Home Assessment and Initiation of Antiretroviral Therapy for HIV in Malawi

NCT01414413 | Completed Results

• 2 other identifiers: MLW-089673WT089673/B/09/Z
• Study Type: interventional
• Target: 16,660
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV

Keywords

HIV; AIDS; Antiretroviral therapy; Community-based study; Cluster-randomised trial; HIV testing; Africa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Uptake of Home-based HIV Testing

  The first 6-months following home assessment and initiation of ART being made available

• Reporting of HIV-positive Results

  The first 6-months following availability of home-based HIV testing

• Loss to Retention

  The first 6-months following availability of home-based HIV testing

• Adherence to ART

  First 6-months following availability of home-based HIV testing

• Adult Mortality

  The first 6-months following availability of home-based HIV testing

Study Arms (2)

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.

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.

Other: Clinic-based ART assessment and initiation

Interventions

Home assessment and initiation of ART OTHER

Home-based ART eligibility assessment (WHO staging, CD4 count measurement and educational treatment preparation) and initiation.

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.

Clinic-based ART assessment and initiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead
• Kamuzu University of Health Sciences: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• Ministry of Health and Population, Malawi: collaborator

Study Sites (1)

Malawi-Liverpool-Wellcome Trust Clinical Research Programme

Blantyre, Chichiri, 3, Malawi

Location

Related Publications (1)

• 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.

  PMID: 25038356 DERIVED

Related Links

• Liverpool School of Tropical Medicine
• Wellcome Trust

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr Peter MacPherson
• Organization: Liverpool School of Tropical Medicine

p.macpherson@liv.ac.uk

0044151 705 3100

Study Officials

• Peter MacPherson, MBChCB MPH

  Liverpool School of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 11, 2011
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: April 1, 2013
• Last Updated: April 7, 2014
• Results First Posted: April 7, 2014

Record last verified: 2014-02

Locations

MA (1)