Kallestrup 2005 ZWE.
Methods | Trial design: randomized, unblinded, controlled trial. Participants: adults with and without HIV‐1 infection who were found to be infected with schistosomes. We only included data from the HIV seropositive cohort in this analysis. Length of follow‐up: HIV‐1 RNA and CD4+ T cell counts were measured at baseline and after 3 months. Monitoring and diagnostics: from Kallestrup 2005; Status for HIV was determined by a rapid HIV‐1/2 test in the field on a dry blood spot and two enzyme‐linked immunosorbent assays on serum. Infection with Schistosoma haematobium was diagnosed by microscopic identification and quantification of fixed‐volume urine samples filtered on Nytrel filters. Diagnosis of infection with Schistosoma mansoni and other helminth eggs or parasites was assessed by the modified formol‐ether concentration technique on 1 g of stool from each participant. |
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Participants | Number of participants: 287 individuals were enrolled of whom we included 130 with HIV‐1 and schistosome co‐infection in this analysis. 64 participants received early praziquantel treatment and 66 received delayed treatment. Inclusion criteria: HIV‐1 and schistosomiasis co‐infection, HIV‐negative schistosomiasis infected, HIV‐1 negative but schistosomiasis infected, or neither infection. Exclusion criteria: pregnant women and participants presenting with clinical signs/symptoms of TB, terminal stages of schistosomiasis, or severe anaemia. |
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Interventions | Intervention: participants received a single oral dose of praziquantel (40 mg/kg) at enrolment or after a delay of 3 months. Control: participants received a single oral dose of praziquantel (40 mg/kg) after a delay of 3 months following enrolment. |
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Outcomes | Outcomes included in this review: changes in plasma HIV‐1 RNA levels, CD4+ T cell count, and haemoglobin levels between individuals randomized to early versus delayed treatment. Other trial outcomes: none |
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Notes | Location: Shamva District, Zimbabwe. Participant helminth status: ascertained. Participant ART status: not stated. Author contact: we requested additional haemoglobin data from the trial authors for this update, who provided the data. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Exact random sequence generation used unclear. From Kallestrup 2005: "Allocation of participants to these 3 control groups was done randomly: 1 participant with schistosomiasis was selected for every 2 coinfected participants, and 1 HIV‐1–positive participant or 1 healthy participant was selected for every 4 coinfected participants." |
Allocation concealment (selection bias) | High risk | Allocation concealment was not done. "On inclusion, all participants infected with schistosomes within each HIV‐1 group were openly randomised". |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Non‐blinded; "On inclusion, all participants infected with schistosomes within each HIV‐1 group were openly randomised into 2 equally sized groups". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | From Kallestrup 2005: "At all stages, when performing parasitological examinations, the technician was blinded to clinical and serological information". |
Incomplete outcome data (attrition bias) All outcomes | High risk | There is a risk of attrition as there was < 80% follow‐up. |