Browsing by Author "Kasaro M"

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Depression, pregnancy, and HIV: the case to strengthen mental health services for pregnant and post-partum women in sub-Saharan Africa.
(2014-Jul) Stringer EM; Meltzer-Brody S; Kasaro M; Stuebe AM; Wiegand S; Paul R; Stringer JS
Hybrid versus vaccine immunity of mRNA-1273 among people living with HIV in East and Southern Africa: a prospective cohort analysis from the multicentre CoVPN 3008 (Ubuntu) study.
(2025-Feb) Garrett N; Tapley A; Hudson A; Dadabhai S; Zhang B; Mgodi NM; Andriesen J; Takalani A; Fisher LH; Kee JJ; Magaret CA; Villaran M; Hural J; Andersen-Nissen E; Ferarri G; Miner MD; Le Roux B; Wilkinson E; Lessells R; de Oliveira T; Odhiambo J; Shah P; Polakowski L; Yacovone M; Samandari T; Chirenje Z; Elyanu PJ; Makhema J; Kamuti E; Nuwagaba-Biribonwoha H; Badal-Faesen S; Brumskine W; Coetzer S; Dawson R; Delany-Moretlwe S; Diacon AH; Fry S; Gill KM; Ebrahim Hoosain ZA; Hosseinipour MC; Inambao M; Innes C; Innes S; Kalonji D; Kasaro M; Kassim P; Kayange N; Kilembe W; Laher F; Malahleha M; Maluleke VL; Mboya G; McHarry K; Mitha E; Mngadi K; Mda P; Moloantoa T; Mutuluuza CK; Naicker N; Naicker V; Nana A; Nanvubya A; Nchabeleng M; Otieno W; Potgieter EL; Potloane D; Punt Z; Said J; Singh Y; Tayob MS; Vahed Y; Wabwire DO; McElrath MJ; Kublin JG; Bekker LG; Gilbert PB; Corey L; Gray GE; Huang Y; Kotze P
BACKGROUND: With limited access to mRNA COVID-19 vaccines in lower income countries, and people living with HIV (PLWH) largely excluded from clinical trials, Part A of the multicentre CoVPN 3008 (Ubuntu) study aimed to assess the safety of mRNA-1273, the relative effectiveness of hybrid versus vaccine immunity, and SARS-CoV-2 viral persistence among PLWH in East and Southern Africa during the omicron outbreak. METHODS: Previously unvaccinated adults with HIV and/or other comorbidities associated with severe COVID-19 received either one (hybrid immunity) or two (vaccine immunity) 100-mcg doses of ancestral strain mRNA-1273 in the first month, depending on baseline evidence of prior SARS-CoV-2 infection. In a prospective cohort study design, we used covariate-adjusted Cox regression and counterfactual cumulative incidence methods to determine the hazard ratio and relative risk of COVID-19 and severe COVID-19 with hybrid versus vaccine immunity within six months. The ongoing Ubuntu study is registered on ClinicalTrials.gov (NCT05168813) and this work was conducted from December 2021 to March 2023. FINDINGS: Between December 2021 and September 2022, 14,237 participants enrolled, and 14,002 (83% PLWH, 69% SARS-CoV-2 seropositive) were included in the analyses. Vaccinations were safe and well tolerated. Common adverse events were pain or tenderness at the injection site (26.7%), headache (20.4%), and malaise (20.3%). Severe adverse events were rare (0.8% of participants after the first and 1.1% after the second vaccination), and none were life-threatening or fatal. Among PLWH, the median CD4 count was 635 cells/μl and 18.5% had HIV viraemia. The six-month cumulative incidences in the hybrid immunity and vaccine immunity groups were 2.02% (95% confidence interval [CI] 1.61-2.44) and 3.40% (95% CI 2.30-4.49) for COVID-19, and 0.048% (95% CI 0.00-0.10) and 0.32% (95% CI 0.59-0.63) for severe COVID-19. Among all PLWH the hybrid immunity group had a 42% lower hazard rate of COVID-19 (hazard ratio [HR] 0.58; 95% CI 0.44-0.77; p < 0.001) and a 73% lower hazard rate of severe COVID-19 (HR 0.27; 95% CI 0.07-1.04; p = 0.056) than the vaccine immunity group, but this effect was not seen among PLWH with CD4 counts <350 cells/μl or HIV viraemia. Twenty PLWH had persistent SARS-CoV-2 virus at least 50 days. INTERPRETATION: Hybrid immunity was associated with superior protection from COVID-19 compared to vaccine immunity with the ancestral mRNA-1273 vaccine. Persistent infections among immunocompromised PLWH may provide reservoirs for emerging variants. FUNDING: National Institute of Allergy and Infectious Diseases.
Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015.
(2016-Sep) Riddler SA; Husnik M; Gorbach PM; Levy L; Parikh U; Livant E; Pather A; Makanani B; Muhlanga F; Kasaro M; Martinson F; Elharrar V; Balkus JE
BACKGROUND: As the effect of biomedical prevention interventions on the natural history of HIV-1 infection in participants who seroconvert is unknown, the Microbicide Trials Network (MTN) established a longitudinal study (MTN-015) to monitor virologic, immunological, and clinical outcomes, as well as behavioral changes among women who become HIV-infected during MTN trials. We describe the rationale, study design, implementation, and enrollment of the initial group of participants in the MTN seroconverter cohort. METHODS: Initiated in 2008, MTN-015 is an ongoing observational cohort study enrolling participants who acquire HIV-1 infection during effectiveness studies of candidate microbicides. Eligible participants from recently completed and ongoing MTN trials are enrolled after seroconversion and return for regular follow-up visits with clinical and behavioral data collection. Biologic samples including blood and genital fluids are stored for future testing. RESULTS: MTN-015 was implemented initially at six African sites and enrolled 100/139 (72%) of eligible women who seroconverted in HIV Prevention Trials Network protocol 035 (HPTN 035, conducted by the MTN). The median time from seroconversion in HPTN 035 to enrollment in MTN-015 was 18 months. Retention was good with >70% of visits completed. Implementation challenges included regulatory reviews, translation, and testing of questionnaires, and site readiness. CONCLUSIONS: Enrollment of HIV-seroconverters into a longitudinal observational follow-up study is feasible and acceptable to participants. Data and samples collected in this protocol will be used to assess safety of investigational HIV microbicides and answer other important public health questions for HIV infected women.
Treatment and outcome of AIDS-related Kaposi sarcoma in South Africa, Malawi and Zambia: an international comparison.
(2017) Rohner E; Kasaro M; Msadabwe-Chikuni SC; Stinson K; Mohamed Z; Tweya H; Egger M; Bohlius J
HIV-related Kaposi sarcoma (KS) is common in sub-Saharan Africa, but optimal treatment strategies in resource-limited settings remain unclear. We did a retrospective cohort study of adults diagnosed with KS before initiating antiretroviral therapy (ART) at three ART programs in South Africa, Malawi and Zambia. We extracted data from medical charts at HIV clinics and oncological referral centers and used electronic data from the International epidemiology Databases to Evaluate AIDS Southern Africa. We used descriptive statistics to assess tumor (T) and systemic illness (S) stage and treatment of AIDS-KS patients. Kaplan-Meier analyses were used to assess survival after KS diagnosis. We analyzed data from 57 patients in total (20 from South Africa, 20 from Zambia, 17 from Malawi). Median age at KS diagnosis was 35 years and similar across sites. The percentage of patients with poor risk AIDS-KS (T1S1) was similar in South Africa (25%) and Malawi (24%) and higher in Zambia (45%). All AIDS-KS patients initiated ART at the HIV clinic. For KS care, in South Africa 18 patients (90%) were referred to an oncology department; in Malawi and Zambia most patients were managed by the HIV clinics. In Malawi and South Africa, most AIDS-KS patients received systemic chemotherapy, in Zambia one patient received chemotherapy at the HIV clinic. A year after KS diagnosis, 15 patients (75%) in South Africa, 10 patients (50%) in Zambia, and 8 patients (47%) in Malawi were still alive; another 3 patients (15%) in South Africa, 8 patients (40%) in Zambia and 4 patients (24%) in Malawi were lost to follow-up. Management of AIDS-KS patients varied considerably across sites in Malawi, South Africa and Zambia. We need more reliable survival data for AIDS-KS patients in sub-Saharan Africa before we can assess which treatments and clinical pathways should be adopted in a specific setting.