Community-based Distribution of Oral HIV Self-testing Kits: A pilot intervention and rapid impact evaluation

A new ancillary study to be nested in an on-going HPTN 071/PopART trial, and is planned to start on January 9, 2017. The aim of the HIV self-testing (HIVST) study is to evaluate whether the inclusion of oral HIV self-testing as an option for HIV testing in addition to the offer of HIV testing with a finger-prick blood sample through Community HIV Providers (CHiPs) increases the uptake of an offer of HIV-testing overall relative to an offer of HIV testing with a finger-prick blood sample alone. The  study will also examine whether the inclusion of oral HIV self-testing as an option for HIV testing increases the uptake of HIV-testing among specific sub-populations including men, adolescents, couples and individuals who recently moved into the community.

The inclusion of Self-testing study was approved by the Ethics committee on 18th November, 2016. This study funded by 3ie will be a cluster-randomized trial in 66 zones in four communities (Ndeke and Chimwemwe in Kitwe District, Chipulukusu in Ndola district and Makululu in Kabwe district). The 66 zones across the four communities will be randomized to one of the two arms:

Arm 1 – clients will be offered door to door home-based finger-prick HIV testing services with referral to HIV care and treatment or preventive services (including VMMC for HIV negative males)

 Arm 2 – clients will be offered door to door home-based offer of options for HIV testing: either an HIV Self-test OR home-based rapid finger-prick HIV testing. Referral to HIV care and treatment or preventive services (including VMMC for HIV negative males).

In PopART, there’s been a significant challenge to reaching the all of individuals using offer of door-to-door HIV testing services. This is particularly so among men and adolescents. With the currently available HIV testing services, there remains a gap in encouraging all individuals to test for HIV. In addition, there’s lack of evidence about whether the community-based distribution of oral HIV self-tests has an impact on uptake and linkage, and the incremental cost effectiveness of such a strategy relative the delivery of more traditional door-to-door HIV testing services.  HIV Self-testing will provide an option on the menu of HIV testing services being offered by the CHiPs and may HIV testing uptake among men, couple and adolescents.

The HIVST study will therefore provide process evaluation data on uptake of HIVST and linkage to care and other preventive services among adolescents and adults aged 16 years and above. The study is also expected to provide evidence on acceptability of HIVST and estimate the impact and incremental cost-effectiveness of providing individuals with self-testing services with PopART. The study will also demonstrate whether addition of community workers can enable higher uptake of testing, especially among the younger age groups and men.

The study is being carried out by Zambart and London School of Hygiene and Tropical Medicine. It will be nested within 4 PopART study communities in Zambia and will run for 6 months.