Home Assessment and Initiation of Antiretroviral Therapy for HIV in Malawi

HIV Clinical Trial

— CONDA-YAPA  

Official title:

Home Assessment and Initiation of ART: a Cluster-randomised Trial in Blantyre, Malawi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414413
• Other study ID #: MLW-089673
• Secondary ID: WT089673/B/09/Z
• Status: Completed
• Phase: N/A
• First received: August 10, 2011
• Last updated: February 19, 2014
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: February 2014
• Source: Liverpool School of Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16660
• Est. completion date: April 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
Malawi	Malawi-Liverpool-Wellcome Trust Clinical Research Programme	Blantyre	Chichiri

Sponsors (4)

Lead Sponsor	Collaborator
Liverpool School of Tropical Medicine	London School of Hygiene and Tropical Medicine, Ministry of Health and Population, Malawi, University of Malawi College of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	First six months following introduction of home-based HIV testing	No
Secondary	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.	The first 6-months following home assessment and initiation of ART being made available	No
Secondary	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	The first 6-months following availability of home-based HIV testing	No
Secondary	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	The first 6-months following availability of home-based HIV testing	No
Secondary	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	First 6-months following availability of home-based HIV testing	No
Secondary	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	The first 6-months following availability of home-based HIV testing	No

External Links

•   Liverpool School of Tropical Medicine
•   Malawi-Liverpool-Wellcome Trust Clinical Research Programme
•   Wellcome Trust