HOSENG trial – Effect of the provision of oral self-testing for absent and refusing individuals during a door-to-door HIV testing campaign on testing coverage: protocol of a cluster randomized clinical trial in rural Lesotho

Abstract

BACKGROUND HIV testing coverage remains below the targeted 90% despite efforts and resources invested. Home-based HIV testing is a key approach endorsed by the World Health Organization (WHO), especially to reach individuals who might not seek testing otherwise. Although acceptance of test-ing during such campaigns is high, coverage remains low due to absent household members. This cluster-randomized trial aims to assess increase in testing coverage using oral HIV self-testing (HIVST) among individuals who are absent or decline testing during home-based HIV testing. METHODS The HOSENG (HOme-based SElf-testiNG) trial is a cluster-randomized, parallel group, superiority trial in two districts of Lesotho, Southern Africa. Clusters are stratified by district, village size, and village access to the nearest health facility. Cluster eligibility criteria include: village is in catchment area of one of the study facilities, village authority provides consent, and village has a registered, capable and consenting village health worker (VHW). In intervention clusters, HIV self-tests are provided for eligible household members who are absent or decline HIV testing in presence of the campaign team. In control clusters, standard of care for absent and refusing individuals applies, i.e. referral to health facility. The primary outcome is HIV testing coverage among individuals 12 years and older within 120 days after enrolment. Secondary objectives include HIV testing coverage among other age groups, and uptake of the different testing modalities. Statistical analyses will be conducted and reported in line with CONSORT guidelines. HOSENG trial is linked to VIBRA (Vil-lage-Based Refill of ART) trial. Together, they constitute the GET ON (GETting tOwards Ninety) research project. DISCUSSION The HOSENG trial tests if oral HIVST may be an add-on during door-to-door testing campaigns towards achieving optimal testing coverage. The provision of oral self-test kits, followed up by VHWs, requires little additional human resources, finances and logistics. If cost-effective, this approach will inform home-based HIV testing policies not only in Lesotho, but in similar high-prevalence settings. TRIAL REGISTRATION This trial has been registered at clinicaltrials.gov (NCT03598686) on July 25, 2018. More information under www.getonproject.wordpress.com.

“If it is left, it becomes easy for me to get tested”: Use of oral self‐tests and community health workers to maximize the potential of home‐based HIV testing among adolescents in Lesotho

“…An independent statistician was responsible for the computer‐generated randomization list. The study protocol of HOSENG including the nested study ADORE has been published [13]. In short, the trial assessed the increase in HIV testing coverage in intervention clusters through secondary HIVST distribution for household members absent or refusing to test during the day of the home‐based testing campaign compared to control clusters, where no HIVST were distributed during the home‐based testing campaign.…”

“…Recruitment lasted for five months. Details about data collection are published elsewhere [13]. The quantitative outcome of ADORE study was testing coverage among AYA (age 12 to 24) within 120 days after home‐based testing, defined as the proportion of all individuals aged 12 to 24 years living in a household of the surveyed area with a confirmed HIV test result.…”

“…One approach to increase testing coverage using oral HIVST may be its secondary distribution for household members not present during a home‐based testing campaign. The HOSENG (HOme‐based SElf‐testiNG) trial assessed the increase in testing coverage through secondary HIVST distribution to household members, all ages, absent or refusing to test during a home‐based testing campaign in rural Lesotho [13]. Overall, 58% of HIVST distributed were used and returned within 120 days, resulting in an overall HIV testing coverage of 81%, more than 20% higher than in the standard of care arm where no HIVST were distributed [14].…”

Linkage to care and treatment among men with reactive HIV self-tests after workplace-based testing in Uganda: A qualitative study

“…Several studies report recurring challenges in ascertaining and confirming HIVST results (11), and linking individuals to HIV treatment and care following a reactive self-test result (12). While studies have reported high uptake of HIVST in other populations (13)(14)(15)(16)(17), linkage to care and measurement of linkage following HIV self-testing remains a challenge (18). We implemented a qualitative study embedded in a clinical trial, to inform the design of future workplace HIV self-testing linkage initiatives, (ClinicalTrials.gov Identifier: NCT04164433) (19).…”

Effect and cost of two successive home visits to increase HIV testing coverage: a prospective study in Lesotho, Southern Africa

“…Moreover, the recent initiative of male-friendly clinics where male health care workers provide services has shown some first promising results [29]. Another approach may be to leave for household members who are absent an oral self-test kit [30]. As for men, it was also difficult to reach school-aged children.…”