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Trial record 3 of 110 for:    test | ( Map: Malawi )

A Cluster Randomised Trial of Community-led Distribution of HIV Self-tests in Rural Malawi (HIV Self-Testing Africa [STAR])

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ClinicalTrials.gov Identifier: NCT03541382
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : May 24, 2019
Sponsor:
Collaborators:
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Liverpool School of Tropical Medicine
University College, London
Population Services International
UNITAID
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:
The aim of this study is to determine the benefits, costs and safety of community-led delivery of HIV self-testing (HIVST) kits in rural Malawi, with a focus on testing and linkage to care and prevention services among defined population sub-groups: men, adolescents aged 15-19 years old, and adults aged 40 years or older.

Condition or disease Intervention/treatment Phase
HIV/AIDS Device: OraQuick® HIV Self-Test Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Community-led Distribution of HIV Self-tests: a Cluster Randomised Trial Investigating Uptake of HIV Testing and Linkage to Treatment and Prevention, Costs and Safety in Rural Malawi (HIV Self-Testing Africa [STAR])
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: HIVST campaign arm

Community representatives will be supported to plan and administer an HIVST campaign linked to HIV care and prevention services in their communities.

Clusters in this arm will also undergo a second stage randomisation with the following arms:

  1. Repeat HIVST campaign arm: Approximately one year after the initial campaign, community representatives will be supported to plan and administer a repeat HIVST campaign linked to HIV care and prevention services in their communities.
  2. Single HIVST campaign arm: Standard HTS will be provided by MoH at health facilities following delivery of a single HIVST campaign in year one.
Device: OraQuick® HIV Self-Test

Community leaders, including GVHs, Village Health Committee members, Village Development Committee members, and members of key community groups will participate in a workshop to facilitate planning of a HIVST campaign. Identified community distributors, who are unpaid volunteers from the community, will also receive a training package in HIVST promotion.

Campaigns will be conducted over a short period (approximately seven days) and under a fixed budget. Community distributors will deliver HIVST kits free of charge to community members, and provide information on how to self-test and access the nearest clinic for linkage to confirmatory HTS, treatment and prevention. Distributors will also provide HIV prevention messages around serodiscordancy, treatment as prevention and VMMC.


No Intervention: SOC arm
Standard HTS will be provided by MoH at health facilities.



Primary Outcome Measures :
  1. First randomisation: Percentage of self-reported lifetime testing in adolescents aged 15-19 years old [ Time Frame: Measured 3-months post-intervention ]
  2. Second randomisation: Percentage of self-reported testing in last 12 months adults aged ≥ 15 years [ Time Frame: Measured 15-months post-intervention ]

Secondary Outcome Measures :
  1. First randomisation: Percentage of self-reported testing in last 3 months in men aged ≥ 15 years [ Time Frame: Measured 3-months post-intervention ]
  2. First randomisation: Percentage of self-reported testing in last 3 months in adults aged ≥ 40 years [ Time Frame: Measured 3-months post-intervention ]
  3. First randomisation: Cumulative incidence of population-level ART uptake in adults aged ≥ 15 years over 6 months [ Time Frame: Measured 6-months post-intervention ]
  4. Secondary randomisation: Knowledge of HIV prevention score [ Time Frame: Measured 3 and 15-months post-intervention ]
  5. Second randomisation: HIV testing stigma score [ Time Frame: Measured 3 and 15-months post-intervention ]
  6. First and second randomisation: Costs per individual tested and newly diagnosed as HIV positive [ Time Frame: Measured 3 and 15-months post-intervention ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged ≥ 15 years
  • Residence in GVH catchment areas included in the intervention arm

Exclusion Criteria:

  • Aged < 15 years old
  • Not resident in GVH catchment areas included in the intervention arm

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): NCT03541382


Contacts
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Contact: Pitchaya Indravudh +44 (0)20 7927 2700 pitchaya.indravudh@lshtm.ac.uk

Locations
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Malawi
Malawi-Liverpool-Wellcome Trust Clinical Research Programme Recruiting
Blantyre, Malawi
Contact: Liz Corbett       llz.corbett@lshtm.ac.uk   
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Liverpool School of Tropical Medicine
University College, London
Population Services International
UNITAID

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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03541382     History of Changes
Other Study ID Numbers: 14761
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by London School of Hygiene and Tropical Medicine:
HIV
HIV Self-Testing
Malawi