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

Pitchaya P Indravudh, Katherine Fielding, Moses K Kumwenda, Rebecca Nzawa, Richard Chilongosi, Nicola Desmond, Rose Nyirenda, Cheryl C Johnson, Rachel C Baggaley, Karin Hatzold, Fern Terris-Prestholt, Elizabeth L Corbett, Pitchaya P Indravudh, Katherine Fielding, Moses K Kumwenda, Rebecca Nzawa, Richard Chilongosi, Nicola Desmond, Rose Nyirenda, Cheryl C Johnson, Rachel C Baggaley, Karin Hatzold, Fern Terris-Prestholt, Elizabeth L Corbett

Abstract

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: 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: 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: Clinicaltrials.gov registry ( NCT03541382 ) registered 30 May 2018.

Keywords: Adolescents; Community mobilisation; Community-led; HIV; HIV self-testing; HIV testing; Malawi; Men.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram of trial design
Fig. 2
Fig. 2
Trial clusters in Mangochi district. Map of Mangochi district, Malawi with trial health facilities and group village head-defined clusters. Data source: data.humdata.org and primary data
Fig. 3
Fig. 3
Intervention design
Fig. 4
Fig. 4
Trial timeline

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