In sub-Saharan Africa, home-based HIV testing is validated and accepted, but coverage is low because household members are often absent during home-based testing campaigns. We aimed to measure the effect of secondary distribution of oral-fluid HIV self-tests during home-based testing in rural Lesotho.
The Home-Based Self-Testing (HOSENG) trial was a cluster-randomised, non-blinded superiority trial in rural villages in the catchment area of 20 health facilities of two districts in Lesotho (Butha-Buthe and Mokhotlong). Eligible villages had a consenting village chief and at least one registered village health worker; eligible households had a consenting representative aged 18 years or older. The HOSENG trial provided a recruitment platform for the interlinked Village-Based Refill of Antiretroviral Therapy (VIBRA) trial. Villages were randomly assigned 1:1:1:1 with block sizes of four to one of four groups: VIBRA control and HOSENG control; VIBRA control and HOSENG intervention; VIBRA intervention and HOSENG control; and VIBRA intervention and HOSENG intervention. Randomisation was stratified by district, village size, and access to the nearest health facility. In the intervention group, oral-fluid HIV self-tests were left for absent or declining household members (aged ≥12 years) during a home visit from the HIV testing campaign team. One present household member was trained on self-test use. Distributed self-tests were followed up by village health workers. In control village clusters, absent or declining household members were referred to the clinic for HIV testing. The primary outcome was HIV testing coverage among all household members aged 12 years or older within 120 days, defined as a confirmed HIV test result or known status, reported in testing registers at the health facilities or on the follow-up forms of the village health worker. Adjusted random-effects logistic regression with individuals as the unit of analysis was used.
Secondary analyses included a mixed-method nested study among the adolescent study population (ADORE study: ADolescent ORal tEsting) and a costing study assessing the per patient costs of the intervention.
Results and discussion
Between July 26, 2018, and Dec 12, 2018, 3091 consenting households with 7816 household members aged 12 years or older were enrolled and randomly assigned (intervention: 57 village clusters, 1620 households, 4174 household members; control: 49 village clusters, 1471 households, 3642 household members). In the control group, 38 (3%) of 1455 initially absent or declining household members tested at a clinic within 120 days. In the intervention group, 841 (53%) of 1601 initially absent or declining household members had a confirmed status within 120 days; 12 (1%) of 841 tested at the clinic and 829 (99%) used their self-test kit. This resulted in a testing coverage of 2201 (60%) of 3642 in the control group versus 3386 (81%) of 4174 in the intervention group (odds ratio 3·00 [95% CI 2·52–3·59]; p<0·0001). Secondary distribution of oral-fluid HIV self-tests during home-based testing increases testing coverage substantially and thus presents a promising add-on during testing campaigns.
Among adolescents the intervention resulted in an absolute 36% increase in coverage. Distribution should, however, go along with clear instructions on the use of the self-tests and a possibility to easily access more personal support. Although the oral self-test is more expensive than the standard blood-based test, the costs per person tested were lower in the intervention than the control group due to the increased coverage.
Swiss National Science Foundation (IZ07Z0_160876/1; PCEFP3_181355; 323530_177576) & International AIDS Society (CIPHER grant)
ClinicalTrials.gov (NCT03598686), registered July 26, 2018
Study protocol: BMC Trials, 13 August 2019
Primary outcomes: The Lancet HIV, 09 October 2020
ADORE mixed-method nested study: JIAS, 31 August 2020
Costing study: The Frontiers in Medicine, 29 June 2021
The GET ON research project
Swiss TPH, 08.10.2020
Uni Basel, 10.10.2020
Podcast with The Lancet HIV, 06.11.2020
Editorial of The Lancet HIV, 09.10.2020