A controlled, observed trial of HIV Self-Testing in the hands of Untrained Users
Study Summary
The HSTAR003 is a controlled study intended to evaluate test performance of the, KHB HIV I/II Ab RAPID TEST (SELF-TEST) in the hands of untrained users, with instructions for use specifically designed for a South African lay person who has not used any kind of HIV Self-Test prior to the study. HSTAR003 is conducted to evaluate the process and performance of HIV Self-Tests by untrained users. Specific critical and non-critical steps are identified from the self-test product’s Instructions for Use. The untrained user is evaluated for process success or difficulty by a silent, non-interacting observer in the same room. Overall processes include self-test Usability (observation to determine if participants perform all critical steps correctly), Interpretation (confirmation by staff to determine if participant interprets the test result correctly), and Comprehension (questionnaire to determine that the participant is aware of test limitations and what to do following the test result). The successful completion of tasks will be evaluated as a percentage of the overall process, with all critical and non-critical errors identified and reported. All self-test results will be confirmed using the South Africa standard HIV testing algorithm. The sensitivity and specificity of the KHB HIV I/II Ab RAPID TEST (SELF-TEST) results will respectively be calculated relative to the confirmatory test process, where applicable. In the event of positive HIV diagnosis, the study participant will be referred for clinical treatment and care.
Background and Rationale
The HSTAR003 is a controlled study intended to evaluate test performance of the, KHB HIV I/II Ab RAPID TEST (SELF-TEST) in the hands of untrained users, with instructions for use specifically designed for a South African lay person who has not used any kind of HIV Self-Test prior to the study. HSTAR003 is conducted to evaluate the process and performance of HIV Self-Tests by untrained users. Specific critical and non-critical steps are identified from the self-test product’s Instructions for Use. The untrained user is evaluated for process success or difficulty by a silent, non-interacting observer in the same room. Overall processes include self-test Usability (observation to determine if participants perform all critical steps correctly), Interpretation (confirmation by staff to determine if participant interprets the test result correctly), and Comprehension (questionnaire to determine that the participant is aware of test limitations and what to do following the test result). The successful completion of tasks will be evaluated as a percentage of the overall process, with all critical and non-critical errors identified and reported. All self-test results will be confirmed using the South Africa standard HIV testing algorithm. The sensitivity and specificity of the KHB HIV I/II Ab RAPID TEST (SELF-TEST) results will respectively be calculated relative to the confirmatory test process, where applicable. In the event of positive HIV diagnosis, the study participant will be referred for clinical treatment and care.
Background and Rationale
South Africa has an instrumental part to play towards the achievement of the UNAIDS 90-90-90 goals for HIV/AIDS. The goal of the first “90” is to have 90 per cent of all people living with HIV aware of their status by the year 2020. Despite significant progress made by the South African government in improving testing rates (DOH, 2011), concern has been raised that conventional, public, facility-based testing has several weaknesses, including long waiting time, needless repeat counselling, the identification of HIV negative people within the testing programme without a subsequent effective prevention message, poor quality control on the part of testers in terms of test administration, and the inability to reach key and vulnerable populations (Miller, Ketlhapile, Rybasack‐Smith, & Rosen, 2010; Pai, Behlim, et al., 2013; Pai, Sharma, et al., 2013).
In the country’s private sector, options for HIV testing and counselling are limited and costly, with the majority of working-class South Africans relying on workplace surveillance, Corporate Wellness Days, or referral by private medical practitioners in order to learn their status. This has created a substantial “testing gap” of individuals unaware of their HIV status and not accessing either public or private services. Increasing access to and uptake of HIV testing by utilizing new and innovative methods in order to close this gap is critical for reducing incidences through onward transmission, and improving access to treatment and support for people living with HIV (Cohen, 2011). Self-Testing for HIV (“HIVST”) is an emerging approach with the potential to increase the uptake of HIV testing as a high impact, low cost, and empowering alternative for those who may not otherwise test, notably in key populations and other people at high risk for HIV infection (Johnson et al., 2014). This technological innovation in the healthcare industry brings to the market an innovation that may be affordable, simple, accessible and convenient. There is a growing body of supporting evidence showing the acceptability and usability of HIVST in various key populations and groups (Augustine Talumba Choko et al., 2011; Augustine T Choko et al., 2015; Johnson et al., 2014; Kalibala et al., 2014), with further plans for evaluations on device performance. There are both potential benefits and risks of HIVST that have been identified as outlined in Section 1.3 below. Furthermore, while acceptability of this innovation has been shown, there is a need to identifying people at higher risk for HIV infection. In order to close this gap, reliable and efficient methods are required to measure HIV-related risk behaviour. The system should be easily administered by the user and able to assess a potential high-risk person. Research has shown that availability of HIV risk-taking behaviour scale have been used and reported to be reliable and valid for intravenous drug users (IVDUs) (Shane Darke et al, 1991).
Investigational Device Description
The KHB HIV I/II Ab RAPID TEST (SELF-TEST) is a single use, in vitro (outside the body) visually read rapid test for the qualitative detection of antibodies against HIV-1/2 in fingerstick whole blood. The KHB HIV I/II Ab RAPID TEST (SELF-TEST) is intended to be used manually by untrained lay users (self-testing) who are twelve years and older and/or by medical professionals. The KHB HIV I/II Ab RAPID TEST (SELF-TEST) is intended to be used as an aid in the diagnosis of HIV 1/2 infection and not as an HIV screening test for blood donation.
Lay User Participants and Observers
Lay User Participant: Refers to a lay user who will conduct the labelling comprehension, questionnaire-based evaluation and / or the contrived (static) results interpretation evaluation.
Observer: A study staff member (trained healthcare worker) who observes the lay-user conducting the labelling comprehension and / or the results interpretation evaluation. The observer and other study staff members can be either a laboratory technician or a non-laboratory healthcare professional (nurse, MD) or a non-certified, but trained healthcare worker (as per WHO definition).
Objectives
Primary Objectives
- The primary objective of this study is to evaluate the ability of untrained users to obtain accurate HIV test results using the, KHB HIV I/II Ab RAPID TEST (SELF-TEST).
Secondary Objectives
- To evaluate the untrained users’ interaction with the device in terms of effectiveness and efficiency, i.e. successful / unsuccessful completion and difficulty of the critical steps as per the Instructions for Use.
- To assess the ability of the untrained users to correctly comprehend key messaging from device packaging and labelling, including the Instructions for Use
- Participants will be surveyed for user experience, and satisfaction with the overall process; in addition, users will be asked for comments and recommended improvements for test process.
Study Eligibility Criteria
Inclusion Criteria This study is open to the general public over the age of 12 who meet the inclusion and exclusion criteria. No participant will be excluded on the basis of race, gender, ethnicity or sexual orientation. As the device is intended to be used by both male and female from the general population, this assessmentaims to recruit as close to a 50% breakdown per gender as possible. For this study, at least 10 participants between 12-17 years should be included. Participants wishing to be enrolled onto the study must meet the following criteria:
- Understands and signs the written informed Consent Form
- Able to complete the required testing on the allocated testing day[s]
- Agree to provide accurate medical history, required specimens of oral fluid or finger prick blood sample, and up to 13ml of blood by venipuncture if needed
- Able to speak and read English,
- ≥12years of age
- Provide level of education
Exclusion Criteria Participants meeting any of the following criteria will be excluded from the study:
- Do not meet the inclusion criteria
- Are known HIV positive
- Have received any experimental HIV vaccine
- Are currently on a PrEP regimen or any ARV medication
- Persons having a blood disorder
- Have participated in any prior, or concurrent trial of HIV self-tests
- A practicing medical healthcare professional (doctor, nurse or HIV Counsellor that performs HIV testing with Rapid Tests)
- Has used an RDT for self-testing previously
- Unwilling to use the biometric enrolment system
- Cannot provide Identity Number or Identity Documentation for the Biometric enrolment
- Any condition which, in the opinion of the facilitator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the assessment, consent form and questionnaire etc. or bias the outcome, i.e. being unable to see / read by forgetting to bring reading glasses, being intoxicated or acute sickness
Study Design
This is a general population study. Participants will be recruited from the Wits RHI clinical trial sites and the areas around such sites which are all areas with high HIV prevalence. The study will also use Primary Healthcare catchment areas in the inner city (Region F) of Johannesburg in the Republic of South Africa. In the event that recruitment numbers are low, the study has the option to utilise its mobile van to recruit from outlying areas of Johannesburg. Approximately 200 participants per product will be enrolled from the collective recruitment sites. Study participants will be recruited from the general population using various methods, following the inclusion and exclusion criteria described above. Clinic-based recruitment. After strategic planning and relevant research, Community Health Workers (CHW’s) will identify healthcare centres, hospitals and institutions which comprises of an appropriate participant base. Community-based recruitment. Participants will be recruited from Wits RHI clinical trial sites and catchment areas in the inner city of Johannesburg in the Republic of South Africa. CHW’s will travel in surrounding areas, a mobile unit is available with testing compartments, recruitment materials and potential advertising enabling successful recruitment. This will be approved by the IRB prior to use. Additional recruitment methods will be utilized such as outreach activities within the community, appearance at community events and at the local malls. Word-of-mouth recruitment. Participants should be encouraged to tell others about the study. Once participants have been identified through the different means of recruitment, they will be approached, informed about the study and the role they will play in the study procedure. The objectives, rationale, eligibility requirements and procedures of the study will be explained to the subjects and will highlight that participation is purely voluntary. Risks and benefits of participation in the study and the rights of participants in the study will also be discussed. Subjects will be encouraged to ask questions to ascertain their level of understanding. Participants that meet inclusion criteria will be scheduled and directed to the clinical research site.
After the consenting procedures, enrolment questionnaire and demographic data has been collected, the study participant will be invited into a private room and introduced to the clinical staff Observer, who will describe the motivation for understanding their self-testing process. The self-testing is to be completed under the direct observation of the study staff. During the study participant self-testing, the study staff will collect the following observational data for correct performance of the test.
After the study participant has completed the self-testing, they will be requested to provide their result to the staff Observer. This will be followed by the questionnaire and a brief interview of the participant by the Observer.
Following the completion of the study participant’s self-testing interpretation, the participant’s self-test result will be read by a trained user (the Observer) for independent verification of the study participant’s test result (within the timeframe recommended in the Instructions for Use).
Following the recommendations of the most recent Technical Specification Series TSS-1 from the WHO for HIV self-test evaluation, all self-test results will be confirmed using the South African National Confirmatory Testing Algorithm (see Appendix E). Following the self-test process completion, a finger stick sample will be obtained for the initial serial rapid tests. A venous whole blood specimen will be collected to establish the ELISA WB reference results for HIV-1 status for all participants.
Duration of Participant’s Study Participation and Total Study Duration
Each participant’s involvement in the study will last approximately 1 hour. The study enrolment is anticipated to occur during 3-4 months.
Statistical analysis
The questionnaires will be evaluated using descriptive statistics.
The positive agreement, negative agreement and overall agreement (total concordance), with their 95% confidence intervals, will be reported for the interpretation of the contrived test results. The agreement for invalid test interpretation, with 95% confidence intervals, will also be reported.
