The effect of proactive, interactive, two-way texting on 12-month retention in antiretroviral therapy: findings from a quasi-experimental study in Lilongwe, Malawi.

Background: Retaining clients on antiretroviral therapy (ART) is challenging especially during the first year on ART. Mobile health (mHealth) interventions show promise to close retention gaps. We aimed to assess reach (who received the intervention?) and effectiveness (did it work?) of a hybrid two-way texting (2wT) intervention to improve ART retention at a large public clinic in Lilongwe, Malawi. Methods: Between August 2021 - June 2023, a quasi-experimental study compared outcomes between two cohorts of new ART clients: 1) those opting into 2wT with combined automated, weekly motivation short messaging service (SMS) messages and response-requested appointment reminders; and 2) a matched historical cohort receiving standard of care (SoC). Reach was defined as "the proportion clients ≤6 months of ART initiation eligible for 2wT". 2wT effectiveness was assessed in time-to-event analysis comparing Kaplan-Meier plots of 6- and 12-month retention between 2wT and SoC using a log-rank test. The effect of 2wT on ART drop out was estimated using multivariable Cox proportional hazard models, adjusting for sex, age and WHO stage at ART initiation. Results: Of the 1,146 clients screened, 645 were ineligible (56%) largely due to lack of phone access (393/645; 61%) and illiteracy (149/645; 23%): a reach of 44%. Among 468 2wT participants, the 12-month probability of ART retention was 91% (95%CI: 88% - 93%) compared to 75% (95%CI: 71% - 79%) among 468 SoC participants (p<0.0001). Compared to SoC participants, 2wT participants had a 62% lower hazard of dropping out of ART care at all time points (hazard ratio 0.38, 95% CI: 0.26-0.54; p<0.001). Conclusions: Not all clients were reached with 2wT. For those who opted-in, 2wT reduced drop out throughout the first year on ART and significantly increased 12-month retention. The proactive 2wT approach should be expanded as a complement to other interventions in routine, low-resource settings to improve ART retention.

High Cancer Burden Among Antiretroviral Therapy Users in Malawi: A Record Linkage Study of Observational Human Immunodeficiency Virus Cohorts and Cancer Registry Data.

BACKGROUND: With antiretroviral therapy (ART), AIDS-defining cancer incidence has declined and non-AIDS-defining cancers (NADCs) are now more frequent among human immunodeficiency virus (HIV)-infected populations in high-income countries. In sub-Saharan Africa, limited epidemiological data describe cancer burden among ART users. METHODS: We used probabilistic algorithms to link cases from the population-based cancer registry with electronic medical records supporting ART delivery in Malawi's 2 largest HIV cohorts from 2000-2010. Age-adjusted cancer incidence rates (IRs) and 95% confidence intervals were estimated by cancer site, early vs late incidence periods (4-24 and >24 months after ART start), and World Health Organization (WHO) stage among naive ART initiators enrolled for at least 90 days. RESULTS: We identified 4346 cancers among 28 576 persons. Most people initiated ART at advanced WHO stages 3 or 4 (60%); 12% of patients had prevalent malignancies at ART initiation, which were predominantly AIDS-defining eligibility criteria for initiating ART. Kaposi sarcoma (KS) had the highest IR (634.7 per 100 000 person-years) followed by cervical cancer (36.6). KS incidence was highest during the early period 4-24 months after ART initiation. NADCs accounted for 6% of new cancers. CONCLUSIONS: Under historical ART guidelines, NADCs were observed at low rates and were eclipsed by high KS and cervical cancer burden. Cancer burden among Malawian ART users does not yet mirror that in high-income countries. Integrated cancer screening and management in HIV clinics, especially for KS and cervical cancer, remain important priorities in the current Malawi context.

Anemia in people on second line antiretroviral treatment in Lilongwe, Malawi: a cross-sectional study.

BACKGROUND: Anemia is common among people living with HIV infection and is frequently associated with poor quality of life and poor prognosis. It has been well described in antiretroviral naïve individuals and those on non-nucleoside reverse transcriptase inhibitor-based first line antiretroviral therapy (ART) regimens. However there is limited information on anemia for ART experienced individuals on protease inhibitor-based second line ART regimens in resource limited settings. Our objective was to describe the prevalence and risk factors of anemia in this ART experienced population in Malawi. METHODS: We conducted a cross-sectional study using routine facility data at two HIV clinics in Lilongwe, Malawi. The analysis included individuals receiving protease inhibitor-based second line ART. Clinical and laboratory data were collected at routine clinic visits. We used descriptive statistics, two-sample t-tests and multivariate logistic regression for data analysis. RESULTS: Three hundred seventy-seven records were included in this analysis (37% male, median age 41 years, median CD4 count 415 cells/µL). The prevalence of anemia was 125/377 (33.2%) - mild, moderate and severe anemia was 17.5%, 13.8%, and 1.9% respectively. Female participants had a higher prevalence than male participants (43.6% vs. 15.7%, p < 0.001). In multivariate logistic regression, female sex (adjusted odds ratio (aOR) 5.3; 95% CI 2.9-9.5) and a CD4 count <200 cell/ul (aOR 3.1; 95%CI 1.6-6.0) were associated with increased risk of having anemia while a BMI ≥30 kg/m2 (aOR 0.8; 95% CI 0.6-1.0) and being on ART for more than 10 years (aOR 0.4; 95% CI 0.2-0.9) were associated with reduced risk of anemia. Being on a zidovudine- containing ART regimen was not associated with anemia. CONCLUSION: Anemia is common in people on second line ART in Lilongwe, Malawi. Screening for anemia in this population would be a useful strategy; especially for female patients, those who are underweight and have a low CD4 cell counts.

Integrating family planning services into HIV care: use of a point-of-care electronic medical record system in Lilongwe, Malawi.

BACKGROUND: Integrating family planning (FP) services into human immunodeficiency virus (HIV) clinical care helps improve access to contraceptives for women living with HIV. However, high patient volumes may limit providers' ability to counsel women about pregnancy risks and contraceptive options. OBJECTIVES: To assess trends in the use of contraceptive methods after implementing an  electronic medical record (EMR) system with FP questions and determine the reasons for non-use of contraceptives among women of reproductive age (15-49 years) receiving antiretroviral therapy (ART) at the Martin Preuss Center clinic in Malawi. METHODS: In February 2012, two FP questions were incorporated into the ART EMR system (initial FP EMR module) to prompt providers to offer contraceptives to women. In July 2013, additional questions were added to the FP EMR module (enhanced FP EMR) to prompt providers to assess risks of unintended pregnancies, solicit reasons for non-use of contraceptives and offer contraceptives to non-pregnant women . We conducted a retrospective, longitudinal cohort study using the EMR routinely collected data. The primary outcome was the use of any modern contraceptive method. Descriptive statistics were used to describe the study population and report trends in contraceptive use during the initial and enhanced study periods. RESULTS: Between February 2012 and December 2016, in HIV clinics, 20,253 women of reproductive age received ART, resulting in 163,325 clinic visits observations. The proportion of women using contraceptives increased significantly from 18% to 39% between February 2012 and June 2013, and from 39% to 67% between July 2013 and December 2016 (chi-square for trend p < 0.001). Common reasons reported for the non-use of contraceptives among those at risk of unintended pregnancy were: pregnancy ambivalence (n = 234, 51%) and never thought about it (n = 133, 29%). CONCLUSION: Incorporating the FP EMR module into HIV clinical care prompted healthcare workers to encourage the use of contraceptives.

A cross-sectional study to evaluate second line virological failure and elevated bilirubin as a surrogate for adherence to atazanavir/ritonavir in two urban HIV clinics in Lilongwe, Malawi.

BACKGROUND: Malawi's national antiretroviral therapy program provides atazanavir/ritonavir-based second line regimens which cause concentration-dependent rise in indirect bilirubin. We sought to determine if elevated bilirubin, as a surrogate of atazanavir/ritonavir adherence, can aid in the evaluation of second line virological failure in Malawi. METHODS: We conducted a cross-sectional study of HIV-infected patients ≥15 years who were on boosted protease inhibitor-based second line antiretroviral therapy for at least 6 months in two urban HIV clinics in Lilongwe, Malawi. Antiretroviral therapy history and adherence data were extracted from the electronic medical records and blood was drawn for viral load, complete blood count, total bilirubin, and CD4 cell count at a clinic visit. Factors associated with virological failure were assessed using multivariate logistic regression model. RESULTS: Out of 376 patients on second line antiretroviral therapy evaluated, 372 (98.9%) were on atazanavir/ritonavir-based therapy and 142 (37.8%) were male. Mean age was 40.9 years (SD ± 10.1), mean duration on second line antiretroviral therapy was 41.9 months (SD ± 27.6) and 256 patients (68.1%) had elevated bilirubin >1.3 mg/dL. Overall, 35 (9.3%) patients had viral load >1000 copies/ml (virological failure). Among the virologically failing vs. non-failing patients, bilirubin was elevated in 34.3% vs. 72.0% respectively (p < 0.001), although adherence by pill count was similar (62.9% vs. 60.7%, p = 0.804). The odds of virological failure were higher for adults aged 25-40 years (adjusted odds ratio (aOR) 2.5, p = 0.048), those with CD4 cell count <100 (aOR 17.5, p < 0.001), and those with normal bilirubin levels (aOR 5.4, p < 0.001); but were lower for the overweight/obese patients (aOR 0.3, p = 0.026). Poor pill count adherence (aOR 0.7, p = 0.4) and male gender (aOR 1.2, p = 0.698) were not associated with second line virological failure. CONCLUSIONS: Among patients receiving atazanavir/ritonavir-based second line antiretroviral therapy, bilirubin levels better predicted virological failure than pill count adherence. Therefore, strategic use of bilirubin and viral load testing to target adherence counseling and support may be cost-effective in monitoring second line antiretroviral therapy adherence and virological failure. Drug resistance testing targeted for patients with virological failure despite elevated bilirubin levels would facilitate timely switch to third line antiretroviral regimens whenever available.