HIV InfectionsNCT00119093
Home-based AIDS Care Project
A study testing Laboratory and clinical monitoring regimens in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in Uganda.
Trial summary
The Home-based AIDS care program pilot project delivers and monitors antiretroviral (ARV) and tuberculosis (TB) medications at the homes of 1,000 people with HIV living in a rural area of Uganda. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Laboratory and clinical monitoring regimens
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUganda
- Study dates
- May 2003to Mar 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV infection
- CD4 cell count <250 or symptomatic AIDS
- Age >13 years
- Karnofsky score >40%
- AST or ALT < 5 times normal values
- Creatinine clearance >25 ml/min
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-based AIDS Care Project, Tororo, Uganda
The Home-based AIDS care program pilot project delivers and monitors antiretroviral (ARV) and tuberculosis (TB) medications at the homes of 1,000 people with HIV living in a rural area of Uganda. This study is evaluating how well this program reduces illness and prolongs the life of participants, changes sexual behavior, influences levels of adherence to medication, affects aspects of perceived stigma by participants and their communities, and other operational components of the program including cost-effectiveness. This study is evaluating the hypothesis that frequent home visits by a trained lay person with a standard questionnaire is equivalent in terms of health outcomes to frequent viral load and CD4 cell count measurements.
Read the detailed description
In Uganda, the high cost and complexity of administering antiretroviral therapy is an obstacle to full implementation country-wide. The Home-based AIDS care program (HBAC) pilot project was designed to deliver and monitor ARV and tuberculosis (TB) medications at the homes of 1,000 people with HIV living in a rural area of Uganda. In addition, the cost and complexity of frequent laboratory monitoring of viral load and CD4 cell counts is a major impediment to widespread use of ARV therapies in Uganda and other resource-limited settings. Nested within the Home-Based AIDS Care (HBAC) project, is a randomized study of strategies for monitoring ARV therapy that involves 3 arms: 1) Quarterly CD4 cell counts, viral loads and home visits by trained lay persons; 2) Quarterly CD4 cell counts and home visits; and 3) Home visits alone.
- Conditions
- HIV Infections
- Being tested
- Laboratory and clinical monitoring regimens
- Keywords
- Antiretroviral therapy, HIV, Adherence, Viral Load, Opportunistic illness
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory and clinical monitoring regimensProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalence of 3 different monitoring regimens for ART
Secondary outcomes (7)
Sexual risk behavior
medication adherence
quality of life
depression
cost-effectiveness
viral load
CD4 cell count
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2005 (estimated)
- Study startMay 2003
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Terminated by IRB for non-compliance with human subject regulations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- The AIDS Support Organization, Ministry of Health, Uganda
- Responsible party
- Sponsor
- Investigators
- Rebecca E Bunnell, ScD, MEd, Principal investigator, Centers for Disease Control and PreventionJonathan H Mermin, MD, MPH, Principal investigator, Centers for Disease Control and PreventionAlex Coutinho, MBChB, MPH, Principal investigator, The AIDS Support OrganizationDavid Moore, MD, Principal investigator, CDC-Uganda and University of British ColumbiaJordan Tappero, MD, MPH, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119093
- Sponsor's protocol ID
- CDC-NCHSTP-3666
- Status last verified
- Sep 2012
- First submitted
- 8 Jul 2005
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ekwaru JP, Campbell J, Malamba S, Moore DM, Were W, Mermin J. The effect of opportunistic illness on HIV RNA viral load and CD4+ T cell count among HIV-positive adults taking antiretroviral therapy. J Int AIDS Soc. 2013 Apr 1;16(1):17355. doi: 10.7448/IAS.16.1.17355.
PubMed 23547778Campbell JD, Moore D, Degerman R, Kaharuza F, Were W, Muramuzi E, Odongo G, Wetaka M, Mermin J, Tappero JW. HIV-infected ugandan adults taking antiretroviral therapy with CD4 counts >200 cells/muL who discontinue cotrimoxazole prophylaxis have increased risk of malaria and diarrhea. Clin Infect Dis. 2012 Apr;54(8):1204-11. doi: 10.1093/cid/cis013. Epub 2012 Mar 14.
PubMed 22423133Mermin J, Ekwaru JP, Were W, Degerman R, Bunnell R, Kaharuza F, Downing R, Coutinho A, Solberg P, Alexander LN, Tappero J, Campbell J, Moore DM. Utility of routine viral load, CD4 cell count, and clinical monitoring among adults with HIV receiving antiretroviral therapy in Uganda: randomised trial. BMJ. 2011 Nov 9;343:d6792. doi: 10.1136/bmj.d6792.
PubMed 22074711Weidle PJ, Moore D, Mermin J, Buchacz K, Were W, Downing R, Kigozi A, Ndazima V, Peters P, Brooks JT. Liver enzymes improve over twenty-four months of first-line non-nucleoside reverse transcriptase inhibitor-based therapy in rural Uganda. AIDS Patient Care STDS. 2008 Oct;22(10):787-95. doi: 10.1089/apc.2008.0020.
PubMed 18778241
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based AIDS Care Project, Tororo, Uganda
- ClinicalTrials.gov ID
- NCT00119093
- Acronym / sponsor ID
- CDC-NCHSTP-3666
- Conditions
- HIV Infections
- Keywords
- Antiretroviral therapy, HIV, Adherence, Viral Load, Opportunistic illness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by IRB for non-compliance with human subject regulations.
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- The AIDS Support Organization, Ministry of Health, Uganda
- Study start
- May 2003
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 13 Jul 2005 (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.
The Home-based AIDS care program pilot project delivers and monitors antiretroviral (ARV) and tuberculosis (TB) medications at the homes of 1,000 people with HIV living in a rural area of Uganda. This study is evaluating how well this program reduces illness and prolongs the life of participants, changes sexual behavior, influences levels of adherence to medication, affects aspects of perceived stigma by participants and their communities, and other operational components of the program including cost-effectiveness. This study is evaluating the hypothesis that frequent home visits by a trained lay person with a standard questionnaire is equivalent in terms of health outcomes to frequent viral load and CD4 cell count measurements.
Detailed description
In Uganda, the high cost and complexity of administering antiretroviral therapy is an obstacle to full implementation country-wide. The Home-based AIDS care program (HBAC) pilot project was designed to deliver and monitor ARV and tuberculosis (TB) medications at the homes of 1,000 people with HIV living in a rural area of Uganda. In addition, the cost and complexity of frequent laboratory monitoring of viral load and CD4 cell counts is a major impediment to widespread use of ARV therapies in Uganda and other resource-limited settings. Nested within the Home-Based AIDS Care (HBAC) project, is a randomized study of strategies for monitoring ARV therapy that involves 3 arms: 1) Quarterly CD4 cell counts, viral loads and home visits by trained lay persons; 2) Quarterly CD4 cell counts and home visits; and 3) Home visits alone.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- HIV infection
- CD4 cell count <250 or symptomatic AIDS
- Age >13 years
- Karnofsky score >40%
- AST or ALT < 5 times normal values
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Laboratory and clinical monitoring regimens | Procedure or surgery | – |
Primary outcome
Equivalence of 3 different monitoring regimens for ART
7 secondary outcomes
Sexual risk behavior
medication adherence
quality of life
depression
cost-effectiveness
viral load
CD4 cell count
Results and safety
The study was stopped early (reason given: Terminated by IRB for non-compliance with human subject regulations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
- Derived from this study: PubMed 23547778Ekwaru JP, Campbell J, Malamba S, Moore DM, Were W, Mermin J. The effect of opportunistic illness on HIV RNA viral load and CD4+ T cell count among HIV-positive adults taking antiretroviral therapy. J Int AIDS Soc. 2013 Apr 1;16(1):17355. doi: 10.7448/IAS.16.1.17355.
- Derived from this study: PubMed 22423133Campbell JD, Moore D, Degerman R, Kaharuza F, Were W, Muramuzi E, Odongo G, Wetaka M, Mermin J, Tappero JW. HIV-infected ugandan adults taking antiretroviral therapy with CD4 counts >200 cells/muL who discontinue cotrimoxazole prophylaxis have increased risk of malaria and diarrhea. Clin Infect Dis. 2012 Apr;54(8):1204-11. doi: 10.1093/cid/cis013. Epub 2012 Mar 14.
- Derived from this study: PubMed 22074711Mermin J, Ekwaru JP, Were W, Degerman R, Bunnell R, Kaharuza F, Downing R, Coutinho A, Solberg P, Alexander LN, Tappero J, Campbell J, Moore DM. Utility of routine viral load, CD4 cell count, and clinical monitoring among adults with HIV receiving antiretroviral therapy in Uganda: randomised trial. BMJ. 2011 Nov 9;343:d6792. doi: 10.1136/bmj.d6792.
- Derived from this study: PubMed 18778241Weidle PJ, Moore D, Mermin J, Buchacz K, Were W, Downing R, Kigozi A, Ndazima V, Peters P, Brooks JT. Liver enzymes improve over twenty-four months of first-line non-nucleoside reverse transcriptase inhibitor-based therapy in rural Uganda. AIDS Patient Care STDS. 2008 Oct;22(10):787-95. doi: 10.1089/apc.2008.0020.
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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.
Rebecca E Bunnell, ScD, MEd principal investigator
Centers for Disease Control and Prevention
Jonathan H Mermin, MD, MPH principal investigator
Centers for Disease Control and Prevention
Alex Coutinho, MBChB, MPH principal investigator
The AIDS Support Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory and clinical monitoring regimens in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in Uganda.
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 6 inclusion and 0 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: stopped early, as of the sponsor's last update on 11 Sep 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 Uganda. 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 was stopped early (reason given: Terminated by IRB for non-compliance with human subject regulations.). 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?
Equivalence of 3 different monitoring regimens for ART. 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 NCT00119093, which also lists 4 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 11 Sep 2012.