Table 4.
Identified Gaps in Research on HIV Self-Testing
| Gaps | Comments | Recommendations | |
|---|---|---|---|
| 1 | Effect of self-testing on levels of uptake of first, repeat, and recent HIV testing | Evidence from studies from many countries that self-testing is highly acceptable. Evidence that there are already high levels of self-testing in African health workers. Unregulated self-test kits are widely available on the Internet, indicating a market for self-testing. Current indications suggest self-testing may be mainly used for the first test, and then by frequent repeaters. | Evaluation of uptake of ever-testing and recent testing should be assessed before implementation of self-testing programs and then monitored at workforce level. Methods to promote regular repeat testing an important issue to be explored in operational research. |
| 2 | Secondary beneficial effects of self-testing | Potential for personal empowerment, diminished HIV stigma associated with knowing one's status needs evaluation. | Qualitative research in representative and pilot sites would allow this to be assessed. |
| 3 | Secondary harmful effects of self-testing | Potential for greater psychological trauma compared to counselor-provided testing, and greater likelihood of inaccurate results from user error needs evaluation and failure to confirm result. | System for reporting serious adverse outcomes should be considered in representative or pilot sites. |
| 4 | Couples testing | There are currently no data on the acceptability and impact of couples self-testing. Ongoing study in Kenyan Health Workers considers this. | Operational research on couples self-testing is need to explore this potential approach. |
| 5 | Training, information, and counseling needed to ensure accuracy and minimize potential harm | Defining the essential components and how to provide them in ways that are effective but do not represent a disincentive will be an important part of operationalizing self-testing programs. | In practice will vary according to distribution strategy and population. |
| 6 | Quality assurance | Some studies have demonstrated a lower sensitivity with oral HIV testing as compared to blood-based testing. Current approach recommends confirmatory testing, but the acceptability of this and need for confirmation of negative results is not known. | Finger prick–based self-testing may be a consideration for future research. Current recommendations regarding confirmation of results should remain in place. Confirmation for repeat tests with no change in result may be less imperative. |
| 7 | Entry into HIV prevention/care services | Only assessed in participants in the USA Home Access service: qualitative research suggests high ability/willingness to accept results and seek entry into care once positive status is known. Other studies suggest that entry into care is lower with community-based testing as compared to clinic-based testing. Some reasons for this may be compounded with home self-testing. | Self-referral into prevention and/or care services should be promoted, with confirmatory testing at this point. Additional data are required to inform linkage to care, and how best to promote this within the context of self-testing. |
| 8 | Cost-effectiveness | Important to determine relative to other options once models are established. | Costs and cost-effectiveness studies are required. |
| 9 | Effect of cost on demand | Few data exist to determine acceptable costs for test kits, including for populations at highest risk, and who are unlikely to test through current testing strategies. | The most acceptable price or price range will vary by country and by populations within a given country. Topic for research |
| 10 | Marketing and distribution of self-testing | No data on what marketing or distribution strategies will attract populations at highest risk, and those who are unlikely to test through current testing strategies. | Topic for research |
| 11 | Systems for monitoring and tracking self-testing | Few data exist on optimal monitoring systems by which we can track who received a test, got results, made the linkage to prevention or care services, etc. Unique challenges for monitoring recruitment and retention at each step in the testing and treatment cascade for those testing without initial contact with a health provider. | The use of mHealth technologies should be explored to track self-testing and linkage to care. |
Abbreviation: HIV, human immunodeficiency virus.