scholarly journals 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

2019 ◽  
Author(s):  
Alain Amstutz ◽  
Thabo Ishmael Lejone ◽  
Lefu Khesa ◽  
Josephine Muhairwe ◽  
Bienvenu Lengo Nsakala ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Health Facility ◽  
World Health ◽  
Eligibility Criteria ◽  
High Coverage ◽  
Home Based ◽  
Self Testing ◽  
Household Members ◽  
Cluster Randomized ◽  
Testing Coverage

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.

scholarly journals 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

2019 ◽  
Author(s):  
Alain Amstutz ◽  
Thabo Ishmael Lejone ◽  
Lefu Khesa ◽  
Josephine Muhairwe ◽  
Bienvenu Lengo Nsakala ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Health Facility ◽  
World Health ◽  
Eligibility Criteria ◽  
High Coverage ◽  
Home Based ◽  
Self Testing ◽  
Household Members ◽  
Cluster Randomized ◽  
Testing Coverage

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 (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 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.

scholarly journals 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

2019 ◽  
Author(s):  
Alain Amstutz ◽  
Thabo Ishmael Lejone ◽  
Lefu Khesa ◽  
Josephine Muhairwe ◽  
Bienvenu Lengo Nsakala ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Health Worker ◽  
Health Facility ◽  
Southern Africa ◽  
Village Health Worker ◽  
Home Based ◽  
Self Testing ◽  
Cluster Randomized ◽  
Testing Coverage ◽  
Village Health

Abstract 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.

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

2021 ◽  
Vol 8 ◽  
Author(s):  
Alain Amstutz ◽  
Lineo Matsela ◽  
Thabo Ishmael Lejone ◽  
Mathebe Kopo ◽  
Tracy Renée Glass ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Patient Costs ◽  
Home Based ◽  
Self Testing ◽  
Costing Study ◽  
Secondary Distribution ◽  
Self Test ◽  
The Cost ◽  
Testing Coverage ◽  
Provider Cost

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

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

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Niklaus Daniel Labhardt ◽  
Isaac Ringera ◽  
Thabo Ishmael Lejone ◽  
Alain Amstutz ◽  
Thomas Klimkait ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Urban Areas ◽  
Home Visits ◽  
Sub Saharan Africa ◽  
Hiv Status ◽  
Home Based ◽  
Household Members ◽  
Catch Up ◽  
First Time ◽  
Testing Coverage

Abstract Background Home-based HIV testing and counselling (HB-HTC) is frequently used to increase awareness of HIV status in sub-Saharan Africa. Whereas acceptance of HB-HTC is usually high, testing coverage may remain low due to household members being absent during the home visits. This study assessed whether two consecutive visits, one during the week, one on the weekend, increase coverage. Methods The study was a predefined nested-study of the CASCADE-trial protocol and conducted in 62 randomly selected villages and 17 urban areas in Butha-Buthe district, Lesotho. HB-HTC teams visited each village/urban area twice: first during a weekday, followed by a weekend visit to catch-up for household members absent during the week. Primary outcome was HTC coverage after first and second visit. Coverage was defined as all individuals who knew their HIV status out of all household members (present and absent). Results HB-HTC teams visited 6665 households with 18,286 household members. At first visit, 69.2 and 75.4% of household members were encountered in rural and urban households respectively (p < 0.001) and acceptance for testing was 88.5% in rural and 79.5% in urban areas (p < 0.001), resulting in a coverage of 61.8 and 61.5%, respectively. After catch-up visit, the HTC coverage increased to 71.9% in rural and 69.4% in urban areas. The number of first time testers was higher at the second visit (47% versus 35%, p < 0.001). Direct cost per person tested and per person tested HIV positive were lower during weekdays (10.50 and 335 USD) than during weekends (20 and 1056 USD). Conclusions A catch-up visit on weekends increased the proportion of persons knowing their HIV status from 62 to 71% and reached more first-time testers. However, cost per person tested during catch-up visits was nearly twice the cost during first visit. Trial registration NCT02692027 (prospectively registered on February 21, 2016).

scholarly journals Testing strategies for couple engagement in prevention of mother-to-child transmission of HIV and family health in Kenya: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zachary Kwena ◽  
Liza Kimbo ◽  
Lynae A. Darbes ◽  
Abigail M. Hatcher ◽  
Anna Helova ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Hiv Testing ◽  
Standard Care ◽  
Family Health ◽  
Child Transmission ◽  
Home Based ◽  
Self Testing ◽  
The Cost ◽  
Mother To Child ◽  
Testing And Counseling

Abstract Background HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa despite increased antenatal care attendance and provision of antiretroviral therapy to pregnant women. In the Jamii Bora (“Better Family” in Swahili) Study, we seek to test the efficacy of an interdependence theory-based couple intervention. The intervention reaches pregnant women and male partners through home visits by male-female pairs of lay health workers. The aim is to increase access to home-based couples’ HIV testing and counseling services to improve family health. Methods This is a three-arm randomized control trial among 1080 pregnant women 15 years of age or older, living with their male partners, and who have not undergone couples’ HIV testing and counseling in Kisumu and Migori Counties in Kenya. Couples will be randomized into three groups: home-based couple visits, HIV self-testing kits for couple use, or standard care (male partner clinic invitation letters). Participants will be followed up to 18 months postpartum. The study has three aims: in aim 1, we will determine the effects of the intervention on our primary outcome of couple HIV testing, compared to HIV self-testing kits and standard care; in aim 2, we will examine the intervention impact on HIV prevention behaviors, facility delivery, and postnatal healthcare utilization, as well as secondary health outcomes of maternal viral suppression and HIV-free child survival up to 18 months for couples living with HIV; and in aim 3, we will compare the cost-effectiveness of the home-based couple intervention to the less resource-intensive strategies used in the other two study arms. Assessments with couples are conducted at baseline, late pregnancy, and at months 3, 6, 12, and 18 after birth. Discussion The results from this study will inform decision-makers about the cost-effective strategies to engage pregnant couples in the prevention of mother-to-child transmission and family health, with important downstream benefits for maternal, paternal, and infant health. Trial registration ClinicalTrials.gov NCT03547739. Registered on May 9, 2018

scholarly journals Mobile Health–Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other)

10.2196/26192 ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. e26192
Author(s):  
Carmen Logie ◽  
Moses Okumu ◽  
Robert Hakiza ◽  
Daniel Kibuuka Musoke ◽  
Isha Berry ◽  
...  
Keyword(s):  
Data Collection ◽  
Condom Use ◽  
Hiv Testing ◽  
Mobile Health ◽  
Implementation Strategies ◽  
Informal Settlements ◽  
Consistent Condom ◽  
Self Testing ◽  
Testing Uptake ◽  
Cluster Randomized

Background HIV is the leading cause of mortality among youth in sub-Saharan Africa. Uganda hosts over 1.43 million refugees, and more than 83,000 live in Kampala, largely in informal settlements. There is limited information about HIV testing uptake and preferences among urban refugee and displaced youth. HIV self-testing is a promising method for increasing testing uptake. Further, mobile health (mHealth) interventions have been effective in increasing HIV testing uptake and could be particularly useful among youth. Objective This study aims to evaluate the feasibility and effectiveness of two HIV self-testing implementation strategies (HIV self-testing intervention alone and HIV self-testing combined with an mHealth intervention) in comparison with the HIV testing standard of care in terms of HIV testing outcomes among refugee/displaced youth aged 16 to 24 years in Kampala, Uganda. Methods A three-arm cluster randomized controlled trial will be implemented across five informal settlements grouped into three sites, based on proximity, and randomization will be performed with a 1:1:1 method. Approximately 450 adolescents (150 per cluster) will be enrolled and followed for 12 months. Data will be collected at the following three time points: baseline enrollment, 8 months after enrollment, and 12 months after enrollment. Primary outcomes (HIV testing frequency, HIV status knowledge, linkage to confirmatory testing, and linkage to HIV care) and secondary outcomes (depression, condom use efficacy, consistent condom use, sexual relationship power, HIV stigma, and adolescent sexual and reproductive health stigma) will be evaluated. Results The study has been conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study has received ethical approval from the University of Toronto (June 14, 2019), Mildmay Uganda (November 11, 2019), and the Uganda National Council for Science and Technology (August 3, 2020). The Tushirikiane trial launched in February 2020, recruiting a total of 452 participants. Data collection was paused for 8 months due to COVID-19. Data collection for wave 2 resumed in November 2020, and as of December 10, 2020, a total of 295 participants have been followed-up. The third, and final, wave of data collection will be conducted between February and March 2021. Conclusions This study will contribute to the knowledge of differentiated HIV testing implementation strategies for urban refugee and displaced youth living in informal settlements. We will share the findings in peer-reviewed manuscripts and conference presentations. Trial Registration ClinicalTrials.gov NCT04504097; https://clinicaltrials.gov/ct2/show/NCT04504097. International Registered Report Identifier (IRRID) DERR1-10.2196/26192

scholarly journals Venues and methods to improve professional men’s access to HIV self-testing and linkage to HIV prevention or treatment: a qualitative study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Patience A. Muwanguzi ◽  
Esther M. Nasuuna ◽  
Florence Namimbi ◽  
Charles Peter Osingada ◽  
Tom Denis Ngabirano
Keyword(s):  
Qualitative Study ◽  
Hiv Testing ◽  
Underserved Populations ◽  
Linkage To Care ◽  
Sub Saharan Africa ◽  
Hiv Care ◽  
Eligibility Criteria ◽  
Prevention Services ◽  
Self Testing ◽  
Engaging Men

Abstract Background HIV testing among men in sub-Saharan Africa is sub-optimal. Despite several strategies to improve access to underserved populations, evidence regarding engaging men in professional and formal occupations in HIV testing is limited. This study explored employed professional men’s preferences for uptake of HIV self-testing, and linkage to HIV care, or prevention services. Methods This was an explorative-descriptive qualitative study where a sample of 33 men from six Ugandan urban centres. Participants were purposively selected guided by the International Standard Classification of Occupations to participate in in-depth interviews. The data were collected using an interview guide and the sample size was determined by data saturation. Eligibility criteria included fulltime formal employment for over a year at that organization. The data were analyzed manually using thematic content analysis. Results Three categories emerged: uptake of HIV self-tests, process of HIV self-testing and linkage to post-test services. The different modes of distribution of HIV self-test kits included secondary distribution, self-tests at typically male dominated spaces, delivery to workplaces and technology-based delivery. The process of HIV self-testing may be optimized by providing collection bins, and mHealth or mobile phone applications. Linkage to further care or prevention services may be enhanced using medical insurance providers, giving incentives and tele counselling. Conclusion We recommend utilization of several channels for the uptake of HIV self-tests. These include distribution of test kits both to offices and men’s leisure and recreation ‘hot spots’, Additionally, female partners, peers and established men’s group including social media groups can play a role in improving the uptake of HIV self-testing. Mobile phones and digital technology can be applied in innovative ways for the return of test results and to strengthen linkage to care or prevention services. Partnership with medical insurers may be critical in engaging men in professional employment in HIV services.

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