Trial of PermaNet 3-barrier bednets as part of an operational distribution programme in Haut-Katanga province, Democratic Republic of Congo
| ISRCTN | ISRCTN14487329 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14487329 |
| Secondary identifying numbers | v2.2 |
- Submission date
- 09/08/2024
- Registration date
- 14/08/2024
- Last edited
- 13/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
The study aims to compare two types of insecticidal bednets used to prevent malaria, PermaNet 3 with PermaNet 3-barrier bednets (BBnets). The study is associated with a programmatic distribution of the bednets in Haut Katanga province, southern Democratic Republic of Congo, which has taken place according to our specified distribution plan in May-June 2023. BBnets are identical to PermaNet 3 except for the addition of a longitudinal upright barrier, which contains the same ingredients (deltamethrin and piperonyl butoxide, PBO) as the roof of a PermaNet 3, and significantly enhances insecticide-resistant mosquito killing capacity.
Who can participate?
Healthy pregnant women aged 15 to 50 years old visiting their first antenatal clinic
What does the study involve?
The study will take place within the health zones of the Lubumbashi area of Haut Katanga. Health areas within the health zones are randomly allocated to receive the 300,000 P3-BBnets available, with all others receiving PermaNet 3. The primary outcome variable for the study is the prevalence of malaria recorded by routine testing of visitors at their first ante-natal clinics (ANC1), which provides an efficient and economical method for data collection. Visitors will be recruited by health centre staff to give their permission to take a rapid diagnostic test (RDT) for malaria and will be treated with artemisinin combination therapy (ACT) if positive; they will also be asked to complete a short questionnaire. All 21 health areas receiving P3-BBnets will be monitored for ANC1 malaria prevalence, as well as 42 areas receiving PermaNet 3. Data will be recorded over a continuous survey period of 3 months within the first year after distribution, during which surveys to characterise the malaria mosquito vector community and their insecticide resistance will also be performed, along with assessments of the hanging of bednets and questionnaires to assess user perceptions of the nets they have received.
What are the possible benefits and risks of participating?
There are no direct benefits but participants will be helping to evaluate malaria control tools which may help their communities in future. There are no expected risks to taking part.
Where is the study run from?
Liverpool School of Tropical Medicine (UK)
When is the study starting and how long is it expected to run for?
October 2023 to June 2024
Who is funding the study?
1. European Regional Development Fund
2. UK Research and Innovation Strength in Places Fund
3. The Bloomsbury Set
4. Against Malaria Foundation
Who is the main contact?
Dr David Weetman, david.weetman@lstmed.ac.uk
Contact information
Public, Scientific, Principal Investigator
Department of Vector Biology, Liverpool School of Tropical Medicine
Liverpool
L35QA
United Kingdom
 ORCID ID |
0000-0002-5820-1388 |
|---|---|
| Phone | +44 (0)151 7053225 |
| david.weetman@lstmed.ac.uk |
Study information
| Study design | Interventional cluster-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | 45918_PIS_v2.2_29Sept2024.pdf |
| Scientific title | Trial of PermaNet 3-barrier bednets as part of an operational distribution programme in Haut-Katanga province, DRC (BBnets) |
| Study acronym | BBnets |
| Study hypothesis | PermaNet 3 Barrier bednets reduce malaria prevalence more than PermaNet 3 bednets lacking the barrier |
| Ethics approval(s) |
1. Approved 01/11/2023, Liverpool School of Tropical Medicine Research ethics Committee (Liverpool School of Tropical Medicine, Liverpool, L35QA, United Kingdom; +44 151 705 3100; LSTMREC@lstmed.ac.uk), ref: 23-035 2. Approved 23/10/2023, University of Kinshasa School of Public Health Ethics Committee (University of Kinshasa School of Public Health, Kinshasa, BP 11850, Congo, Democratic Republic; +243 817493194; espec_unikin@yahoo.fr), ref: ESP/CE/163/2023 |
| Condition | Prevention of malaria in antenatal clinic visitors |
| Intervention | This two-armed study intervention involves the distribution of two types of insecticide-treated bednets to compare PermaNet 3 with PermaNet 3-barrier bednets (P3-BBnets). The study arms are represented by clusters, each of which is an administrative health area. Health areas will be randomised using a random number generator to receive one or the other net type. The nets are distributed as part of a programme and all areas within the study (and in the province generally, beyond the study area boundaries) keep their nets for a period of approximately 3 years until the next programmatic distribution. Participants are women from areas with each type of bednet who are enrolled on the study as they attend their first antenatal clinic appointment. If they agree to be enrolled, they receive a test for malaria and complete a short questionnaire. This provides the data for the study and there is no further observation or follow-up. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | PermaNet 3.0 barrier bednet, PermaNet 3.0 bednet |
| Primary outcome measure | Malaria prevalence in antenatal clinic visitors measured using a rapid diagnostic test (RDT) for malaria at one timepoint when visitors attend their first antenatal clinic |
| Secondary outcome measures | User perception and acceptance of barrier bednets measured using a bespoke questionnaire made for the study at the time when the participants are tested for malaria |
| Overall study start date | 01/10/2023 |
| Overall study end date | 30/06/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 15 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target number of participants | 8856 |
| Total final enrolment | 6779 |
| Participant inclusion criteria | Pregnant women visiting their first antenatal clinic |
| Participant exclusion criteria | 1. Young adolescents (<15 years) 2. Women presenting with symptoms of severe malaria 3. Women suffering from other illnesses requiring prompt treatment 4. Limited capacity to consent assessed by understanding of procedures and requirements of the study |
| Recruitment start date | 01/12/2023 |
| Recruitment end date | 29/04/2024 |
Locations
Countries of recruitment
- Congo, Democratic Republic
Study participating centre
Kinshasa
BP11850
Congo, Democratic Republic
Sponsor information
University/education
Liverpool School of Tropical Medicine
Liverpool
L35QA
England
United Kingdom
| Phone | +44 (0)151 7053225 |
|---|---|
| lstmgov@lstmed.ac.uk | |
| Website | https://www.lstmed.ac.uk/ |
"ROR" |
https://ror.org/03svjbs84 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Europski Fond za Regionalni Razvoj, Den Europæiske Fond for Regionaludvikling, Europees Fonds voor Regionale Ontwikkeling, Euroopa Regionaalarengu Fond, Fonds Européen de Développement Régional, Europäischer Fonds für regionale Entwicklung, Európai Regionális Fejlesztési Alap, Fondo Europeo di Sviluppo Regionale, Eiropas Reģionālās attīstības fonds, Europos Regionines Pletros Fondas, Europejski Fundusz Rozwoju Regionalnego, Fundo Europeu de Desenvolvimento Regional, Fondul European de Dezvoltare Regională, Európsky Fond Regionálneho Rozvoja, Fondo Europeo de Desarrollo Regional, Европейски фонд за регионално развитие, Evropský fond pro regionální rozvoj, Ευρωπαϊκό Ταμείο Περιφερειακής Ανάπτυξης, Il-Fond Ewropew għall-Iżvilupp Reġjonali, Evropski sklad za regionalni razvoj, Euroopan aluekehitysrahasto, Europeiska regionala utvecklingsfonden, ERDF, FEDER, EFRE, ЕФРР, EFRR, EFRU, ERFi, ΕΤΠΑ, FEDER, FESR, ERAF, ERPF, ERFA, L-FEŻR, EFRO, EFRR, FEDR, ESRR, EAKR, Eruf
Government organisation / National government
- Alternative name(s)
- Europski Fond za Regionalni Razvoj, Den Europæiske Fond for Regionaludvikling, Europees Fonds voor Regionale Ontwikkeling, Euroopa Regionaalarengu Fond, Fonds Européen de Développement Régional, Europäischer Fonds für regionale Entwicklung, Európai Regionális Fejlesztési Alap, Fondo Europeo di Sviluppo Regionale, Eiropas Reģionālās attīstības fonds, Europos Regionines Pletros Fondas, Europejski Fundusz Rozwoju Regionalnego, Fundo Europeu de Desenvolvimento Regional, Fondul European de Dezvoltare Regională, Európsky Fond Regionálneho Rozvoja, Fondo Europeo de Desarrollo Regional, Европейски фонд за регионално развитие, Evropský fond pro regionální rozvoj, Ευρωπαϊκό Ταμείο Περιφερειακής Ανάπτυξης, Il-Fond Ewropew għall-Iżvilupp Reġjonali, Evropski sklad za regionalni razvoj, Euroopan aluekehitysrahasto, Europeiska regionala utvecklingsfonden, ERDF, FEDER, EFRE, ЕФРР, EFRR, EFRU, ERFi, ΕΤΠΑ, FEDER, FESR, ERAF, ERPF, ERFA, L-FEŻR, EFRO, EFRR, FEDR, ESRR, EAKR, Eruf
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a peer reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.2 | 29/09/2024 | 13/08/2024 | No | Yes |
| Protocol file | version 2.2 | 29/09/2024 | 13/08/2024 | No | No |
Additional files
Editorial Notes
12/08/2024: Study's existence confirmed by the University of Kinshasa School of Public Health Ethics Committee.
