HIV InfectionsNCT00273780
Highly Active Antiretroviral Therapy (HAART) Adherence Interventions
A study testing Adherence counseling and Alarm device in people with HIV Infections, run by University of Washington at 1 site in Kenya.
Trial summary
This study proposes a 4-armed factorial randomized clinical trial in Nairobi, Kenya to determine the effect of cognitive and behavioral interventions on HAART adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Adherence counseling and Alarm device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteKenya
- Study dates
- May 2006to Sep 2008
- 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
- Individuals must qualify for HAART treatment by World Health Organization (WHO) criteria (Clinical Stage IV disease) and/or CD4 count of less than 200 and plan to start HAART therapy.
- Must be above 18 years of age
- Must be HAART treatment-naïve
- Must agree to home visits, and plan to live in Kenya for at least two years.
Who cannot join
- Individuals who are mentally incompetent or are pregnant are excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HAART Adherence Interventions in Africa: An RCT
This study proposes a 4-armed factorial randomized clinical trial in Nairobi, Kenya to determine the effect of cognitive and behavioral interventions on HAART adherence.
Read the detailed description
The study will be a prospective randomized clinical control trial among HIV-1 seropositive adult participants beginning HAART (highly active antiretroviral therapy) for the first time. Patients who are eligible to be initiated on HAART at the UW/Coptic Hope Center for Infectious Diseases will be referred for enrollment. Eligible patients who are referred will learn about the study and be invited to enroll after signing a written informed consent.
Study participants will be randomized to one of four arms:educational counseling, a pocket alarm device, both education and alarm, or neither. Participants will be followed in the study for 1 ½ years after enrollment and randomization. Participants will return to clinic every month to pick up a renewal of their antiretroviral prescriptions at which time pill counts will be performed. During follow-up visits, blood will be drawn and stored for CD4 counts and HIV-1 viral analyses.
Within this trial, the study also proposes to identify sociodemographic and spatial correlates of adherence. The study hypothesizes that educational counseling and medication alarm devices may significantly improve adherence, and that poor adherence may be associated with low socioeconomic standing, increased mobility, and distance from clinic.
- Conditions
- HIV Infections
- Being tested
- Adherence counseling, Alarm device
- Keywords
- Patient compliance
- Medical subject headings
- HIV Infections, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence counselingBehavioural
Three adherence counseling sessions will be given to participants in the trial. Two sessions will occur prior to initiation of antiretroviral medications and one session will be given one month after drug administration.
Alarm deviceDevice
Also called ALRT Med Reminder PC200
This pocket alarm device will be set to ring at designated times during the day that the participant should take their antiretroviral medication.
| Study group | Role | What they receive |
|---|---|---|
| Adherence counseling | Active comparator | Not described Receives: Behavioral: Adherence counseling |
| Alarm device | Active comparator | Not described Receives: Device: Alarm device |
| Counseling and alarm | Active comparator | Participants in this arm will receive both education counseling and a pocket alarm device. Receives: Behavioral: Adherence counseling; Device: Alarm device |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pill count
Measured: 18 months
Secondary outcomes (2)
CD4 count
Measured: 18 months
HIV-1 viral load
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startMay 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael H Chung, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273780
- Sponsor's protocol ID
- 29936-G
- Other IDs
- 1K23AI065222-01, 5K23AI065222-02
- Status last verified
- Aug 2012
- First submitted
- 5 Jan 2006
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marson KG, Tapia K, Kohler P, McGrath CJ, John-Stewart GC, Richardson BA, Njoroge JW, Kiarie JN, Sakr SR, Chung MH. Male, mobile, and moneyed: loss to follow-up vs. transfer of care in an urban African antiretroviral treatment clinic. PLoS One. 2013 Oct 24;8(10):e78900. doi: 10.1371/journal.pone.0078900. eCollection 2013.
PubMed 24205345Chung MH, Richardson BA, Tapia K, Benki-Nugent S, Kiarie JN, Simoni JM, Overbaugh J, Attwa M, John-Stewart GC. A randomized controlled trial comparing the effects of counseling and alarm device on HAART adherence and virologic outcomes. PLoS Med. 2011 Mar;8(3):e1000422. doi: 10.1371/journal.pmed.1000422. Epub 2011 Mar 1.
PubMed 21390262
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAART Adherence Interventions in Africa: An RCT
- ClinicalTrials.gov ID
- NCT00273780
- Acronym / sponsor ID
- 29936-G
- Conditions
- HIV Infections
- Keywords
- Patient compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- May 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 9 Jan 2006 (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 proposes a 4-armed factorial randomized clinical trial in Nairobi, Kenya to determine the effect of cognitive and behavioral interventions on HAART adherence.
Detailed description
The study will be a prospective randomized clinical control trial among HIV-1 seropositive adult participants beginning HAART (highly active antiretroviral therapy) for the first time. Patients who are eligible to be initiated on HAART at the UW/Coptic Hope Center for Infectious Diseases will be referred for enrollment. Eligible patients who are referred will learn about the study and be invited to enroll after signing a written informed consent.
Study participants will be randomized to one of four arms:educational counseling, a pocket alarm device, both education and alarm, or neither. Participants will be followed in the study for 1 ½ years after enrollment and randomization. Participants will return to clinic every month to pick up a renewal of their antiretroviral prescriptions at which time pill counts will be performed. During follow-up visits, blood will be drawn and stored for CD4 counts and HIV-1 viral analyses.
Within this trial, the study also proposes to identify sociodemographic and spatial correlates of adherence. The study hypothesizes that educational counseling and medication alarm devices may significantly improve adherence, and that poor adherence may be associated with low socioeconomic standing, increased mobility, and distance from clinic.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adherence counseling | Active comparator | Behavioral: Adherence counseling |
| Alarm device | Active comparator | Device: Alarm device |
| Counseling and alarm | Active comparator | Behavioral: Adherence counseling, Device: Alarm deviceParticipants in this arm will receive both education counseling and a pocket alarm device. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals must qualify for HAART treatment by World Health Organization (WHO) criteria (Clinical Stage IV disease) and/or CD4 count of less than 200 and plan to start HAART therapy.
- Must be above 18 years of age
- Must be HAART treatment-naïve
- Must agree to home visits, and plan to live in Kenya for at least two years.
Key exclusion criteria (1 listed)
- Individuals who are mentally incompetent or are pregnant are excluded from the study.
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 |
|---|---|---|
| Adherence counselingThree adherence counseling sessions will be given to participants in the trial. Two sessions will occur prior to initiation of antiretroviral medications and one session will be given one month after drug administration. | Behavioural | Adherence counseling, Counseling and alarm |
| Alarm deviceAlso: ALRT Med Reminder PC200This pocket alarm device will be set to ring at designated times during the day that the participant should take their antiretroviral medication. | Device | Alarm device, Counseling and alarm |
Primary outcome
Pill count
Time frame: 18 months
2 secondary outcomes
CD4 count
Time frame: 18 months
HIV-1 viral load
Time frame: 18 months
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 27 Aug 2012.
- Derived from this study: PubMed 24205345Marson KG, Tapia K, Kohler P, McGrath CJ, John-Stewart GC, Richardson BA, Njoroge JW, Kiarie JN, Sakr SR, Chung MH. Male, mobile, and moneyed: loss to follow-up vs. transfer of care in an urban African antiretroviral treatment clinic. PLoS One. 2013 Oct 24;8(10):e78900. doi: 10.1371/journal.pone.0078900. eCollection 2013.
- Derived from this study: PubMed 21390262Chung MH, Richardson BA, Tapia K, Benki-Nugent S, Kiarie JN, Simoni JM, Overbaugh J, Attwa M, John-Stewart GC. A randomized controlled trial comparing the effects of counseling and alarm device on HAART adherence and virologic outcomes. PLoS Med. 2011 Mar;8(3):e1000422. doi: 10.1371/journal.pmed.1000422. Epub 2011 Mar 1.
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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.
Michael H Chung, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adherence counseling and Alarm device in people with HIV Infections, run by University of Washington at 1 site in Kenya.
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 27 Aug 2012. 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 Kenya. 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?
Pill count (time frame: 18 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 NCT00273780, which also lists 2 linked publications.
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 27 Aug 2012.