Home Assessment and Initiation of Antiretroviral Therapy for HIV in Malawi (CONDA-YAPA)
This study is currently recruiting participants.
Verified January 2012 by Liverpool School of Tropical Medicine
Sponsor:
Liverpool School of Tropical Medicine
Collaborators:
University of Malawi College of Medicine
London School of Hygiene and Tropical Medicine
Ministry of Health and Population, Malawi
Information provided by (Responsible Party):
Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01414413
First received: August 10, 2011
Last updated: January 31, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV |
Other: Home assessment and initiation of ART Other: Clinic-based ART assessment and initiation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Home Assessment and Initiation of ART: a Cluster-randomised Trial in Blantyre, Malawi |
Resource links provided by NLM:
Further study details as provided by Liverpool School of Tropical Medicine:
Primary Outcome Measures:
- ART initiation [ Time Frame: First six months following introduction of home-based HIV testing ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Uptake of home-based HIV testing [ Time Frame: The first 6-months following home assessment and initiation of ART being made available ] [ Designated as safety issue: No ]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.
- Disclosure of HIV-positive results [ Time Frame: The first 6-months following availability of home-based HIV testing ] [ Designated as safety issue: No ]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
- Retention on ART [ Time Frame: The first 6-months following availability of home-based HIV testing ] [ Designated as safety issue: No ]Comparison between study arms of the proportion of participants who initiate ART during the first 6-months of the HIV-testing intervention who are retained on ART 6-months after initiation
- Adherence to ART [ Time Frame: First 6-months following availability of home-based HIV testing ] [ Designated as safety issue: No ]Comparison between study arms of the proportion of HIV-positive participants who are adherent to ART during the 1-year study period
- Adult mortality [ Time Frame: The first 6-months following availability of home-based HIV testing ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 16800 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Home assessment and initiation of ART
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:
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. |
Other: Home assessment and initiation of ART
Home-based ART eligibility assessment (WHO staging, CD4 count measurement and educational treatment preparation) and initiation.
|
|
Clinic-based ART assessment and initiation
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.
|
Other: Clinic-based ART assessment and initiation
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414413
Contacts
| Contact: Peter MacPherson, MBChB MPH | +265 191 9304 | p.macpherson@liverpool.ac.uk |
Locations
| Malawi | |
| Malawi-Liverpool-Wellcome Trust Clinical Research Programme | Recruiting |
| Blantyre, Chichiri, Malawi, 3 | |
| Contact: Peter MacPherson, MBChB MPH MRes +265 191 9304 p.macpherson@liverpool.ac.uk | |
| Contact: Lucky Ngwira +265 191 9304 lngwira@mlw.medcol.mw | |
| Principal Investigator: Peter MacPherson, MBChB MPH | |
| Sub-Investigator: Elizabeth L Corbett, PhD | |
| Sub-Investigator: David G Lalloo, MD | |
| Sub-Investigator: Joep van Oosterhout | |
| Sub-Investigator: S Bertel Squire | |
| Sub-Investigator: Gillian H Mann, PhD | |
| Sub-Investigator: Edward Manda | |
| Sub-Investigator: Frank Chimbwandira | |
| Sub-Investigator: Simon Makombe | |
| Sub-Investigator: Emily Webb, PhD | |
Sponsors and Collaborators
Liverpool School of Tropical Medicine
University of Malawi College of Medicine
London School of Hygiene and Tropical Medicine
Ministry of Health and Population, Malawi
Investigators
| Principal Investigator: | Peter MacPherson, MBChCB MPH | Liverpool School of Tropical Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Liverpool School of Tropical Medicine |
| ClinicalTrials.gov Identifier: | NCT01414413 History of Changes |
| Other Study ID Numbers: | MLW-089673, WT089673/B/09/Z |
| Study First Received: | August 10, 2011 |
| Last Updated: | January 31, 2012 |
| Health Authority: | Malawi: College of Medicine Research and Ethics Committee |
Keywords provided by Liverpool School of Tropical Medicine:
|
HIV AIDS Antiretroviral therapy Community-based study |
Cluster-randomised trial HIV testing Africa |
ClinicalTrials.gov processed this record on May 23, 2013