HIVCONDA-YAPANCT01414413
Home Assessment and Initiation of Antiretroviral Therapy for HIV in Malawi
A study testing Home assessment and initiation of ART and Clinic-based ART assessment and initiation in people with HIV, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
Trial summary
Despite increasing availability of antiretroviral therapy (ART) for HIV in high prevalence countries, the majority of people with HIV infection still initiate treatment at an advanced stage of disease. This leads to a high risk of death soon after HIV diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Home assessment and initiation of ART and Clinic-based ART assessment and initiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,660 participants
- Where
- 1 siteMalawi
- Study dates
- Jan 2012to Apr 2013
- Phase
- Interventional
- 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
- Usual resident of an eligible cluster
- Has had a positive HIV test (regardless of source) and requests facilitated access to HIV care from the resident community counsellor
- Confirmatory HIV test is positive
- No previous ART treatment, or less than one month's treatment in the past (including PMTCT interventions) and not currently receiving HIV care
- No contraindications to receiving ART (as defined by Integrated Management of Adult Illnesses, HIV Department, WHO)
- No acute danger signs requiring hospital referral
- Aged 18 years or older
- Written or witnessed informed consent to participate in the study
Who cannot join
- Not a usual resident of an eligible cluster
- No previous HIV test, or HIV infection not confirmed by home-based ART nurse
- Already receiving ART, or has had more than 1 month's treatment in the past
- Known contraindication to firstline ART (known hypersensitivity, renal failure, chronic liver disease)
- Acute danger sign present (as defined by Integrated Management of Adult Illnesses, HIV Department, WHO)
- Age younger than 18 years
- Not willing to accept home-based ART initiation
- Suspected or confirmed TB disease will not be an exclusion criteria, but will be an indication for deferral, until completion of the screening algorithm, with initiation of TB treatment if indicated.
Trial locations and contacts
1 site in 1 country.
Malawi1 site
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Blantyre, Chichiri, 3
About this study
Official title: Home Assessment and Initiation of ART: a Cluster-randomised Trial in Blantyre, Malawi
Despite increasing availability of antiretroviral therapy (ART) for HIV in high prevalence countries, the majority of people with HIV infection still initiate treatment at an advanced stage of disease. This leads to a high risk of death soon after HIV diagnosis. Prompt HIV diagnosis is, therefore, necessary for both individual and public health benefit and is being strongly promoted as international and national policy in Malawi. However timely HIV diagnosis may not in itself be sufficient to ensure ART initiation: this is reflected by the relatively high proportion of individuals who defer treatment-seeking for months or years following diagnosis of HIV.
Here the researchers investigate the extent to which home assessment and initiation of ART adds to the effectiveness of a home-based HIV testing and counseling strategy, using entry to, adherence with, and retention in HIV care as the outcome of interest.
- Conditions
- HIV
- Being tested
- Home assessment and initiation of ART, Clinic-based ART assessment and initiation
- Keywords
- HIV, AIDS, Antiretroviral therapy, Community-based study, Cluster-randomised trial, HIV testing, Africa
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home assessment and initiation of ARTOther
Home-based ART eligibility assessment (WHO staging, CD4 count measurement and educational treatment preparation) and initiation.
Clinic-based ART assessment and initiationOther
Participants who meet eligibility criteria and reside in a cluster that has been allocated to the control arm of this study will receive supported access to ART care through the primary care system for confirmation of HIV status and entry into HIV following disclosure to the resident community counsellor.
| Study group | Role | What they receive |
|---|---|---|
| Home assessment and initiation of ART | Experimental | Participants with a positive home-based HIV test result will receive a home visit from a study nurse who will complete the following on the first home visit:
* Confirmatory fingerprick HIV testing
* TB symptom screening
* ART eligibility assessment (Word Health Organization clinical staging, sampling of blood for measurement of CD4 count and treatment education)
At a second home visit (within 5 days), participants who are ART eligible (as defined in National ART guidelines) will be initiated onto ART (using National Treatment Programme ART regimens).
Following home initiation of ART, participants in the intervention arm will receive detailed counselling from the study nurse about the need to attend their first 2-week follow-up appointment at the primary health care clinic that serves their household's residence. They will receive a referral slip detailing the date, time and place of their appointment. Receives: Other: Home assessment and initiation of ART |
| Clinic-based ART assessment and initiation | Other | Participants who meet eligibility criteria and reside in a cluster that has been allocated to the control arm of this study will receive supported access to ART care through the primary care system for confirmation of HIV status and entry into HIV following disclosure to the resident community counsellor. HIV care, including ART, will be started from the primary care clinic. Receives: Other: Clinic-based ART assessment and initiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ART Initiation
Comparison between study arms of the proportion of all resident adults (per capita, and irrespective of HIV status or participation in home-based HIV testing intervention) who initiate ART during the first 6 months of the home-based HIV-testing intervention.
Measured: First six months following introduction of home-based HIV testing
Secondary outcomes (5)
Uptake of Home-based HIV Testing
Comparison between study arms of the proportion of all resident adults who request HIV testing (either as standard HTC or as supervised HIV self-testing) from the resident community counsellor during the first year of the study.
Measured: The first 6-months following home assessment and initiation of ART being made available
Reporting of HIV-positive Results
Comparison of the proportion of all cluster adults confiding HIV-positive results to the resident community counsellor between study arms during the 1-year study period
Measured: The first 6-months following availability of home-based HIV testing
Loss to Retention
Comparison between study arms of the proportion of participants who initiate ART during the first 6-months of the HIV-testing intervention who are lost to retention within 6 months after initiating ART 6-months
Measured: The first 6-months following availability of home-based HIV testing
Adherence to ART
Comparison between study arms of the proportion of HIV-positive participants who are adherent to ART during the 1-year study period
Measured: First 6-months following availability of home-based HIV testing
Adult Mortality
Comparison between study arms of non-traumatic and HIV-related adult (15-49) mortality rates during the first 6 months of the HIV-testing intervention
Measured: The first 6-months following availability of home-based HIV testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startJan 2012
- Primary completionNov 2012
- Study completionApr 2013
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 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16,660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, London School of Hygiene and Tropical Medicine, Ministry of Health, Malawi
- Responsible party
- Sponsor
- Investigators
- Peter MacPherson, MBChCB MPH, Principal investigator, Liverpool School of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414413
- Sponsor's protocol ID
- MLW-089673
- Other IDs
- WT089673/B/09/Z
- Acronym
- CONDA-YAPA
- Status last verified
- Feb 2014
- First submitted
- 10 Aug 2011
- Last updated
- 7 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
MacPherson P, Lalloo DG, Webb EL, Maheswaran H, Choko AT, Makombe SD, Butterworth AE, van Oosterhout JJ, Desmond N, Thindwa D, Squire SB, Hayes RJ, Corbett EL. Effect of optional home initiation of HIV care following HIV self-testing on antiretroviral therapy initiation among adults in Malawi: a randomized clinical trial. JAMA. 2014 Jul 23-30;312(4):372-9. doi: 10.1001/jama.2014.6493.
PubMed 25038356
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Assessment and Initiation of ART: a Cluster-randomised Trial in Blantyre, Malawi
- ClinicalTrials.gov ID
- NCT01414413
- Acronym / sponsor ID
- CONDA-YAPA / MLW-089673
- Conditions
- HIV
- Keywords
- HIV, AIDS, Antiretroviral therapy, Community-based study, Cluster-randomised trial, HIV testing, Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16,660 participants (actual)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, London School of Hygiene and Tropical Medicine, Ministry of Health, Malawi
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Posted 7 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite increasing availability of antiretroviral therapy (ART) for HIV in high prevalence countries, the majority of people with HIV infection still initiate treatment at an advanced stage of disease. This leads to a high risk of death soon after HIV diagnosis. Prompt HIV diagnosis is, therefore, necessary for both individual and public health benefit and is being strongly promoted as international and national policy in Malawi. However timely HIV diagnosis may not in itself be sufficient to ensure ART initiation: this is reflected by the relatively high proportion of individuals who defer treatment-seeking for months or years following diagnosis of HIV.
Here the researchers investigate the extent to which home assessment and initiation of ART adds to the effectiveness of a home-based HIV testing and counseling strategy, using entry to, adherence with, and retention in HIV care as the outcome of interest.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home assessment and initiation of ART | Experimental | Other: Home assessment and initiation of ARTParticipants with a positive home-based HIV test result will receive a home visit from a study nurse who will complete the following on the first home visit: * Confirmatory fingerprick HIV testing * TB symptom screening * ART eligibility assessment (Word Health Organization clinical staging, sampling of blood for measurement of CD4 count and treatment education) At a second home visit (within 5 days), participants who are ART eligible (as defined in National ART guidelines) will be initiated onto ART (using National Treatment Programme ART regimens). Following home initiation of ART, participants in the intervention arm will receive detailed counselling from the study nurse about the need to attend their first 2-week follow-up appointment at the primary health care clinic that serves their household's residence. They will receive a referral slip detailing the date, time and place of their appointment. |
| Clinic-based ART assessment and initiation | Other | Other: Clinic-based ART assessment and initiationParticipants who meet eligibility criteria and reside in a cluster that has been allocated to the control arm of this study will receive supported access to ART care through the primary care system for confirmation of HIV status and entry into HIV following disclosure to the resident community counsellor. HIV care, including ART, will be started from the primary care clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Usual resident of an eligible cluster
- Has had a positive HIV test (regardless of source) and requests facilitated access to HIV care from the resident community counsellor
- Confirmatory HIV test is positive
- No previous ART treatment, or less than one month's treatment in the past (including PMTCT interventions) and not currently receiving HIV care
- No contraindications to receiving ART (as defined by Integrated Management of Adult Illnesses, HIV Department, WHO)
Key exclusion criteria (8 listed)
- Not a usual resident of an eligible cluster
- No previous HIV test, or HIV infection not confirmed by home-based ART nurse
- Already receiving ART, or has had more than 1 month's treatment in the past
- Known contraindication to firstline ART (known hypersensitivity, renal failure, chronic liver disease)
- Acute danger sign present (as defined by Integrated Management of Adult Illnesses, HIV Department, WHO)
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 |
|---|---|---|
| Home assessment and initiation of ARTHome-based ART eligibility assessment (WHO staging, CD4 count measurement and educational treatment preparation) and initiation. | Other | Home assessment and initiation of ART |
| Clinic-based ART assessment and initiationParticipants who meet eligibility criteria and reside in a cluster that has been allocated to the control arm of this study will receive supported access to ART care through the primary care system for confirmation of HIV status and entry into HIV following disclosure to the resident community counsellor. | Other | Clinic-based ART assessment and initiation |
Primary outcome
ART Initiation
Time frame: First six months following introduction of home-based HIV testing
Comparison between study arms of the proportion of all resident adults (per capita, and irrespective of HIV status or participation in home-based HIV testing intervention) who initiate ART during the first 6 months of the home-based HIV-testing intervention.
5 secondary outcomes
Uptake of Home-based HIV Testing
Time frame: The first 6-months following home assessment and initiation of ART being made available
Reporting of HIV-positive Results
Time frame: The first 6-months following availability of home-based HIV testing
Loss to Retention
Time frame: The first 6-months following availability of home-based HIV testing
Adherence to ART
Time frame: First 6-months following availability of home-based HIV testing
Adult Mortality
Time frame: The first 6-months following availability of home-based HIV testing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25038356MacPherson P, Lalloo DG, Webb EL, Maheswaran H, Choko AT, Makombe SD, Butterworth AE, van Oosterhout JJ, Desmond N, Thindwa D, Squire SB, Hayes RJ, Corbett EL. Effect of optional home initiation of HIV care following HIV self-testing on antiretroviral therapy initiation among adults in Malawi: a randomized clinical trial. JAMA. 2014 Jul 23-30;312(4):372-9. doi: 10.1001/jama.2014.6493.
- Wellcome TrustLink provided by the sponsor.
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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.
Peter MacPherson, MBChCB MPH principal investigator
Liverpool School of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home assessment and initiation of ART and Clinic-based ART assessment and initiation in people with HIV, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
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 8 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 7 Apr 2014. 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 Malawi. 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?
Yes. Results are posted in the registry (first posted 7 Apr 2014). 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?
ART Initiation (time frame: First six months following introduction of home-based HIV testing). 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 NCT01414413, 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 7 Apr 2014.