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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03541382
Recruitment Status : Completed
First Posted : May 30, 2018
Last Update Posted : November 15, 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)
Actual Enrollment : 7880 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
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 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.
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. Percentage of self-reported lifetime testing in adolescents aged 15-19 years old [ Time Frame: Measured 3-months post-intervention ]

Secondary Outcome Measures :
  1. Percentage of self-reported testing in last 3 months in men aged ≥ 15 years [ Time Frame: Measured 3-months post-intervention ]
  2. Percentage of self-reported testing in last 3 months in adults aged ≥ 40 years [ Time Frame: Measured 3-months post-intervention ]
  3. Cumulative incidence of population-level ART uptake in adults aged ≥ 15 years over 6 months [ Time Frame: Measured 6-months post-intervention ]


Information from the National Library of Medicine

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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


Locations
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Malawi
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Blantyre, Malawi
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

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: NCT03541382     History of Changes
Other Study ID Numbers: 14761
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
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