Home Assessment and Initiation of Antiretroviral Therapy for HIV in Malawi (CONDA-YAPA)
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|ClinicalTrials.gov Identifier: NCT01414413|
Recruitment Status : Completed
First Posted : August 11, 2011
Results First Posted : April 7, 2014
Last Update Posted : April 7, 2014
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 or disease||Intervention/treatment||Phase|
|HIV||Other: Home assessment and initiation of ART Other: Clinic-based ART assessment and initiation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16660 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Home Assessment and Initiation of ART: a Cluster-randomised Trial in Blantyre, Malawi|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||April 2013|
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.
- 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.
- Uptake of Home-based HIV Testing [ Time Frame: The first 6-months following home assessment and initiation of ART being made available ]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.
- Reporting of HIV-positive Results [ Time Frame: The first 6-months following availability of home-based HIV testing ]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
- Loss to Retention [ Time Frame: The first 6-months following availability of home-based HIV testing ]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
- Adherence to ART [ Time Frame: First 6-months following availability of home-based HIV testing ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414413
|Malawi-Liverpool-Wellcome Trust Clinical Research Programme|
|Blantyre, Chichiri, Malawi, 3|
|Principal Investigator:||Peter MacPherson, MBChCB MPH||Liverpool School of Tropical Medicine|