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1.  The Lablite project: A cross-sectional mapping survey of decentralized HIV service provision in Malawi, Uganda and Zimbabwe 
Background
In sub-Saharan Africa antiretroviral therapy (ART) is being decentralized from tertiary/secondary care facilities to primary care. The Lablite project supports effective decentralization in 3 countries. It began with a cross-sectional survey to describe HIV and ART services.
Methods
81 purposively sampled health facilities in Malawi, Uganda and Zimbabwe were surveyed.
Results
The lowest level primary health centres comprised 16/20, 21/39 and 16/22 facilities included in Malawi, Uganda and Zimbabwe respectively. In Malawi and Uganda most primary health facilities had at least 1 medical assistant/clinical officer, with average 2.5 and 4 nurses/midwives for median catchment populations of 29,275 and 9,000 respectively. Primary health facilities in Zimbabwe were run by nurses/midwives, with average 6 for a median catchment population of 8,616. All primary health facilities provided HIV testing and counselling, 50/53 (94%) cotrimoxazole preventive therapy (CPT), 52/53 (98%) prevention of mother-to-child transmission of HIV (PMTCT) and 30/53 (57%) ART management (1/30 post ART-initiation follow-up only). All secondary and tertiary-level facilities provided HIV and ART services. In total, 58/81 had ART provision. Stock-outs during the 3 months prior to survey occurred across facility levels for HIV test-kits in 55%, 26% and 9% facilities in Malawi, Uganda and Zimbabwe respectively; for CPT in 58%, 32% and 9% and for PMTCT drugs in 26%, 10% and 0% of facilities (excluding facilities where patients were referred out for either drug). Across all countries, in facilities with ART stored on-site, adult ART stock-outs were reported in 3/44 (7%) facilities compared with 10/43 (23%) facility stock-outs of paediatric ART. Laboratory services at primary health facilities were limited: CD4 was used for ART initiation in 4/9, 5/6 and 13/14 in Malawi, Uganda and Zimbabwe respectively, but frequently only in selected patients. Routine viral load monitoring was not used; 6/58 (10%) facilities with ART provision accessed centralised viral loads for selected patients.
Conclusions
Although coverage of HIV testing, PMTCT and cotrimoxazole prophylaxis was high in all countries, decentralization of ART services was variable and incomplete. Challenges of staffing and stock management were evident. Laboratory testing for toxicity and treatment effectiveness monitoring was not available in most primary level facilities.
Electronic supplementary material
The online version of this article (doi:10.1186/1472-6963-14-352) contains supplementary material, which is available to authorized users.
doi:10.1186/1472-6963-14-352
PMCID: PMC4148932  PMID: 25138583
HIV services; Sub-Saharan Africa; Antiretroviral therapy rollout; Primary care health facilities; Stock-outs; Decentralization
2.  Towards elimination of mother-to-child transmission of HIV: performance of different models of care for initiating lifelong antiretroviral therapy for pregnant women in Malawi (Option B+) 
Introduction
Malawi introduced a new strategy to improve the effectiveness of prevention of mother-to-child HIV transmission (PMTCT), the Option B+ strategy. We aimed to (i) describe how Option B+ is provided in health facilities in the South East Zone in Malawi, identifying the diverse approaches to service organization (the “model of care”) and (ii) explore associations between the “model of care” and health facility–level uptake and retention rates for pregnant women identified as HIV-positive at antenatal (ANC) clinics.
Methods
A health facility survey was conducted in all facilities providing PMTCT/antiretroviral therapy (ART) services in six of Malawi's 28 districts to describe and compare Option B+ service delivery models. Associations of identified models with program performance were explored using facility cohort reports.
Results
Among 141 health facilities, four “models of care” were identified: A) facilities where newly identified HIV-positive women are initiated and followed on ART at the ANC clinic until delivery; B) facilities where newly identified HIV-positive women receive only the first dose of ART at the ANC clinic, and are referred to the ART clinic for follow-up; C) facilities where newly identified HIV-positive women are referred from ANC to the ART clinic for initiation and follow-up of ART; and D) facilities serving as ART referral sites (not providing ANC). The proportion of women tested for HIV during ANC was highest in facilities applying Model A and lowest in facilities applying Model B. The highest retention rates were reported in Model C and D facilities and lowest in Model B facilities. In multivariable analyses, health facility factors independently associated with uptake of HIV testing and counselling (HTC) in ANC were number of women per HTC counsellor, HIV test kit availability, and the “model of care” applied; factors independently associated with ART retention were district location, patient volume and the “model of care” applied.
Conclusions
A large variety exists in the way health facilities have integrated PMTCT Option B+ care into routine service delivery. This study showed that the “model of care” chosen is associated with uptake of HIV testing in ANC and retention in care on ART. Further patient-level research is needed to guide policy recommendations.
doi:10.7448/IAS.17.1.18994
PMCID: PMC4116618  PMID: 25079437
PMTCT; Option B+; Malawi; service delivery model; model of care; retention
3.  Follow-Up Visit Patterns in an Antiretroviral Therapy (ART) Programme in Zomba, Malawi 
PLoS ONE  2014;9(7):e101875.
Background
Identifying follow-up (FU) visit patterns, and exploring which factors influence them are likely to be useful in determining which patients on antiretroviral therapy (ART) may become Lost to Follow-Up (LTFU). Using an operation and implementation research approach, we sought 1) to describe the timing of FU visits amongst patients who have been on ART for shorter and longer periods of time; and 2) to determine the median time to late visits, and 3) to identify specific factors that may be associated with these patterns in Zomba, Malawi.
Methods and Findings
Using routinely collected programme monitoring data from Zomba District, we performed descriptive analyses on all ART visits among patients who initiated ART between Jan. 1, 2007–June 30, 2010. Based on an expected FU date, each FU visit was classified as early (≥4 day before an expected FU date), on time (3 days before an expected FU date/up to 6 days after an expected FU date), or late (≥7 days after an expected FU date). In total, 7,815 patients with 76417 FU visits were included. Ninety-two percent of patients had ≥2 FU visits. At the majority of visits, patients were either on time or late. The median time to a first late visit among those with 2 or more visits was 216 days (IQR: 128–359). Various patient- and visit-level factors differed significantly across Early, On Time, and Late visit groups including ART adherence and frequency of, and type of side effects.
Discussion
The majority of patients do not demonstrate consistent FU visit patterns. Individuals were generally on ART for at least 6 months before experiencing their first late visit. Our findings have implications for the development of effective interventions that meet patient needs when they present early and can reduce patient losses to follow-up when they are late. In particular, time-varying visit characteristics need further research.
doi:10.1371/journal.pone.0101875
PMCID: PMC4102478  PMID: 25033285
4.  Building a national direction for research in the prevention of mother to child transmission of HIV: results from a national prioritization initiative in Malawi 
Background
In 2011, Malawi initiated an ambitious program for the prevention of maternal to child transmission (PMTCT) of HIV, called 'Option B+,’ which employs a universal test and life-long treatment strategy for all pregnant women. Priority setting should take place in defining a national research agenda for evaluating Option B + rollout in Malawi.
Methods
In April 2011, a three-day workshop took place for all major stakeholders in PMTCT aiming to provide an update on current PMTCT operational research in Malawi, find consensus on key questions not yet being addressed, identify opportunities for collaboration, and develop multi-partner research proposals.
Results
Overall, 24 participants attended the workshop including representatives from the Ministry of Health, the National AIDS Commission and 12 multilateral, non-governmental organizations and academic partners.
Three interrelated clusters emerged as priorities for research: i) pregnancy intentions and family planning needs; ii) evaluation of models of care; and iii) determinants of uptake, adherence, and retention of women for Option B+. In addition, two cross-cutting themes arose: partner involvement in PMTCT services and cost-effectiveness as a guide to priority setting.
Within each cluster a coordinator was designated and a proposed plan for research and potential collaborators were discussed. The results of the workshop were presented to the national technical working groups and the National AIDS Commission. Several large-scale, collaborative proposals have been developed and funded to address the research areas defined.
Conclusions
Option B + represents a significant change in PMTCT policy in Malawi and the process for evaluation of the Malawi PMTCT strategy is outlined. This workshop contributed to defining and coordinating the national agenda for research priorities.
doi:10.1186/1478-4505-11-40
PMCID: PMC4231351  PMID: 24161044
Malawi; National agenda; PMTCT Option B+; Research priorities
5.  Patient costs associated with accessing HIV/AIDS care in Malawi 
Introduction
The decentralization of HIV services has been shown to improve equity in access to care for the rural poor of sub-Saharan Africa. This study aims to contribute to our understanding of the impact of decentralization on costs borne by patients. Such information is valuable for economic evaluations of anti-retroviral therapy programmes that take a societal perspective. We compared costs reported by patients who received care in an urban centralized programme to those in the same district who received care through rural decentralized care (DC).
Methods
A cross-sectional survey on patient characteristics and costs associated with accessing HIV care was conducted, in May 2010, on 120 patients in centralized care (CC) at a tertiary referral hospital and 120 patients in DC at five rural health centres in Zomba District, Malawi. Differences in costs borne by each group were compared using χ2 and t-tests, and a regression model was developed to adjust for confounders, using bootstrapping to address skewed cost data.
Results
There was no significant difference between the groups with respect to sex and age. However, there were significant differences in socio-economic status, with higher educational attainment (p<0.001), personal income (p=0.007) and household income per person (p=0.005) in CC. Travel times were similar (p=0.65), as was time waiting at the clinic (p=0.63) and total time spent seeking care (p=0.65). There was a significant difference in travel-related expenses (p<0.001) related to the type of travel participants noted that they used. In CC, 60% of participants reported using a mini-bus to reach the clinic; in DC only 4% reported using a mini-bus, and the remainder reported travelling on foot or by bicycle. There were no significant differences between the groups in the amount of lost income reported or other out-of-pocket costs. Approximately 91 Malawi Kwacha (95% confidence intervals: 1–182 MKW) or US$0.59 represents the adjusted difference in total costs per visit between CC and DC.
Conclusions
Even within a system of HIV/AIDS care where patients do not pay to see clinicians or for most medications, they still incur costs. We found that most costs are travel related. This has important implications for poorer patients who live at a distance from health facilities for whom these costs may be significant.
doi:10.7448/IAS.16.1.18055
PMCID: PMC3604364  PMID: 23517716
antiretroviral therapy; highly active; costs and cost analysis; Malawi; HIV; acquired immunodeficiency syndrome
6.  Six-Month Mortality among HIV-Infected Adults Presenting for Antiretroviral Therapy with Unexplained Weight Loss, Chronic Fever or Chronic Diarrhea in Malawi 
PLoS ONE  2012;7(11):e48856.
Background
In sub-Saharan Africa, early mortality is high following initiation of antiretroviral therapy (ART). We investigated 6-month outcomes and factors associated with mortality in HIV-infected adults being assessed for ART initiation and presenting with weight loss, chronic fever or diarrhea, and with negative TB sputum microscopy.
Methods
A prospective cohort study was conducted in Malawi, investigating mortality in relation to ART uptake, microbiological findings and treatment of opportunistic infection (OIs), 6 months after meeting ART eligibility criteria.
Results
Of 469 consecutive adults eligible for ART, 74(16%) died within 6 months of enrolment, at a median of 41 days (IQR 20–81). 370(79%) started ART at a median time of 18 days (IQR 7–40) after enrolment. Six-month case-fatality rates were higher in patients with OIs; 25/121(21%) in confirmed/clinical TB and 10/50(20%) with blood stream infection (BSI) compared to 41/308(13%) in patients with no infection identified. Median TB treatment start was 27 days (IQR 17–65) after enrolment and mortality [8 deaths (44%)] was significantly higher among 18 culture-positive patients with delayed TB diagnosis compared to patients diagnosed clinically and treated promptly with subsequent culture confirmation [6/34 (18%);p = 0.04]. Adjusted multivariable analysis, excluding deaths in the first 21 days, showed weight loss >10%, low CD4 count, severe anemia, laboratory-only TB diagnosis, and not initiating ART to be independently associated with increased risk of death.
Conclusions
Mortality remains high among chronically ill patients eligible for ART. Prompt initiation of ART is vital: more than half of deaths were among patients who never started ART. Diagnostic and treatment delay for TB was strongly associated with risk of death. More than half of deaths occurred without identification of a specific infection. ART programmes need access to rapid point-of-care-diagnostic tools for OIs. The role of early empiric OI treatment in this population requires further evaluation in clinical trials.
doi:10.1371/journal.pone.0048856
PMCID: PMC3501502  PMID: 23185278
7.  Mortality and Health Outcomes of HIV-Exposed and Unexposed Children in a PMTCT Cohort in Malawi 
PLoS ONE  2012;7(10):e47337.
Background
Mortality and morbidity among HIV-exposed children are thought to be high in Malawi. We sought to determine mortality and health outcomes of HIV-exposed and unexposed infants within a PMTCT program.
Method
Data were collected as part of a retrospective cohort study in Zomba District, Malawi. HIV-infected mothers were identified via antenatal, delivery and postpartum records with a delivery date 18–20 months prior; the next registered HIV-uninfected mother was identified as a control. By interview and health record review, data on socio-demographic characteristics, service uptake, and health outcomes were collected. HIV-testing was offered to all exposed children.
Results
173 HIV-infected and 214 uninfected mothers were included. 4 stillbirths (1.0%) occurred; among the 383 livebirths, 41 (10.7%) children died by 20 months (32 (18.7%) HIV-exposed and 9 unexposed children (4.3%; p<0.0001)). Risk factors for child death included: HIV-exposure [adjOR2.9(95%CI 1.1–7.2)], low birthweight [adjOR2.5(1.0–6.3)], previous child death (adjOR25.1(6.5–97.5)] and maternal death [adjOR5.3(11.4–20.5)]. At 20 months, HIV-infected children had significantly poorer health outcomes than HIV-unexposed children and HIV-exposed but uninfected children (HIV-EU), including: hospital admissions, delayed development, undernutrition and restrictions in function (Lansky scale); no significant differences were seen between HIV-EU and HIV-unexposed children. Overall, no difference was seen at 20 months among HIV-infected, HIV-EU and HIV-unexposed groups in Z-scores (%<−2.0) for weight, height and BMI. Risk factors for poor functional health status at 20 months included: HIV-infection [adjOR8.9(2.4–32.6)], maternal illness [adjOR2.8(1.5–5.0)] and low birthweight [adjOR2.0(1.0–4.1)].
Conclusion
Child mortality remains high within this context and could be reduced through more effective PMTCT including prioritizing the treatment of maternal HIV infection to address the effect of maternal health and survival on infant health and survival. HIV-infected children demonstrated developmental delays, functional health and nutritional deficits that underscore the need for increased uptake of early infant diagnosis and institution of ART for all infected infants.
doi:10.1371/journal.pone.0047337
PMCID: PMC3474798  PMID: 23082157
8.  Mortality and Health Outcomes in HIV-Infected and HIV-Uninfected Mothers at 18–20 Months Postpartum in Zomba District, Malawi 
PLoS ONE  2012;7(9):e44396.
Background
Maternal morbidity and mortality among HIV-infected women is a global concern. This study compared mortality and health outcomes of HIV-infected and HIV-uninfected mothers at 18–20 months postpartum within routine prevention of mother-to-child transmission of HIV (PMTCT) services in a rural district in Malawi.
Methods
A retrospective cohort study of mother-child dyads at 18–20 months postpartum in Zomba District. Data on socio-demographic characteristics, service uptake, maternal health outcomes and biometric parameters were collected.
Results
173 HIV-infected and 214 HIV-uninfected mothers were included. HIV-specific cohort mortality at 18–20 months postpartum was 42.4 deaths/1000 person-years; no deaths occurred among HIV-uninfected women. Median time to death was 11 months post-partum (range 3–19). Women ranked their health on a comparative qualitative scale; HIV-infected women perceived their health to be poorer than did HIV-uninfected women (RR 2.4; 95% CI 1.6–3.7). Perceived maternal health status was well correlated with an objective measure of functional status (Karnofsky scale; p<0.001). HIV-infected women were more likely to report minor (RR 3.8; 95% CI 2.3–6.4) and major (RR 6.2; 95% CI 2.2–17.7) signs or symptoms of disease. In multivariable analysis, HIV-infected women remained twice as likely to report poorer health [adjusted OR (aOR) 2.3; 95% CI 1.4–3.6], as did women with low BMI (aOR 2.1; 95% CI 1.1–4.0) and scoring lowest on the welfare scale (aOR 2.0; 95% CI 1.1–3.8).
Conclusions
HIV-infected women show increased mortality and morbidity at 18–20 months postpartum. In our rural Malawian operational setting, where there is documented under-application of ART and poor adherence to PMTCT services, these results support attention to optimizing maternal participation in PMTCT programs.
doi:10.1371/journal.pone.0044396
PMCID: PMC3433431  PMID: 22973443
9.  High Prevalence of Tuberculosis and Serious Bloodstream Infections in Ambulatory Individuals Presenting for Antiretroviral Therapy in Malawi 
PLoS ONE  2012;7(6):e39347.
Background
Tuberculosis (TB) and serious bloodstream infections (BSI) may contribute to the high early mortality observed among patients qualifying for antiretroviral therapy (ART) with unexplained weight loss, chronic fever or chronic diarrhea.
Methods and Findings
A prospective cohort study determined the prevalence of undiagnosed TB or BSI among ambulatory HIV-infected adults with unexplained weight loss and/or chronic fever, or diarrhea in two routine program settings in Malawi. Subjects with positive expectorated sputum smears for AFB were excluded. Investigations Bacterial and mycobacterial blood cultures, cryptococcal antigen test (CrAg), induced sputum (IS) for TB microscopy and solid culture, full blood count and CD4 lymphocyte count. Among 469 subjects, 52 (11%) had microbiological evidence of TB; 50 (11%) had a positive (non-TB) blood culture and/or positive CrAg. Sixty-five additional TB cases were diagnosed on clinical and radiological grounds. Nontyphoidal Salmonellae (NTS) were the most common blood culture pathogens (29 cases; 6% of participants and 52% of bloodstream isolates). Multivariate analysis of baseline clinical and hematological characteristics found significant independent associations between oral candidiasis or lymphadenopathy and TB, marked CD4 lymphopenia and NTS infection, and severe anemia and either infection, but low positive likelihood ratios (<2 for all combinations).
Conclusions
We observed a high prevalence of TB and serious BSI, particularly NTS, in a program cohort of chronically ill HIV-infected outpatients. Baseline clinical and hematological characteristics were inadequate predictors of infection. HIV clinics need better rapid screening tools for TB and BSI. Clinical trials to evaluate empiric TB or NTS treatment are required in similar populations.
doi:10.1371/journal.pone.0039347
PMCID: PMC3382251  PMID: 22761767
10.  Involving expert patients in antiretroviral treatment provision in a tertiary referral hospital HIV clinic in Malawi 
Background
Current antiretroviral treatment (ART) models in Africa are labour intensive and require a high number of skilled staff. In the context of constraints in human resources for health, task shifting is considered a feasible alternative for ART service delivery. In 2006, Dignitas International in partnership with the Malawi Ministry of Health trained a cadre of expert patients at the HIV Clinic at a tertiary referral hospital in Zomba, Malawi. Expert patients were trained to assist with clinic tasks including measurement of vital signs, anthropometry and counseling.
Methods
A descriptive observational study using mixed methods was conducted two years after the start of program implementation. Semi-structured interviews were conducted with 20 patients, seven expert patients and six formal health care providers to explore perceptions towards the expert patients’ contributions in the clinic. Structured exit interviews with 81 patients, assessed whether essential ART information was conveyed during counseling sessions. Vital signs and anthropometry measurements performed by expert patients were repeated by a nurse to assess accuracy of measurements. Direct observations quantified the time spent with each patient.
Results
There were minor differences in measurement of patients’ weight, height and temperature between the expert patients and the nurse. The majority of patients exiting a counseling session reported, without prompting, at least three side effects of ART, correct actions to be taken on observing a side-effect, and correct consequences of non-adherence to ART. Expert patients carried out 368 hours of nurse tasks each month, saving two and a half full-time nurse equivalents per month. Formal health care workers and patients accept and value expert patients’ involvement in ART provision and care. Expert patients felt valued by patients for being a ‘role model’, or a ‘model of hope’, promoting positive living and adherence to ART.
Conclusions
Expert patients add value to the ART services at a tertiary referral HIV clinic in Malawi. Expert patients carry out shifted tasks acceptably, saving formal health staff time, and also act as ‘living testimonies’ of the benefits of ART and can be a means of achieving greater involvement of People Living with HIV in HIV treatment programs.
doi:10.1186/1472-6963-12-140
PMCID: PMC3439714  PMID: 22681872
Task Shifting; Expert patients; Antiretroviral treatment; Malawi
11.  Uptake and outcomes of a prevention-of mother-to-child transmission (PMTCT) program in Zomba district, Malawi 
BMC Public Health  2011;11:426.
Background
HIV prevalence among pregnant women in Malawi is 12.6%, and mother-to-child transmission is a major route of transmission. As PMTCT services have expanded in Malawi in recent years, we sought to determine uptake of services, HIV-relevant infant feeding practices and mother-child health outcomes.
Methods
A matched-cohort study of HIV-infected and HIV-uninfected mothers and their infants at 18-20 months post-partum in Zomba District, Malawi. 360 HIV-infected and 360 HIV-uninfected mothers were identified through registers. 387 mother-child pairs were included in the study.
Results
10% of HIV-infected mothers were on HAART before delivery, 27% by 18-20 months post-partum. sd-NVP was taken by 75% of HIV-infected mothers not on HAART, and given to 66% of infants. 18% of HIV-infected mothers followed all current recommended PMTCT options. HIV-infected mothers breastfed fewer months than HIV-uninfected mothers (12 vs.18, respectively; p < 0.01). 19% of exposed versus 5% of unexposed children had died by 18-20 months; p < 0.01. 28% of exposed children had been tested for HIV prior to the study, 76% were tested as part of the study and 11% were found HIV-positive. HIV-free survival by 18-20 months was 66% (95%CI 58-74). There were 11(6%) maternal deaths among HIV-infected mothers only.
Conclusion
This study shows low PMTCT program efficiency and effectiveness under routine program conditions in Malawi. HIV-free infant survival may have been influenced by key factors, including underuse of HAART, underuse of sd-NVP, and suboptimal infant feeding practices. Maternal mortality among HIV-infected women demands attention; improved maternal survival is a means to improve infant survival.
doi:10.1186/1471-2458-11-426
PMCID: PMC3126744  PMID: 21639873
12.  Outcome Assessment of a Dedicated HIV Positive Health Care Worker Clinic at a Central Hospital in Malawi: A Retrospective Observational Study 
PLoS ONE  2011;6(5):e19789.
Background
Malawi has one of the world's lowest densities of Health Care Workers (HCW) per capita. This study evaluates outcomes of a dedicated HCW HIV clinic in Malawi, created at Zomba Central Hospital in January 2007.
Methods and Findings
Retrospective cohort data was analyzed comparing HCW clinic patient baseline characteristics and treatment outcomes at 18 months after inception, against those attending the general HIV clinic. In-depth interviews and focus group discussions were conducted to explore perceptions of patients and caregivers regarding program value, level of awareness and barriers for uptake amongst HCW. 306 patients were enrolled on antiretroviral therapy (ART) in the HCW HIV clinic, 6784 in the general clinic. Significantly (p<0.01) more HCW clients were initiated on ART on the basis of CD4 as opposed to WHO Stage 3/4 (36% vs.23%). Significantly fewer HCW clients defaulted (6% vs.17%), and died (4% vs.12%). The dedicated HCW HIV clinic was perceived as important and convenient in terms of reduced waiting times, and prompt and high quality care. Improved confidentiality was an appreciated quality of the HCW clinic however barriers included fear of being recognized.
Conclusions/Significance
Outcomes at the HCW clinic appear better compared to the general HIV clinic. The strategy of dedicated clinics to care for health providers is a means of HIV impact mitigation within human resource constrained health systems in high prevalence settings.
doi:10.1371/journal.pone.0019789
PMCID: PMC3098249  PMID: 21625545
13.  Fatal pulmonary Mycobacterium xenopi in a patient with rheumatoid arthritis receiving etanercept 
Thorax  2007;62(8):739-740.
Mycobacterium xenopi is a water‐related mycobacterium with low pathogenicity in humans. Little is known about the association between anti‐tumour necrosis factor (TNF)α and non‐tuberculous mycobacterial infections. The case history is presented of fatal M xenopi infection in a patient receiving anti‐TNFα treatment.
doi:10.1136/thx.2005.056952
PMCID: PMC2117264  PMID: 17687101

Results 1-14 (14)