA-using
MSM to transform population-level patterns of HIV transmission.
Specific Aims Aim 1. To assess the logistics, feasibility, and acceptability of a
point-of-care urine assay to assess short-term adherence to Tenofovir (TFV)-based
antiretrovirals (ARVs) or PrEP regimens among MA-using MSM. The investigators plan to enroll
10 HIV-infected and 10 HIV-uninfected MSM with recent use of MA and a tenofovir-based HIV
treatment or prevention regimen. Participants will be randomly assigned to traditional CM
(Arm A) or ARV-based CM (Arm B) and asked to attend monitoring visits three times per week
over a 30-day period. Each visit will include urine monitoring for recent MA use and ART
adherence (in both Arms). At each visit where a participant's urine either does not contain
MA (Arm A) or does contain tenofovir (Arm B), they will receive a small financial incentive.
Incentives will gradually increase with each successful urine test, or they will reset to
zero if the participant fails the urine screen or misses a visit. Aim 1 outcomes will assess
participant retention, satisfaction and acceptability of the CM format for supporting ARV
adherence.
Aim 2. To collect preliminary data on the effect of ARV-based CM in promoting ARV adherence.
To design an R01 trial of CM to support ARV adherence, the investigators plan to collect
preliminary effect estimates for the two CM platforms in promoting: i) MA abstinence; ii) ARV
adherence, and iii) Reductions in high-risk sexual behavior. Findings will be used to project
sample size and refine monitoring procedures in the larger trial.
Methods Recruitment and Screening.
The investigators will recruit active MA users from community venues. Potential subjects will
be recruited by a team of experienced, community-based researchers. To avoid withholding an
effective CM therapy intervention from individuals trying to limit their use, for this pilot
study the investigators will only enroll MSM who are not currently seeking substance use
treatment. Enrollment will be limited to individuals who:
1. Identify as male or transgender;
2. Report condomless anal intercourse with a male or transgender partner in the prior 6
months;
3. Report current MA use (at least once per week) with MA present in urine at screening;
and
4. Are currently taking Truvada for PrEP (if HIV-uninfected) or a Tenofovir-based ART
regimen (if HIV-infected).
Potential participants will undergo preliminary screening by the study recruiter using
an IRB-approved screening script. Eligible participants will be scheduled for an
Enrollment visit at the UCLA Vine Street Clinic.
At the Enrollment visit, all participants will be asked to provide informed consent
prior to the initiation of any study procedures. Upon providing consent, participants
will be assessed for eligibility by a study physician and asked to provide a urine
sample to test for presence of methamphetamine metabolites.
Eligible subjects participants will be asked to complete the following Enrollment visit
procedures.
i) Behavioral Survey: All participants will be asked to complete a computer-assisted
self-administered (CASI) survey assessing their demographic characteristics, substance
use practices, current use of PrEP (if HIV-uninfected) or antiretroviral therapy (if
HIV-infected), sexual practices, characteristics of recent partners, and social and
sexual network composition.
ii) HIV Testing: Study counselors will provide HIV risk reduction counseling using the
CDC RESPECT-2 model and test for HIV with a 5th Generation HIV-1/2 Ab assay. Positive
results will be confirmed by HIV-1 PCR testing for viral load quantification. Referrals
to prevention and treatment services will be provided as needed.
iii) STI Testing: Participants will undergo syphilis testing by rapid plasma reagin
(RPR) with T palladium particle agglutination (TPPA) assay confirmation and serial
dilution of positive titers. Participants will be asked to provide urine, rectal and
pharyngeal swabs for gonorrhea and chlamydia (GC/CT) testing. Participants with an STI
will receive appropriate antibiotic treatment and partner notification counseling.
iv) Urine Toxicology Screen: Urine samples will be tested for stimulants and other drugs
of abuse using a point-of-care liquid chromatography (LC) assay.
At the Enrollment visit, participants will be randomly assigned to a CM program with
incentives based either on MA abstinence or TFV adherence and with monitoring visits
either twice per week or three times per week.
b. Contingency Management Visits. Eligible participants will be counseled on CM
procedures at the Enrollment visit. Participants will be asked to return to the site
either two or three times per week (T-Th or M-W-F) for 4 weeks. At each visit,
participants will meet with a counselor to discuss their use of PrEP/ART, MA, and sexual
risk behavior. Participants will be asked to provide a urine sample for point of care
testing to detect presence of: a) Methamphetamine (MA); and b) Tenofovir (TFV). Verified
MA abstinence (Arm A) OR TFV use (Arm B) for the prior 3-day period will be rewarded
with an escalating series of incentives.
If a participant fails urine testing, their incentive schedule resets to the Baseline
value.
Following Enrollment, all participants will be asked to return for Contingency
Management visits two or three times per week for four weeks. Each visit will include
the following procedures:
i) Behavioral Assessment: Participants will complete a brief, 12-item CASI survey
assessing recent MA use, PrEP/ART adherence, and frequency of CAI with
serodiscordant/unknown status partners.
ii) Counseling: After completing the survey, study counselors will conduct a brief
check-in session using motivational interviewing techniques to encourage MA abstinence,
ARV adherence, and condom use.
iii) Urine Toxicology Screening: Urine samples will be tested for presence of MA
metabolites.
iv) Tenofovir Screening: Urine samples will be tested at point-of-care for presence of
Tenofovir metabolites using an experimental assay developed by Alere with Dr. Gandhi
(UCSF). Similar to urine toxicology screening, this point-of-care LC assay can be
performed in 15 minutes without specialized training and detects presence of both TDF
and TAF metabolites indicating Tenofovir use in the prior 3-day period.
c. Final Visit.
At the Final visit, participants will be asked to complete the following procedures:
i) Behavioral Assessment: Participants will be asked to complete a CASI survey similar
to the enrollment instrument, with attention to changes in sexual behavior, substance
use practices, and network composition.
ii) Biological Assessment: Participants will undergo repeat testing for HIV (including
viral load, if HIV-infected) and STIs, as well as urine screening for MA and Tenofovir
metabolites.
iii) Assessment of Study Procedures: Participants will be asked to complete a structured
survey evaluating their satisfaction with and specific study procedures (e.g., frequency
of visits, length of visits, individual counseling, incentive structures, and perceived
impact on ARV adherence, MA use, and sexual risk behavior).
