Adherence clubs and decentralized medication delivery to support patient retention and sustained viral suppression in care: Results from a cluster-randomized evaluation of differentiated ART delivery models in South Africa

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.

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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 ◽

10.1186/s13063-020-05010-w ◽

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

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Potential challenges to sustained viral load suppression in the HIV treatment programme in South Africa: a narrative overview

AIDS Research and Therapy ◽

10.1186/s12981-020-00324-w ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Pascal O. Bessong ◽

Nontokozo D. Matume ◽

Denis M. Tebit

Keyword(s):

South Africa ◽

Drug Resistance ◽

Viral Load ◽

Viral Suppression ◽

Transmitted Drug Resistance ◽

Pharmacokinetics And Pharmacodynamics ◽

Viral Load Suppression ◽

Sustained Viral Suppression ◽

Concurrent Use ◽

Universal Test And Treat

Abstract Background South Africa, with one of the highest HIV prevalences in the world, introduced the universal test and treat (UTT) programme in September 2016. Barriers to sustained viral suppression may include drug resistance in the pre-treated population, non-adherence, acquired resistance; pharmacokinetics and pharmacodynamics, and concurrent use of alternative treatments. Objective The purpose of this review is to highlight potential challenges to achieving sustained viral load suppression in South Africa (SA), a major expectation of the UTT initiative. Methodology Through the PRISMA approach, published articles from South Africa on transmitted drug resistance; adherence to ARV; host genetic factors in drug pharmacokinetics and pharmacodynamics, and interactions between ARV and herbal medicine were searched and reviewed. Results The level of drug resistance in the pre-treated population in South Africa has increased over the years, although it is heterogeneous across and within Provinces. At least one study has documented a pre-treated population with moderate (> 5%) or high (> 15%) levels of drug resistance in eight of the nine Provinces. The concurrent use of ARV and medicinal herbal preparation is fairly common in SA, and may be impacting negatively on adherence to ARV. Only few studies have investigated the association between the genetically diverse South African population and pharmacokinetics and pharmacodynamics of ARVs. Conclusion The increasing levels of drug resistant viruses in the pre-treated population poses a threat to viral load suppression and the sustainability of first line regimens. Drug resistance surveillance systems to track the emergence of resistant viruses, study the burden of prior exposure to ARV and the parallel use of alternative medicines, with the goal of minimizing resistance development and virologic failure are proposed for all the Provinces of South Africa. Optimal management of the different drivers of drug resistance in the pre-treated population, non-adherence, and acquired drug resistance will be beneficial in ensuring sustained viral suppression in at least 90% of those on treatment, a key component of the 90-90-90 strategy.

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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

10.21203/rs.2.212/v2 ◽

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.

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