HIV/ AIDS

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Assessing factors associated with attrition among older adults on antiretroviral therapy in Malawi
(Kamuzu University of Health Sciences, 2021-10-18) Londo, Mathias
Type of research study: This quantitative study will employ a retrospective observational cohort design. The problem: Access to HIV services among adults aged ≥50 is compromised due to the stereotypes surrounding their perceived low susceptibility to HIV. This leads to minimal interventions targeting them as well as low follow-up for them after ART initiation. In SSA, attrition after ART initiation ranges from 23.4% to 57% and is mainly due to either death or loss to follow-up. Polypharmacy, drug toxicities, and co-infections increase the risk of attrition among older adults. However, most HIV interventions primarily focus on populations aged 15-49 and children neglecting those aged ≥50. There is still inadequate information on levels of attrition and associated factors among these adults, hence the need for this study. Broad objective: To assess attrition after antiretroviral therapy initiation among adults at Nkhatabay district hospital. Specific objectives • To compare levels of attrition between older and younger adults 24 months after ART initiation • To determine the predictors of mortality and loss to follow up among older adults 24 months after ART initiation. Methodology: The study will be a quantitative retrospective observational cohort design. The study will analyze outcomes of adults aged 15-49 and those aged ≥50 initiated on ART between 2015 and 2019 at Nkhatabay District Hospital. The sample size will be 208 and participants will be selected using a simple random method. Data will be collected using patients' master cards and ART registers. Data analysis will be done using STATA 14.0. Attrition post ART initiation will be determined by the Kaplan-mier survival function. Cox proportional hazard model will be used to measure factors associated with attrition. Expected findings and their dissemination: It is expected that there will be variations in attrition levels post ART initiation between older and younger adults. Predictors of attrition among older adults will be ascertained. The study findings will be shared with the College of Medicine Research. Committee (COMREC), Nkhatabay District Office, the library of COM, and the Department of HIV/AIDS at the Ministry of Health. The results will also be published and presented at research conferences.
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Assessing the effectiveness of Multi Month Scripting of Anti Retroviral Therapy amongst stable patients: A comparative case of Bwaila Martin Preuss Center and Kapiri In Malawi
(Kamuzu University of Health Sciences, 2021-03-17) Longwe Matupa, Elinat
Type of research: A quantitative multiple retrospective study aimed at evaluating the effectiveness of multi-month scripting (MMS) on ART amongst stable adult patients living with HIV under care using a comparative case of Bwaila Martin Preuss Clinic in Lilongwe and Kapiri Mission Hospital in Mchinji, Malawi. Secondary data will be used. The problem: The United Nations Programme on HIV/AIDS (UNAIDS) and WHO promote adoption of the Differentiated Service Delivery (DSD) approach with its 95-95-95 targets by 2030. Malawi adopted the multi-month scripting (MMS) among other models to relieve the burden of frequent 28 September 2016. National Health Sciences Research Committee (NHSRC) number 15/11/1513”. The study population will include stable adult patients living with HIV on Regimen 5A TDF/3TC/EFV (300/300/600mg) at Bwaila Martin Pruess Clinic and Kapiri Health Centre. A total of 3,565 patient records receiving three months (90days) dispensing intervals in these two health facilities will be used for the study. Data used will be secondary quantitative data collected routinely as part of clinic Electronic Medical Records (EMR) at the two health facilities. Collected data will be stored securely in computer data base that have a password and only limited access to key study team will be provided. Stata version 15 will be used for analysis with summary statistics including percentages, medians and ranges calculated and presented for quantitative variables. Ethical approval will be sought from the College of Medicine Research and Ethics Committee (COMREC). Expected findings and their Dissemination: It is anticipated that the study will generate findings that are well enriched with adequate information that provides a deep understanding of the subject and contribute meaningfully to the body of knowledge on Differentiated Service Delivery. We expect to determine the effectiveness of MMS on ART among stable patients and if patient characteristics are associated with retention. Research results will be disseminated in writing and presentations. The report will be submitted to College of Medicine, University of Malawi being the institution to award the degree. Research findings will be presented to health care workers and senior management teams the participating health facilities. The researcher will be available to share the results from the study through local dissemination conferences, seminars and workshops organized by the College of Medicine’s Research Support Centre (RSC) and Research and Ethics Committee (COMREC). An abstract will be developed for submission to conferences and publication in journals. appointments of patients and providers, freeing up resources to provide more intensive care to complex patients where HIV mortality is high. Since 2016 all government health facilities in Malawi have implemented 3 months multi- month scripting for stable patients on ART. However, there is no evidence on the comparative effect of MMS on improved patient outcomes in terms of adherence to ART and the influence of the captured patient characteristics on the adherence to ART. Objectives: The aim of the study is to evaluate the effectiveness of multi-month scripting (MMS) on ART amongst stable adult patients living with HIV under care using a comparative case of Bwaila Martin Preuss Clinic in Lilongwe and Kapiri Mission Hospital in Mchinji, Malawi. The study specifically seeks to determine the effect of MMS on patient retention; assess the patient characteristics that are associated with the degree of compliance to ART treatment and assess the influence of patient characteristics on retention in care for patients on MMS. Methodology: A quantitative multiple retrospective study will be used to evaluate the effectiveness of multi month scripting (MMS) on ART amongst stable adult patients living with HIV under care at Bwaila Martin Preuss Clinic in Lilongwe and Kapiri Mission Hospital in Mchinji. Secondary data analysis will be done on data collected from the study titled “Assessing Implementation of Models of Differentiated Care for HIV Service Delivery in Malawi: A Process Evaluation dated
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Assessing viral load testing adherence and coverage and the related client outcomes in the 90:90:90 era
(Kamuzu University of Health Sciences, 2020-06-05) Kholomana, Thokozani
The type of research study This will be a retrospective quantitative cohort study. The problem to be studied: Viral load (VL) testing is one of the essential measure of HIV client progress in regards to ART where suppression shows treatment success. So this study intends to find out the level of VL coverage and adherence to protocol and describe the relationship between those clinical factors and the development of Tuberculosis (TB), infantile deaths and miscarriages. Main objectives: To assess the viral load testing adherence and coverage and the related client outcomes Specific objectives 1. To assess the level of clinical adherence and coverage in regards to viral load time frames 2. To measure the prevalence of Tuberculosis in HIV care enrolled clients and the related VL adherence and coverage before diagnosis 3. To estimate the rate of miscarriages in HIV clients and the related VL adherence and coverage prior to incident 4. To determine the prevalence of infantile deaths and the related VL adherence and coverage prior to the incident Methodology Study design: The study will employ a retrospective quantitative cohort design. Study place: This will be conducted in Ntchisi district. Respondents will be recruited from Ntchisi district hospital ART clinic. Study population: HIV reactive clients attending Ntchisi district hospital ART clinic will be eligible for this study. Study Period: The study will run from April 2019 to July 2020. This is a 16-month period which conceptualization of the proposal to thesis submission will be done. Data collection procedures: This study will utilize a checklist to extract data following the subjects consent. The checklist will look at such variables as age, sex, marital status of HIV positive patients, TB status, infantile deaths status, miscarriages, the number of VL tests and the times when their viral load testing was done. Mainly the clients master cards, and the prevention of mother to child transmission (PMTCT) registers utilized will be used to extract such data. Data management and analysis: All data will be kept in Microsoft excel with a passcode for safety. So, these data will be exported to Stata wherein cleaning and analysis will occur. Moreover, respondents’ identities will not be identifiable since they will be represented by codes. Data analysis will involve both descriptive and inferential statistics. Constraints: The researcher supposes there might be missing VL results in other study participants. In regards to this, the researcher plans to rectify this by following up with the central laboratory. Implications of the study: Results from this study are expected to contribute knowledge to the body of research in HIV medicine. For that cause, this information will be important when developing interventions for HIV clients’ care, providers protocol, including mentorship and supervision schedules. Expected findings and their dissemination: This study will find the period prevalence of Tuberculosis, miscarriages, and infantile deaths in people living with HIV (PLHIV). Moreover, this will show coverage and adherence frequencies in regards to VL testing in PLHIV and the relationship and association between the dependent and independent variables. Moreover, the results be contained in the author’s Master of Global Health thesis that will be submitted to COMREC and college library.
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Association between pregnancy progression and HIV acquisition among the reproductive age group at Machinga District Hospital
(Kamuzu University of Health Sciences, 2020-06-05) Kang'oma, Melina; Kaonga, Clevereen; Chitanje, Olivetta
Pregnancy is a crucial period in planning for interventions against HIV [1], since it is associated with many behavioral and physiological changes. These changes are associated with an increased risk of HIV acquisition [2]. One of the interventions put in place is the PMTCT programme, which has 4 pronged strategies that targets both HIV negative and positive women. The prongs include; primary prevention of HIV in women of child bearing age, prevention of unintended pregnancies among HIV positive women, prevention of HIV transmission from mother to child and provision of continuous care and treatment for infected mothers, partners and their children. This study aims at measuring the association between progression of pregnancy and HIV acquisition among women of the reproductive age group in Machinga. The first specific objective is to measure the incidence of HIV among pregnant women during their second Ante natal care clinic visit. This is in accordance with one of the prongs that targets primary prevention of HIV among women of reproductive age and the prevention of HIV transmission from HIV positive mothers to their unborn child. Analyzing the trend in HIV incidence among pregnant women according to their characteristics is the second specific objective. These characteristics will include marital status, age, occupation or their spouse occupation and trimester period. This will help in finding the characteristics associated with an increased rate of seroconversion. The last specific objective will involve finding out the risk factors for HIV acquisition as pregnancy progresses from both male and female perspective. This will both help to know if the community thinks pregnancy can really increase the chances of seroconverting and to know the exact area to be targeted for interventions in reducing the HIV incidence. The research will involve a mixed study design. The incidence of HIV will be measured among women who attended at least two ANC visits and were HIV negative on their first ANC visit. This will use a retrospective cohort study which will involve secondary data analysis for the past 5 years (from 2015-2020). The study will describe people’s knowledge on the risk factors of acquisition of HIV during pregnancy using in-depth interviews with a minimum of 10 and a maximum of 30 participants depending on the saturation point. The expected outcome is, there is an increased chance of acquiring HIV as the pregnancy progresses. A copy of the research results will be presented to the board of supervisors from the University of Malawi-College of Medicine and the District health office of Machinga.
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Barriers and facilitators to screening for dyslipidaemia, hypertension and diabetes among people living with HIV aged 40 years and above at ART clinics in district hospitals in Southern Malawi
(Kamuzu University of Health Sciences, 2021-11-18) Katundu, Kondwani
Study Type: The study will utilise a mixed-methods (convergent) approach. Background: Malawi is ranked among the countries in the world with the highest burden of atherosclerotic cardiovascular diseases (ASCD) among people living with HIV (PLWH). Dyslipidaemia, Hypertension, and diabetes mellitus (DM) are major risk factors for ASCD and lead to debilitating consequences such as stroke. There is a gap in the effectiveness in identifying and managing hypertension dyslipidaemia and DM among PLWH in many public health facilities across Malawi. Investigating the local barriers and facilitators in the Malawian setting is critical to creating better implementation strategies for the effective screening and management of these cardiovascular risk factors in district hospitals of the country. Study Objectives: The objectives of this study are: (a) to determine the proportion of PLWH aged 40 years and older who are evaluated for dyslipidaemia, hypertension and DM in routine care at district hospital ART clinics in Southern Malawi (b) to identify the barriers and facilitators to screening for dyslipidaemia, hypertension and DM among PLWH) aged 40 years and older at ART clinics in district hospitals in Southern Malawi. Methods: A mixed-methods (convergence) approach will be used to collect the study data. Firstly, we will quantitatively collect retrospective data on the performance of five randomly selected district hospital ART clinics in Southern Malawi to screen for hypertension, dyslipidaemia and DM in routine care. From these clinics, we will purposefully select three clinics rated as highest, intermediate and low on the screening performance for hypertension, which is the expected standard routine assessment in these clinics, according to Malawi standard clinical guidelines for the management of PLWH. In the three clinics we will collect qualitative data guided by the Consolidated Framework for Implementation Research (CFIR), and we will assess for three major domains namely the intervention, the inner setting and the characteristics of individuals. Expected findings and dissemination: We expect to find a relatively high prevalence of screening for hypertension since it is in the national management guidelines. However, we hypothesize that the prevalence for screening for DM and dyslipidaemia will be lower due to the lack of inclusion in the national guidelines and screening resources in district hospitals. We expect to identify the barriers and facilitators to the integration of screening of hypertension, DM and dyslipidaemia in the ART clinics. The results once analysed will be published in an international scientific journal and will be presented both at local and regional or international conferences. Published results will also be submitted to the district hospitals engaged, the HIV and non-communicable diseases units of the Malawi Ministry of Health, the College of Medicine Research and Ethics Committee (COMREC) and the Kamuzu University of Health Sciences Library.
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A comparative analysis of Antiretroviral Therapy treatment outcomes in the public, private and Christian Health Association of Malawi by service delivery system in Blantyre city of Malawi
(Kamuzu University of Health Sciences, 2020-11-11) Chuka, Stuart
The Antiretroviral Therapy (ART) Program for Malawi started in 2004 and the key providers in provision of ART services in Malawi include; the public sector, the private sector for-profit and nonprofit and Christian Health Association of Malawi (CHAM. Since then, no known studies have been conducted to compare primary ART treatment outcomes across private, public and CHAM health facilities by service provider type. In addition, information on variation of primary ART treatment outcomes by service provider type thus; private, public and CHAM is not known and probably has not been published. This is a cross-sectional study and will utilize both quantitative and qualitative methods. The quantitative method will use facility level secondary data from the Malawi National ART Program in the Department of HIV in the Ministry of Health. The qualitative method will use in-depth interviews using an interview guide to key informants. Data will be analyzed using STATA statistical software package version 15. T-test and Analysis of Variance (ANOVA) will be used to compare the variations of primary ART outcomes among in public, private and CHAM ART sites. To compare proportions, will use Chi-Square Test and Fisher Exact Test. Logistic regression will be used to describe data and to explain the relationship between the variables. The results of this study will assist to improve the health care service delivery across private sector, CHAM and Public ART Clinics in Malawi through policy decisions which will also have a major impact in the National ART Program and the global world as a whole. The results of the study will be submitted to College of Medicine Ethics Review Committee (COMREC), COM library and presented at the COM Research Dissemination conference.
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A comparison of antiretroviral therapy outcomes among adolescents in teen clubs and standard care clinics: Blantyre, Malawi
(Kamuzu University of Health Sciences, 2021-05-12) Alibi, Michael
Introduction This is a retrospective cohort study designed to investigate the impact of the teen club model among adolescents living with HIV on antiretroviral therapy (ART) outcomes in Blantyre. Teen clubs are among the Differentiated Service Delivery (DSD) models being implemented in Malawi to improve antiretroviral treatment outcomes. Currently, more studies have been conducted in Malawi focusing on the impact of teen clubs in adherence to ART and reducing loss to follow up, but very little has been done to investigate the impact of the model in improving long-term outcomes of ART such as viral load suppression, reduced virological failure, and prolonged life. Some African countries such as South Africa and Namibia have recently conducted similar studies. Objectives The primary objective of the study is to compare antiretroviral therapy outcomes among adolescents living with the human immune-deficiency virus (HIV) in teen clubs compared to those in standard care clinics. The primary outcome is differences in virological suppression among the two groups, the exposed (adolescents in teen clubs) and the unexposed (adolescents in the standard of care). Virological failure and 24 months survival analysis for adolescents in teen clubs and those receiving standard of care will as be assessed. Methodology The retrospective cohort study will be from the 1st of January, 2018 to the 31st of December, 202019. A sample of 182 adolescents living with HIV on ART from the 6 public health care clinics in Blantyre will be identified (3 with teen clubs and 3 using the standard of care model). The health care clinics were identified through stratified random sampling. Stratification was based on the type of adolescent ART service being provided by the health facility (teen club model or standard of care). The study sample is all-inclusive of the study population. A case report form will be used to extract demographic and clinical data from the ART registers, client master cards, and Electronic Medical Records database. Virological data will be obtained from the master cards and demographic and ART outcome data will be obtained from the ART registers. STATA 16.0 will be used to analyze the data and chi-squared and poison regression will be used to analyze the differences in the two groups and Kaplan Meier curves and Cox proportional hazard method will be used for survival analysis. The study will be conducted from February to December 2021. Expected findings and their dissemination. Based on studies conducted in other countries with a similar setting as Malawi, it is expected that the teen club model is most likely to improve the long-term ART outcomes as compared to the standard of care. The outcomes include viral load suppression and virological failure. The results will be disseminated to the College of Medicine Research and Ethics Committee (CoMREC), College of Medicine Library, and the University Research and Publication Committee, to College of Medicine as partial fulfillment of the Master of Epidemiology (MSc in Epidemiology) program, the District and city health offices, Blantyre city and District AIDS coordination committees and the Blantyre HIV treatment and care, technical working group.
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Examining factors that influence Anti-Retro viral Treatment (ART) adherence among HIV positive adolescents in Mwanza district- Malawi
(Kamuzu University of Health Sciences, 2021-06-16) Nyong’onya, Ireen
Study type Quantitative study Statement of the problem Mwanza district has an adolescent HIV prevalence rate of 2.2% (Mwanza HMIS office, 2019). Despite having free ART services being offered at the district hospital, it registered a default rate of 23.2% among adolescents aged 10-19years old. (Mwanza HMIS, 2019). However, there is scarcity of studies that have addressed factors that influence ART adherence among adolescents in Malawi; therefore this study aims at unveiling factors that ART adherence among adolescents. Broad objective To explore factors that influence ART adherence among adolescents living with HIV aged 10-19 years old at Mwanza District Hospital in Mwanza district, Malawi. Specific objectives  To determine individual factors affecting ART adherence among HIV positive adolescents  To examine family and community factors affecting ART adherence among HIVpositive adolescents  To assess health system factors affecting ART adherence among HIV positive adolescents  To determine ART adherence rate among HIV- positive adolescents Study setting The study will be conducted at Mwanza District Hospital ART clinic. Study population All adolescents aged 10-19 living with HIV/AIDS and on life prolonging ART for more than six months. Inclusion criteria Adolescents aged 10-19 years old on ART for more than six months. Those under 18 years old will be required to have a caregiver to give consent on their behalf. Exclusion criteria HIV positive adolescents who are under 18 years old and do not have a caregiver. Data collection and management Collected data will be checked for mistakes then it will be entered into Statistical Package for Social Science Version 20.0 for analysis. Chi- square test will be used to calculate the association between demographic characteristics of the participants and the factors that influence ART adherence. Ethical consideration An ethical approval will be obtained from College of Medicine Research and Ethics Committee (COMREC) before data collection. Permission to conduct the study at Mwanza District Hospital will be sought from Mwanza District Health Office. Caregivers will give consent for those under 18 years of age and those without care givers will be excluded from the study. Study limitations The study is being done for academic purposes and with limited funds just to achieve the purpose therefore cannot be done on a large scale. Expected findings The study is expected to unveil the challenges that prevent adolescents from adhering to ART. Dissemination of findings Findings from the study will be disseminated through presentation at relevant forums and presentation of copies to College of Medicine Research and Ethics Committee (COMREC), Kamuzu College of Nursing and Mwanza District Health Office
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Exploration of factors that influence uptake and retention in ART care and treatment among clients diagnosed HIV positive through Active index testing in Dedza, Malawi.
(Kamuzu Univeristy of Health Sciences, 2021-07-15) Thandolo, Chisomo
Study type A qualitative study will be conducted from July to August 2021 in Dedza district, Malawi. Indepth interviews will be conducted among contacts of index clients who have been diagnosed HIV positive. Problem Despite existing structures provided by department of HIV and the National ART policies coupled with the 2016 universal treatment for all in Malawi, people living with HIV/ AIDS are not initiating or delay in starting ART care. This challenge is huge in clients identified through active index testing. In the sub–Saharan African, less than one third of those identified are linked to care and for those that are linked in care less than three quarters of them continue to be in care Despite the 2016 universal treatment policy, Malawi is still facing the challenges where clients identified through AIT are taking time and some do not show up in the facilities to engage in care. There is limited data on strategies for optimising uptake and retention of AIT clients in care to achieve suppression which may reduce mortality and morbidity rates due to HIV/AIDS. Objectives of the study Broad objective 1. To explore factors that influence uptake and retention in ART care and treatment among clients diagnosed HIV positive through Active Index Testing in Dedza Malawi. Specific objectives 1. To investigate facilitators to initiate and remain in ART care and treatment among HIV clients diagnosed through index testing. 2. To identify potential strategies that can facilitate ART initiation and retention in care among clients diagnosed through index clients and 3. To identify differentiated service delivery models of care to improve linkage and retention in ART care among clients diagnosed HIV positive through AIT. Methodology The study setting will be Dedza, Malawi in three health facilities that are currently implementing Active index testing. The health facilities are Mtendere, Mua, and Dedza district Hospital. The study population will be contacts of index clients (18 years of age and above) who can willingly consent and are HIV positive diagnosed through Active index testing. In addition, ART providers and expert clients who have been providing ART for not less than 12 months will also be Commented [CMM1]: Citation removed Commented [CMM2]: Citation removed Commented [CMM3]: Objectives in executive summary put in bullets and indicated as broad and specific objectives 15-Jul-2021 Exploration of factors to increase uptake and retention in ART care among AIT client’s version 2.0, 25 June 2021 4 approached and asked to participate in the study. Hence 10 ART providers, 10 expert clients and 20 contacts of indexes that have been diagnosed HIV positive through Active index testing will be asked to participate in the study. The study will employ maximum variation purposive sampling to study participants from all angles for better understanding of the topic and to achieve heterogeneity. Index clients’ registers in the three facilities will be used to identify contacts who tested positive. All contacts aged 18 and above who can consent and were tested HIV positive regardless of whether they initiated or did not initiate ART care will be earmarked to be enrolled after consenting to participate. While certified ART providers and known expert clients that have been working at the facility for not less than 12 months and are willing to participate will be asked to take part in the study. Semi structured in-depth interviews will be conducted for data collection. The interviews will be recorded, transcribed and translated into English for analysis. The PI will do the analysis where coding themes will be developed. Social Ecological Model will guide analysis of data in this study. Expected findings and dissemination Study findings will help health workers to identify barriers and influencers of clients identified HIV positive through active index testing to linkage and continuation in treatment. It will also guide policy makers to come up with targeted interventions to close existing gaps on index testing program across the HIV cascade. Research findings will be disseminated at COMREC and Dedza District Health Office. In addition, the research findings will be disseminated at local and international conferences and manuscripts of results will be submitted for publication in peer reviewed journals Study type A qualitative study will be conducted from July to August 2021 in Dedza district, Malawi. Indepth interviews will be conducted among contacts of index clients who have been diagnosed HIV positive. Problem Despite existing structures provided by department of HIV and the National ART policies coupled with the 2016 universal treatment for all in Malawi, people living with HIV/ AIDS are not initiating or delay in starting ART care. This challenge is huge in clients identified through active index testing. In the sub–Saharan African, less than one third of those identified are linked to care and for those that are linked in care less than three quarters of them continue to be in care Despite the 2016 universal treatment policy, Malawi is still facing the challenges where clients identified through AIT are taking time and some do not show up in the facilities to engage in care. There is limited data on strategies for optimising uptake and retention of AIT clients in care to achieve suppression which may reduce mortality and morbidity rates due to HIV/AIDS. Objectives of the study Broad objective 1. To explore factors that influence uptake and retention in ART care and treatment among clients diagnosed HIV positive through Active Index Testing in Dedza Malawi. Specific objectives 1. To investigate facilitators to initiate and remain in ART care and treatment among HIV clients diagnosed through index testing. 2. To identify potential strategies that can facilitate ART initiation and retention in care among clients diagnosed through index clients and 3. To identify differentiated service delivery models of care to improve linkage and retention in ART care among clients diagnosed HIV positive through AIT. Methodology The study setting will be Dedza, Malawi in three health facilities that are currently implementing Active index testing. The health facilities are Mtendere, Mua, and Dedza district Hospital. The study population will be contacts of index clients (18 years of age and above) who can willingly consent and are HIV positive diagnosed through Active index testing. In addition, ART providers and expert clients who have been providing ART for not less than 12 months will also be Commented [CMM1]: Citation removed Commented [CMM2]: Citation removed Commented [CMM3]: Objectives in executive summary put in bullets and indicated as broad and specific objectives 15-Jul-2021 Exploration of factors to increase uptake and retention in ART care among AIT client’s version 2.0, 25 June 2021 4 approached and asked to participate in the study. Hence 10 ART providers, 10 expert clients and 20 contacts of indexes that have been diagnosed HIV positive through Active index testing will be asked to participate in the study. The study will employ maximum variation purposive sampling to study participants from all angles for better understanding of the topic and to achieve heterogeneity. Index clients’ registers in the three facilities will be used to identify contacts who tested positive. All contacts aged 18 and above who can consent and were tested HIV positive regardless of whether they initiated or did not initiate ART care will be earmarked to be enrolled after consenting to participate. While certified ART providers and known expert clients that have been working at the facility for not less than 12 months and are willing to participate will be asked to take part in the study. Semi structured in-depth interviews will be conducted for data collection. The interviews will be recorded, transcribed and translated into English for analysis. The PI will do the analysis where coding themes will be developed. Social Ecological Model will guide analysis of data in this study. Expected findings and dissemination Study findings will help health workers to identify barriers and influencers of clients identified HIV positive through active index testing to linkage and continuation in treatment. It will also guide policy makers to come up with targeted interventions to close existing gaps on index testing program across the HIV cascade. Research findings will be disseminated at COMREC and Dedza District Health Office. In addition, the research findings will be disseminated at local and international conferences and manuscripts of results will be submitted for publication in peer reviewed journals Study type A qualitative study will be conducted from July to August 2021 in Dedza district, Malawi. Indepth interviews will be conducted among contacts of index clients who have been diagnosed HIV positive. Problem Despite existing structures provided by department of HIV and the National ART policies coupled with the 2016 universal treatment for all in Malawi, people living with HIV/ AIDS are not initiating or delay in starting ART care. This challenge is huge in clients identified through active index testing. In the sub–Saharan African, less than one third of those identified are linked to care and for those that are linked in care less than three quarters of them continue to be in care Despite the 2016 universal treatment policy, Malawi is still facing the challenges where clients identified through AIT are taking time and some do not show up in the facilities to engage in care. There is limited data on strategies for optimising uptake and retention of AIT clients in care to achieve suppression which may reduce mortality and morbidity rates due to HIV/AIDS. Objectives of the study Broad objective 1. To explore factors that influence uptake and retention in ART care and treatment among clients diagnosed HIV positive through Active Index Testing in Dedza Malawi. Specific objectives 1. To investigate facilitators to initiate and remain in ART care and treatment among HIV clients diagnosed through index testing. 2. To identify potential strategies that can facilitate ART initiation and retention in care among clients diagnosed through index clients and 3. To identify differentiated service delivery models of care to improve linkage and retention in ART care among clients diagnosed HIV positive through AIT. Methodology The study setting will be Dedza, Malawi in three health facilities that are currently implementing Active index testing. The health facilities are Mtendere, Mua, and Dedza district Hospital. The study population will be contacts of index clients (18 years of age and above) who can willingly consent and are HIV positive diagnosed through Active index testing. In addition, ART providers and expert clients who have been providing ART for not less than 12 months will also be Commented [CMM1]: Citation removed Commented [CMM2]: Citation removed Commented [CMM3]: Objectives in executive summary put in bullets and indicated as broad and specific objectives 15-Jul-2021 Exploration of factors to increase uptake and retention in ART care among AIT client’s version 2.0, 25 June 2021 4 approached and asked to participate in the study. Hence 10 ART providers, 10 expert clients and 20 contacts of indexes that have been diagnosed HIV positive through Active index testing will be asked to participate in the study. The study will employ maximum variation purposive sampling to study participants from all angles for better understanding of the topic and to achieve heterogeneity. Index clients’ registers in the three facilities will be used to identify contacts who tested positive. All contacts aged 18 and above who can consent and were tested HIV positive regardless of whether they initiated or did not initiate ART care will be earmarked to be enrolled after consenting to participate. While certified ART providers and known expert clients that have been working at the facility for not less than 12 months and are willing to participate will be asked to take part in the study. Semi structured in-depth interviews will be conducted for data collection. The interviews will be recorded, transcribed and translated into English for analysis. The PI will do the analysis where coding themes will be developed. Social Ecological Model will guide analysis of data in this study. Expected findings and dissemination Study findings will help health workers to identify barriers and influencers of clients identified HIV positive through active index testing to linkage and continuation in treatment. It will also guide policy makers to come up with targeted interventions to close existing gaps on index testing program across the HIV cascade. Research findings will be disseminated at COMREC and Dedza District Health Office. In addition, the research findings will be disseminated at local and international conferences and manuscripts of results will be submitted for publication in peer reviewed journals 15
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Investigation into the Prevalence of Beijing Strain among HIV TB Patients in Blantyre
(Kamuzu University of Health Sciences, 2021-09-06) Mulungu, Kennedy; Mkwangwanya, Chifundo
Type of study A retrospective cohort method will be used in this study. The Problem The prevalence of the Beijing strains among HIV positive patients in the southern region of Malawi specifically Blantyre has not been investigated. Blantyre would be an interesting case owing to its proximity to both Mozambique and South Africa and the bi-directional migration taking place with these two countries. Data from such a study would be important in the design of TB control strategies among HIV positive individuals. Broad Objective The aim of the study is to determine investigate the prevalence of the Beijing strains among HIV positive TB patients in Blantyre, Malawi. Specific objectives i. To establish the prevalence of the Beijing strain among HIV positive patients in Blantyre ii. To establish a possible association between Beijing strain and drug resistance among HIV positive patients in Blantyre. Methodology A total of 50 culture confirmed Mtb clinical isolates with drug resistant profiles from GeneXpert will be used in the study. These will be selected from frozen sputum samples collected between 2009 and 2018 from TB patients presenting at QECH. Drug resistance will be confirmed using custom made sensititre plates by determining the minimum inhibitory concentrations (MICs). DNA will be extracted and subjected to RD207 (targeting the Beijing strain) singleplex PCR assay. The resulting information will be analysed to establish genotype-phenotype associations. The PCR assay will determine the rate of occurrence of the Beijing strain among HIV positive individuals while MICs will determine the extent of drug resistance within these strains. The expected results are to find high prevalence of Beijing strain in HIV positive TB patients who are resistant to Tb therapy. Expected findings and their dissemination The results will be presented at the College of Medicine Annual Research Dissemination conference shared with COMREC and presented at National TB research conferences and published in a peer review journal.
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Mental health and antiretroviral therapy: an exploration of the association between depression and ART adherence among the youth in Lilongwe, Malawi
(Kamuzu University of Health Sciences, 2021-09-15) Msefula, Mary Carolyne
Type of study: A crosssectional mixed methods design study with Quantitative and Qualitative approaches with each provising equal weight (QUANT-QUAL). Problem: Martin Preus Centre (MPC) provides comprehensive HIV services to youths aged 15- 24. However, from October, 2020 – March, 2021, 154 youths aged 15-24 either self -referred or provider initiated referred for psychosocial counselling services due to poor ART adherence related factors. Despite collaborative efforts in improving ART adherence among youth in Lilongwe, MPC has 28.5 % of ART non adherence. Therefore, this study intends to measure the association between depression and ART non-adherence among the youth in Lilongwe. Main objective  To establish the association between depression and ART non- adherence among the youth in Lilongwe Specific Objectives  To determine the characteristics of depression among the youth on ART at MPC in Lilongwe  To explore the factors leading to depression among the youth at MPC in Lilongwe  To assess ART adherence among the youth on ART at MPC in Lilongwe  To examine the association between depression and ART non- adherence among the youth at MPC in Lilongwe Methodology: The study will be conducted at Lighthouse Trust- Martin Preus Centre (MPC) at Bwaila Hospital in urban city of Lilongwe, Malawi. 310 participants will recruited in the study comprising of psychosocial counsellors, ART providers and youths aged 15-24 accessing ART services at MPC. Quantitatively: Data will be collected using Patient Health Questionnaire (PHQ 9) scale for depression assessment. Secondary data will be extracted from the Electronic Medical Records (EMR) to assess youths ART adherence. The quantitative data will be analyzed using Stata. In measuring the association between depression (predictor variable) and ART adherence (Outcome variable) comparison of the proportion of patients with poor ART adherence among the group with depression versus those without depression will be done. Furthermore, multivariable logistic regression model and chi-square test will be used to compute Odds Ratio and compare the various variables in proportions whenever it will be applicable. Qualitatively: Data will be collected using semi structured interview guide on In-depth interviews (IDI) .The IDI’s will be guided with open ended questions which will be audio recorded and backed with field notes.Themantic content analsysis will be conducted in qualitative data aided by NVivo software. Expected findings: Study is expected to measure the association between depression and ART nonadherence amongst the youth accessing ART services at MPC. Dissemination: A well detailed report of findings will be prepared and disseminated to the implementing partner Health Lighthouse Trust- MPC clinic and other relevant stake holders including Ministry of College of Medicine and Research Ethics Committee, College of Medicine library for student’s reference and further study gap identification. The results shall further be published in relevant peer reviewed journals.
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Pilot of an intervention for Malawian pregnant women with HIV to improve depression, viral suppression and engagement of partners in HIV self-testing
(Kamuzu University of Health Sciences, 2021-03-17) Abas, Melanie;
Type of research study: This will be a mixed-methods pilot study employing both qualitative and quantitative data collection approaches. Qualitative methods will be used during formative work to adapt an intervention to treat depression and optimise adherence to HIV medication for the Malawian antenatal context. Quantitative methods will be used within a Phase 2 exploratory pilot trial aimed at testing the feasibility and acceptability of the integrated intervention, and feasibility of collecting clinical outcome measures at baseline and post randomisation follow up to inform a future fully powered cluster randomised trial. The problem to be studied Globally, 38 million people are living with HIV, with nearly 70% of these in sub-Saharan Africa. Policies to improve access to antiretroviral therapy (ART) for the treatment of HIV have dramatically reduced the rate of HIV related mortality in sub-Saharan Africa. This is because ART supresses the level of virus in the blood which halts the virus’s ability to attack the immune system. The result is that people living with HIV have a significantly reduced risk of transmitting the virus to sexual partners and from mother to child. HIV infection remains one of the biggest killers globally. However, the benefits of ART are reliant on daily adherence to the regimen. Malawi has a successful programme for prevention of mother to child transmission of HIV based on routine antenatal testing and provision of ART. However, 23% of women attending HIV antenatal care are lost to care at one year. Depression is an important cause of poor adherence to medication for the treatment of HIV and disengagement from HIV care. Depression is two to three times higher in people living with HIV than in the general population, and common in pregnant and post-natal women in Southern Africa. Symptoms of depression such as reduced concentration, memory, problem-solving ability and motivation, adversely affect engagement with health care and adherence to medication. Malawi's successful programme of antenatal testing presents an opportunity to engage their male partners in HIV testing. Men are less likely than women to test for HIV and know their status. In Malawi over 45% of HIV-positive women in stable relationships have an HIV-negative partner. Without intervention, HIV-negative partners acquire HIV at up to 12% per year. Supporting women to adhere optimally to their HIV medication to ensure their virus is well controlled reduces the risk of transmission to zero. HIV self-testing, whereby an individual collects their own sample, conducts the test and interprets their result increases coverage and frequency of testing. Partner-delivered self-test kits, where woman distribute a test to their male partner, is becoming routine antenatal policy and practice in high HIV prevalence settings including Malawi. Study objectives The aim of the proposed research is to finalise and test the feasibility and acceptability of an intervention for pregnant women living with HIV and depression, to reduce depression and optimise engagement in HIV care, and to increase uptake of HIV testing, prevention and care for their male partners.Specific aims are: The overall aim of the study is to test the feasibility and acceptability of an intervention for depression in people living with HIV called TENDAI-Together among pregnant women living with HIV and depression in Blantyre. Specific objectives in the Formative Phase of our research are: 1. To translate and back-translate the existing draft TENDAI-Together intervention from English to Chichewa, a main language used in Blantyre2. To use qualitative methods (in-depth interviews and focus groups discussions) and Theory of Change in Malawi to learn from women, partners, and health staff about terminology for distress and views about an intervention, to learn how to adapt the intervention and how to implement it in antenatal clinics in Bangwe Health Centre 3. To review emerging evidence on ingredients of efficacious brief psychological interventions for couples, so we can strengthen the content of the intervention, and add 1-2 sessions for the partner or significant other Aim 1: To finalise “Task-shifting to improve Depression and Adherence to HIV medication” (TENDAI-Together), a task-shifted intervention to treat depression and optimize adherence to ART for antenatal women living with HIV in Malawi. 4. Aim 2: To develop finalise an Short-Message Service (SMS) -based intervention for providing to information on the correct use of HIV self-test kits and provide "U = U" "Undetectable = Untransmutable" HIV messages education for targeting male partners of antenatal women living with HIV. 5. To integrate knowledge gathered through 1-3 to inform adaption and a draft intervention protocol for TENDAI-Together with the SMS-based HIV-self testing intervention. 6. Pilot test the intervention through a small case series to learn about training of interventionists and to iteratively finalise the intervention. Specific objectives in the Feasibility Phase of our research are: 7. To test the feasibility of clinic-based recruitment, through running an individually randomised pilot trial, with 20 women in the Tendai-Together arm and 20 women receiving enhanced usual care 8. To test the fidelity of Tendai Together intervention delivery within the health centre context in Malawi Through these objectives, we will be ready to apply for a future RCT to test the effectiveness and costeffectiveness of TT, and we will be in a position to justify whether the future trial will be in Malawi alone or multi-country. Aim 3a: To integrate TENDAI-Together with the SMS-based HIV-self testing intervention Aim 3b: To test feasibility and acceptability of the integrated intervention, and feasibility of collecting clinical outcome measures at baseline and post randomisation follow up through a Phase 2 exploratory trial to inform a future fully powered RCT. Methodology Formative work will involve finalising the TENDAI Together intervention to be suitable for the Malawian antenatal context will include formative work, comprising focus group discussions(FGD) and in-depth interviews (IDI) with 30 key informants (pregnant women, male partners, families, and health workers). This work will ensure that our final checklist of barriers to ART adherence includes those of most relevance for the ANC context, and to gather views and approaches about bringing the woman’s partner, or an alternative significant other, into two of the sessions, to provide education about depression and to inform about the U=U message (using self-testing SMS platform) and the benefits of both partners knowing their HIV status. The Pilot Trial will recruit 40 women in the 2nd trimester and randomise them, 3:1 to the active intervention or enhanced usual care. We will test the feasibility and acceptability of providing the TENDAI Together intervention with the self-testing SMS platform to allow the woman access to simple care for depression, optimise her engagement in HIV care, and engage her partner with HIVST and subsequent HIV care and prevention steps. We will also asses the feasibility of collecting clinical outcome measures at baseline and at 6 months post randomisation follow up and 6 weeks postdelivery for the infant, to inform a future fully powered RCT. Expected findings and dissemination. The expected findings for this study will include 1) Acceptability of the TENDAI Together intervention to participants, intervention providers and clinic staff; Feasibility of methods for conducting a future randomised controlled trial powered to determine the effectiveness of the stepped care Tendai Together intervention for depressed pregnant women living with HIV on viral suppression, depression, infant outcomes and serostatus of male partner at 12 months follow up; and 3) Feasibility of collecting clinical outcome measures for depression, viral load, infant clinical outcomes and uptake of HIV self-testing by male partner. Our aim to share our findings with scientists in the field, COMREC, College of Medicine Library, research participants and Malawians who can influence local policy. We plan to publish the findings of this study in peer-reviewed journals. Participants will be given written feedback on the results of the trial. We plan to present findings from this study at scientific conferences.
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Prevalence of and risk factors associated with treatment failure among HIV positive adult patients on Dulotegravir based regimen at Nsanje district,
(Kamuzu University of Health Sciences, 2021-10-18) Lipenga, Chisomo Davie
The study will aim to determine the prevalence and risk factors associated with the treatment failure among HIV positive adult patients (15-64) on Dolutegravir (DTG) based regimen at Nsanje district. DTG has been a major breakthrough in the management of HIV. In 2013 the USA Food and Drug Administration (FDA) approved DTG (an integrase inhibitor) to be used as a first line drug of choice(1). In the late 2017, the drug was available in low and middle income countries (LMIC) as a stand-alone generic formulation. It was only at the beginning of 2018 when fixed dose combinations (FDC) of the drug were tentatively approved by the FDA and the European Medicines Agency (EMA)(2). A good example of a FDC is 13A which comprises of Tenofovir (TDF)/Lamuvidine(3TC)/Dolutegravir(DTG). DTG is a drug of choice as it has high potency, good tolerability and low cost(3). The drug also has good ability to withstand resistance and less side effects compared to the previous drugs which consisted of the non-nucleoside reverse transcriptase inhibitors Efavirenz (EFV) and Nevirapine (NVP). Despite that, mutation of the HIV and other factors such as poor adherence, inevitably will lead to treatment failure development among HIV positive people on DTG based regimen. A study was carried out to determine the HIV drug resistance and treatment failure against the strand transfer integrase inhibitors Raltegravir (RAL), Elvitegravir (EVG), and DTG(4). While resistance which contributes to failure was determined in RAL and EVG it was not ascertained in DTG hence the need to conduct such a study to discover the same. Objectives Broad Objective To explore the prevalence, socio-demographic and patient comorbidity factors associated with the treatment failure among HIV positive adult patients (15-64) on Dolutegravir based regimen at Nsanje district. Specific Objectives 1. To calculate the prevalence of treatment failure among adult HIV patients on DTG based regimen. 2. To establish socio-demographic factors associated with treatment failure among adult HIV patients on DTG based regimen 3. To determine patient comorbidity factors associated with treatment failure among adult HIV patients on DTG based regimen. Methodology This study will use a cross sectional design to determine the prevalence of treatment failure and a retrospective cohort design to determine the socio-demographic factors associated with the treatment failure among patients on DTG based regimen. Data will be collected by following patients from January 2018 to December 2020. Treatment failure in the study, will be defined as the presence of a WHO stage 3/4 condition (clinical), a CD4 of less than 200 cells (immunological) and/or a viral load of greater than 1000 copies (virological). Factors that contributed to the treatment failure will also be determined by collecting and assessing the obtained social demographic and patient comorbidity secondary data from the patient files and Antiretroviral (ART) registry. Open Data Kit (ODK) platform will be used to form a database of patient comorbidities and socio-demographic variables. The variables of interest will be entered into tablets and the data will be routed to a server. ODK has been chosen because it will be programmed to check for errors before data is sent to the server and this will act as quality control measure to ensure high quality data is entered and analysed. STATA Version 16.0 software will be used to analyze the collected data. Microsoft Excel or Tableau will be used to come up with graphs at the analysis phase. Descriptive statistics, univariate and bivariate analysis will be done during the analysis phase. Logistic regression will be used to analyze predictors of the outcome variable, treatment failure. Expected findings and dissemination The study will determine the prevalence of treatment failure among adult HIV positive patients on DTG based regimen in Nsanje District. The expected prevalence might be lesser, greater or equal to 13%, which was a prevalence of treatment failure that was found out in another study done in Ethiopia(5). The study in Ethiopia found out that the prevalence of treatment failure among those who were on DTG based regimen was 13%. Factors associated with treatment failure will also be determined. The study results will be shared with the College of Medicine Research Ethics Committee (COMREC), the College of Medicine library, Nsanje District Commissioner and Nsanje District Hospital Management Team (DHMT). Presentation of the study findings will also be done at international conferences and published in peer reviewed journals for further scrutiny and a contribution to the research fraternity.
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Prevalence of oral candidiasis among HIV seropositive individuals attending Umodzi family centre lighthouse, QECH in Blantyre, Malawi(Version2)
(Kamuzu University of Health Sciences, 2021-08-11) Mlongoti, Lukerencia; Madengu, Gift
Type of research study and study design: This will be a Cross-sectional descriptive study whereby study participants will be followed at a specific point in time and this will help to determine the prevalence oral candidiasis. Cross sectional studies are relatively inexpensive and can be conducted over a short period of time, results can be easily generalized (if sample is randomly selected), good for diseases with long duration and low case fatality rate as in cases in HIV/AIDS patients and may simultaneously investigate several exposure/outcome relationships. Problem to be studied: The main objective of this descriptive cross-sectional study is to determine the prevalence of oral candidiasis, identify the various candida species and investigate these species susceptibility patterns in HIV seropositive individuals attending Lighthouse at QECH, Blantyre Malawi. Knowing prevalence of oral candidiasis and its susceptibility patterns in HIV patients; would help in proper treatment and management as nurses, doctors and even patients’ attendants get aware of both nature of oral candidiasis and its significance when detected hence helping patients to cope with unpleasant symptoms of oral candidiasis. Following studies that have been done in Malawi concerning oral candidiasis, they do not provide enough data relating to HIV positive individuals. Therefore, this study will serve as baseline information on candida species associated with HIV seropositive patients for future reference as would help to increase the awareness of clinicians in diagnosis and early treatment of these infections. Treatment of opportunistic infections is key to successful ART program and in mitigating the impact of HIV/AIDS in resource constraint settings. Furthermore, knowledge about the prevalence of oral candidiasis to HIV patients will be important for informed healthcare planning and resource allocation, the way the providers treat the admitted patients and administration of antifungals as formulated above. Objectives. Broad objectives:  To determine the prevalence of oral candidiasis and its susceptibility patterns in HIV seropositive individuals at UFC Lighthouse in Blantyre, Malawi Specific objectives: 1 . To identify the most isolated candida species among HIV patients with oral lesions. 2. To determine the candida species resistant to some selected antifungal drugs 3. To explain the correlation between candida colonization and Antiretroviral Therapy (ART). METHODOLOGY STUDY PLACE Samples will be collected from HIV positive individuals at QECH Umodzi Family Centre Lighthouse clinic in Blantyre since this institution provides health care services related to the diagnosis, treatment and prevention of HIV/AIDS and also takes a role in monitoring Antiretroviral Therapy. The swabs will then be taken for processing at COM Microbiology laboratory. STUDY POPULATION This will cover a total of 66 HIV seropositive individuals with oral lesions and attending QECH Lighthouse, Blantyre Malawi. These individuals will be those on different Antiretroviral Therapy stages and on different stages of HIV infection. All individuals greater than 18 years of age and also those on antifungal drugs will be included in the study. EXPECTED FINDINGS Based on study outcomes done in some African countries, it is estimated that about 80 to 90 percent of people with HIV infection will in their lives experience thrush in their mouth or throat and is most often caused by fungus in the genus Candida. Therefore, we expect even higher percentages of oral candidiasis among HIV seropositive patients with oral lesions at QECH Lighthouse.

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