Webb 2012 UGA.

Methods	Trial design: 2 x 2 randomized double‐blind placebo controlled trial. Partcipants: HIV‐positive ART‐naive pregnant women. Length of follow‐up: viral load was measured 6 weeks post‐treatment and at delivery. However, this analysis included data at 6 weeks post‐treatment only in order to minimize the effects of prenatal HIV care provided to study participants. Monitoring and diagnostics: stool samples were processed and examined for helminth ova using a duplicate Kato‐Katz method and by charcoal culture for Strongyloides.
Participants	Number of participants: 2507 women were enrolled in the parent study (EMaBS), of whom 299 tested positive for HIV. Of these, 222 participants were randomized and followed‐up to 6 weeks post‐enrolment. Sixty‐four participants were randomized to single‐dose albendazole, 54 participants to praziquantel, 67 participants to both albendazole and praziquantel, and 70 participants to placebo only. Inclusion criteria: pregnant women presenting at the government‐funded antenatal clinic at Entebbe General Hospital, who were resident in the study area, planning to deliver in the hospital, willing to know their HIV status, and in the 2nd or 3rd trimester of pregnancy. Exclusion criteria: evidence of possible helminth‐induced pathology (haemoglobin < 8 g/dL, clinically apparent severe liver disease, diarrhoea with blood in stool), history of adverse reaction to antihelminthics, prior enrolment in an earlier pregnancy, or abnormal pregnancy as assessed by the midwife.
Interventions	Intervention 1: albendazole (400 mg). Intervention 2: praziquantel (40 mg/kg). Intervention 3: both albendazole (400 mg) and praziquantel (40 mg/kg). Control: equivalent placebos.
Outcomes	Outcomes included in this review: changes in plasma HIV‐1 RNA levels 6 weeks post‐treatment, adverse events (defined as post‐treatment hospitalizations), and mortality. Other trial outcomes: primary outcomes for EMaBS were response to immunisation and incidence of infectious diseases in the offspring, and vertical transmission of HIV (Webb 2011). Secondary outcomes in this analysis included viral load at delivery.
Notes	Location: Entebbe, Uganda. Participant helminth status: ascertained. Participant ART status: ART naive. However, in accordance with guidelines at the time, HIV‐positive women were counselled and given intrapartum and neonatal single dose nevirapine for prevention of mother‐to‐child HIV transmission. After enrolment, women received standard antenatal care, including haematinics, tetanus immunization, and intermittent presumptive treatment for malaria. Author contact: we requested additional HIV‐1 RNA and adverse events data from the trial authors, who provided this information.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Women were then randomised in a 1:1:1:1 ratio to single‐dose albendazole 400 mg or matching placebo and praziquantel 40 mg/kg or matching placebo in a 2×2 factorial design. The randomisation code was generated by the trial statistician in blocks of 100."
Allocation concealment (selection bias)	Low risk	"Sealed envelopes containing the study intervention were prepared by colleagues at the Medical Research Council Unit in Entebbe with no other involvement in the trial. Treatments were allocated in numerical order by trained interviewer‐counsellors and taken under observation."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"All participants and staff were blinded to treatment allocation."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	It is unclear whether or not the assessor was blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	There is no risk of attrition; 10% of participants were lost to follow‐up.

Abbreviations: antiretroviral treatment (ART), circulating filarial antigens (CFA), diethylcarbamazine (DEC), human immunodeficiency virus (HIV), immunochromatographic tests (ICT), soil‐transmitted helminths (STHs), tuberculosis (TB)