HIVNCT02907697
Adherence Intervention for HIV-infected Drug Users
A study testing Life Steps-Drug Use and General Health Education in people with HIV and Substance Use, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Substance Use
- What is being tested?
- Life Steps-Drug Use and General Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 30 Dec 2022
- 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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Unviersity of Texas Dell Medical School
Austin, Texas, 78712
About this study
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.
Read the 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.
- Conditions
- HIV, Substance Use
- Being tested
- Life Steps-Drug Use, General Health Education
- Keywords
- HIV/AIDS, adherence, substance use, HIV care continuum
- Medical subject headings
- Substance-Related Disorders, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Steps-Drug UseBehavioural
General Health EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| LifeSteps-Drug Use | Experimental | The investigators expect the LifeSteps-Drug Use adaptation will be modeled after the Life Steps adherence intervention with the addition of a Drug Use module based on motivational interviewing and the FRAMES approach. The LifeSteps-Drug Use intervention is expected to include two in-person sessions and two telephone booster sessions. While anticipated preliminary adaptations have been based on the extant literature, changes to the protocol will be based on data obtained during the qualitative phase which will be sufficiently broad and open to assess for factors that we have not anticipated. Receives: Behavioral: Life Steps-Drug Use |
| Health Education | Active comparator | The health education condition is a time-matched, active control arm. It will consist of two in-person sessions and two telephone sessions. Each session will cover a general health education topic. Receives: Behavioral: General Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-, 3-, and 6-months
Secondary outcomes (8)
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.
Measured: 1-, 3-, and 6-months
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.
Measured: 1-, 3-, and 6-months
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
Measured: 1-, 6-months
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.
Measured: 1-, 3-, and 6-months
HIV1 Ultra RT PCR-Roche test
This lab assay will be used to assess change in HIV viral load over time.
Measured: 1-, 3-, and 6-months
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.
Measured: 1-, 3-, and 6-months
ACTG Self-Reported Antiretroviral Medication Adherence
The ACTG scale will be used to assess self-reported adherence to antiretroviral medications.
Measured: 1-, 3-, and 6-months
30-day Timeline Followback (TLFB)
The TLFB will be used to assess change in alcohol, tobacco, and illicit drugs over time.
Measured: 1-, 3-, and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start1 Jan 2016
- Primary completion1 Oct 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Principal investigator, Kasey Claborn, University of Texas at Austin
- Investigators
- Kasey Claborn, PhD, Principal investigator, The Unviersity of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907697
- Sponsor's protocol ID
- K23DA039037
- Status last verified
- Jul 2022
- First submitted
- 26 Aug 2016
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29606129
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence Intervention for HIV-infected Drug Users
- ClinicalTrials.gov ID
- NCT02907697
- Acronym / sponsor ID
- K23DA039037
- Conditions
- HIV, Substance Use
- Keywords
- HIV/AIDS, adherence, substance use, HIV care continuum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 20 Sep 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LifeSteps-Drug Use | Experimental | Behavioral: Life Steps-Drug UseThe investigators expect the LifeSteps-Drug Use adaptation will be modeled after the Life Steps adherence intervention with the addition of a Drug Use module based on motivational interviewing and the FRAMES approach. The LifeSteps-Drug Use intervention is expected to include two in-person sessions and two telephone booster sessions. While anticipated preliminary adaptations have been based on the extant literature, changes to the protocol will be based on data obtained during the qualitative phase which will be sufficiently broad and open to assess for factors that we have not anticipated. |
| Health Education | Active comparator | Behavioral: General Health EducationThe health education condition is a time-matched, active control arm. It will consist of two in-person sessions and two telephone sessions. Each session will cover a general health education topic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Life Steps-Drug Use | Behavioural | LifeSteps-Drug Use |
| General Health Education | Behavioural | Health Education |
Primary outcome
Antiretroviral Adherence
Time frame: 1-, 3-, and 6-months
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.
8 secondary outcomes
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 1-, 3-, and 6-months
HIV Treatment Adherence Self-Efficacy (HIV-ASES)
Time frame: 1-, 3-, and 6-months
U.S. Health Resources and Service Administration measure of HIV treatment retention
Time frame: 1-, 6-months
Risk Assessment Battery
Time frame: 1-, 3-, and 6-months
HIV1 Ultra RT PCR-Roche test
Time frame: 1-, 3-, and 6-months
Urine Toxicology Screens
Time frame: 1-, 3-, and 6-months
ACTG Self-Reported Antiretroviral Medication Adherence
Time frame: 1-, 3-, and 6-months
30-day Timeline Followback (TLFB)
Time frame: 1-, 3-, and 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Derived from this study: PubMed 29606129Claborn 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.
- 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.
Kasey Claborn, PhD principal investigator
The Unviersity of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life Steps-Drug Use and General Health Education in people with HIV and Substance Use, run by University of Texas at Austin 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Jul 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. 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?
Results are not available in the source record.
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?
Antiretroviral Adherence (time frame: 1-, 3-, and 6-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 NCT02907697, which also lists 1 linked publication.
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 25 Jul 2022.