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 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 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 VIBRA trial – Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: 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):  
Clinical Trial ◽  
Southern Africa ◽  
Viral Suppression ◽  
Standard Of Care ◽  
Community Based ◽  
Art Initiation ◽  
Home Based ◽  
Cluster Randomized ◽  
Village Health ◽  
Art Delivery

Abstract Background: There is a need for evaluating community-based antiretroviral therapy (ART) delivery models to improve overall performance of HIV programs, specifically in populations that may have difficulties to access continuous care. This cluster-randomized clinical trial aims to evaluate the efficacy of a multicomponent differentiated ART delivery model (VIBRA model) after home-based same-day ART initiation in remote villages in Lesotho, Southern Africa. Methods: VIBRA (Village-Based Refill of ART) trial is a cluster-randomized, parallel-group, superiority clinical trial conducted in two districts of Lesotho, Southern Africa. Clusters (i.e. villages) are randomly assigned to either the VIBRA model or standard of care, stratified by district, village size, and village access to the nearest health facility. Eligible individuals (HIV-positive, aged 10 years or older, not taking ART) found during community-based HIV testing campaigns are offered same-day home-based ART initiation. Intervention clusters offer a differentiated ART delivery package with two features: Firstly, drug-refill and follow-up through trained and supervised village health workers. Secondly, the option of receiving individually tailored adherence reminders and viral load result notifications via SMS. Standard of care applies for the control clusters, i.e. ART visits at the clinic and no SMS. The primary endpoint is viral suppression 12 months after enrolment. Secondary endpoints include linkage to and engagement in care. Furthermore, safety and cost-effectiveness analyses plus qualitative research are planned. Minimum target sample size is 262 participants. Statistical analyses will follow CONSORT guidelines. VIBRA trial is linked to another trial, the HOSENG (HOme-based SElf-testiNG) trial, in the GET ON (GETing tOwards Ninety) research project. Discussion: VIBRA trial is among the first to evaluate ART delivery through VHW immediately after ART-initiation and it assesses the entire HIV care cascade from testing to viral suppression. As most countries in sub-Saharan Africa have cadres similar to the VHW program in Lesotho, this model – if shown to be effective – has potential to be scaled up. The system impact evaluation will provide valuable cost estimations, and the qualitative research will suggest how the model could further be modified to optimize impact. Trial Registration: This trial has been registered at clinicaltrials.gov (NCT03630549) on August 15, 2018. Keywords: HIV, cluster randomized controlled trial, village health worker, community health worker, home-based, differentiated care and delivery, antiretroviral therapy, Lesotho, Southern Africa, multi component intervention.

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 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

Collaborative model as a training for increasing village health worker competency about complementary feeding

2021 ◽  
Vol 9 (2) ◽  
pp. 198-207
Author(s):  
Habibah Abidin ◽  
Apoina Kartini ◽  
Ani Margawati
Keyword(s):  
Treatment Group ◽  
Health Worker ◽  
Self Efficacy ◽  
Complementary Feeding ◽  
Control Group ◽  
Counseling Skills ◽  
Collaborative Model ◽  
Village Health Worker ◽  
The Mean ◽  
Village Health

Background: A Kader refers to a Village Health Worker (VHW), a volunteer, which becomes one of the sources of community reference. Commonly, they sustain a mother's knowledge regarding adequate complementary feeding. However, there are still some VHW who have not possessed a health education background nor been able to be independent.Objectives: This study aimed to analyze the impact of collaborative models on VHW's competence as in knowledge, self-efficacy, attitudes, and counseling skill on the topic of complementary feeding.Materials and Methods: The design of this research is a quasi-experiment control group pretest-postest, with the retrieval of subjects using purposive sampling. Subjects were selected based on the location of the posyandu. The population in this research was VHWs in the Lembang district were 40 VHWs in each group. The treatment group was given training intervention for 1 month with a collaborative model, combining several methods into a series. The main topic was counseling and complementary feeding. The control group was given booklets and leaflets. VHW's competence was measured using questionnaires. This research was conducted in January-April 2020.Results: Statistical test results before the treatment of both groups showed no difference (p>0,05) in each variable. Two months after the intervention, there were significant differensces in the mean score of knowledge (p=0,001), attitude (p=0,001), and VHWs self-efficacy (p=0,000) in both groups. VHW counseling skills (p=0,149) until the first month there was not a significant difference. Unexpectedly, in the second month, the VHW counseling skills could not be observed due to the global COVID-19 pandemic. The mean score of each group increased significantly, but the score of the treatment group was higher than the control group.Conclusions: A collaborative model is effective when compared to only providing booklets and leaflets in increasing VHW's knowledge, attitudes, and self-efficacy but not effective yet for VHW counseling skills.

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