The 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

Amstutz, Alain; Lejone, Thabo Ishmael; Khesa, Lefu; Muhairwe, Josephine; Nsakala, Bienvenu Lengo; Tlali, Katleho; Bresser, Moniek; Vanobberghen, Fiona; Kopo, Mathebe; Kao, Mpho; Klimkait, Thomas; Battegay, Manuel; Labhardt, Niklaus Daniel; Glass, Tracy R.

doi:10.1186/s13063-019-3469-2

Cited by 6 publications

(4 citation statements)

References 27 publications

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“…A home-based HIV testing campaign in the eligible villages, set up for an interlinked trial, called the HOSENG (Home-Based Self-Testing) trial [ 10 ], formed the recruitment platform for the VIBRA trial. The HOSENG trial assessed the secondary distribution of oral self-tests to household members absent or refusing to test during home-based testing.…”

Section: Methodsmentioning

confidence: 99%

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Offering ART refill through community health workers versus clinic-based follow-up after home-based same-day ART initiation in rural Lesotho: The VIBRA cluster-randomized clinical trial

Amstutz

Lejone²,

Khesa³

et al. 2021

PLoS Med

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Background Community-based antiretroviral therapy (ART) dispensing by lay workers is an important differentiated service delivery model in sub-Sahara Africa. However, patients new in care are generally excluded from such models. Home-based same-day ART initiation is becoming widespread practice, but linkage to the clinic is challenging. The pragmatic VIBRA (Village-Based Refill of ART) trial compared ART refill by existing lay village health workers (VHWs) versus clinic-based refill after home-based same-day ART initiation. Methods and findings The VIBRA trial is a cluster-randomized open-label clinical superiority trial conducted in 249 rural villages in the catchment areas of 20 health facilities in 2 districts (Butha-Buthe and Mokhotlong) in Lesotho. In villages (clusters) randomized to the intervention arm, individuals found to be HIV-positive during a door-to-door HIV testing campaign were offered same-day ART initiation with the option of refill by VHWs. The trained VHWs dispensed drugs and scheduled clinic visits for viral load measurement at 6 and 12 months. In villages randomized to the control arm, participants were offered same-day ART initiation with clinic-based ART refill. The primary outcome was 12-month viral suppression. Secondary endpoints included linkage and 12-month engagement in care. Analyses were intention-to-treat. The trial was registered on ClinicalTrials.gov (NCT03630549). From 16 August 2018 until 28 May 2019, 118 individuals from 108 households in 57 clusters in the intervention arm, and 139 individuals from 130 households in 60 clusters in the control arm, were enrolled (150 [58%] female; median age 36 years [interquartile range 30–48]; 200 [78%] newly diagnosed). In the intervention arm, 48/118 (41%) opted for VHW refill. At 12 months, 46/118 (39%) participants in the intervention arm and 64/139 (46%) in the control arm achieved viral suppression (adjusted risk difference −0.07 [95% CI −0.20 to 0.06]; p = 0.256). Arms were similar in linkage (adjusted risk difference 0.03 [−0.10 to 0.16]; p = 0.630), but engagement in care was non-significantly lower in the intervention arm (adjusted risk difference −0.12 [−0.23 to 0.003]; p = 0.058). Seven and 0 deaths occurred in the intervention and control arm, respectively. Of the intervention participants who did not opt for drug refill from the VHW at enrollment, 41/70 (59%) mentioned trust or conflict issues as the primary reason. Study limitations include a rather small sample size, 9% missing viral load measurements in the primary endpoint window, the low uptake of the VHW refill option in the intervention arm, and substantial migration among the study population. Conclusions The offer of village-based ART refill after same-day initiation led to similar outcomes as clinic-based refill. The intervention did not amplify the effect of home-based same-day ART initiation alone. The findings raise concerns about acceptance and safety of ART delivered by lay health workers after initiation in the community. Trial registration Registered with Clinicaltrials.gov (NCT03630549).

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Section: Methodsmentioning

confidence: 99%

“…We describe the process of cluster selection and randomization in detail in the published study protocols of the HOSENG trial [ 10 ] and the VIBRA trial [ 9 ].…”

Section: Methodsmentioning

confidence: 99%

Offering ART refill through community health workers versus clinic-based follow-up after home-based same-day ART initiation in rural Lesotho: The VIBRA cluster-randomized clinical trial

Amstutz

Lejone²,

Khesa³

et al. 2021

PLoS Med

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“…VHWs are the existing Lesotho Ministry of Health (MoH) lay community health worker network and are supervised by the corresponding health facility where they attend regular monthly meetings. The comprehensive details of the trial design and intervention are published elsewhere ( 9 , 20 ). Briefly, a trained team of 15 campaign counselors and three drivers conducted the 5-month door-to-door testing campaign and spent 1 to 2 days per village.…”

Section: Methodsmentioning

confidence: 99%

“…The HOSENG (HOme-based SElf-testiNG) cluster-randomized trial in rural Lesotho assessed the effect of the one-time secondary distribution of oral-fluid self-tests to absent and household members who refuse standard blood-based HIV testing during a home-based testing campaign on testing coverage. It resulted in 21% higher testing coverage compared to no secondary distribution, however without investigating the cost implications ( 9 ).…”

Section: Introductionmentioning

confidence: 99%

Reaching Absent and Refusing Individuals During Home-Based HIV Testing Through Self-Testing—at What Cost?

et al. 2021

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Introduction: In the HOSENG trial (NCT03598686), the secondary distribution of oral self-tests for persons absent or refusing to test during a home-based HIV testing campaign in rural Lesotho resulted in an increase in testing coverage of 21% compared to a testing campaign without secondary distribution. This study aims to determine the per patient costs of both HOSENG trial arms.Method: We conducted a micro-costing study to estimate the cost of home-based HIV testing with (HOSENG intervention arm) and without (HOSENG control arm) secondary self-test distribution from a provider's perspective. A mixture of top-down and bottom-up costing was used. We estimated both the financial and economic per patient costs of each possible testing cascade scenario. The costs were adjusted to 2018 US$.Results: The overall provider cost for delivering the home-based HIV testing with secondary distribution was US$36,481 among the 4,174 persons enumerated and 3,094 eligible for testing in the intervention villages compared to US$28,620 for 3,642 persons enumerated and 2,727 eligible for testing in the control. The cost per person eligible for testing was US$11.79 in the intervention vs. US$10.50 in the control. This difference was mainly driven by the cost of distributed oral self-tests. The cost per person tested was, however, lower in intervention villages (US$15.70 vs. US$22.15) due to the higher testing coverage achieved through self-test distribution. The cost per person confirmed new HIV+ was US$889.79 in the intervention and US$753.17 in the control.Conclusion: During home-based HIV testing in Lesotho, the secondary distribution of self-tests for persons absent or refusing to test during the visit reduced the costs per person tested and thus presents a promising add-on for such campaigns.Trial Registration:https://ClinicalTrials.gov/, identifier: NCT03598686

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“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

Amstutz

Kopo²,

Lejone³

et al. 2020

J Intern AIDS Soc

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Introduction Home‐based HIV testing fails to reach high coverage among adolescents and young adults (AYA), mainly because they are often absent during the day of home‐based testing. ADORE (ADolescent ORal tEsting) is a mixed‐method nested study among AYA in rural Lesotho, measuring the effect of home‐based secondary distribution of oral HIV self‐tests (HIVST) on coverage, as well as exploring how AYA perceive this HIV self‐testing model. Methods ADORE study was nested in a cluster‐randomized trial. In intervention village‐clusters, oral HIVST were left for household members who were absent or declined testing during a testing campaign. One present household member was trained on HIVST use. Distributed HIVST were followed up by village health workers (VHW). In control clusters no self‐tests were distributed. The quantitative outcome was testing coverage among AYA (age 12 to 24) within 120 days, defined as a confirmed HIV test result or known status, using adjusted random‐effects logistic regression on the intention‐to‐treat population. Qualitatively, we conducted in‐depth interviews among both AYA who used and did not use the distributed HIVST. Results From July 2018 to December 2018, 49 and 57 villages with 1471 and 1620 consenting households and 1236 and 1445 AYA in the control and intervention arm, respectively, were enrolled. On the day of the home‐visit, a testing coverage of 37% (461/1236) and 41% (596/1445) in the control and the intervention arm, respectively, were achieved. During the 120 days follow‐up period, an additional 23 and 490 AYA in control and intervention clusters, respectively, knew their status. This resulted in a testing coverage of 484/1236 (39%) in the control versus 1086/1445 (75%) in the intervention arm (aOR 8.80 [95% CI 5.81 to 13.32]; p < 0.001). 21 interviews were performed. Personal assistance after the secondary distribution emerged as a key theme and VHWs were generally seen as a trusted cadre. Conclusions Secondary distribution of HIVST for AYA absent or refusing to test during home‐based testing in Lesotho resulted in an absolute 36% increase in coverage. Distribution should, however, go along with clear instructions on the use of the HIVST and a possibility to easily access more personal support.

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The 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

Cited by 6 publications

References 27 publications

Offering ART refill through community health workers versus clinic-based follow-up after home-based same-day ART initiation in rural Lesotho: The VIBRA cluster-randomized clinical trial

Offering ART refill through community health workers versus clinic-based follow-up after home-based same-day ART initiation in rural Lesotho: The VIBRA cluster-randomized clinical trial

Reaching Absent and Refusing Individuals During Home-Based HIV Testing Through Self-Testing—at What Cost?

“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

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