Community-led delivery of HIV self-testing to improve HIV testing, ART initiation and broader social outcomes in rural Malawi: study protocol for a cluster-randomised trial.
Adolescent
Adult
Anti-Retroviral Agents
/ therapeutic use
Community Networks
Cost-Benefit Analysis
Cross-Sectional Studies
Female
HIV Infections
/ diagnosis
Health Promotion
Humans
Malawi
Male
Mass Screening
/ economics
Randomized Controlled Trials as Topic
Registries
Serologic Tests
/ economics
Young Adult
Adolescents
Community mobilisation
Community-led
HIV
HIV self-testing
HIV testing
Malawi
Men
Journal
BMC infectious diseases
ISSN: 1471-2334
Titre abrégé: BMC Infect Dis
Pays: England
ID NLM: 100968551
Informations de publication
Date de publication:
18 Sep 2019
18 Sep 2019
Historique:
received:
04
07
2019
accepted:
30
08
2019
entrez:
20
9
2019
pubmed:
20
9
2019
medline:
27
11
2019
Statut:
epublish
Résumé
Prevention of new HIV infections is a critical public health issue. The highest HIV testing gaps are in men, adolescents 15-19 years old, and adults 40 years and older. Community-based HIV testing services (HTS) can contribute to increased testing coverage and early HIV diagnosis, with HIV self-testing (HIVST) strategies showing promise. Community-based strategies, however, are resource intensive, costly and not widely implemented. A community-led approach to health interventions involves supporting communities to plan and implement solutions to improve their health. This trial aims to determine if community-led delivery of HIVST can improve HIV testing uptake, ART initiation, and broader social outcomes in rural Malawi. The trial uses a parallel arm, cluster-randomised design with group village heads (GVH) and their defined catchment areas randomised (1:1) to community-led HIVST or continue with the standard of the care (SOC). As part of the intervention, informal community health cadres are supported to plan and implement a seven-day HIVST campaign linked to HIV treatment and prevention. Approximately 12 months after the initial campaign, intervention GVHs are randomised to lead a repeat HIVST campaign. The primary outcome includes the proportion of adolescents 15-19 years old who have tested for HIV in their lifetime. Secondary outcomes include recent testing in adults 40 years and older and men; ART initiation; knowledge of HIV prevention; and HIV testing stigma. Outcomes will be measured through cross-sectional surveys and clinic registers. Economic evaluation will determine the cost per person tested, cost per person diagnosed, and incremental cost effectiveness ratio. To the best of our knowledge, this is the first trial to assess the effectiveness of community-led HTS, which has only recently been enabled by the introduction of HIVST. Community-led delivery of HIVST is a promising new strategy for providing periodic HIV testing to support HIV prevention in rural communities. Further, introduction of HIVST through a community-led framework seems particularly apt, with control over healthcare concurrently devolved to individuals and communities. Clinicaltrials.gov registry ( NCT03541382 ) registered 30 May 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Prevention of new HIV infections is a critical public health issue. The highest HIV testing gaps are in men, adolescents 15-19 years old, and adults 40 years and older. Community-based HIV testing services (HTS) can contribute to increased testing coverage and early HIV diagnosis, with HIV self-testing (HIVST) strategies showing promise. Community-based strategies, however, are resource intensive, costly and not widely implemented. A community-led approach to health interventions involves supporting communities to plan and implement solutions to improve their health. This trial aims to determine if community-led delivery of HIVST can improve HIV testing uptake, ART initiation, and broader social outcomes in rural Malawi.
METHODS
METHODS
The trial uses a parallel arm, cluster-randomised design with group village heads (GVH) and their defined catchment areas randomised (1:1) to community-led HIVST or continue with the standard of the care (SOC). As part of the intervention, informal community health cadres are supported to plan and implement a seven-day HIVST campaign linked to HIV treatment and prevention. Approximately 12 months after the initial campaign, intervention GVHs are randomised to lead a repeat HIVST campaign. The primary outcome includes the proportion of adolescents 15-19 years old who have tested for HIV in their lifetime. Secondary outcomes include recent testing in adults 40 years and older and men; ART initiation; knowledge of HIV prevention; and HIV testing stigma. Outcomes will be measured through cross-sectional surveys and clinic registers. Economic evaluation will determine the cost per person tested, cost per person diagnosed, and incremental cost effectiveness ratio.
DISCUSSION
CONCLUSIONS
To the best of our knowledge, this is the first trial to assess the effectiveness of community-led HTS, which has only recently been enabled by the introduction of HIVST. Community-led delivery of HIVST is a promising new strategy for providing periodic HIV testing to support HIV prevention in rural communities. Further, introduction of HIVST through a community-led framework seems particularly apt, with control over healthcare concurrently devolved to individuals and communities.
TRIAL REGISTRATION
BACKGROUND
Clinicaltrials.gov registry ( NCT03541382 ) registered 30 May 2018.
Identifiants
pubmed: 31533646
doi: 10.1186/s12879-019-4430-4
pii: 10.1186/s12879-019-4430-4
pmc: PMC6751650
doi:
Substances chimiques
Anti-Retroviral Agents
0
Banques de données
ClinicalTrials.gov
['NCT03541382']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
814Subventions
Organisme : Wellcome Trust
ID : 200901/Z/16/Z
Pays : United Kingdom
Organisme : Unitaid
ID : PO#8477-0-600
Organisme : Wellcome Trust
ID : WT091769
Pays : United Kingdom
Organisme : World Health Organization
ID : 001
Pays : International
Organisme : Medical Research Council
ID : MR/R010161/1
Pays : United Kingdom
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