scholarly journals A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mohammed Limbada ◽  
◽  
Chiti Bwalya ◽  
David Macleod ◽  
Sian Floyd ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Viral Suppression ◽  
Standard Of Care ◽  
Community Based Interventions ◽  
Community Based ◽  
Resource Limited Settings ◽  
Hiv Patients ◽  
Resource Limited ◽  
Cluster Randomized ◽  
Art Delivery

Abstract Background Following the World Health Organization’s (WHO) 2015 guidelines recommending initiation of antiretroviral therapy (ART) irrespective of CD4 count for all people living with HIV (PLHIV), many countries in sub-Saharan Africa have adopted this strategy to reach epidemic control. As the number of PLHIV on ART rises, maintenance of viral suppression on ART for over 90% of PLHIV remains a challenge to government health systems in resource-limited high HIV burden settings. Non facility-based antiretroviral therapy (ART) delivery for stable HIV+ patients may increase sustainable ART coverage in resource-limited settings. Within the HPTN 071 (PopART) trial, two models, home-based delivery (HBD) or adherence clubs (AC), were offered to assess whether they achieved similar viral load suppression (VLS) to standard of care (SoC). In this paper, we describe the trial design and discuss the methodological issues and challenges. Methods A three-arm cluster randomized non-inferiority trial, nested in two urban HPTN 071 trial communities in Zambia, randomly allocated 104 zones to SoC (35), HBD (35), or AC (34). ART and adherence support were delivered 3-monthly at home (HBD), adherence clubs (AC), or clinic (SoC). Adult HIV+ patients defined as “stable” on ART were eligible for inclusion. The primary endpoint was the proportion of PLHIV with virological suppression (≤ 1000 copies HIV RNA/ml) at 12 months (± 3months) after study entry across all three arms. Viral load measurement was done at the routine government laboratories in accordance with national guidelines, annually. The study was powered to determine if either of the community-based interventions would yield a viral suppression rate drop compared to SoC of no more than 5% in its absolute value. Both community-based interventions were delivered by community HIV providers (CHiPs). An additional qualitative study using observations, interviews with PLHIV, and FGDs with community HIV providers was nested in this study to complement the quantitative data. Discussion This trial was designed to provide rigorous randomized evidence of safety and efficacy of non-facility-based delivery of ART for stable PLHIV in high-burden resource-limited settings. This trial will inform policy regarding best practices and what is needed to strengthen scale-up of differentiated models of ART delivery in resource-limited settings. Trial registration ClinicalTrials.gov NCT03025165. Registered on 19 January 2017

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 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 ◽  
Qualitative Research ◽  
Southern Africa ◽  
Viral Suppression ◽  
Standard Of Care ◽  
Community Based ◽  
Art Initiation ◽  
Home Based ◽  
Cluster Randomized ◽  
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 as-signed 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 fea-tures: Firstly, drug-refill and follow-up through trained and supervised village health workers (VHW). 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. Second-ary 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) re-search 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.

scholarly journals 880. Interim Analysis of Real-World Community-Based HIV Rapid Start Antiretroviral with BFTAF Versus Conventional HIV Antiretroviral Therapy Start – The RoCHaCHa Study, A Pilot Study

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S531-S532
Author(s):  
Ashley R Zuppelli ◽  
Jacob Scutaru ◽  
Alexandra Danforth ◽  
Robert Biernbaum ◽  
Roberto Corales ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Interim Analysis ◽  
Viral Suppression ◽  
Standard Of Care ◽  
Retention In Care ◽  
Community Based ◽  
Art Initiation ◽  
Study Participants ◽  
Historical Controls ◽  
Research Grant

Abstract Background Trillium Health (TH) is a Federally Qualified Health Center look-alike and Ryan White C grantee in Rochester, NY providing primary and specialty care, including HIV prevention and treatment. Rapid Start Antiretroviral therapy (RSA) has been shown to decrease time to viral suppression while increasing linkage to and retention in care. However, data on a fixed-dose combination of BFTAF with these benefits are limited. We aim to show RSA with BFTAF time to viral suppression, adherence to medication, and retention in care is statistically significant in comparison to older treatment models. Additionally, we aim to demonstrate the feasibility and acceptability of RSA with BFTAF. Methods This is an interim analysis of participants who enrolled in the study and been in care at TH for at least 3 months as of May 2021. All participants complete a baseline assessment and start BFTAF. Follow up visits are conducted through 48 weeks. Primary and secondary endpoints are included in the attached table 2 Barriers to care and patient reported outcomes were evaluated through a standardized questionnaire at the final study visit. Study results were compared with non-RSA historical control data from patients who received standard of care universal ART initiation at TH. Results Thirty-four participants have been enrolled in the study for at least 12 weeks, 33 (97%) of whom have reached and maintained viral suppression. Twenty-one participants have completed all 48 weeks, with 20 (95%) reaching and maintaining viral suppression. In comparison to historical controls, the RSA study participants had a statistically significant shorter time to viral suppression, both from diagnosis and from ART initiation. The RSA patients had statistically significant higher retention at 12, 24, and 48 weeks in comparison to historical controls. Adherence was higher in the RSA patients, though not statistically significant. Enrollment Graphic for the Rochacha Study Baseline Demographics of Study Participants and Controls Clinical Outcomes of Study Participants compared to Controls Conclusion Our data show that RSA with BFTAF can be effective in a community based health center setting in participants facing barriers to care. The patients who were treated by RSA with BFTAF had a high viral suppression rate. To date, no BFTAF regimen had to be changed due to resistance or virologic failure in this study. These data support implementation of RSA with BFTAF as standard of care. Disclosures Ashley R. Zuppelli, PHARMD, BCACP, AAHIVP, Gilead Sciences (Research Grant or Support) Robert Biernbaum, DO, MS, FAAEM, AAHIVS, Gilead Sciences (Research Grant or Support) Roberto Corales, DO, AAHIVS, Gilead Sciences (Employee, Scientific Research Study Investigator) Shealynn Hilliard, MS, Gilead Sciences (Research Grant or Support) William M. Valenti, MD, FIDSA, Gilead Sciences (Research Grant or Support)

scholarly journals Improving maternal, newborn, and child health outcomes through a community-based women’s health education program (Chamas for Change): a cluster randomized controlled trial

2020 ◽  
Author(s):  
Lauren Y. Maldonado ◽  
Jeffrey Bone ◽  
Michael L. Scanlon ◽  
Gertrude Anusu ◽  
Sheilah Chelagat ◽  
...  
Keyword(s):  
Health Education ◽  
Women’S Health ◽  
Women's Health ◽  
Standard Of Care ◽  
Sub Saharan Africa ◽  
List Type ◽  
Community Based ◽  
Resource Limited Settings ◽  
Resource Limited ◽  
Sub Saharan

ABSTRACTIntroductionCommunity-based women’s health education groups may improve maternal, newborn, and child health (MNCH); however, evidence from sub-Saharan Africa is lacking. Chamas for Change (Chamas) is a community health volunteer (CHV)-led health education program for pregnant and postpartum women in western Kenya. We evaluated Chamas’ effect on facility-based deliveries and other MNCH outcomes.MethodsWe conducted a cluster randomized controlled trial involving 74 communities in Trans Nzoia County. We included pregnant women who presented to health facilities for their first antenatal care visits by 32 weeks gestation. We randomized community clusters 1:1 without stratification or matching; we masked data collectors, investigators, and analysts to allocation. Intervention clusters were invited to bimonthly, group-based, CHV-led health lessons (Chamas); control clusters had monthly CHV home-visits (standard of care). The primary outcome was facility-based delivery at 12-months follow-up. We conducted an intention-to-treat approach with multilevel logistic regression models using individual-level data. We prospectively registered this trial with ClinicalTrials.gov (NCT03187873).ResultsBetween November 27, 2017 and March 8, 2018, we enrolled 1920 participants from 37 intervention and 37 control clusters. A total of 1550 (80.7%) participants completed the study with 822 (82.5%) and 728 (78.8%) in the intervention and control arms, respectively. Facility-based deliveries improved in the intervention arm (80.9% vs 73.0%; Risk Difference (RD) 7.4%, 95% CI 3.0-12.5, OR=1.58, 95% CI 0.97-2.55, p=0.057). Chamas participants also demonstrated higher rates of 48-hour postpartum visits (RD 15.3%, 95% CI 12.0-19.6), exclusive breastfeeding (RD 11.9%, 95% CI 7.2-16.9), contraceptive adoption (RD 7.2%, 95% CI 2.6-12.9), and infant immunization completion (RD 15.6%, 95% CI 11.5-20.9).ConclusionChamas participation was associated with significantly improved MNCH outcomes compared with the standard of care. This trial contributes robust data from sub-Saharan Africa to support community-based, women’s health education groups for MNCH in resource-limited settings.KEY QUESTIONSWhat is already known?Globally, maternal and infant deaths have declined over the last three decades; however, low and middle-income countries (LMICs), including Kenya, still disproportionately incur the highest morbidity and mortality.The World Health Organization recommends leveraging lay health workers (LHWs), including community health volunteers (CHVs), to promote maternal, newborn, and child health (MNCH) in resource-limited settings.Prior research suggests coupling strategies that promote community-based approaches (i.e. integrating LHWs) and women’s health education and support groups during pregnancy and postpartum may improve MNCH; however, robust evidence from sub-Saharan Africa is lacking.What are the new findings?Using a cluster randomized controlled trial design, we found that participation in Chamas for Change (Chamas) – a group-based women’s health education program led by CHVs – was associated with significantly improved MNCH outcomes, including facility-based deliveries, compared with the standard of care (i.e. monthly home-visits) in rural Kenya.This trial also demonstrated significant associations between program participation and receiving 48 hour postpartum home-visits, breastfeeding exclusively, adopting a contraceptive method postpartum, and immunizing infants fully by 12 months of life as compared to the standard of care.These findings support pilot data from a preceding evaluation of the Chamas program as well as the current literature on community-based interventions delivered by LHWs to promote MNCH in other resource-limited settings.What do the new findings imply?Effective community-based strategies that build upon existing infrastructure to promote MNCH are needed to continue to improve the health and well-being of women and infants in rural sub-Saharan Africa and other LMICs.Chamas offers an innovative approach to improve MNCH in resource-limited settings with significant health policy implications; collective evidence from this trial and preceding studies support community-based women’s health education groups as an effective strategy for improving uptake of facility-based deliveries and other life-saving MNCH practices.

scholarly journals Community-based model for the delivery of antiretroviral therapy in Cambodia: a quasi-experimental study protocol

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sovannary Tuot ◽  
Alvin Kuo Jing Teo ◽  
Kiesha Prem ◽  
Pheak Chhoun ◽  
Chamroen Pall ◽  
...  
Keyword(s):  
Experimental Study ◽  
Antiretroviral Therapy ◽  
Scale Up ◽  
Economic Evaluations ◽  
People Living With Hiv ◽  
Cad Model ◽  
Community Based ◽  
Quasi Experimental ◽  
Living With Hiv ◽  
Art Delivery

Abstract Background Multi-month dispensing (MMD) is the mainstay mechanism for clinically stable people living with HIV in Cambodia to refill antiretroviral therapy (ART) every 3-6 months. However, less frequent ART dispensing through the community-based ART delivery (CAD) model could further reduce the clients’ and health facilities’ burden. While community-based services have been recognized as an integral component of HIV response in Cambodia, their role and effectiveness in ART delivery have yet to be systematically assessed. This study aims to evaluate the CAD model’s effectiveness on the continuum of care and treatment outcomes for stable people living with HIV in Cambodia. Methods We will conduct this quasi-experimental study in 20 ART clinics across the capital city and nine provinces between May 2021 and April 2023. Study sites were purposively selected based on the availability of implementing partners, the number of people living with HIV each clinic serves, and the accessibility of the clinics. In the intervention arm, approximately 2000 stable people living with HIV will receive ART and services from the CAD model. Another 2000 stable people living with HIV in the control arm will receive MMD—a standard care model for stable people living with HIV. The primary outcomes will be retention in care, viral load suppression, and adherence to ART. The secondary endpoints will include health providers’ work burden, the model’s cost-effectiveness, quality of life, mental health, social support, stigma, and discrimination. We will compare the outcome indicators within each arm at baseline, midline, and endline using descriptive and inferential statistics. We will evaluate the differences between the intervention and control arms using the difference-in-differences method. We will perform economic evaluations to determine if the intervention is cost-effective. Discussion This study will build the evidence base for future implementation and scale-up of CAD model in Cambodia and other similar settings. Furthermore, it will strengthen engagements with community stakeholders and further improve community mobilization, a vital pillar of the Cambodian HIV response. Trial registration ClinicalTrials.gov, NCT04766710. Registered 23 February 2021, Version 1.

scholarly journals Community intervention for child tuberculosis active contact investigation and management: study protocol for a parallel cluster randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anca Vasiliu ◽  
Sabrina Eymard-Duvernay ◽  
Boris Tchounga ◽  
Daniel Atwine ◽  
Elisabete de Carvalho ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Standard Of Care ◽  
Preventive Therapy ◽  
Community Based ◽  
Randomized Controlled ◽  
Eligible Child ◽  
Contact Investigation ◽  
Cluster Randomized ◽  
The Impact ◽  
Index Cases

Abstract Background There are major gaps in the management of pediatric tuberculosis (TB) contact investigation for rapid identification of active tuberculosis and initiation of preventive therapy. This study aims to evaluate the impact of a community-based intervention as compared to facility-based model for the management of children in contact with bacteriologically confirmed pulmonary TB adults in low-resource high-burden settings. Methods/design This multicenter parallel open-label cluster randomized controlled trial is composed of three phases: I, baseline phase in which retrospective data are collected, quality of data recording in facility registers is checked, and expected acceptability and feasibility of the intervention is assessed; II, intervention phase with enrolment of index cases and contact cases in either facility- or community-based models; and III, explanatory phase including endpoint data analysis, cost-effectiveness analysis, and post-intervention acceptability assessment by healthcare providers and beneficiaries. The study uses both quantitative and qualitative analysis methods. The community-based intervention includes identification and screening of all household contacts, referral of contacts with TB-suggestive symptoms to the facility for investigation, and household initiation of preventive therapy with follow-up of eligible child contacts by community healthcare workers, i.e., all young (< 5 years) child contacts or older (5–14 years) child contacts living with HIV, and with no evidence of TB disease. Twenty clusters representing TB diagnostic and treatment facilities with their catchment areas are randomized in a 1:1 ratio to either the community-based intervention arm or the facility-based standard of care arm in Cameroon and Uganda. Randomization was stratified by country and constrained on the number of index cases per cluster. The primary endpoint is the proportion of eligible child contacts who initiate and complete the preventive therapy. The sample size is of 1500 child contacts to identify a 10% difference between the arms with the assumption that 60% of children will complete the preventive therapy in the standard of care arm. Discussion This study will provide evidence of the impact of a community-based intervention on household child contact screening and management of TB preventive therapy in order to improve care and prevention of childhood TB in low-resource high-burden settings. Trial registration ClinicalTrials.gov NCT03832023. Registered on 6 February 2019

scholarly journals Efavirenz induced gynecomastia, hidden reality: a case series

2020 ◽  
Vol 7 (11) ◽  
pp. 1747
Author(s):  
Dnyanesh N. Morkar ◽  
Ankita Aneja ◽  
Rishabh Agarwal
Keyword(s):  
Side Effects ◽  
Hiv Infection ◽  
Side Effect ◽  
Case Series ◽  
Drug Adherence ◽  
Resource Limited Settings ◽  
Hiv Patients ◽  
Highly Active ◽  
Resource Limited ◽  
Haart Therapy

The prognosis of HIV infection has considerably improved following the introduction of highly active anti-retroviral therapy by reducing AIDS related morbidity and mortality. At the same time, ART drugs are well known for their side effects. Gynaecomastia is a lesser known side effect of a commonly used anti-retroviral drug efavirenz. There are very few reports of HAART-induced gynaecomastia in resource-limited settings. The current study presents a series of three cases that developed ultrasound confirmed gynaecomastia following efavirenz containing HAART. Initial reports of gynaecomastia related to HAART were in HIV patients with lipodystrophy, they were termed as pseudogynaecomastia. Gradually, few reports of efavirenz related gynaecomastia were published wherein other causes of gynaecomastia were ruled out. Several hypothesis have been suggested for the pathophysiology of development of gynaecomastia related to efavirenz consumption. All other causes were ruled out in our patients too. The incidence of gynaecomastia is increasing in men with HIV on HAART therapy, proper identification and management will promote better drug adherence.

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