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

NCT03541382 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7880

Last updated 2020-08-11

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Malawi-Liverpool-Wellcome Trust Clinical Research Programme

    collaborator OTHER

  • Liverpool School of Tropical Medicine

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • Population Services International

    collaborator OTHER

  • UNITAID

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-08
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03541382 on ClinicalTrials.gov