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Blood-based HIV self-testing: establishing evidence on feasibility and acceptability in high burden African countries


Author
Hatzold et al.

Publication year

Country
Multi-country

Type of approach
Community-based

Type of assistance
Directly assisted

Specimen
Fingerstick/whole blood, Oral-fluid

Study population
Mixed: Key populations (female sex workers, men who have sex with men), vulnerable populations (truckers) and general population (rural and urban areas)

Study design
Feasibility/acceptability

Sample size
n/a

UNAIDS HIV prevalence (2017)
n/a

Methodology
Several studies were combined in this project, including a willingness to pay study, observational accuracy study, and several feasibility and uptake studies. The willingness to pay study addressed the optimal pricing policies and distribution strategies for HIV self-testing (HIVST) using a field experiment to obtain “revealed preference” estimates of the likelihood that individuals will purchase oral fluid-based and blood-based HIVST at alternative prices in order to estimate the price sensitivity (or elasticity) of demand for self-tests. The proposed field experiment for HIVST estimated how demand for self-tests differs by certain distribution channels such as retail outlets, public sector health facilities, and other community-based venues. The study tested whether the provision of HIVST can be targeted more cost-effectively to reach high-risk persons and non-recent testers. The study developed a culturally-relevant set of materials, pictorial and distribution aides and instructions for use (IFUs) to support HIVST with blood based RDTs. Prior to the observational accuracy study, cognitive interviewing among 15-25 HIV-negative clients recruited at rural and urban HIV testing services (HTS) sites in Zimbabwe and Malawi was conducted to better understand comprehension of the IFUs and facilitate the most appropriate translation of text into the local languages. A demonstration video for both HIVST kits was also developed based on these findings. Recruitment was conducted through convenience sampling of HIV negative clients from New Africa House New Start Centre and its corresponding rural site. An observational accuracy studies for blood-based HIVST was performed among a total of 3000 participants accessing HTS offered at 1) a fixed HTS facility in an urban setting and 2) through mobile HTS outreach services offered in a rural setting and 3) to 100 adolescent participants aged 15-17 years recruited at a fixed HTS facility. Participants, who agreed to supervised self-testing received instructions for use (IFUs) leaflets in English and the local language. Participants were left alone to test and were video recorded undertaking the self-test. Participants noted their test results on a results card. After the participant conducted the HIV self-testing, a finger prick blood sample was taken by a trained provider and used for confirmatory rapid HIV testing using the standard national algorithm. When self-testing is complete, a nurse counsellor reviewed the results card and evaluated the test kit to determine if the self-test was performed correctly, and results read accurately. An interviewer-administered semi-structured post-test questionnaire was administered to collect information on self-testing materials, the self-testing experience, potential strategies to promote and support self-testing and to facilitate linkage to care, and potential safety or other concerns. Sensitivity, specificity, and predictive values were calculated, in order to determine the accuracy of test results obtained by the participant with HIVST. A field study among key populations including men who have sex with men, female and male sex workers and truck drivers was conducted to assess acceptability, uptake of blood-based rapid diagnostic test self-test kits using peer-delivered vouchers and evaluate linkage to care and treatment after HIVST. Men who have sex with men and male and female sex workers were also geographically and socially mapped in Karoi District/Mashonaland Central Province, Zimbabwe. Linkage to care and prevention using a telephone platform and automated SMS systems were also assessed. As participants were provided with self-test kits, they also received SMS messages that linked to informational telephone services. Users of the system were directed to the appropriate audio message according to the type of post-test service needed. The impact of secondary distribution of HIVST kits through respondent-driven sampling among men who have sex with men and sex workers was also completed. Participants were offered HIVST, and received information materials to support accurate self-testing, results interpretation, and linkage to appropriate post-test services. They received 2-5 voucher coupons for self-test kits which they can distribute among their peers. Easily accessible, community-based redemption sites were identified where those receiving vouchers redeemed them for a self-test kit and the package of support materials. All those who redeemed vouchers at the distribution points were given 2-5 voucher coupons to distribute to their own sexual and social networks. Two weeks after the kits were handed out, participants were contacted by phone and interviewed about self-test kit use, their experience and engagement in appropriate post-test services and whether they had distributed additional vouchers to their peers. In-depth interviews were conducted with truck drivers at various points along the major highways to explore views on how HIVST kits can be distributed. Truckers were asked about their preferences for distributors, distribution points, time of distribution and how use of kits among those who receive them can be documented, including views on use of the telephone application and views on secondary distribution of kits to their social and sexual networks. A mobile phone app was developed to track distribution of HIVST kits, document use of kits and linkage to post-test services among truckers. Distribution agents distributes HIVST at major truck stops, drop-in centres and clinics along the major highways. Truckers were encouraged to take a photo of the used test kit and share the photo via SMS/Whatapp with the study team. Truckers received information on post-test support services via SMS and linked to the service provider nearest to them.

Summary of findings
Forthcoming

Acceptability
n/a

Acceptability details
n/a

Willingness to pay
n/a

Willingness to pay details
n/a

Sensitivity
n/a

Specificity
n/a

Concordance
n/a

HIV positivity
n/a

Accuracy details
n/a

Social harm
n/a

Linkage to prevention, care and treatment
n/a

Source
n/a

Study status
Ongoing