LLIN Evaluation in Uganda Project

NCT04566510 | Completed Results

• 2 other identifiers: LLINEUP2U19AI089674
• Study Type: interventional
• Target: 32,895
• Locations: 1 country
• Sites: 1

Brief Summary

In Uganda, the National Malaria Control Division (NMCD) and implementing partners plan to deliver long-lasting insecticidal nets (LLINs) nationwide in 2020-21, through a mass distribution campaign supported by generous contributions from international donors. LLINs will be distributed free-of-charge to all Ugandan households, aiming to achieve universal coverage. The Against Malaria Foundation has agreed to provide LLINs treated with a pyrethroid insecticide plus pyriproxyfen (PPF) (Royal Guard, Disease Control Technology) and LLINs treated with a pyrethroid insecticide plus piperonyl butoxide (PBO) (PermaNet 3.0, Vestergaard), presenting an opportunity to rigorously evaluate and compare these two LLINs at scale across Uganda. In collaboration with the MOH, the investigators propose to embed a cluster-randomised trial to compare the impact of LLINs with PPF to LLINs with PBO into Uganda's 2020 LLIN distribution campaign. The primary objective of the study is: To evaluate the impact of LLINs treated with a pyrethroid insecticide plus pyriproxyfen (PPF LLINs), as compared to LLINs treated with a pyrethroid plus piperonyl butoxide (PBO LLINs), on malaria incidence in Uganda. The study will test the hypothesis that malaria incidence will be lower in intervention clusters (randomised to receive PPF LLINs) than in control clusters (randomised to receive PBO LLINs).

Conditions

Malaria

Keywords

long-lasting insecticidal net; pyriproxyfen; piperonyl butoxide; alpha-cypermethrin; deltamethrin

Outcome Measures

Primary Outcomes (1)

• Malaria Incidence

  Number of cases of laboratory-confirmed malaria diagnosed at the MRC among patients residing in the catchment areas per unit time/the population of the catchment areas

  24 months following LLIN distribution

Secondary Outcomes (10)

• Prevalence of Parasitaemia

  12 months following LLIN distribution

• Prevalence of Parasitaemia

  24 months following LLIN distribution

• Prevalence of Anaemia

  12 months following LLIN distribution

• Prevalence of Anaemia

  24 months following LLIN distribution

• Proportion of Households That Owned at Least One LLIN

  12 months following LLIN distribution

Study Arms (2)

Royal Guard

EXPERIMENTAL

alpha-cypermethrin + pyriproxyfen (PPF)

Other: long lasting insecticidal nets with alpha-cypermethrin + pyriproxyfen (PPF LLIN, Royal Guard)); Behavioral: Social behaviour change communication

PermaNet 3.0

ACTIVE COMPARATOR

deltamethrin + piperonyl butoxide (PBO)

Other: long lasting insecticidal nets with deltamethrin + piperonyl butoxide (PBO LLIN, PermaNet 3.0)); Behavioral: Social behaviour change communication

Interventions

long lasting insecticidal nets with alpha-cypermethrin + pyriproxyfen (PPF LLIN, Royal Guard)) OTHER

Next-generation bed net combining insecticides with different modes of action

Royal Guard

long lasting insecticidal nets with deltamethrin + piperonyl butoxide (PBO LLIN, PermaNet 3.0)) OTHER

Next-generation bed net combining an insecticide with a synergist

PermaNet 3.0

Social behaviour change communication BEHAVIORAL

SBCC activities will use digital and other platforms, similar to those used for the COVID-19 response, including the following: (1) LLIN launch on television and radio; (2) regional advocacy meetings on Zoom; (3) mass media platforms (for advertisements, mini skits, DJ mentions, radio spots, interactive talks); (4) social media platforms; (5) VHTs; (6) operation hotlines and toll-free call centres; (7) community mobilisation (megaphones); and (8) use of appropriate information, education, and communication materials. Communication will include messages about COVID-19, malaria, and use, care, repair and repurposing of LLINs.

PermaNet 3.0; Royal Guard

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one adult aged 18 years or older present
• Adult is a usual resident who slept in the sampled household on the night before the survey
• Agreement of the adult resident to provide informed consent for the household survey

You may not qualify if:

• Dwelling destroyed or not found
• Household vacant
• No adult resident home on more than 3 occasions

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Infectious Diseases Research Collaboration

Kampala, Uganda

Location

Related Publications (1)

• Gonahasa S, Namuganga JF, Nassali MJ, Maiteki-Sebuguzi C, Nabende I, Epstein A, Snyman K, Nankabirwa JI, Opigo J, Donnelly MJ, Dorsey G, Kamya MR, Staedke SG. LLIN Evaluation in Uganda Project (LLINEUP2) - Effect of long-lasting insecticidal nets (LLINs) treated with pyrethroid plus pyriproxyfen vs LLINs treated with pyrethroid plus piperonyl butoxide in Uganda: A cluster-randomised trial. PLOS Glob Public Health. 2025 Feb 26;5(2):e0003558. doi: 10.1371/journal.pgph.0003558. eCollection 2025.

  PMID: 40009611 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

cypermethrin; pyriproxyfen; decamethrin; Piperonyl Butoxide

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Benzodioxoles; Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Grant Dorsey
• Organization: UCSF

grant.dorsey@ucsf.edu

628-206-4680

Study Officials

• Sarah Staedke, MD, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Moses Kamya, MBChB, MMed, PhD

  Infectious Diseases Research Collaboration

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cluster-randomised trial

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: October 17, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)