Trial record 16 of 34 for:    " August 10, 2011":" September 09, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Collaborators:
University of Malawi College of Medicine
London School of Hygiene and Tropical Medicine
Ministry of Health and Population, Malawi
Information provided by (Responsible Party):
Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01414413
First received: August 10, 2011
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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 Intervention
HIV
Other: Home assessment and initiation of ART
Other: Clinic-based ART assessment and initiation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Home Assessment and Initiation of ART: a Cluster-randomised Trial in Blantyre, Malawi

Resource links provided by NLM:


Further study details as provided by Liverpool School of Tropical Medicine:

Primary Outcome Measures:
  • ART Initiation [ Time Frame: First six months following introduction of home-based HIV testing ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Uptake of Home-based HIV Testing [ Time Frame: The first 6-months following home assessment and initiation of ART being made available ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Enrollment: 16660
Study Start Date: January 2012
Study Completion Date: April 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414413

Locations
Malawi
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Blantyre, Chichiri, Malawi, 3
Sponsors and Collaborators
Liverpool School of Tropical Medicine
University of Malawi College of Medicine
London School of Hygiene and Tropical Medicine
Ministry of Health and Population, Malawi
Investigators
Principal Investigator: Peter MacPherson, MBChCB MPH Liverpool School of Tropical Medicine
  More Information

Additional Information:
No publications provided by Liverpool School of Tropical Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier: NCT01414413     History of Changes
Other Study ID Numbers: MLW-089673, WT089673/B/09/Z
Study First Received: August 10, 2011
Results First Received: February 19, 2014
Last Updated: February 19, 2014
Health Authority: Malawi: College of Medicine Research and Ethics Committee

Keywords provided by Liverpool School of Tropical Medicine:
HIV
AIDS
Antiretroviral therapy
Community-based study
Cluster-randomised trial
HIV testing
Africa

ClinicalTrials.gov processed this record on July 26, 2014