Home Assessment and Initiation of Antiretroviral Therapy for HIV in Malawi (CONDA-YAPA)

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Other: Home assessment and initiation of ART; Other: Clinic-based ART assessment and initiation

• Study Type: Interventional
• Enrollment (Actual): 16660
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Chichiri
    • Blantyre, Chichiri, Malawi, 3
      • Malawi-Liverpool-Wellcome Trust Clinical Research Programme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: 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.	Other: Home assessment and initiation of ART; Home-based ART eligibility assessment (WHO staging, CD4 count measurement and educational treatment preparation) and initiation.
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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Liverpool School of Tropical Medicine
• Collaborators: London School of Hygiene and Tropical Medicine; Kamuzu University of Health Sciences; Ministry of Health and Population, Malawi
• Investigators: Principal Investigator: Peter MacPherson, MBChCB MPH, Liverpool School of Tropical Medicine

Publications and helpful links

General 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.

Helpful Links

• Liverpool School of Tropical Medicine
• Wellcome Trust

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: August 10, 2011
• First Submitted That Met QC Criteria: August 10, 2011
• First Posted (Estimate): August 11, 2011

Study Record Updates

• Last Update Posted (Estimate): April 7, 2014
• Last Update Submitted That Met QC Criteria: February 19, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: HIV; AIDS; Africa; Antiretroviral therapy; HIV testing; Community-based study; Cluster-randomised trial
• Other Study ID Numbers: MLW-089673; WT089673/B/09/Z (Other Grant/Funding Number: Wellcome Trust, UK)