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Completed

NCT Number: NCT01414413

Home Assessment and Initiation of Antiretroviral Therapy for HIV in 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malawi-Liverpool-Wellcome Trust Clinical Research Programme

Blantyre, Chichiri, 3, Malawi

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home assessment and initiation of ART

Other

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Liverpool School of Tropical Medicine

Other

Collaborators

  • Kamuzu University of Health Sciences
  • London School of Hygiene and Tropical Medicine
  • Ministry of Health, Malawi

Registry information

Official study title

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

Acronym: CONDA-YAPA

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Aug 11, 2011
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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