HIV Self-Testing Africa (STAR) Malawi: General Population
STAR Malawi
HIV Self-testing Africa (STAR) Malawi: General Population - A Cluster Randomized Trial of Providing HIV and Self-testing Kits Through Community-based Distribution Agents
1 other identifier
interventional
5,504
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2016
CompletedFirst Posted
Study publicly available on registry
March 24, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedMay 14, 2018
August 1, 2017
1.8 years
March 18, 2016
May 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
13 months
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
13 months
Secondary Outcomes (2)
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
13 months
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
13 months
Study Arms (3)
Control
NO INTERVENTIONStandard of care.
Self-testing
ACTIVE COMPARATORCommunity-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.
Self-testing + home HIV care home initiation
ACTIVE COMPARATORCBDAs 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.
Interventions
Community based distribution of self-tests
Home-based initiation of ARVs by study nurse linked to follow-up at clinic
Eligibility Criteria
You may qualify if:
- Age 16 years or above
- Usual residence within a study PHC catchment area
- Able and willing to provide oral consent to HTC
You may not qualify if:
- Age 15 years or below
- Usual residence outside of the intervention cluster
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London School of Hygiene and Tropical Medicinelead
- UNITAIDcollaborator
- Malawi-Liverpool-Wellcome Trust Clinical Research Programmecollaborator
- Liverpool School of Tropical Medicinecollaborator
- University College, Londoncollaborator
- Population Services Internationalcollaborator
- World Health Organizationcollaborator
Study Sites (1)
Unknown Facility
Blantyre, Malawi
Related Publications (4)
Indravudh PP, Fielding K, Chilongosi R, Nzawa R, Neuman M, Kumwenda MK, Nyirenda R, Johnson CC, Taegtmeyer M, Desmond N, Hatzold K, Corbett EL. Effect of door-to-door distribution of HIV self-testing kits on HIV testing and antiretroviral therapy initiation: a cluster randomised trial in Malawi. BMJ Glob Health. 2021 Jul;6(Suppl 4):e004269. doi: 10.1136/bmjgh-2020-004269.
PMID: 34275866DERIVEDJohnson C, Kumwenda M, Meghji J, Choko AT, Phiri M, Hatzold K, Baggaley R, Taegtmeyer M, Terris-Prestholt F, Desmond N, Corbett EL. 'Too old to test?': A life course approach to HIV-related risk and self-testing among midlife-older adults in Malawi. BMC Public Health. 2021 Apr 3;21(1):650. doi: 10.1186/s12889-021-10573-7.
PMID: 33812381DERIVEDKumwenda MK, Johnson CC, Choko AT, Lora W, Sibande W, Sakala D, Indravudh P, Chilongosi R, Baggaley RC, Nyirenda R, Taegtmeyer M, Hatzold K, Desmond N, Corbett EL. Exploring social harms during distribution of HIV self-testing kits using mixed-methods approaches in Malawi. J Int AIDS Soc. 2019 Mar;22 Suppl 1(Suppl Suppl 1):e25251. doi: 10.1002/jia2.25251.
PMID: 30907508DERIVEDNeuman M, Indravudh P, Chilongosi R, d'Elbee M, Desmond N, Fielding K, Hensen B, Johnson C, Mkandawire P, Mwinga A, Nalubamba M, Ncube G, Nyirenda L, Nyrienda R, Kampe EOI, Taegtmeyer M, Terris-Prestholt F, Weiss HA, Hatzold K, Ayles H, Corbett EL. The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluations. BMC Public Health. 2018 Nov 6;18(1):1234. doi: 10.1186/s12889-018-6120-3.
PMID: 30400959DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2016
First Posted
March 24, 2016
Study Start
April 1, 2016
Primary Completion
January 31, 2018
Study Completion
January 31, 2018
Last Updated
May 14, 2018
Record last verified: 2017-08