A Community-Based, Mobile Electronic Medical Record System App for High-Quality, Integrated Antiretroviral Therapy in Lilongwe, Malawi: Design Process and Pilot Implementation.

BACKGROUND: Differentiated service delivery (DSD) increases antiretroviral therapy (ART) access in sub-Saharan Africa by moving clients out of congested ART clinics to communities for care. However, DSD settings challenge provider adherence to complex, chronic care treatment guidelines and have burdensome systems for client monitoring and evaluation (M&E), reducing data for decision-making. Electronic medical record systems (EMRS) improve client outcomes and reduce M&E workload. Traditional EMRS cannot operate in most DSD settings with unreliable power and poor connectivity. OBJECTIVE: This study aims to detail the human-centered design (HCD) process of developing a mobile EMRS for community-based DSD services in Lilongwe, Malawi. METHODS: Lighthouse Trust (LT) operates 2 Ministry of Health (MoH) clinics in Lilongwe, Malawi, with a combined total of >35,000 ART clients. LT's real-time, point-of-care EMRS collects complex client M&E data and provides decision-making support, ensuring adherence to integrated HIV and tuberculosis guidelines that optimize client and program outcomes. LT's EMRS scaled to all large MoH ART clinics. LT also implements a nurse-led community-based ART program (NCAP), a DSD model to provide ART and rapid assessment for 2400 stable LT clients in the community. LT, alongside collaborators, from the University of Washington's International Training and Education Center for Health and technology partner, Medic, used the open-source Community Health Toolkit (CHT) and HCD to develop an open-source, offline-first, mobile EMRS-like app, "community-based ART retention and suppression" (CARES). CARES aims to bring EMRS-like provider benefits to NCAP's DSD clients. RESULTS: CARES design took approximately 12 months and used an iterative process of highly participatory feedback sessions with provider, data manager, and M&E team inputs to ensure CARES optimization for the NCAP and LT settings. The CARES mobile EMRS prototype supports NCAP providers with embedded prompts and alerts to ensure adherence to integrated MoH ART guidelines, aiming to improve the quality of client care. CARES facilitates improved data quality and flow for NCAP M&E, aiming to reduce data gaps between community and clinic settings. The CARES pilot demonstrates the potential of a mobile, point-of-care EMRS-like app that could benefit NCAP clients, providers, and program teams with integrated client care and complete M&E data for decision-making. CARES challenges include app speed, search features to align longitudinal records, and CARES to EMRS integration that supports timely care alerts. CONCLUSIONS: Leveraging the CHT and HCD processes facilitated the design of a locally specified and optimized mobile app with the promise to bring EMRS-like benefits to DSD settings. Moving from the CARES prototype to routine NCAP implementation should result in improved client care and strengthened M&E while reducing workload. Our transparent and descriptive process shares the progress and pitfalls of the CARES design and development, helping others in this digital innovation area to learn from our experiences at this stage.

Blood pressure changes during tenofovir-based antiretroviral therapy among people living with HIV in Lilongwe, Malawi: results from the prospective LighTen Cohort Study.

BACKGROUND: Sub-Saharan Africa is one of the regions in the world with the highest numbers of uncontrolled hypertension as well as people living with HIV/AIDS (PLHIV). However, the association between hypertension and antiretroviral therapy is controversial. METHODS: Participant demographics, medical history, laboratory values, WHO clinical stage, current medication, and anthropometric data were recorded at study entry and during study visits at 1, 3, 6 months, and every 6 months thereafter until month 36. Patients who stopped or changed their antiretroviral therapy (tenofovir, lamivudine, efavirenz) were censored on that day. Office blood pressure (BP) was categorized using ≥ 2 measurements on ≥ 2 occasions during the first three visits. Factors associated with systolic and mean BP were analyzed using bivariable and multivariable multilevel linear regression. RESULTS: 1,288 PLHIV (751 females, 58.3%) could be included and 832 completed the 36 months of observation. Weight gain and a higher BP level at study entry were associated with an increase in BP (p < 0.001), while female sex (p < 0.001), lower body weight at study entry (p < 0.001), and high glomerular filtration rate (p = 0.009) protected against a rise in BP. The rate of uncontrolled BP remained high (73.9% vs. 72.1%) and despite indication treatment, adjustments were realized in a minority of cases (13%). CONCLUSION: Adherence to antihypertensive treatment and weight control should be addressed in patient education programs at centers caring for PLHIV in low-resources settings like Malawi. Together with intensified training of medical staff to overcome provider inertia, improved control rates of hypertension might eventually be achieved. TRIAL REGISTRATION: NCT02381275.

24-h-Ambulatory Blood Pressure Monitoring in Sub-Saharan Africa: Hypertension Phenotypes and Dipping Patterns in Malawian HIV+ Patients on Antiretroviral Therapy.

Background: Cardiovascular disease and especially hypertension are a growing problem among people living with HIV (PLHIV) on antiretroviral therapy (ART) in sub-Saharan Africa. Objectives: As robust data on hypertension phenotypes associated with distinct cardiovascular risks among PLHIV are limited, we aimed to assess the frequency of white-coat (WCH), masked (MH) hypertension, and blood pressure dipping-patterns in a group of Malawian PLHIV. Methods: As part of the prospective Lighthouse-Tenofovir-Cohort-Study, we analyzed clinical, laboratory and 24-h-ambulatory blood pressure monitoring (ABPM) data of PLHIV from urban Lilongwe with treated or untreated hypertension or raised office blood pressure (OBP) during routine study-visits. Results: 118 PLHIV were included and data of 117 participants could be analyzed. Twenty-four-hour ABPM normotension was found in a total of 73 PLHIV including 14/37 on antihypertensive treatment (37.8%). Using strict definitions, i.e. normal OBP plus normal mean BP for all periods of ABPM, controlled hypertension was found in only 4/37 (10.8%) PLHIV on antihypertensive treatment while true normotension was observed in 10/24 untreated patients (41.7%) with previously diagnosed hypertension and 22/56 patients (39.3%) without a medical history of hypertension. WCH with normal BP during all periods of 24-h-ABPM was identified in 12/64 OBP-hypertensive PLHIV (18.8%), primarily in patients with grade 1 hypertension (11/41 patients; 26.8%). MH was found in 17/53 PLHIV with OBP-normotension (32.1%), predominantly in patients with high normal BP (11/20 patients; 55%). The estimated glomerular filtration rate tended to be lower in MH compared to strictly defined normotensive PLHIV (92.0±20.4 vs. 104.8±15.7 ml/min/m²). 64.1 percent of PLHIV (59.5% with 24-h hypertension and 66.7% with 24-h normotension) had abnormal systolic dipping. Conclusion: The high prevalence of WCH and MH with signs of early renal end-organ damage and an abnormal dipping in approximately 2/3 of PLHIV warrants further investigation as these factors may contribute to the increased cardiovascular risk in PLHIV in resource-limited settings like Malawi. Clinical Trial Registration: https://clinicaltrials.gov (NCT02381275), registered March 6th, 2015.

Factors associated with desired fertility among HIV-positive women and men attending two urban clinics in Lilongwe, Malawi.

As access to antiretroviral therapy increases, more HIV-infected patients in sub-Saharan Africa may desire fertility. We conducted a cross-sectional study of reproductive health knowledge, attitudes and practices to identify factors associated with desired fertility among women and men receiving care at two large public HIV clinics in Lilongwe, Malawi. Research assistants administered questionnaires to participants. We performed descriptive, bivariable and multivariable analysis of factors related to desired fertility and of factors related to contraceptive non-use among participants who did not desire fertility. One-third of participants desired future children. Having a partner who desired fertility and having lower parity were associated with desiring children among both genders. For women, believing that pregnancy was unhealthy was associated with decreased fertility desire. Fifty-five percent of women and 69% of men who did not want children in the future reported using contraception at last intercourse. Increasing age, lower parity, and making the decision to use contraception herself were associated with contraceptive non-use among women who did not desire fertility. Having discussed family planning with his partner was associated with contraceptive use among men who did not desire fertility. Knowledge of these factors can guide reproductive health counseling and service provision.

Factors associated with condom use among men and women living with HIV in Lilongwe, Malawi: a cross-sectional study.

BACKGROUND: Understanding the influences on condom use among men and women living with HIV is critical to tailoring sexually transmitted infection/HIV prevention efforts. METHODS: This is a sub-analysis of a cross-sectional survey including 255 women and 220 men who were sexually active, HIV-positive, and attending HIV care visits in Lilongwe, Malawi. We estimated adjusted prevalence ratios (aPRs) to evaluate for factors associated with consistent condom use (always using condoms in the past month) and use at last coitus for men and women in separate models. RESULTS: Among women: 38% and 55% reported consistent condom use and condom use at last coitus, respectively. For women, consistent use and use at last coitus were positively associated with the ability to refuse sex without condoms and shared decision-making compared with making the decision alone regarding condom use, and negatively associated with desire for children in the future. Consistent use also increased with longer antiretroviral therapy (ART) use (≥1 year compared with no ART use). Among men: 51% and 69% reported consistent condom use and condom use at last coitus, respectively. For men, the ability to refuse sex without condoms was associated with consistent use and use at last coitus, and believing that condoms should be used with other contraception was associated with consistent use. CONCLUSIONS: Our findings demonstrate ongoing low condom utilisation among HIV-positive individuals, and highlight that ART and contraceptive use do not deter condom use. Efforts to increase condom utilisation must recognise individual-level factors that influence use and should focus on relationship dynamics and promotion of empowerment and self-efficacy.

Characteristics and outcomes of older HIV-infected patients receiving antiretroviral therapy in Malawi: A retrospective observation cohort study.

OBJECTIVE: To estimate patients enrolling on antiretroviral therapy (ART) over time; describe trends in baseline characteristics; and compare immunological response, loss to follow-up (LTFU), and mortality by three age groups (25-39, 40-49 and ≥50 years). DESIGN: A retrospective observation cohort study. METHODS: This study used routine ART data from two public clinics in Lilongwe, Malawi. All HIV-infected individuals, except pregnant or breastfeeding women, aged ≥ 25 years at ART initiation between 2006 and 2015 were included. Poisson regression models estimated risk of mortality, stratified by age groups. RESULTS: Of 37,378 ART patients, 3,406 were ≥ 50 years old. Patients aged ≥ 50 years initiated ART with more advanced WHO clinical stage and lower CD4 cell count than their younger counterparts. Older patients had a significantly slower immunological response to ART in the first 18 months on ART compared to patients aged 25-39 years (p = 0.04). Overall mortality rates were 2.3 (95% confidence Interval (CI) 2.2-2.4), 2.9 (95% CI 2.7-3.2) and 4.6 (95% CI 4.2-5.1) per 100 person-years in patients aged 25-39 years, 40-49 years and 50 years and older, respectively. Overall LTFU rates were 6.3 (95% CI 6.1-6.5), 4.5 (95% CI 4.2-4.7), and 5.6 (95% CI 5.1-6.1) per 100 person years among increasing age cohorts. The proportion of patients aged ≥ 50 years and newly enrolling into ART care remained stable at 9% while the proportion of active ART patients aged ≥50 years increased from 10% in 2006 to 15% in 2015. CONCLUSION: Older people had slower immunological response and higher mortality. Malawi appears to be undergoing a demographic shift in people living with HIV. Increased consideration of long-term ART-related problems, drug-drug interactions and age-related non-communicable diseases is warranted.

Influences in fertility decisions among HIV-infected individuals in Lilongwe, Malawi: a qualitative study.

BACKGROUND: The motivation to have a child may be complex with numerous influencing factors, particularly among individuals living with HIV. This study sought to understand factors influencing fertility decision-making for HIV-infected men and women in Lilongwe, Malawi. METHODS: Thirteen focus groups were conducted among HIV-infected individuals enrolled in antiretroviral treatment services. RESULTS: Participants identified a hierarchy of influences in fertility decisions including the importance of childbearing, patriarchal influence, family influences and concern regarding HIV transmission. CONCLUSIONS: Addressing fertility conversations beyond the confines of a relationship may be important, as family plays a significant role in fertility choices. Childbearing remains a fundamental desire among many individuals with HIV; however, concerns regarding transmission risk need to be addressed with efforts made to overcome misconception and assist individuals in balancing what may be competing influences.

Pregnancy prevention and condom use practices among HIV-infected women on antiretroviral therapy seeking family planning in Lilongwe, Malawi.

BACKGROUND: Programs for integration of family planning into HIV care must recognize current practices and desires among clients to appropriately target and tailor interventions. We sought to evaluate fertility intentions, unintended pregnancy, contraceptive and condom use among a cohort of HIV-infected women seeking family planning services within an antiretroviral therapy (ART) clinic. METHODS: 200 women completed an interviewer-administered questionnaire during enrollment into a prospective contraceptive study at the Lighthouse Clinic, an HIV/ART clinic in Lilongwe, Malawi, between August and December 2010. RESULTS: Most women (95%) did not desire future pregnancy. Prior reported unintended pregnancy rates were high (69% unplanned and 61% unhappy with timing of last pregnancy). Condom use was inconsistent, even among couples with discordant HIV status, with lack of use often attributed to partner's refusal. Higher education, older age, lower parity and having an HIV negative partner were factors associated with consistent condom usage. DISCUSSION: High rates of unintended pregnancy among these women underscore the need for integ rating family planning, sexually transmitted infection (STI) prevention, and HIV services. Contraceptive access and use, including condoms, must be improved with specific efforts to enlist partner support. Messages regarding the importance of condom usage in conjunction with more effective modern contraceptive methods for both infection and pregnancy prevention must continue to be reinforced over the course of ongoing ART treatment.

Managing HIV-infected children in a low-resource, public clinic: a comparison of nurse vs. clinical officer practices in ART refill, calculation of adherence and subsequent appointments.

BACKGROUND: In Malawi, as in other sub-Saharan African countries, nurses manage patients of all ages on antiretroviral treatment(ART). Nurse management of children is rarely studied.We compare ART prescribing between nurses and clinical officers during routine clinic visits at an urban, public clinic to inform policy in paediatric ART management. METHODS: Caregivers of children on first-line ART provided information about visit dates, pill counts, ART dosage and formulation to a nurse and, subsequently, to a clinical officer. Nurses and clinical officers independently calculated adherence, dosage based on body weight, and set next appointment date. Clinical officers, but not nurses, accessed an electronic data system that made the calculations for them based on information from prior visits, actual and expected pill consumption, and standard drug supplies. Nurses calculated with pen and paper. For numerical variables, Bland-Altman graphs plot differences of each nurse clinical officer pair against the mean, show the 95% limits of agreement (LoA), and also show the mean difference across all reviews. Kappa statistics assess agreement for categorical variables. RESULTS: A total of 704 matched nurse clinical officer reviews of 367 children attending the ART clinics between March and July 2010 were analyzed. Eight nurses and 18 clinical officers were involved; two nurses and five clinical officers managed 100 visits or more. Overall, there was a good agreement between the two cadres. Differences between nurses and clinical officers were within narrow LoA and mean differences showed little deviation from zero, indicating little skewing towards one cadre. LoA of adherence and morning and evening ART dosages varied from -24% to 24%, -0.4 to 0.4 and -0.41 to 0.40 tablets,respectively, with mean differences (95% CI) of 0.003 (-0.9, 0.91), -0.005 (-0.02, 0.01) and -0.009 (-0.02, 0.01). Next appointment calculations differed more between cadres with LoA from -40 to 42 days [mean difference: 0.96 days (95%CI:-0.6 to 2.5)], but agreement in the ART formulation prescribed was very good (kappa 0.93). CONCLUSIONS: Nurses' ART prescribing practices and calculations of adherence and next appointments are similar to clinical officers, although clinical officers used an electronic system. Our findings support the decision of Malawi's health officials to utilize nurses to manage paediatric ART patients.

Ensuring HIV-infected pregnant women start antiretroviral treatment: an operational cohort study from Lilongwe, Malawi.

OBJECTIVES: HIV-infected women identified through antenatal care (ANC) often fail to access antiretroviral treatment (ART), leaving them and their infants at risk for declining health or HIV transmission. We describe results of measures to improve uptake of ART among eligible pregnant women. METHODS: Between October 2006 and December 2009, interventions implemented at ANC and ART facilities in urban Lilongwe aimed to better link services for women with CD4 counts <250/µl. A monitoring system followed women referred for ART to examine trends and improve practices in referral completion, on-time ART initiation and ART retention. RESULTS: Six hundred and twelve women were ART eligible: 604 (99%) received their CD4 result, 344 (56%) reached the clinic, 286 (47%) started ART while pregnant and 261 (43%) were either alive on ART or transferred out after 6 months. Between 2006 and 2009, the median (IQR) time between CD4 blood draw and ART initiation fell from 41 days (17, 349) to 15 days (7,42) (P = 0.183); the proportion of eligible individuals starting ART while pregnant and retained for 6 months improved from 17% to 65% (P < 0.001). Delays generally shortened within the continuum of care from 2006 to 2009; however, time from CD4 blood draw to ART referral increased from 7 to 14 days. CONCLUSIONS: Referrals between facilities and delays through CD4 count measurements create bottlenecks in patient care. Retention improved over time, but delays within the linkage process remained. ART initiation at ANC plus use of point-of-care CD4 tests may further enhance ART uptake.