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

doi:10.21203/rs.2.211/v1

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Method Article

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

https://doi.org/10.21203/rs.2.211/v1

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published 13 Aug, 2019

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BACKGROUND: HIV testing coverage remains below the targeted 90% despite efforts and resources invested into testing in sub-Saharan Africa. Home-based HIV testing is a key approach endorsed by the World Health Organization, especially to reach individuals who might not seek testing otherwise. Although acceptance of testing during such campaigns is high, coverage remains low due to absent house-hold members. This cluster-randomized trial aims to assess increase in testing coverage using oral HIV self-testing 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. 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 of age 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 (Village-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 international settings.

TRIAL REGISTRATION: This trial has been registered at clinicaltrials.gov (NCT03598686) on July 25, 2018. More information under www.getonproject.wordpress.com.

KEYWORDS: HIV, cluster randomized controlled trial, village health worker, community health worker, community-based, self-testing, HIV testing coverage, Lesotho, Southern Africa, implementation research.

General Medicine

HIV

cluster randomized controlled trial

village health worker

community health worker

community-based

self-testing

HIV testing coverage

Lesotho

Southern Africa

implementation research

The UNAIDS has shown a way forward in controlling and finally ending the deadly AIDS epidemic by launching the 90-90-90 strategy.¹ Globally, in 2017, progress towards the first UNAIDS target, i.e. that 90% of people living with HIV are aware of their status, was lower than other stages of the HIV care cascade.² Most recent data from Eastern and Southern Africa show that the percentage of people living with HIV who know their HIV status has steadily improved in the last years, currently at a level of 81% (64%-95%), but still leaving a gap of approximately 1.7 million HIV-positive people to reach the target of 90% knowing their HIV status.^3,4 In order to reach the first UNAIDS target, home-/community-based testing, i.e. HIV testing close to where people live or work, is a key strategy endorsed by World Health Organization (WHO).^5,6 Many studies from Southern Africa, including Lesotho, have shown that home-based HIV testing is highly promising for closing the crucial gap to achieve the first 90.⁷ Yet, it is critical to distinguish between the principal acceptance (uptake) of HIV testing and the HIV testing coverage. While in most cases the former is above 90%, the coverage often remains below 90% due to household members that are absent at the time of the campaign, mainly men and young adults – both of which have a disproportionately high risk of HIV acquisition and poorer clinical outcomes.⁸

HIV self-testing (HIVST) has shown to be an accurate diagnostic tool with high acceptance rates, is feasible in sub-Saharan Africa, increases uptake of HIV testing, facilitates linkage to care among target-populations, and may be more cost-effective than provider-delivered HIV testing.^9–17 Thus, WHO strongly endorses oral HIVST.¹⁸ In a WHO review, 16 countries reported having a policy supportive of HIVST, including Lesotho.^19,20

However, to date only limited data are available, assessing the effect of oral HIVST in increasing HIV testing coverage. This randomized controlled trial thus aims to determine the added effect of distributing oral HIVST to absent individuals or individuals refusing to test during a campaign for home-based HIV testing on HIV testing coverage.

1.1 Procedure

Two to three specifically trained teams, each consisting of 5-6 lay-counsellors, 1 campaign organizer and 1 supervising study nurse will visit all households in selected villages, going from door to door. The teams will propose HIV testing and counselling and multi-disease screenings and prevention. The population of the selected areas are informed about the campaign beforehand by their village chief. Specifically, the campaign team will arrive in the village in the morning, meet with the village chief and then start systematically visiting all households in the pre-defined area by going from door to door. At the household, the teams will proceed as follows:

The counselor will introduce him-/herself and the purpose of the testing/screening campaign
The counselor will ask the head of household or the representative (aged 18 years and older) for written informed consent to the testing/screening campaign, and to obtaining data about present and absent household members for study purpose
1. If the head of household or the representative refuses his/her household participation, the team will leave the house, record the refusal reason, and proceed to the next household
The counselor will assess the total number of present and absent household members
1. Definition of household member: 1) is acknowledged by the household head or the representative as part of the household and 2) sleeps in the household regularly (at least once a month) and 3) if absent during the campaign: returns to the household no later than three months after the date of home-visit
The counselor will provide information about HIV and testing, prevention aspects, and the other disease screenings (see below)
The counselor will assess the HIV status of all household members and screen the patients’ health booklets (“bukana”)
Household members who are eligible for and consent to testing (by filling in the Lesotho national informed consent form for HIV testing) undergo HIV testing by the counselor according to specific cluster arm allocation procedure and according to national HIV testing guidelines.²⁰ For absent or declining household members, the specific procedures differs between the two cluster arms, and are described in detail below in the section on intervention clusters. Figure 2 presents all possible HIV testing scenarios during the campaign.
1. Once the HIV test is done, the counselor documents the result in the patients’ health booklet and provides post-test counseling. If the HIV test is confirmed positive, the counselor contacts the study nurse, who then provides further counseling and assesses the participant for enrolment into the inter-linked follow-up study (VIBRA trial).

The HIV testing campaign is combined with additional multi-disease screening. The campaign screens for tuberculosis (TB) according to national guidelines using the clinical symptom screening tool.²³ If TB is suspected, one sputum sample is collected on spot, transported to the health facility the same day by the campaign team for testing with GeneXpert. Another sputum bottle for collecting a morning sample is left behind, the individual is instructed how to use it and a follow-up plan for collection (i.e. collection by VHW) is agreed upon. Further campaign services include alcohol abuse screening using the CAGE questionnaire²⁴, information and referral of males aged 15-50 years old (HIV-negative and -positive due to stigma reasons) for voluntary medical male circumcision (VMMC) according to WHO recommendations²⁵, and promotion and provision of male condoms. Figure 3 presents the overview of the HIV and multi-disease campaign and its algorithm.

1.1.1 Intervention clusters

Figure 4 summarizes the procedures in the HOSENG clusters and Figure 5 the SPIRIT flow diagram. In the intervention clusters, the campaign team will leave an oral HIV self-test (HIVST) kit (OraQuick® ADVANCE HIV I/II) for every household member 12 years or older who is absent or declined HIV testing on the day of the campaign. We chose 12 years as threshold because adolescents are an important risk group and this is the legal age for providing HIV testing consent in Lesotho.²³ The household can refuse to have an oral HIVST left behind for their absent household members. The oral HIVST kit is prepacked, includes a written and pictoral instruction for use in the local language, Sesotho, and the package is labelled with a written request to consult the VHW within 2 weeks after use of the test – irrespective of the result. In cases where more than one trained VHW serves the village, the household will be asked for the VHW of choice. The team will label the kit with the name of the absent member before dispensation.

One household member – the one with the closest relation to the absent person(s) – will be tested and trained using the oral HIVST. All other present household members are tested using the standard blood-based point-of-care HIV test according to Lesotho national guidelines.²⁰

The VHWs in the intervention custers will receive a list of all household members that were absent or refused to test and, hence, for whom an oral HIVST was dispensed. The VHW will visit all households 2-4 weeks after the campaign to collect the oral HIVST in case the oral HIVST was not returned to him/her. If an oral HIVST is reactive, the VHW will either provide further blood-based testing on the spot or organize referral to the nearby health facility for confirmatory testing. All VHWs from intervention clusters will receive a second extensive training about oral HIVST, handling disclosure and stigma, and data entering on paper-based study forms and the patients health booklet.

1.1.2 Control clusters

Following standard of care during home-based HIV testing, every absent household member or those declining HIV testing will be encouraged to get an HIV test done by the VHW or the nearby health facility. The research team will screen the registers at the health facilities in order to assess if these individuals came for testing in the timeframe of the primary endpoint window.

1.2 Endpoints

The primary endpoint is HIV testing coverage among individuals aged 12 years or older in the surveyed area within 120 days after the home visit, defined as the proportion of all individuals 12 years or older living in a household of the surveyed area with a confirmed HIV test result.

We define a confirmed HIV-negative result as either being tested HIV-negative as per the algorithm defined in Figure 2, or being tested HIV-negative within the last 4 weeks with proof of documentation (i.e. documentation in patients’ health booklet). We define a confirmed HIV-positive result as a) tested HIV-positive as per the algorithm defined in Figure 2, or b) being tested HIV-positive but not yet on antiretroviral therapy (ART) with proof of documentation, or c) being on ART with proof of documentation.

The rationale for the time-point of 120 days is that we leave oral HIVST kits at the households for all absent household members aged 12 years or older who return within a maximum of 3 months (see definition of household member above in section Procedure). An interval of 120 days after home visit allows sufficient time for absent members to return to their households, conduct self-testing, and be followed up by the VHW.

The secondary endpoints are outlined in Table 2.

1.3 Additional research within the project

For the entire GET ON project we will collect cost data, see more details in the VIBRA trial protocol published elsewhere. Thus, we will be able to perform a cost-effectiveness analysis of the HOSENG intervention.

A nested study (ADORE study: “ADolescent ORal sElf-testing”) will explore the efficacy of oral HIVST among adolescents and young adults, including a qualitative case-control study.

1.4 Data collection and management

The campaign team will capture all data collected during the campaign using a tablet-based application and platform (MACRO, Elsevier). The randomization assignment of the villages is pre-loaded into the program and a unique household identifier is automatically generated. Before leaving the household, the completed questionnaire will be checked for mistakes and completeness. Data from the tablet devices will be uploaded regularly via secure electronic transfer and stored on a secure server at the Swiss Tropical and Public Health Institute (Swiss TPH). The informed consent forms will be stored in a secure way in the headquarter of the study center (SolidarMed Office in Butha-Buthe, Lesotho). Participant files will be maintained in storage for a period of at least 10 years after completion of the trial.

The VHWs enter data for following up the dispensed oral HIVST kits on standardized paper study forms (Case Report Forms), that act as source documents. These data will be collected regularly by the study team and entered into the above mentioned platform. A study data manager will monitor data quality and completeness on a weekly basis. Queries about the data will be sent to the local principal investigators for follow-up and correction, as needed. Data integrity checks will be written into the database to limit missing fields or the entry of incorrect data. The type of activity that an individual user in the online study database may undertake, will be regulated by the privileges associated with his/her user identification code and password.

1.5 Sample-size

The sample size is driven by the VIBRA trial. We assume to achieve the VIBRA trial sample size (minimum 262 HIV-positive individuals not on ART) by testing about 10’000 individuals in 100 villages, based on a previous trial.²⁶ According to a previous home-based HIV testing campaign²⁷, we estimate an HIV testing coverage rate of individuals 12 years or older in rural villages of 63%. We consider a 15% increase in coverage as relevant from a policy perspective. Using an intra-cluster correlation of 0.028, with a sample of 100 clusters, we will have >90% power to detect an increase in coverage rates to 78% or higher.

1.6 Analyses

Analyses will be performed following CONSORT guidelines for cluster-randomized trials.²⁸ Clusters will be set as unit of randomization (stratified by district, size of village, and village access to the nearest health facility), whereas individuals are set as unit of analysis. An intention-to-treat set will be used, i.e. all study participants will be evaluated according to arm assignment at randomization. The primary analysis will use a multi-level logistic regression model to assess the difference between HIV testing coverage in the intervention versus control arm, adjusted for a) the pre-specified randomization stratification factors, b) clustering according to village and c) other baseline factors found to be randomly unbalanced between intervention and control clusters.

Baseline characteristics will be presented according to randomized groups; no formal testing will be performed. Categorical variables will be described with absolute and relative frequencies and continuous variables with medians and interquartile ranges. As with the primary analysis, secondary endpoints will be analyzed with multi-level logistic regression models. All results will be presented as odds ratios and 95% confidence intervals. The effect of sociodemographic determinants (age groups, gender, education status, employment status, HIV testing history) on the primary endpoint will be assessed in subgroup analyses. Sensitivity analyses will be conducted in order to provide evidence that the result seen from the primary analysis are robust. These analyses will focus on the deviations in model assumptions. All analyses will be done using Stata (version 14, Stata Corporation, Austin/Texas, USA). For all tests, we will use 2-sided p-values with alpha 0.05 level of significance.

1.7 Monitoring, auditing, and data safety and monitoring board

At least one external monitoring visit will assess adherence to the approved trial protocol, accuracy of completed study forms, and the electronic dataset. The Principal Investigator agrees to allow inspectors from regulatory agencies to review records and will assist the inspectors in their duties, if requested.

HOSENG trial represents implementation research and the oral HIVST is a well-established diagnostic tool. Thus, we do not expect serious adverse effects (SAE) on patients’ health from this intervention. However, for the purpose of this trial, we will try to capture the following SAEs: a) Death due to any reason (especially within 30 days of a positive HIVST results), b) Hospitalisation due to self-inflicted injuries within 30 days of a positive HIVST results, and c) Hospitalisation resulting from violent assault by others (intimate partner violence, assault by family or community members) within 30 days of a positive HIVST result. A separate, detailed safety monitoring plan has been developed to handle these SAEs in line with Swiss and Basotho ethics regulations. It is not planned to establish a data safety and monitoring board.

HIV testing constitutes the front door to reach the UNAIDS 90-90-90 targets.²⁹ Home-based HIV testing campaigns have shown to be very effective in achieving high testing uptake, especially in resource-limited countries.⁷ However, one major question is still unanswered: How to reach the absent people during these campaigns in a cost-effective way?

During the CASCADE trial, we visited close to 7000 households in rural and semi-rural areas to provide home-based HIV testing. We assessed testing coverage achieved through home-based HTS. We hypothesized that many individuals will be absent when home-based HTS is done during a weekday. The testing team thus visited each village twice - a first visit during a workday and a second visit to reach household members during the weekend who were absent during the workday. HIV testing coverage was 63% after the first visit and increased to 71% after the second visit. A coverage of 71% is, however, still short of the targeted 90% testing coverage and was only achieved using significant resources.

The HOSENG trial tests if oral HIVST may be an effective add-on during door-to-door testing campaigns towards achieving optimal testing coverage. Linkage to further testing and care after usage of oral HIVST will be provided by the VHWs, a trusted and long-standing public-sector cadre. VHW programs exist in all countries of Southern Africa and are being expanded. If cost-effective, this approach could easily be scaled up in the region, as the provision of oral self-test kits, followed up by VHWs, requires little additional human resources, finances and logistics. It will inform home-based HIV testing policies not only in Lesotho, but in similar international settings. However, we will have to closely monitor the linkage after testing and the additional burden of work for the VHWs.

Currently, UNITAID invests $23 million into a four-year research initiative, called STAR, to gather evidence and catalyse the market for HIVST, and eventually improve testing coverage through HIVST in three African countries (Malawi, Zambia, and Zimbabwe).³⁰ Whereas the STAR trials assess HIVST on a large scale, the HOSENG trial will focus on the use of oral HIVST during home-based HIV testing campaigns. As such, its result will be complementary to the findings of the STAR project.

ART	Antiretroviral Therapy
HIV	Human Immune Deficiency Virus
HIVST	HIV self-test/ing
HOSENG	HOme-based SElftestiNG
HTS	HIV testing and services
GET ON	GETting tOwards Ninety
ICMJE	International Committee of Medical Journal Editors
VIBRA	Village-Based Refill of ART
ADORE	ADolescent ORal sElf-testing
SAE	Serious Adverse Events
Swiss TPH	Swiss Tropical and Public Health Institute
TB	Tuberculosis
UNAIDS	United Nations Programme on HIV/AIDS
VHW	Village Health Worker
VMMC	Voluntary Medical Male Circumcision
WHO	World Health Organization

6 Trial status and recruitment

The trial has been launched on July 26, 2018 in both study districts. The recruitment time is driven by VIBRA trial, as HOSENG trial is the main recruitment platform for the VIBRA trial. We assume a recruitment period of 6-8 months.

6.1 Ethics approval and consent to participate

This trial has been approved by the National Health Research and Ethics Committee of the Ministry of Health of Lesotho (ID06-2018) and the Ethics committee in Switzerland (Ethikkomission Nordwest- und Zentralschweiz; 2018-00283).

Before cluster-randomization and trial start, the study team obtains verbal consent from all involved village chiefs by attending the village chiefs’ councils and presenting the project. On the day of the HIV testing campaign, the counsellors obtain a written consent from the household head (or representative aged 18 years or older), to collect household data and to propose HIV testing to all household members. Allocation to cluster arm is concealed at the household level in order to keep the risk of selection bias as low as possible. IIliterate participants will provide a thumb print and a witness (independent to the trial and >21 years old), chosen by the participant, will co-sign the form. The informed consent is provided in the local language, Sesotho, and the participant will receive a copy of the consent forms. The household head has the right to withdraw consent at any time without giving reasons. In case of withdrawal, only data collected until the time of withdrawal will be used for research purposes (fully anonymized, identifier removed).

If the household consents to participate, then the counselors obtain from each household member written informed consent for HIV testing, following national HIV testing guidelines and using the national HIV testing form.²⁰ According to national guidelines individuals aged 12 years or older can consent to HIV testing. For younger individuals a witness has to sign the national testing form. For HIVST no written consent will be obtained as the act of self-testing itself represents consent. Individual consent for interventions/screenings other than HIV testing, such as referral for VMMC, is obtained using standard procedures according to national guidelines as these are considered part of the routine delivery of HIV prevention services and not specifically study-related.

Results of this research project will be shared at three levels: At district level, national level, and on an international level, by presenting at conferences and publication in peer-reviewed journals. The current version of the International Committee of Medical Journal Editors (ICMJE) recommendations³¹ is applicable regarding authorship eligibility and the use of professional writers is not intended.

6.2 Consent for publication

Not applicable

6.3 Availability of data and materials

The datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.

6.4 Competing interests

The Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, under the lead of MB receives unrestricted education and research grants from Gilead, MSD, Janssen, and ViiV. All other authors declare that they have no competing interests.

6.5 Funding

This trial is predominantly funded by a grant from the Swiss National Science Foundation (Grant Number IZ07Z0_160876/1) and the Eccellenza Professorship Grant of the Swiss National Science Foundation (Grant Number PCEFP3_181355), both obtained by NDL. AA receives his salary through a grant from the MD-PhD programme of the Swiss National Science Foundation (Grant number 323530_177576). Further funding came from a grant of the Stiftung für Infektiologie beider Basel, obtained by NDL. Funding for the nested study (ADORE study) was made possible by a CIPHER grant from the International AIDS Society, obtained by AA. The Swiss TPH acts as sponsor of the study. The study is embedded in the SolidarMed country programme and thus benefits from logistics and human resources from SolidarMed Lesotho.

The funding sources have no role in the design of the study, and will not be involved in data collection, data analysis, interpretation of the results and writing of the manuscript.

6.6 Author’s contribution

TRG is the Principal Investigator of this trial. AA, JM, LK, NDL, TIL and TRG conceived and designed the trial. BLN, FV, MB, MBa, MK, MKa were involved in critical revision of the article for important intellectual content. TK and KT provide laboratory expertise. All authors read, revised, and approved the final manuscript.

6.7 Acknowledgements

We would like to recognize the hard work and valuable contributions of the entire study staff in both districts, as well as the data management team at Swiss TPH for their assistance. We thank the participating health facilities and laboratory personnel for their dedication to research, and we gratefully acknowledge the study participants.

90-90-90 An ambitious treatment target to help end the AIDS epidemic. UNAIDS/JC2684 (accessed 30th October 2014 at www.unaids.org) 2014. http://www.unaids.org.
UNAIDS data 2018. http://www.unaids.org/sites/default/files/media_asset/unaids-data-2018_en.pdf. Accessed September 23, 2018.
UNAIDS. Joint United Nations Programme on HIV/AIDS (UNAIDS). ENDING AIDS - Progress Towards the 90-90-90 Targets. GLOBAL AIDS UPDATE 2017. http://www.unaids.org/sites/default/files/media_asset/Global_AIDS_update_2017_en.pdf. Accessed July 24, 2017.
UNAIDS. Prevention Gap Report. 2016. http://www.unaids.org/sites/default/files/media_asset/UNAIDS_Gap_report_en.pdf. Accessed April 10, 2016.
WHO. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection; Recommendations for a public health approach - Second edition June 2016. http://apps.who.int/iris/bitstream/10665/208825/1/9789241549684_eng.pdf?ua=1. Accessed October 3, 2016.
WHO. Consolidated guidelines on HIV testing services. http://apps.who.int/iris/bitstream/10665/179870/1/9789241508926_eng.pdf?ua=1&ua=1. Accessed August 8, 2017.
Labhardt ND, Motlomelo M, Cerutti B, Pfeiffer K, Kamele M, Hobbins MA, Ehmer J. Home-Based Versus Mobile Clinic HIV Testing and Counseling in Rural Lesotho: A Cluster-Randomized Trial. PLoS Med. 2014;11:e1001768.
Sharma M, Ying R, Tarr G, Barnabas R. A systematic review and meta-analysis of community and facility-based approaches to address gaps in HIV testing and linkage in sub-Saharan Africa. Nature. 2015;528(7580):S77-S85. doi:10.1038/nature16044
Mugo PM, Micheni M, Shangala J, et al. Uptake and Acceptability of Oral HIV Self-Testing among Community Pharmacy Clients in Kenya: A Feasibility Study. PLOS ONE. 2017;12(1):e0170868. doi:10.1371/journal.pone.0170868
Mokgatle MM, Madiba S. High Acceptability of HIV Self-Testing among Technical Vocational Education and Training College Students in Gauteng and North West Province: What Are the Implications for the Scale Up in South Africa? PLOS ONE. 2017;12(1):e0169765. doi:10.1371/journal.pone.0169765
Masters SH, Agot K, Obonyo B, Napierala Mavedzenge S, Maman S, Thirumurthy H. Promoting Partner Testing and Couples Testing through Secondary Distribution of HIV Self-Tests: A Randomized Clinical Trial. PLOS Med. 2016;13(11):e1002166. doi:10.1371/journal.pmed.1002166
Pant Pai N, Sharma J, Shivkumar S, et al. Supervised and Unsupervised Self-Testing for HIV in High- and Low-Risk Populations: A Systematic Review. Weiser SD, ed. PLoS Med. 2013;10(4):e1001414. doi:10.1371/journal.pmed.1001414
Napierala Mavedzenge S, Baggaley R, Corbett EL. A Review of Self-Testing for HIV: Research and Policy Priorities in a New Era of HIV Prevention. Clin Infect Dis Off Publ Infect Dis Soc Am. 2013;57(1):126-138. doi:10.1093/cid/cit156
Choko AT, MacPherson P, Webb EL, et al. Uptake, Accuracy, Safety, and Linkage into Care over Two Years of Promoting Annual Self-Testing for HIV in Blantyre, Malawi: A Community-Based Prospective Study. Bangsberg DR, ed. PLoS Med. 2015;12(9):e1001873. doi:10.1371/journal.pmed.1001873
Cambiano V, Ford D, Mabugu T, et al. Assessment of the Potential Impact and Cost-effectiveness of Self-Testing for HIV in Low-Income Countries. J Infect Dis. 2015;212(4):570-577. doi:10.1093/infdis/jiv040
Choko AT, Desmond N, Webb EL, et al. The Uptake and Accuracy of Oral Kits for HIV Self-Testing in High HIV Prevalence Setting: A Cross-Sectional Feasibility Study in Blantyre, Malawi. Bangsberg DR, ed. PLoS Med. 2011;8(10):e1001102. doi:10.1371/journal.pmed.1001102
Johnson CC, Kennedy C, Fonner V, et al. Examining the effects of HIV self-testing compared to standard HIV testing services: a systematic review and meta-analysis. J Int AIDS Soc Vol 20 No 1 2017. 2017. http://www.jiasociety.org/index.php/jias/article/view/21594.
World Health Organization. Guidelines on HIV Self-Testing and Partner Notification: Supplement to Consolidated Guidelines on HIV Testing Services. http://apps.who.int/iris/bitstream/10665/251655/1/9789241549868-eng.pdf. Published 2016. Accessed March 9, 2017.
Country policy review on HIV self-testing - Guidelines on HIV Self-Testing and Partner Notification: Supplement to Consolidated Guidelines on HIV Testing Services - NCBI Bookshelf. https://www.ncbi.nlm.nih.gov/books/NBK401685/. Accessed August 17, 2017.
LESOTHO. 2016 HTS GUIDELINES. FINAL May 2016.pdf.
LePHIA report 2016-2017_summary sheet. https://phia.icap.columbia.edu/wp-content/uploads/2018/02/Lesotho-Summary-Sheet_A4.2.7.18.HR_.pdf. Accessed August 27, 2018.
Bowen P, Govender R, Edwards P. Validating survey measurement scales for AIDS-related knowledge and stigma among construction workers in South Africa. BMC Public Health. 2016;16. doi:10.1186/s12889-016-2756-z
Lesotho 2016 National ART Guidelines. http://www.hivpolicywatch.org/duremaps/data/guidelines/LesothoARTGuidelinesAllChaptersandAnnex2016.pdf. Accessed September 15, 2016.
CAGE. https://pubs.niaaa.nih.gov/publications/inscage.htm. Accessed January 6, 2018.
WHO. New Data on Male Circumcision and HIV Prevention: Policy and Programme Implications. 2007. http://apps.who.int/iris/bitstream/10665/43751/1/9789241595988_eng.pdf. Accessed January 6, 2018.
Labhardt ND, Ringera I, Lejone TI, et al. Effect of Offering Same-Day ART vs Usual Health Facility Referral During Home-Based HIV Testing on Linkage to Care and Viral Suppression Among Adults With HIV in Lesotho: The CASCADE Randomized Clinical Trial. JAMA. March 2018. doi:10.1001/jama.2018.1818
Labhardt ND, Ringera I, Lejone TI, Muhairwe J, Fritz C, Klimkait T, Glass TR. “The first 90”: how close can we get with home-based HIV testing? First results from recruitment for the CASCADE trial in rural Lesotho. In: Abstracts of the HIV Glasgow Supplement, Journal of the International AIDS Society 2016. Glasgow UK; 2016. http://jiasociety.org/index.php/jias/issue/view/1485.
Campbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345. doi:10.1136/bmj.e5661
Iwuji C, Newell M-L. HIV testing: the ‘front door’ to the UNAIDS 90–90–90 target. Public Health Action. 2017;7(2):79. doi:10.5588/ijtld.17.0046
STAR. Brochure_July2016.pdf. http://hivstar.lshtm.ac.uk/files/2016/08/STARBrochure_July2016.pdf. Accessed May 26, 2017.
ICMJE | Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals. http://www.icmje.org/recommendations/. Accessed September 11, 2017.

Table 1. Cluster and household eligibility criteria for HOSENG trial

		*Inclusion Criteria*	*Exclusion Criteria*
	Cluster eligibility
1		The cluster is rural and clearly confined to the catchment area of one of the study clinics a. Note: one cluster usually consists of one village, but could include several small villages if serviced by the same VHW	The village authority (=village chief) is opposed to trial participation
2		The cluster has at least one registered VHW who is willing to participate and fulfills the following criteria: a. is at least 18 years of age b. has adequate reading and writing skills c. successfully passes the training assessment evaluated by a local person independent to the research project and the research team, by checking if the VHW: 1) is able to fill in the assessment (ticking boxes, writing in correct fields) 2) is able to give an adequate answer regarding the open question, which implies adequate reading and writing skills and a basic logic thinking	The VHW is not willing to attend the training or opposed to trial participation or not fulfilling the criteria: a. Note: if a cluster entails several VHWs, then the cluster can still participate if there is at least one VHW in the cluster who is willing to participate and fulfills the criteria
	Household eligibility
1		Signed informed consent from household head or representative aged 18 years or older	No signed informed consent from household head or representative aged 18 years or older

Table 2. Secondary endpoints of HOSENG trial

	*Endpoint*	*Definition*	*Time point following enrolment*
1	Testing coverage irrespective of age	Proportion of all individuals living in a household of the surveyed area with a confirmed HIV test result	Within 120 days
2	Blood-based HIV testing uptake	Proportion of all present individuals living in a household of the surveyed area, being eligible for blood-based HIV testing and accepting to be tested using blood-based point-of-care HIV test	On the day of the campaign
3	Oral-based HIV testing uptake	Proportion of all individuals living in a household of the surveyed area for whom an oral HIVST was left behind and who performed the oral HIVST.	Within 120 days
4	Adolescent and young adult HIV testing coverage (ADORE nested study outcome)	Proportion of all 12-24 years old individuals living in a household of the surveyed area with a confirmed HIV test result	Within 120 days

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published 13 Aug, 2019

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Editorial decision: Minor revision
26 Feb, 2019
Review #3 received at journal
17 Feb, 2019
Review #2 received at journal
17 Feb, 2019
Review #1 received at journal
12 Feb, 2019
Reviewer #3 agreed at journal
03 Feb, 2019
Reviewer #2 agreed at journal
30 Jan, 2019
Reviewer #1 agreed at journal
28 Jan, 2019
Reviewers invited by journal
24 Jan, 2019
Editor assigned by journal
14 Jan, 2019
Submission checks completed at journal
11 Jan, 2019

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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

Status:

Journal Publication

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Abstract

Figures

Background

Methods

1.1 Procedure

1.1.1 Intervention clusters

1.1.2 Control clusters

1.2 Endpoints

1.3 Additional research within the project

1.4 Data collection and management

1.5 Sample-size

1.6 Analyses

1.7 Monitoring, auditing, and data safety and monitoring board

Discussion

Abbreviations

Declarations

6 Trial status and recruitment

6.1 Ethics approval and consent to participate

6.2 Consent for publication

6.3 Availability of data and materials

6.4 Competing interests

6.5 Funding

6.6 Author’s contribution

6.7 Acknowledgements

References

Tables

Supplementary Files

Status:

Journal Publication

Version 1