Study design
We conducted a prospective cross-sectional study in the community to provide quantitative details of the pilot implementation of the AgRDT in Tanzania. This study was undertaken between March 2022 and September 2022. The pilot was implemented by distributing and offering test kits to people suspected of having COVID-19 in Dar es Salaam through community health workers. Using a national standard testing algorithm, eligible individuals were tested, and the results were documented. Furthermore, for the evaluation of the performance of the Ministry of Health screening algorithm for testing, several other individuals lacking eligibility for testing were also offered the test for validation purposes. Our evaluations were based on the number of people who received the test kits; moreover, we explored the perceptions and acceptability of AgRDT as an enabler or inhibitor of COVID-19 deployment in Tanzania. A proof of acceptability and feasibility of using the diagnostic test was an important pre-requisite before the Government of Tanzania through the Ministry of Health authorize its use in fighting the COVID-19 pandemic. The prevalence of the AgRDT positive test was the main outcome of the main operational research; but for this sub-study the main outcome was the feasibility and acceptability.
Institution review board statement
All the research procedures were conducted in accordance with Tanzania National laws and the guidelines of the Ethical committees and the regulatory authority22. The study received approval from IHI-ethics, with approval number IHI/IRB/No: 55 and the National Ethics Committee (NatHREC) NIMR/HQ/R8a/Vol.IX/3883. Written informed consent forms were sought for those individuals who participated in the evaluations that were conducted as part of the program. The consent forms outlined the proposed assessment, including the rationale, objectives, characteristics of those who participated and assessment procedures.
Study setting
Dar es Salaam remains a major city in Tanzania and a centre of business, industry, commerce and banking activities after the government decided to move its capital to Dodoma. Administratively, Dar es Salaam has a regional administration headed by the Dar es Salaam Regional Commissioner. It also has a city council administration headed by the mayor of Dar es Salaam. The city is divided into five municipalities, namely, Ilala, Kinondoni, Ubungo, Kigamboni and Temeke, as detailed elsewhere23. In an effort to address the pandemic, this program aimed to cover all municipalities in Dar Es Salaam. However, due to scarcity resources, we recruited and distributed the AgRDT kits in three Municipalities only– Ilala, Kinondoni, and Temeke to capture urban, semi-urban and rural characteristics respectively.
In brief, we selected wards with at least a population of 10,000 people in Temeke Municipality, namely, Buza, Chamazi, Mbagala kuu and Sandali, while in Kinondoni, we selected the Kigogo, Kijitonyama, Msasani and Ndugumbi wards. In the Ilala Municipality, we selected the Mnazi Mmoja, Pugu, Tabata and Kivule wards.
Community engagement
A series of open meetings were held at higher and lower levels of the local government structure as well as in the selected communities. The study team presented the proposal to the National COVID-19 Response Committee twice to fine-tune the protocol into the local context. In addition, a number of local stakeholders, such as counsellors, ward leaders and street leaders, were engaged to create demand for AgRDT testing in the selected areas in Dar es Salaam. These meetings helped to establish buy in the program implementation activities, as well as to structure a range of materials to support the development of information and education and communication (IEC) campaigns. In these meetings, the communities were informed about the availability of AgRDT Kits in the health facilities and through the CHWs for COVID-19 detection. Mobile numbers of CHWs were provided/displayed in the selected communities to request AgRDT testing from the CHWs. The campaign materials were pilot tested within the study team and the stakeholders before printing and distribution to the communities and clinic outlets. The content of the materials included information on the aim of the study, targeted group, risk and benefit for participation, how to join in the study, who is implementing the study. The material, had a space for putting a mobile number of the CHW. These materials were put into the offices of the ward secretaries as well as local health facilities.
In each municipality of Dar es Salaam region, network CHWs were identified. After consultations with the three municipality health authorities, 4 health facilities (lower level) were selected in each municipality as deployment points for the AgRDT kits. In total, 12 health facilities were identified as deployment sites. A research assistant (RA) was positioned at each municipality to supervise operational research activities and CHWs in the selected areas. Likewise, after consultations with health facility staff and village/street leaders, 5 CHWs were selected among the existing CHWs in the selected health facilities. The selected CHWs distributed and supervised the testing in the community passively and actively. With passive distribution and testing, the community members requested AgRDT kits from the CHWs through mobile phones. With active distribution, the CHWs were moving around the households to find the cases.
The selection criteria of the CHWs were based on sex balance, residential area and the ability to read, write and keep records. One-day training with CHWs was conducted by medical technologists from the national laboratory at the Ifakara Health Institute. The CHWs were trained on how to recognize symptoms of COVID-19 as per the MoH guidelines. In addition, the CHW were trained on how to perform and interpret AgRDT according to the manufacturer’s instructions and simplified pictorial instructions (AgRDT job aid).
Recruitment procedure at the community
Although the prevalence of the positive test was not one of the outcomes in this study, it was primarily driven by the projected burden of COVID-19 in the selected community and this was to be compared to the proportion of COVID-19 positive person identified in the health facility. It was assumed that the proportion of COVID-19 positive samples would be 2% in the health facility and 1% in the community. To estimate the 1% prevalence (+ /– 1%) at 97% confidence level a total number 1000 individuals (including 9% incomplete information) to be offered the test was to be sampled. As the estimate of the proportion of positive tests in those that were not selected to be offered the test was expected to be very low a convenient sample of 1000 were to be recruited in this group. The percentage of refusals for the test was assumed to be 20% and hence the stated sample was adequate to correctly estimate the proportion of refusals.
All identified adults older than 18 years were subjected to AgRDT tests, and the results were obtained during implementation in the community using the established clinical algorithm of the MoH. A convenient sampling of those who agreed to participate in the AgRDT was given study information and asked for written consent to participate in a prospective cross-sectional study during evaluation. According to this study, we defined uptake as the willingness to have a Covid-19 rapid test and wait the results for 20 min and recommend AgRDT test to others. In addition, feasibility was defined as perception or experience with regards to the use of AgRDT devices. Likewise, acceptability was defined as the likelihood of recommending AgRDT test to others or willingness to purchase for a COVID-19 test kit if it’s not available for free. For the purpose of this study, we therefore designed the tool to capture the information related to feasibility and acceptability accordingly.
All the consented participants had their sociodemographic information, such as sex, age, occupation, educational level, COVID-19 testing history, COVID-19 symptoms, medical history, signs and symptoms documented. Questions related to knowledge, attitudes, practices as well as feasibility, acceptability and uptake of AgRDT were also captured.
Data collection, management, storage and analysis
All the data were collected using semi structured questionnaires loaded on tablets/mobile phones, except for the consent forms, which were completed on paper. We trained RAs and CHWs on how to capture, enter and submit community data to the IHI server through tablets, computers or smartphones loaded with the open data kit (ODK)-open mobile data collection platform.
We used descriptive statistics to summarize the quantitative data; categorical data were summarized using frequency counts and percentages, whereas continuous variables were summarized with means and standard deviations. For knowledge, a question with multiple choices was given a score of one for each choice, and an average was calculated. An average score of 50% or above was arbitrarily considered to indicate knowledge of that question. Disease symptoms, disease spread and risk group were scored24. Data analysis was performed with Stata 15 standard editions (StataCorp, Texas, USA)25.
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