HIV InfectionsNCT00602758
Effectiveness of Enhanced Counseling and Observed Therapy on Antiretroviral Adherence in People With HIV
A study testing Motivational interviewing with cognitive behavioral therapy and Modified directly observed therapy in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by University of Missouri, Kansas City at 4 sites in United States.
Trial summary
This study will compare the effectiveness of enhanced counseling alone versus enhanced counseling combined with observed therapy at improving medication adherence in people with HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Acquired Immunodeficiency Syndrome
- What is being tested?
- Motivational interviewing with cognitive behavioral therapy and Modified directly observed therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2004to Aug 2009
- 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
- Patient at participating clinical site
- English-speaking
- Initiating new ART (new or change in therapy) or nonadherent to ART as documented by care provider's assessment, patient self-report, and consistent HIV RNA laboratory results
- Lives within 45-mile radius of participating clinical site or able to participate in observed therapy procedures
Who cannot join
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kansas University Medical Center ID Clinic
Kansas City, Kansas, 66160
Truman Medical Center ID Clinic
Kansas City, Missouri, 64108
Kansas City Free Health Clinic
Kansas City, Missouri, 64110
Kansas City Veterans Administration Medical Center
Kansas City, Missouri, 641128
About this study
Official title: ART Adherence: Enhanced Counseling and Observed Therapy
This study will compare the effectiveness of enhanced counseling alone versus enhanced counseling combined with observed therapy at improving medication adherence in people with HIV.
Read the detailed description
HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. HIV is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. Antiretroviral therapy (ART) has proven to be an effective treatment for inhibiting the replication of HIV, allowing for improved quality of life and survival. However, the long-term effectiveness of ART depends on strict adherence to a prescribed medication regimen. Previous studies have indicated that observing patients while they take their medications for a period of time can improve adherence to their prescribed drug regimens. This study will evaluate the effectiveness of enhanced counseling (EC) alone versus EC combined with modified directly observed therapy (mDOT) at improving medication adherence in people with HIV.
Participants in this 48-week study will be randomly placed into one of the following three treatment groups:
- Group 1 participants will receive standard care, which will involve the care that the clinic staff normally provide to all patients on HIV therapy.
- Group 2 participants will receive EC.
- Group 3 participants will receive EC with mDOT.
All participants will continue to take the anti-HIV medication regimen prescribed by their health care provider. However, participants will be asked to keep one medication type in a bottle that has a special Micro-Electro-Mechanical System (MEMS) cap. This electronic cap will record each time the participant opens the bottle. Participants will meet with study staff for MEMS cap data collection once weekly for the first 4 weeks, every 2 weeks up to Week 12, and then every 4 weeks thereafter.
EC will consist of 30- to 45-minute counseling sessions about medication adherence. Participants will meet in person with a counselor for the first five sessions, occurring at baseline and Weeks, 1, 2, 6, and 11. An additional five counseling sessions will be conducted by phone during Weeks 4, 9, 15, 19, and 23. Participants receiving mDOT will have their doses of HIV medication delivered to them by an mDOT worker for the first 24 weeks of treatment. Participants will select a time and location to meet with an mDOT staff member, who will then provide the daily doses of drugs and observe participants taking those drugs. Participants will meet with an mDOT worker 5 times a week from baseline to Week 16. Starting at Week 17, the number of weekly meetings will gradually taper until Week 24 when there will be no meeting and participants will return to obtaining and taking their HIV medications as done prior to study enrollment.
Evaluation visits will occur for all participants at baseline and Weeks 12, 24, 36, and 48. Evaluation sessions will last 45 minutes to 1 hour and will include questionnaires about adherence, knowledge and attitudes about HIV and HIV therapy, quality of life, support systems, health status, medical history, drug and alcohol use, and satisfaction with HIV care. Blood samples will also be taken to measure CD4 cell count and amount of virus in the blood.
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome
- Being tested
- Motivational interviewing with cognitive behavioral therapy, Modified directly observed therapy
- Keywords
- AIDS, Adherence, Antiretroviral Therapy, HIV
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing with cognitive behavioral therapyBehavioural
Also called Enhanced counseling (EC)
Counseling sessions are completed face-to-face or by telephone at baseline and Weeks 1, 2, 4, 6, 9, 11, 15, 19, and 23. Counselors are trained in motivational interview technique and focus on ART medication adherence.
Modified directly observed therapyBehavioural
Also called OT, Modified observed therapy (MDOT)
From baseline to Week 16, Monday through Friday, study staff meet the participants daily to observe one dose of their ART and to leave with the participants all other doses needed until the next observed dose. The frequency of observed doses begins to taper at Week 17 through to Week 24.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Counseling | Experimental | Participants meet with a counselor trained in motivational interviewing and cognitive behavioral techniques Receives: Behavioral: Motivational interviewing with cognitive behavioral therapy |
| Standard Care | No intervention | Participants receive usual clinical care provided by health care providers and they participate only in evaluation components of the study |
| Enhanced Counseling/Modified Directly Observed Therapy | Experimental | Participants receive their ART medications delivered to them by study staff and they receive the enhanced counseling Receives: Behavioral: Motivational interviewing with cognitive behavioral therapy; Behavioral: Modified directly observed therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence with ART as measured by Micro-Electro-Mechanical Systems (MEMS)
Measured: Measured at Week 48
Secondary outcomes (1)
HIV RNA suppression
Measured: Measured at Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startDec 2004
- Primary completionAug 2009
- Study completionAug 2009
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 HIV InfectionsStudies 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
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Kathy Goggin, PhD, Principal investigator, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602758
- Sponsor's protocol ID
- R01MH068197
- Other IDs
- R01MH068197, PA 01 0173, DAHBR 9A-ASGA
- Status last verified
- May 2016
- First submitted
- 4 Jan 2008
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Goggin K, Liston RJ, Mitty JA. Modified directly observed therapy for antiretroviral therapy: a primer from the field. Public Health Rep. 2007 Jul-Aug;122(4):472-81. doi: 10.1177/003335490712200408.
PubMed 17639650
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ART Adherence: Enhanced Counseling and Observed Therapy
- ClinicalTrials.gov ID
- NCT00602758
- Acronym / sponsor ID
- R01MH068197
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome
- Keywords
- AIDS, Adherence, Antiretroviral Therapy, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2004
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 28 Jan 2008 (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.
This study will compare the effectiveness of enhanced counseling alone versus enhanced counseling combined with observed therapy at improving medication adherence in people with HIV.
Detailed description
HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. HIV is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. Antiretroviral therapy (ART) has proven to be an effective treatment for inhibiting the replication of HIV, allowing for improved quality of life and survival. However, the long-term effectiveness of ART depends on strict adherence to a prescribed medication regimen. Previous studies have indicated that observing patients while they take their medications for a period of time can improve adherence to their prescribed drug regimens. This study will evaluate the effectiveness of enhanced counseling (EC) alone versus EC combined with modified directly observed therapy (mDOT) at improving medication adherence in people with HIV.
Participants in this 48-week study will be randomly placed into one of the following three treatment groups:
- Group 1 participants will receive standard care, which will involve the care that the clinic staff normally provide to all patients on HIV therapy.
- Group 2 participants will receive EC.
- Group 3 participants will receive EC with mDOT.
All participants will continue to take the anti-HIV medication regimen prescribed by their health care provider. However, participants will be asked to keep one medication type in a bottle that has a special Micro-Electro-Mechanical System (MEMS) cap. This electronic cap will record each time the participant opens the bottle. Participants will meet with study staff for MEMS cap data collection once weekly for the first 4 weeks, every 2 weeks up to Week 12, and then every 4 weeks thereafter.
EC will consist of 30- to 45-minute counseling sessions about medication adherence. Participants will meet in person with a counselor for the first five sessions, occurring at baseline and Weeks, 1, 2, 6, and 11. An additional five counseling sessions will be conducted by phone during Weeks 4, 9, 15, 19, and 23. Participants receiving mDOT will have their doses of HIV medication delivered to them by an mDOT worker for the first 24 weeks of treatment. Participants will select a time and location to meet with an mDOT staff member, who will then provide the daily doses of drugs and observe participants taking those drugs. Participants will meet with an mDOT worker 5 times a week from baseline to Week 16. Starting at Week 17, the number of weekly meetings will gradually taper until Week 24 when there will be no meeting and participants will return to obtaining and taking their HIV medications as done prior to study enrollment.
Evaluation visits will occur for all participants at baseline and Weeks 12, 24, 36, and 48. Evaluation sessions will last 45 minutes to 1 hour and will include questionnaires about adherence, knowledge and attitudes about HIV and HIV therapy, quality of life, support systems, health status, medical history, drug and alcohol use, and satisfaction with HIV care. Blood samples will also be taken to measure CD4 cell count and amount of virus in the blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enhanced Counseling | Experimental | Behavioral: Motivational interviewing with cognitive behavioral therapyParticipants meet with a counselor trained in motivational interviewing and cognitive behavioral techniques |
| Standard Care | No intervention | –Participants receive usual clinical care provided by health care providers and they participate only in evaluation components of the study |
| Enhanced Counseling/Modified Directly Observed Therapy | Experimental | Behavioral: Motivational interviewing with cognitive behavioral therapy, Behavioral: Modified directly observed therapyParticipants receive their ART medications delivered to them by study staff and they receive the enhanced counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient at participating clinical site
- English-speaking
- Initiating new ART (new or change in therapy) or nonadherent to ART as documented by care provider's assessment, patient self-report, and consistent HIV RNA laboratory results
- Lives within 45-mile radius of participating clinical site or able to participate in observed therapy procedures
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| Motivational interviewing with cognitive behavioral therapyAlso: Enhanced counseling (EC)Counseling sessions are completed face-to-face or by telephone at baseline and Weeks 1, 2, 4, 6, 9, 11, 15, 19, and 23. Counselors are trained in motivational interview technique and focus on ART medication adherence. | Behavioural | Enhanced Counseling, Enhanced Counseling/Modified Directly Observed Therapy |
| Modified directly observed therapyAlso: OT, Modified observed therapy (MDOT)From baseline to Week 16, Monday through Friday, study staff meet the participants daily to observe one dose of their ART and to leave with the participants all other doses needed until the next observed dose. The frequency of observed doses begins to taper at Week 17 through to Week 24. | Behavioural | Enhanced Counseling/Modified Directly Observed Therapy |
Primary outcome
Adherence with ART as measured by Micro-Electro-Mechanical Systems (MEMS)
Time frame: Measured at Week 48
1 secondary outcome
HIV RNA suppression
Time frame: Measured at Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Background: PubMed 17639650Goggin K, Liston RJ, Mitty JA. Modified directly observed therapy for antiretroviral therapy: a primer from the field. Public Health Rep. 2007 Jul-Aug;122(4):472-81. doi: 10.1177/003335490712200408.
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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.
Kathy Goggin, PhD principal investigator
University of Missouri, Kansas City
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing with cognitive behavioral therapy and Modified directly observed therapy in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by University of Missouri, Kansas City at 4 sites 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 4 inclusion and 1 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 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Adherence with ART as measured by Micro-Electro-Mechanical Systems (MEMS) (time frame: Measured at Week 48). 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 NCT00602758, 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 20 May 2016.