Clinical trial NCT02907697: Adherence Intervention for HIV-infected Drug Users
Official title: Adherence Intervention for HIV-infected Drug Users
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Substance Use
Keywords: HIV/AIDS
adherence
substance use
HIV care continuum
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2016-09-20
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many people living with HIV use illicit drugs, which leads to worsened health outcomes and increased transmission of HIV due to poor adherence to medication regimens. This research will develop an intervention targeting medication adherence that is tailored to the unique needs of HIV-infected drug users. This research will promote adherence and improve treatment outcomes among HIV-infected drug users thereby minimizing the development of drug resistant strains of HIV and reducing transmission.

Detailed description: This K23 research and training award advances the long-term goal of improving treatment outcomes and reducing transmission of HIV among HIV-infected drug users. The proposed training and research plans will enable the PI to develop the skills needed for an independent research career in the area of illicit drug use and HIV adherence intervention. The objective of this award is to develop skills in implementation science, behavioral intervention development and evaluation with drug using populations, and in-depth qualitative data analysis to accelerate refinement and effective implementation of interventions for HIV-infected drug users. Multiple comorbidities such as drug use and HIV act synergistically to produce poorer health outcomes and increase morbidity, mortality, and transmission of HIV. Consequently, effective and sustainable interventions adapted to drug users to improve antiretroviral medication adherence and reduce risk behaviors are urgently needed. Drug users present unique treatment challenges compared with other HIV-infected populations, including lower rates of adherence and inferior treatment outcomes. Additionally, interpersonal factors, including social support, negative patient-provider interactions, and socioeconomic challenges present significant barriers to adherence. Thus, the generalizability of current adherence interventions to drug users is limited, and there is a pressing need for efficacious interventions adapted to HIV-infected drug using populations. This project addresses this gap by being the first to adapt and test the acceptability and efficacy of a combined adherence and brief motivational intervention for HIV-infected drug users. Specifically, the intervention will augment the established Life Steps adherence intervention to include: (1) a tailored Life Steps module addressing the unique needs of illicit drug users, aimed at improving medication adherence; (2) a brief Motivational Interview to address drug use and other risk behaviors; and (3) two follow-up booster sessions. A three-phase, top-down research approach to adapt, refine, and pilot test the intervention will be conducted. Phase 1 will include focus groups with HIV-infected drug users currently prescribed antiretroviral medications and individual interviews with community-based clinicians. Phase 2 will include manual development, therapist training, a pilot trial, in-depth qualitative interviews, and further manual revisions. Phase 3 will include a small, 2-armed (intervention vs. health education control) randomized controlled trial with 60 HIV-infected drug users. Feasibility, acceptability, and preliminary indication of improvement in antiretroviral adherence and reduction in drug use will be examined at 1-, 3-, and 6-month follow-ups. To enable the PI to pursue this long-term research agenda, she will work with experienced mentors to build three areas of expertise: (1) proficiency in qualitative research methods and analysis; (2) skills in intervention development and evaluation with illicit drug using populations; (3) expertise in advanced longitudinal data analysis; and (4) implementation science. This K23 study addresses a key priority in HIV treatment science, and it will fully prepare the PI for an independent research career as an HIV intervention scientist.

Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* HIV-infected
* prescribed an antiretroviral regimen
* meet DSM-V criteria for a substance use disorder (other than tobacco and alcohol) and report ≥3 days of use of an illicit drug per month over the past 90 days.
* self-report \<100% adherence and have experienced a detectable viral load (\>20 copies/mL) within the last 6 months.

Exclusion Criteria:

* cognitive impairments that jeopardize informed consent
* active psychosis
* current suicidal ideation
* not fluent in English
* have a prescription for and report only medicinal use of marijuana

Primary outcomes:
measure: Antiretroviral Adherence
timeFrame: 1-, 3-, and 6-months
Secondary outcomes:
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 1-, 3-, and 6-months
measure: HIV Treatment Adherence Self-Efficacy (HIV-ASES)
timeFrame: 1-, 3-, and 6-months
measure: U.S. Health Resources and Service Administration measure of HIV treatment retention
timeFrame: 1-, 6-months
measure: Risk Assessment Battery
timeFrame: 1-, 3-, and 6-months
measure: HIV1 Ultra RT PCR-Roche test
timeFrame: 1-, 3-, and 6-months
measure: Urine Toxicology Screens
timeFrame: 1-, 3-, and 6-months
measure: ACTG Self-Reported Antiretroviral Medication Adherence
timeFrame: 1-, 3-, and 6-months
measure: 30-day Timeline Followback (TLFB)
timeFrame: 1-, 3-, and 6-months
Other outcomes:
Locations:
city: Austin
country: United States
facility: Unviersity of Texas Dell Medical School
state: Texas
Study officials:
affiliation: The Unviersity of Texas
name: Kasey Claborn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Claborn K, Becker S, Operario D, Safren S, Rich JD, Ramsey S. Adherence intervention for HIV-infected persons who use drugs: adaptation, open trial, and pilot randomized hybrid type 1 trial protocol. Addict Sci Clin Pract. 2018 Apr 2;13(1):12. doi: 10.1186/s13722-018-0113-5.