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HIV Self-Testing Africa (STAR) Malawi: General Population (STAR Malawi)

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ClinicalTrials.gov Identifier: NCT02718274
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : May 14, 2018
Sponsor:
Collaborators:
UNITAID
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Liverpool School of Tropical Medicine
University College, London
Population Services International
World Health Organization
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:
The aim of this project is to investigate the feasibility, affordability as well as the health and social impact of introducing HIV self-testing to rural communities through existing community-based volunteer services.

Condition or disease Intervention/treatment Phase
HIV Device: OraQuick ADVANCE HIV I/II test kits, packaged for self-use (manufactured in Thailand) Other: Home-based initiation of ARVs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: HIV Self-testing Africa (STAR) Malawi: General Population - A Cluster Randomized Trial of Providing HIV and Self-testing Kits Through Community-based Distribution Agents
Study Start Date : April 2016
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Control
Standard of care.
Active Comparator: Self-testing
Community-Based Distribution Agents (CBDAs) in the HIV Self-Testing (HIVST) Arm villages will be trained to provide HIVST services as well as reproductive health services.
Device: OraQuick ADVANCE HIV I/II test kits, packaged for self-use (manufactured in Thailand)
Community based distribution of self-tests

Active Comparator: Self-testing + home HIV care home initiation
CBDAs will be trained to provide HIV Self-Testing plus offer home assessment and HIV care initiation (first assessment and first 14 days of HIV care medications), with this additional intervention aimed at facilitating linkage into care.
Device: OraQuick ADVANCE HIV I/II test kits, packaged for self-use (manufactured in Thailand)
Community based distribution of self-tests

Other: Home-based initiation of ARVs
Home-based initiation of ARVs by study nurse linked to follow-up at clinic




Primary Outcome Measures :
  1. Comparison between randomisation arms in coverage of recent (within the last 12 months) HIV testing among adult (16 years and above) village residents 12 months after the initiation of the intervention, measured by self-report through a household survey [ Time Frame: 13 months ]
  2. Comparison between randomisation arms of number of adult (16 yrs or older) village residents disclosing a positive results to the CBDA during months 1 to 12 of intervention, with a confidential post-test log book used to capture these data [ Time Frame: 13 months ]

Secondary Outcome Measures :
  1. Comparison between randomisation arms of ART initiation rates for adult (16 yrs or older) cluster residents, during months 1 to 12 of intervention, measured using clinic data extraction [ Time Frame: 13 months ]
  2. Comparison between randomisation arms of ART initiation rates for adult (16 yrs or older) village residents during months 1 to 12 of intervention, with ART clinic records used for this assessment [ Time Frame: 13 months ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 16 years or above
  • Usual residence within a study PHC catchment area
  • Able and willing to provide oral consent to HTC

Exclusion Criteria:

  • Age 15 years or below
  • Usual residence outside of the intervention cluster

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718274


Locations
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Malawi
Blantyre, Malawi
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
UNITAID
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Liverpool School of Tropical Medicine
University College, London
Population Services International
World Health Organization
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02718274    
Other Study ID Numbers: 10566
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by London School of Hygiene and Tropical Medicine:
HIV self-testing
Malawi
HIV