3ie and Kenya’s National AIDS and STI Control Programme (NASCOP) collaborated to select six questions for formative research under phase 1 of the HIV Self-Testing Thematic Window.
These studies assessed the accuracy of self-test kits. They identified potential users, messaging to reach users as well as potential distribution outlets. These formative research studies also assessed packaging and labelling of self-test kits and explored how best to promote linkage to care and avoid potential social harms.
Findings from the formative research in the Republic of Kenya show that there is nearly universal interest in self-testing with some concern about access to counselling and linkage to care. The research suggests that linkage to care may be a challenge. Communication around sensitisation and awareness was desired both before and during the roll-out of HIV oral-self-tests. The formative research also shows that many people would like to get HIV oral self-tests from public health facilities but others also expect to find them in pharmacies, private health facilities, shops, and through the local government administration. Improved instructions in the packaging of HIV oral self-tests may help, but in person demonstration of usage may be necessary to increase use.
The results of the formative research indicate that there are still many unanswered questions regarding how HIV oral self-tests can best be used to increase overall testing rates and promote more frequent testing among specific populations.
The formative research study reports are available for download below the project summaries on this page.
To read more about 3ie’s Thematic Window 2, click here.
Accuracy of oral HIV self-tests in Kenya
Principal Investigators: Ann Elizabeth Kurth and Abraham Mosigisi Siika
Organisation: NYU College of Nursing and AMPATH Kenya
This study seeks to evaluate the ability of individuals with unknown HIV status to correctly perform and interpret a rapid oral HIV test correctly, and to determine the accuracy of HIV self-test results compared to staff and lab testing. The research team hypothesises that 1) key at-risk populations can accurately determine their oral HIV self-test results; 2) oral HIV self-test will be acceptable and feasible; and 3) the proportion of those whose preliminary oral self-test results are HIV positive, who are referred to care, and will attend clinic within one month post the HIV self-test confirmed result, will be the same level or higher than those who go for regular voluntary counselling and testing.
AMPATH clients from the following categories, will be recruited: HIV-discordant couples, men who have sex with men (MSM), and female sex workers , living in urban and rural settings. This sample size will have the power to detect key user errors in HIV self-testing steps, as well as the lower limit of clinically acceptable sensitivity and specificity of HIV self-test compared to gold standard testing. Study sites will include one urban and one rural clinic.
Insights into packaging and labelling for oral HIV self-test kits in Kenya
Principal Investigators: Petra Stankard, Olivier LeTouzé, and Meghann Jones
Organisation: Population Services International (PSI) and PSI/Kenya
This study will answer several questions related to packaging and labelling for oral HIV self-test kits in Kenya. Specifically, these questions will relate to the Government of Kenya’s existing and planned regulations and considerations regarding the packaging and labelling of medical products that are applicable to the oral self-test; considerations related to packaging and labelling for test kit manufacturers; and how packaging and labelling of the product can ensure accurate use of the self-test kits by intended users. The study will answer these questions by using qualitative methods in five target study populations including key policymakers and regulatory officers of the Government of Kenya, oral HIV test kit manufacturers, potential product distributors such as pharmacists and health care providers, potential self-test kit users, and packaging manufacturers. The study will take place both in an urban setting (Mombasa) and Siaya, a rural district of Nyanza province in the southwest of Kenya.
Insights into potential users and messaging for oral HIV self-test kits in Kenya
Principal Investigators: Rhoune Ochako
Organisation: Population Services International and PSI/Kenya
This study will use a mixed methods approach to conduct formative research among potential consumers to understand their specific motivations and incentives to use oral HIV self-tests. The study also seeks to learn what messaging and other methods might be effective for increasing the acceptability and demand for self-tests, particularly among at-risk populations. Study participants will include members of the general population and key populations at risk, specifically men who have sex with men (MSM) and female sex workers (FSW). Participants will be drawn from both urban and rural settings. The study will meet its objective in part through a structured survey conducted among adults in Mombasa and Siaya. The sample will include men and women. Additionally, exit interviews will be conducted among MSM and FSW at three existing drop-in centres in Mombasa. Quantitative research will be conducted with the aim to provide generalised knowledge on the profile of the potential consumers and the estimate of the potential market. The qualitative component will be used to add context and richness to quantitative findings.
Assessment of possible outlets for distribution of oral HIV self-tests in Kenya
Principal Investigators: Jerry Okal and Francis Obare
Organisation: Population Council
The overall goal of the project is to generate evidence that will inform the design and evaluation of programmes using oral HIV self-tests in Kenya. The specific objectives of the project are 1) to examine the possible outlets and/or networks for the distribution of oral HIV self-tests among potential users in Kenya and 2) to explore how the distribution of oral HIV self-tests through various channels can be organised to better meet the needs of potential users. To achieve these objectives, the research team will use a cross-sectional exploratory study involving quantitative and qualitative interviews with individuals from communities in Kisumu, Uasin Gishu, Nyandarua, and Kilifi Counties in Nyanza, Rift Valley, Central and Coast Provinces respectively, as well as individuals from organisations implementing HIV programmes in these sites and in Nairobi County. For the quantitative element of the study, a survey will be conducted among women and men of reproductive age (15-49 years for women and 15-54 years for men), public and private health facilities, and community-based service providers. For the qualitative approach, in-depth interviews will be conducted with representatives from community-based groups, key stakeholders and opinion leaders.
Exploring potentially effective methods for counselling and linkage to care in the context of HIV self-testing in Kenya
Principal Investigators: Wanjiru Mukoma and Nduku Kilonzo
Organisation: Liverpool VCT, Care and Treatment (LVCT)
This formative study will explore community and technology-based counselling strategies for linkages to prevention, care and treatment following self-testing. It will describe the feasibility of these strategies, their acceptability and uptake in order to identify those that would be most effective in the scale up of self-testing in Kenya. The study seeks to learn about the characteristics of people likely to take up self-testing, the counselling needs and preferred strategies of people taking up self-testing, the kinds of strategies that will support uptake of a confirmatory test after HIV self-testing results. The study also seeks to learn which models are likely to be effective for linkage and uptake of care for those who test HIV-positive in the context of self-testing. To achieve this objective, the study will employ a mixed-methods approach with a baseline and follow-up design, using qualitative and quantitative data collection techniques.
Understanding and preventing potential social harms and abuses of oral HIV self-testing in Kenya
Principal Investigators: Caroline W Kabiru and Chimaraoke Izugbara
Organisation: African Population and Health Research Center, Inc.
This study will adopt a mixed-methods design to assess the potential social harms and abuses associated with oral HIV self-testing among male and female adults aged (15-49 years) in urban and rural contexts in Kenya. The study will encompass 1) a comprehensive review of the literature on social harms associated with diagnostic self-testing; 2) a qualitative study to explore potential social harms that could emanate from self-testing in the study population and identify potential strategies to mitigate them; and 3) a quantitative study to evaluate the prevalence of perceived social harms identified in the qualitative study and the factors associated with social harm perceptions. In order to achieve this aim, the research team will conduct in-depth qualitative interviews and collect data among 484 individuals including men and women as well as young and adult residents in urban and rural areas.