Acceptability of a home-based antiretroviral therapy delivery model among HIV patients in Lusaka district

Magister Public Health - MPHBackground: The Zambian anti-retroviral therapy (ART) program has successfully enrolled over 770, 000 people living with HIV (PLWH), out of a population of 1.2 million PLWH. This tremendous success has overburdened the clinic system resulting in many challenges for both patients and healthcare staff. To promote ART initiation, adherence, and retention and at the same time relieve pressure on the health system, a home-based ART delivery model (HBM) was piloted in two urban communities of Lusaka. This study explored levels of acceptability of the model and factors influencing this among PLWH living in the two communities. Acceptability was defined as degree of fit between the patient’s expectations and circumstances and the home-based delivery model of ART, taking into consideration all the contextual elements surrounding the patient. Methodology: A qualitative study of HBM acceptability was nested within a clusterrandomized trial comparing outcomes in patients receiving HBM intervention compared to the standard of care in two communities in Lusaka, Zambia. Using an exploratory qualitative study design and a purposive sampling technique, qualitative data were collected using observations of HBM delivery (n=12), in-depth interviews with PLWH (n=15) and Focus Group Discussions with a cadre of community health workers called community HIV care providers (CHiPs) administering the HBM (n=2). Data were managed and coded using Atlas.ti 7 and analysed thematically. Results: Overall, the HBM was found to be a good fit with the lives and expectations of PLWH and therefore highly acceptable to them. This acceptability was influenced by a combination of cross cutting clinic based, program design and socio-economic factors that have been categorized into push and pull factors. Push factors were those related to the challenges that PLWH faced when accessing ART from the clinic and included congestion, long waiting times, confidentiality breaches and stigma arising from attending a dedicated clinic. These factors resulted in considerable direct and indirect livelihood opportunity costs. The HBM as an alternative had a number of ‘pull factors’. PLHW described services offered through the model as convenient, confidential, trusted, personalized, less stigmatizing, comprehensive, client centred, responsive, and respectful. Disclosure of client’s HIV status to people they lived with was found to be critical for the acceptability of the model. Conclusions and recommendations: The HBM is highly acceptable and this acceptability is influenced by a combination of crosscutting push and pull factors. Key to the HBM’s acceptability was its delivery design that was responsive to individual patient needs and the steps CHiPs took to minimize the ever-present threat of disclosure and stigma. Future adoption and scaling up of HBM should recognize the importance of these design features

Acceptability of a home-based antiretroviral therapy delivery model among HIV patients in Lusaka district

Master of Public Health - MPHBACKGROUND: The Zambian anti-retroviral therapy (ART) program has successfully enrolled over 770, 000 people living with HIV (PLWH), out of a population of 1.2 million PLWH. This tremendous success has overburdened the clinic system resulting in many challenges for both patients and healthcare staff. To promote ART initiation, adherence, and retention and at the same time relieve pressure on the health system, a home-based ART delivery model (HBM) was piloted in two urban communities of Lusaka. This study explored levels of acceptability of the model and factors influencing this among PLWH living in the two communities. Acceptability was defined as degree of fit between the patient’s expectations and circumstances and the home-based delivery model of ART, taking into consideration all the contextual elements surrounding the patient. METHODOLOGY: A qualitative study of HBM acceptability was nested within a clusterrandomized trial comparing outcomes in patients receiving HBM intervention compared to the standard of care in two communities in Lusaka, Zambia. Using an exploratory qualitative study design and a purposive sampling technique, qualitative data were collected using observations of HBM delivery (n=12), in-depth interviews with PLWH (n=15) and Focus Group Discussions with a cadre of community health workers called community HIV care providers (CHiPs) administering the HBM (n=2). Data were managed and coded using Atlas.ti 7 and analysed thematically. RESULTS: Overall, the HBM was found to be a good fit with the lives and expectations of PLWH and therefore highly acceptable to them. This acceptability was influenced by a combination of cross cutting clinic based, program design and socio-economic factors that have been categorized into push and pull factors. Push factors were those related to the challenges that PLWH faced when accessing ART from the clinic and included congestion, long waiting times, confidentiality breaches and stigma arising from attending a dedicated clinic. These factors resulted in considerable direct and indirect livelihood opportunity costs. The HBM as an alternative had a number of ‘pull factors’. PLHW described services offered through the model as convenient, confidential, trusted, personalized, less stigmatizing, comprehensive, client centred, responsive, and respectful. Disclosure of client’s HIV status to people they lived with was found to be critical for the acceptability of the model. CONCLUSIONS AND RECOMMENDATIONS: The HBM is highly acceptable and this acceptability is influenced by a combination of crosscutting push and pull factors. Key to the HBM’s acceptability was its delivery design that was responsive to individual patient needs and the steps CHiPs took to minimize the ever-present threat of disclosure and stigma. Future adoption and scaling up of HBM should recognize the importance of these design features

Assessing knowledge, acceptability and social implications of a peer-to-peer HIV self-testing kit distribution model among adolescents aged 15-24 in Zambia and Uganda-HISTAZU: a mixed-method study protocol.

INTRODUCTION: HIV self-testing (HIVST) across sub-Saharan African countries may be acceptable as it overcomes significant barriers to clinic-based HIV testing services such as privacy and confidentiality. There are a number of suggested HIVST distribution models. However, they may not be responsive to the testing service needs of adolescents and young people (AYP). We will investigate the knowledge, acceptability and social implications of a peer-to-peer distribution model of HIVST kits on uptake of HIV prevention including pre-exposure prophylaxis, condoms, and voluntary medical male circumcision and testing services and linkage to anti-retroviral therapy among AYP aged 15-24 in Zambia and Uganda. METHODS AND ANALYSIS: We will conduct an exploratory mixed methods study among AYP aged 15-24 in Uganda and Zambia. Qualitative data will be collected using audio-recorded in-depth interviews (IDIs), focus group discussions (FGDs), and participant observations. All IDIs and FGDs will be transcribed verbatim, coded and analysed through a thematic-content analysis. The quantitative data will be collected through a structured survey questionnaire derived from the preliminary findings of the qualitative work and programme evaluation quantitative data collected on uptake of services from a Zambian trial. The quantitative phase will evaluate the number of AYP reached and interested in HIVST and the implication of this on household social relations and social harms. The quantitative data will be analysed through bivariate analyses. The study will explore any social-cultural and study design barriers or facilitators to uptake of HIVST. ETHICS AND DISSEMINATION: This study is approved by the Uganda Virus Research Institute Research and Ethics committee, Uganda National Council for Science and Technology, University of Zambia Biomedical Ethics Committee, Zambia National Health Research Authority and the London School of Hygiene and Tropical Medicine. Dissemination activities will involve publications in peer-reviewed journals, presentations at conferences and stakeholder meetings in the communities

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.

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

Social response to the delivery of HIV self-testing in households: experiences from four Zambian HPTN 071 (PopART) urban communities

Background Door-to-door distribution of HIV self-testing kits (HIVST) has the potential to increase uptake of HIV testing services (HTS). However, very few studies have explored the social response to and implications of door-to-door including secondary distribution of HIVST on household relations and the ability of individuals to self-test with or without supervision within households. Methods A CRT of HIVST distribution was nested within the HPTN 071 (PopART) trial, in four Zambian communities randomised to receive the PopART intervention. The nested HIVST trial aimed to increase knowledge of HIV status at population level. Between February 1 and April 30, 2017, 66 zones (clusters) within these four communities were randomly allocated to either the PopART standard of care door-to-door HTS (33 clusters) or PopART standard of care door-to-door HTS plus oral HIVST (33 clusters). In clusters randomised to HIVST, trained Community HIV care provider (CHiPs) visited households and offered individuals aged ≥ 16 and eligible for an offer of HTS the choice of HIV testing using HIVST or routine door-to-door HTS (finger-prick RDT). To document participants’ experiences with HIVST, Interviews (n = 40), observations (n = 22) and group discussions (n = 91) with household members and CHiPs were conducted. Data were coded using Atlas.ti 7 and analysed thematically. Results The usage and storage of HIVST kits was facilitated by familiarity with and trust in CHiPs, the novelty of HIVST, and demonstrations and supervision provided by CHiPs. Door-to-door distribution of HIVST kits was appreciated for being novel, convenient, private, empowering, autonomous and easy-to-use. Literacy and age influenced accurate usage of HIVST kits. The novelty of using oral fluids to test for HIV raised questions, some anxiety and doubts about the accuracy of HIVST. Although HIVST protected participants from experiencing clinic-based stigma, it did not address self-stigma. Within households, HIVST usually strengthened relationships but, amongst couples, there were a few reports of social harms. Conclusion Door-to-door distribution of HIVST as a choice for how to HIV test is appreciated at community level and provides an important testing option in the sub-Saharan context. However, it should be accompanied by counselling to manage social harms and by supporting those testing HIV-positive to link to care

Closing the gap: did delivery approaches complementary to home-based testing reach men with HIV testing services during and after the HPTN 071 (PopART) trial in Zambia?

INTRODUCTION: The HPTN 071 (PopART) trial demonstrated that universal HIV testing-and-treatment reduced community-level HIV incidence. Door-to-door delivery of HIV testing services (HTS) was one of the main components of the intervention. From an early stage, men were less likely to know their HIV status than women, primarily because they were not home during service delivery. To reach more men, different strategies were implemented during the trial. We present the relative contribution of these strategies to coverage of HTS and the impact of community hubs implemented after completion of the trial among men. METHODS: Between 2013 and 2017, three intervention rounds (IRs) of door-to-door HTS delivery were conducted in eight PopART communities in Zambia. Additional strategies implemented in parallel, included: community-wide "Man-up" campaigns (IR1), smaller HTS campaigns at work/social places (IR2) and revisits to households with the option of HIV self-testing (HIVST) (IR3). In 2018, community "hubs" offering HTS were implemented for 7 months in all eight communities. Population enumeration data for each round of HTS provided the denominator, allowing for calculation of the proportion of men tested as a result of each strategy during different time periods. RESULTS: By the end of the three IRs, 65-75% of men were reached with HTS, primarily through door-to-door service delivery. In IR1 and IR2, "Man-up" and work/social place campaigns accounted for ∼1 percentage point each and in IR3, revisits with the option of self-testing for ∼15 percentage points of this total coverage per IR. The yield of newly diagnosed HIV-positive men ranged from 2.2% for HIVST revisits to 9.9% in work/social places. At community hubs, the majority of visitors accepting services were men (62.8%). In total, we estimated that ∼36% (2.2% tested HIV positive) of men resident but not found at their household during IR3 of PopART accessed HTS provided at the hubs after trial completion. CONCLUSIONS: Achieving high coverage of HTS among men requires universal, home-based service delivery combined with an option of HIVST and delivery of HTS through community-based hubs. When men are reached, they are willing to test for HIV. Reaching men thus requires implementers to adapt their HTS delivery strategies to meet men's needs. CLINICAL TRIAL NUMBER: NCT01900977

Acceptability and Preferences of Two Different Community Models of ART Delivery in a High Prevalence Urban Setting in Zambia: Cluster-Randomized Trial, Nested in the HPTN 071 (PopART) Study.

Community delivery of Antiretroviral therapy (ART) is a novel innovation to increase sustainable ART coverage for People living with HIV (PLHIV) in resource limited settings. Within a nested cluster-randomised sub-study in two urban communities that participated in the HPTN 071 (PopART) trial in Zambia we investigated individual acceptability and preferences for ART delivery models. Stable PLHIV were enrolled in a cluster-randomized trial of three different models of ART: Facility-based delivery (SoC), Home-based delivery (HBD) and Adherence clubs (AC). Consenting individuals were asked to express their stated preference for ART delivery options. Those assigned to the community models of ART delivery arms could choose ("revealed preference") between the assigned arm and facility-based delivery. In total 2489 (99.6%) eligible individuals consented to the study and 95.6% chose community models of ART delivery rather than facility-based delivery when offered a choice. When asked to state their preference of model of ART delivery, 67.6% did not state a preference of one model over another, 22.8% stated a preference for HBD, 5.0% and 4.6% stated a preference for AC and SoC, respectively. Offering PLHIV choices of community models of ART delivery is feasible and acceptable with majority expressing HBD as their stated preferred option

The Broad-Brush Survey Approach. A set of methods for rapid qualitative community assessment

Using a combination of qualitative data collection methods to collect data rapidly from a place on a particular topic is not a novel idea. Rapid participatory and qualitative appraisal approaches have been used in many different settings for the past 40 years, with the influential scholar Robert Chambers, and those he worked with, doing much to shape the practice from the 1970s. The methods spread beyond a rural, agriculture focus (Chambers, 1994) to embrace urban settings and the assessment of health and other areas of interest as well as settings in the Global North as well as South (Annett and Rifkin, 1995, Murray et al., 1994). I first used these approaches in the 1980s, while working in the Annapurna foothills in Nepal at an agricultural research station. We established the practice of a one week data collection exercise, which we called a `Combined Trek’ where a group of scientists from different disciplines, including me – a social anthropologist – systematically collected information using interviews, observations and discussions in a village and the surrounding area – working closely with the local people. Our purpose was to inform future agricultural interventions, building from what people were already doing. Cecilia Vindrola-Padros and Ginger Johnson (2020) detail in a review article how different qualitative methods have been adapted to be used to collect data rapidly. The need for speed, as they explain, has been a response to the increasing pressure many of us are under to deliver study findings quickly. Their review sets out how conventional methods have been adapted to be used rapidly in different settings. Among the combination of methods that they describe is the `rapid ethnographic assessment’. This assessment approach has grown as a response of anthropologists to pressure to produce results far more quickly that more conventional ethnographic approaches would allow. This set of methods is described in detail in the recent manual produced by Sangaramoorthy and Kroeger (2020). We are not, therefore, claiming that the approach set out in this manual is particularly novel nor indeed unique. The Broad Brush Survey, described in this manual is an approach originally developed by Valdo Pons (1993, 1996) and further developed and popularized through the work of Sandra Wallman (1996), which can be used to capture both the landscape and ‘feel’ of a community and the people in it. The research findings can be used to shape further investigators or interventions to address the problem at hand in a useful and practical manner rapidly, succinctly and systematically. This `Broad Brush Survey’ approach manual is, therefore, a contribution to the burgeoning literature on methods for rapid qualitative data collection methods and assessment. The use of the word ‘survey’ in the title of the set of methods may be perplexing to those who consider the term to be synonymous with `questionnaire’. This 6 is not the way we use the word – the Oxford English Dictionary offers several definitions of word `survey’, which include `the act of viewing, examining, or inspecting in detail [...] for some specific purpose’ and `the, or an, act of looking at something as a whole from a commanding position; a general or comprehensive look’. Both definitions convey the sense of our intention: to engage with, and in, a community for a short but concentrated period of time, seeking quickly, but thoroughly, to take a comprehensive look at the place for a specific purpose, and document the place at that moment in time. As we explain in the first chapter, the approach is systematic with a defined sequence of qualitative data collection methods, which gradually allows the user to build an understanding of place and people. The combination of methods used, however, is not set in stone and can be adapted to suit the purpose at hand. As such we hope that this manual serves as a guide to the possibilities which using this approach can offer both for those working in interdisciplinary projects as well as those from anthropology and sociology, for example, laying the groundwork for in-depth longitudinal research

Corrigendum to: community-based health workers implementing universal access to HIV testing and treatment: lessons from South Africa and Zambia-HPTN 071 (PopART).

In the originally published version of this manuscript, the spelling of the co-author’s name was incorrect. The name should be “Mubekapi-Musadaidzwa” but is listed as “Mubekapi-Muzadaidzwa”. This error has now been corrected online

Community-based health workers implementing universal access to HIV testing and treatment: lessons from South Africa and Zambia-HPTN 071 (PopART).

The global expansion of HIV testing, prevention and treatment services is necessary to achieve HIV epidemic control and promote individual and population health benefits for people living with HIV (PLHIV) in sub-Saharan Africa. Community-based health workers (CHWs) could play a key role in supporting implementation at scale. In the HPTN 071 (PopART) trial in Zambia and South Africa, a cadre of 737 study-specific CHWs, working closely with government-employed CHW, were deployed to deliver a 'universal' door-to-door HIV prevention package, including an annual offer of HIV testing and referral services for all households in 14 study communities. We conducted a process evaluation using qualitative and quantitative data collected during the trial (2013-2018) to document the implementation of the CHW intervention in practice. We focused on the recruitment, retention, training and support of CHWs, as they delivered study-specific services. We then used these descriptions to: (i) analyse the fidelity to design of the delivery of the intervention package, and (ii) suggest key insights for the transferability of the intervention to other settings. The data included baseline quantitative data collected with the study-specific CHWs (2014-2018); and qualitative data from key informant interviews with study management (n = 91), observations of CHW training events (n = 12) and annual observations of and group discussions (GD) with intervention staff (n = 68). We show that it was feasible for newly recruited CHWs to implement the PopART intervention with good fidelity, supporting the interpretation of the trial outcome findings. This was despite some challenges in managing service quality and CHW retention in the early years of the programme. We suggest that by prioritizing the adoption of key elements of the in-home HIV services delivery intervention model-including training, emotional support to workers, monitoring and appropriate remuneration for CHWs-these services could be successfully transferred to new settings