Adherence Intervention for HIV-infected Drug Users

HIV Clinical Trial

Official title:

Adherence Intervention for HIV-infected Drug Users

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02907697
• Other study ID #: K23DA039037
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2022
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: December 30, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• Life Steps-Drug Use

• General Health Education

Locations

Country	Name	City	State
United States	Unviersity of Texas Dell Medical School	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antiretroviral Adherence	Change in Antiretroviral Adherence will be assessed by use of medical event monitoring systems (MEMS). MEMS is a pill-bottle-cap with a pressure activated chip which records time/date the bottle is opened. MEMS data will be collected on one antiretroviral medication following a triage criterion established in studies of antiretroviral adherence.	1-, 3-, and 6-months
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D)	Change in depression over time will be assessed using the Center for Epidemiologic Studies Depression Scale (CES-D) is a widely used 20-item measure and has good sensitivity and specificity and high internal consistency and has been used extensively with PLWH and is related to ART adherence.	1-, 3-, and 6-months
Secondary	HIV Treatment Adherence Self-Efficacy (HIV-ASES)	Change in treatment self-efficacy will be assessed using the HIV-ASES whic is a 12-item scale of patient confidence in their ability to carry out behaviors related to adhering to medication regimens.	1-, 3-, and 6-months
Secondary	U.S. Health Resources and Service Administration measure of HIV treatment retention	Change in HIV Treatment Retention will be measured with the U.S. Health Resources and Service Administration measure of HIV treatment retention, which defines treatment retention as having at least two outpatient visits separated by at least 90 days during a 12-month period	1-, 6-months
Secondary	Risk Assessment Battery	Change in HIV risk behavior will be assessed using the Risk Assessment Battery which assesses HIV risk behavior, including sex risk and drug risk, in the past six months.	1-, 3-, and 6-months
Secondary	HIV1 Ultra RT PCR-Roche test	This lab assay will be used to assess change in HIV viral load over time.	1-, 3-, and 6-months
Secondary	Urine Toxicology Screens	Participants will be asked to give a urine sample at each assessment. Redwood Toxicology Redi-cups urine drug screens have test strips in the specimen lids allowing for fast screening without spillage. The Redi-cups 5-panel urine drug screen tests for cocaine, THC, methamphetamines, opiates, and benzodiazepines. This will provide biological verification of drug use to assess change in drug use over time.	1-, 3-, and 6-months
Secondary	ACTG Self-Reported Antiretroviral Medication Adherence	The ACTG scale will be used to assess self-reported adherence to antiretroviral medications.	1-, 3-, and 6-months
Secondary	30-day Timeline Followback (TLFB)	The TLFB will be used to assess change in alcohol, tobacco, and illicit drugs over time.	1-, 3-, and 6-months