HIV InfectionsPhase 2NCT00076804
Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
A Phase 2 study testing Directly Observed Therapy in people with HIV Infections, run by Johns Hopkins University at 1 site in South Africa.
Trial summary
Three or more anti-HIV drugs are taken in combination as part of a treatment regimen. These drug regimens must be closely followed in order to be successful. Having a support person watch a patient take his or her anti-HIV drugs each day may help a patient follow his or her regimen. 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?
- Directly Observed Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteSouth Africa
- Study dates
- Feb 2005to Sep 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- HIV infected
- Viral load greater than 1000 copies/ml
- CD4 count of 200 cells/mm3 or less, or World Health Organization Stage 4 disease
- Living in the area of the study site
- Had a known address for more than 3 months
- Willing to nominate a treatment supervisor (a close family member, sexual partner, friend, or community volunteer) to observe daily ingestion of tablets
- Willing to disclose HIV status to a treatment supervisor and ready to commit to long-term antiretroviral therapy
- Acceptable methods of contraception
Who cannot join
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DOT-HAART for HIV-Infected South African Adults
Three or more anti-HIV drugs are taken in combination as part of a treatment regimen. These drug regimens must be closely followed in order to be successful. Having a support person watch a patient take his or her anti-HIV drugs each day may help a patient follow his or her regimen. This study will see if patient-chosen treatment supporters help patients take HIV medicines correctly and improve their health.
Study hypothesis: The mean change in CD4 count at 12 and 24 months will be significantly higher in the directly observed therapy-highly active antiretroviral therapy (DOT-HAART) arm as compared to the self-administered arm.
Read the detailed description
South Africa has one of the worst and fastest growing HIV epidemics in the world. Highly active antiretroviral therapy (HAART) has been shown both at the individual and public health levels to reduce morbidity, mortality, and vertical and possibly horizontal HIV transmission. However, expenses, feasibility, long-term adherence, and effective delivery of HAART remain formidable barriers, particularly in developing nations. Recently, international initiatives have provided hope for widespread use of HAART at affordable cost in sub-Saharan Africa. Simplified, once-daily HAART regimens with directly observed therapy (DOT) may help to achieve high levels of treatment adherence, a key component for long-term viral suppression and treatment success. Peer advocates have been used to improve adherence with medical therapies in a variety of settings. This study will evaluate the effectiveness and feasibility of DOT using patient-nominated peer supervisors to improve adherence to HAART in HIV infected adults in South Africa.
Participants will be randomly assigned to either Peer-DOT-HAART or self-administration of a once-daily combination of the Western Cape Province ART program medications for 24 months. Study measures will include CD4 cell count and HIV viral load, adherence questionnaires, genotypic HAART resistance testing, and incidence of new or recurrent opportunistic infections.
- Conditions
- HIV Infections
- Being tested
- Directly Observed Therapy
- Keywords
- Directly Observed Therapy, DOT
- Medical subject headings
- HIV Infections, Directly Observed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Directly Observed TherapyBehavioural
Use of a patient nominated peer supporter who will observe the morning dose of ARVs
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Use of a patient nominated peer supporter who will observe the morning dose of ARVs Receives: Behavioral: Directly Observed Therapy |
| 2 | No intervention | Self administration of ARVs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment
Proportion of Patients with HIV RNA Levels of <400 at 12 Months - Intention-to-treat
Measured: at 12 and 24 months of treatment
Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment
Proportion of Patients with HIV RNA Levels of <400 Copies/mL at 24 Months [Intention-to-treat (ITT)
Measured: 24 months
Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm
Measured: 12 months
Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2004 (estimated)
- Study startFeb 2005
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: DSMB stopped trial for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 Johns Hopkins UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town
- Responsible party
- Principal investigator, Dr. Richard Chaisson, Johns Hopkins University
- Investigators
- Richard E Chaisson, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076804
- Sponsor's protocol ID
- 1R01AI055359-01A1
- Other IDs
- 1R01AI055359-01A1
- Status last verified
- Mar 2015
- First submitted
- 3 Feb 2004
- Last updated
- 27 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Nachega JB, Chaisson RE, Goliath R, Efron A, Chaudhary MA, Ram M, Morroni C, Schoeman H, Knowlton AR, Maartens G. Randomized controlled trial of trained patient-nominated treatment supporters providing partial directly observed antiretroviral therapy. AIDS. 2010 Jun 1;24(9):1273-80. doi: 10.1097/QAD.0b013e328339e20e.
PubMed 20453627
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOT-HAART for HIV-Infected South African Adults
- ClinicalTrials.gov ID
- NCT00076804
- Acronym / sponsor ID
- 1R01AI055359-01A1
- Conditions
- HIV Infections
- Keywords
- Directly Observed Therapy, DOT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB stopped trial for futility
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Cape Town
- Study start
- Feb 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 6 Feb 2004 (estimated)
- Results
- Posted 2 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Three or more anti-HIV drugs are taken in combination as part of a treatment regimen. These drug regimens must be closely followed in order to be successful. Having a support person watch a patient take his or her anti-HIV drugs each day may help a patient follow his or her regimen. This study will see if patient-chosen treatment supporters help patients take HIV medicines correctly and improve their health.
Study hypothesis: The mean change in CD4 count at 12 and 24 months will be significantly higher in the directly observed therapy-highly active antiretroviral therapy (DOT-HAART) arm as compared to the self-administered arm.
Detailed description
South Africa has one of the worst and fastest growing HIV epidemics in the world. Highly active antiretroviral therapy (HAART) has been shown both at the individual and public health levels to reduce morbidity, mortality, and vertical and possibly horizontal HIV transmission. However, expenses, feasibility, long-term adherence, and effective delivery of HAART remain formidable barriers, particularly in developing nations. Recently, international initiatives have provided hope for widespread use of HAART at affordable cost in sub-Saharan Africa. Simplified, once-daily HAART regimens with directly observed therapy (DOT) may help to achieve high levels of treatment adherence, a key component for long-term viral suppression and treatment success. Peer advocates have been used to improve adherence with medical therapies in a variety of settings. This study will evaluate the effectiveness and feasibility of DOT using patient-nominated peer supervisors to improve adherence to HAART in HIV infected adults in South Africa.
Participants will be randomly assigned to either Peer-DOT-HAART or self-administration of a once-daily combination of the Western Cape Province ART program medications for 24 months. Study measures will include CD4 cell count and HIV viral load, adherence questionnaires, genotypic HAART resistance testing, and incidence of new or recurrent opportunistic infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Directly Observed TherapyUse of a patient nominated peer supporter who will observe the morning dose of ARVs |
| 2 | No intervention | –Self administration of ARVs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HIV infected
- Viral load greater than 1000 copies/ml
- CD4 count of 200 cells/mm3 or less, or World Health Organization Stage 4 disease
- Living in the area of the study site
- Had a known address for more than 3 months
Key exclusion criteria (1 listed)
- Pregnant
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 |
|---|---|---|
| Directly Observed TherapyUse of a patient nominated peer supporter who will observe the morning dose of ARVs | Behavioural | 1 |
Primary outcome
Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment
Time frame: at 12 and 24 months of treatment
Proportion of Patients with HIV RNA Levels of <400 at 12 Months - Intention-to-treat
Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment
Time frame: 24 months
Proportion of Patients with HIV RNA Levels of <400 Copies/mL at 24 Months [Intention-to-treat (ITT)
Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm
Time frame: 12 months
Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20453627Nachega JB, Chaisson RE, Goliath R, Efron A, Chaudhary MA, Ram M, Morroni C, Schoeman H, Knowlton AR, Maartens G. Randomized controlled trial of trained patient-nominated treatment supporters providing partial directly observed antiretroviral therapy. AIDS. 2010 Jun 1;24(9):1273-80. doi: 10.1097/QAD.0b013e328339e20e.
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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.
Richard E Chaisson, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Directly Observed Therapy in people with HIV Infections, run by Johns Hopkins University at 1 site in South Africa.
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 8 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: stopped early, as of the sponsor's last update on 27 Mar 2015. 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 South Africa. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment (time frame: at 12 and 24 months of treatment). The study lists 4 primary outcomes in all. 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 NCT00076804, 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 27 Mar 2015.