Accuracy and Acceptability of the OraQuickTM HIV Self-Test Kit Among Female Sex Workers and Men Who Have Sex with Men Attending Projet San Francisco in Kigali, Rwanda

Research Article

Austin J Nurs Health Care. 2021; 8(2): 1063.

Accuracy and Acceptability of the OraQuickTM HIV Self-Test Kit Among Female Sex Workers and Men Who Have Sex with Men Attending Projet San Francisco in Kigali, Rwanda

Mudenge M¹, Ngomi N², Mochama M¹ and Rutayisire E¹*

1Department of Public Health, Mount Kenya University, Rwanda

2School of Pure and Applied Health Sciences, Murang’a University of Technology, Kenya

*Corresponding author: Erigene Rutayisire, Head of Public Health Department, Mount Kenya University, Kigali, Rwanda

Received: September 14, 2021; Accepted: October 06, 2021; Published: October 13, 2021


HIV self-testing is the process where a person who wants to know his or her HIV status collects a sample and performs a test him/herself and interprets the test result in private. The overall objectives of this study were assessment of the accuracy of OraQuickTM HIV self-testing procedures used to detect HIV-1 and HIV-2 antibodies. This Research adopted a cross-sectional study design where participants were recruited voluntarily. The Self-Test Kits were provided to participants after receiving instructions on how to use them and verbal consent was obtained from respondents. A questionnaire was provided to participants to collect relevant information related to the study. The target population of the study was Female Sexual Workers and Men who have sex with Men attending project San Francisco clinic located in Kigali City, Rwanda. The sample size was 275 respondents. Data collected was stored in a database and further analyzed using SPSS. The study findings revealed that 57.5% of respondents were aged 18-29, 60% were male and 85% were single. The accuracy of the OraQuickTM HIV self-test was 99% and acceptability was at 93.6%. The findings revealed that respondents who ever diagnosed and treated for STI were about 8 fold more likely to have high acceptability of OraQuickTM HIV self-test. The OraQuickTM HIV self-test kit was found to be accurate and compare very well with the gold standard HIV kit using blood in laboratory. The use and adaptation of the self-test kit among the citizens of Rwanda is recommendable.

Keywords: HIV self-testing; OraQuickTM; HIV-2 antibodies; Acceptability; Accuracy; Key populations (KP); Men who have sex with men (MSM); Sex workers (SW)


Globally, the incidence of HIV infections is rising: The world has committed to work hard on stopping the HIV/AIDS epidemic by 2030 [1]. In order to reach this bold target, health authorities such as the Centers of Disease Control strongly recommend regular HIV testing. Although HIV/AIDS testing is strongly recommended as a routine health service to everyone, new HIV infections are noticed late or not at all detected [2]. Globally, about 36.9 million average (31.1 million–43.9 million) people were living with HIV/AIDS in 2017 [3]. Only Sub-Saharan Africa have about 25.5 million individuals who are living with HIV infection with an incidence of 1.5 million annually [2,3].

Fear of stigmatization continues in most of the population where accessibility to HIV testing is a big issue in many regions and continues to hinder the acceptance of HIV testing and counseling services [4]. Globally, the acceptance of services offered for HIV counseling and testing remains very low mainly high number of groups who are at risk around the world. Fear of confidentiality breaching, stigma, discrimination from other members of the society lowers down the use of health services among risk groups [5].

In Rwanda, the prevalence of HIV has been stabilized to 3% since 2010. Although the country has a generalized epidemic, several means and channels are used among certain key populations which accelerate on increasing their risk behaviors and HIV transmission among the general populations [5].

Worldwide, women who exchange sex for money are at high risk of Human Immunodeficiency Virus (HIV), Sexually Transmitted Infections (STIs), and unplanned pregnancy, but are often less likely to seek HIV testing due to transportation costs, time constraints, and the stigma and discrimination associated with sex work and being HIV-positive [6]. There has been a long time formal discussion about the idea of HIV home-based testing, but approval of the test method has not been done. Recently, the discussion on home-based testing has been reopened again, after approving HIV self-testing kit using oral fluid in the United States of America [7]. The benefits would result from flagging new infections and initiating treatment as soon as it is detected as well as improving both effectiveness and costeffectiveness [8].

The whole population is going to benefit from HIV self-testing especially those who are in high prevalence of HIV infection like key population, community health workers and the priority populations in all settings and those who frequently keep on re-testing due to ongoing risk [6].

The presence of lower proportion among males and females attending HIV testing was attributed to different methodologies including stigma. HIV Self Testing methods has been discussed in UNAIDS/WHO documents however, several countries have addressed the issue and it is useful to consider the range of thinking on this issue while maintaining a focus on the particular context and needs of developing countries [9].

Acceptability of HIV self-testing which is conducted at home especially by those most-at-risk populations like MSM and FSW is one of the solutions in marginalized and stigmatized society in the world [10-12]. The main focus of this study is to evaluate the accuracy and acceptability of OraQuickTM HIV self-test use among female sex workers and men who have sex with men in Kigali Rwanda.

Materials and Methods

Research design and target population

The study was conducted under descriptive cross-sectional design, whereby data were collected on a group of the population at a point in time and then analyzed. This study adopts quantitative methods approach. Since this study envisaged the key population and it is not easy to get them everywhere at the field, the researcher preferred to enroll the section of key population as the target population of 670 FSW and MSM participants at Project San Francisco as routine clients attending the cite in Kigali Rwanda. This project is intended to help FSWs and MSM who are followed at the project’s clinic in order to sustain their best livelihood by providing HIV prevention services mainly. All data represents the target research population of this study. Therefore, the target population consists of FSWs and MSM who are the beneficiaries of the project ‘activities during research period.

Sample Size and sampling technique

In this study, the sample was calculated by considering a crosssectional study where the prevalence of acceptability is not well known for this type of population. Therefore, the researcher has adopted the Yamane formula to calculate the adequate sample to be used and the following formula was considered:


n = the sample size

N = the size of the target population

e = the error of 5 percentage points

For the purpose of this study, size of the target population under the study is equal to 670 and after all necessary calculations; the adequate sample size was approximately 250 participants. However, the researcher has taken into account the attrition that may arise during the collection of the data and the attrition rate was set to 10%. After considering this attrition rate the final sample size was 275 participants.

FSW and MSM normally come in after getting information from key informants or radio advertisements. All KP who came for baseline and/or follow up were eligible for this study. After explanation and video demonstration, all clients who are eligible for HIV lab test were given OraQuickTM HIV Self-Test. The convenience sampling was used to the participants given the limitation in time and other resources necessary.

Data collection methods and tools

Quantitative methods used by the researcher. Collecting data was done through different tools such as: Questionnaires survey, counseling messages. Instruments were used in Collection of data and other information quantitatively.

Used questionnaires were standards in order to produce accurate information. The questionnaire comprised of two sections as follows: The first section comprised of demographic data such as age, sex, occupation, living situation, marital status and education. The second section comprised of data describing the behaviors of beneficiaries about the sexual, HIV history and techniques of HIV self-testing.

The HIV test results from OraQuickTM HIV Self-Test were offered in Nurse’s office, after each individual result was recorded on the designated sheet. The sheet shows the Date, Client ID, File number, Volunteer type, OraQuickTM HIV Self-Test results and Laboratory results. This sheet was filled by a trained nurse and blood specimen was taken to PSF Clinical Laboratory where HIV Rapid Test was used to test the sample as usual. Then the lab results were reviewed and recorded on the same sheet for comparison.

Data analysis procedure

The data which are collected were processed and organized for statistical analysis. Data analysis involved first coding the responses; tabulating the data; and performing several statistical computations (i.e. averages, frequencies and percentages). Statistical Package for the Social Science (SPSS) was used in the analysis of the data.

To assess the validity of OraQuick self-test, the specificity and sensitivity as well as positive and negative predictive values were calculated by comparing the results provided by the self-test against the best existing currently used test as per the Ministry of Health algorithm which are the alere Combo Determine and the STAT-PAK considered as the confirmatory test.

Moreover, descriptive statistics using counts and percentage were computed to describe the basic demographic characteristics, sexual habits and acceptability of OraQuick self-test. A score assessment was used to determine the overall level of acceptability of OraQuick selftest. Five questions were considered with “yes” and “no” responses. The score 1 was given to “Yes” and score 0 for “No” and those who scored 3 and above were grouped with high acceptability and below 3 with low acceptability. Logistic regression and chi square test were performed to establish the factors associated with the level of acceptability for OraQuick self-test. Multiple logistic regressions were used to assess the independent factors associated with HIV selftesting acceptability by adjusting for potential confounders.

Ethical consideration

Ethical clearance was obtained from Mount Kenya University Rwanda ethical review board. Values of voluntary participation, anonymity and protection of rights of respondents and from any possible harm that could arise from participating in the study were considered in this study. Participants were requested to join the study on a voluntary basis and refusal or abstaining from participating was permitted.

Informed consent for key informants was considered, where verbal consent used by nurse counselors. Respondent’s confidentiality on the information and protection from any possible harm that may arise from the study was ensured.


Characteristics of respondents

Out of the 275 distributed questionnaires, 200 were well answered and returned back with a response rate of 72.27%.

As shown in Table 1, the average age of the respondents was 30.6 years with majority (57.5%) were in the age group of 18 to 29 years. The proportions of males were more (60.0%) compare to 40.0% of females. The respondents were requested to indicate their marital status and large percentage were single (85.0%).