Centre for Infectious Disease Research in Zambia
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Screening, brief intervention, and referral to treatment compared with treatment as usual for alcohol use in an integrated refugee settlement in Zambia: a hybrid, type 1, randomised controlled trial.
(2026-Jul-23) Greene MC; Loongo H; Metz K; Shawa M; Mtongo N; Lukoma I; Chiluba P; Chibemba V; Kamono S; Mushabati N; Chibambula M; Watson K; Vaughan K; Demis L; Skavenski S; Murray LK; Ventevogel P; Busse A; Tol WA; Ezard N; Mwanza D; Lungu G; Kamanga M; Kane JC
BACKGROUND: Alcohol and other drug use represent a leading cause of preventable death and disability globally, disproportionately burdening low-resource settings. Alcohol and other drug use interventions remain neglected in humanitarian health research and programming. We evaluated the effectiveness of a multicomponent intervention in reducing alcohol use in a refugee setting in Zambia.
METHODS: We conducted a parallel, individually randomised trial in the Mantapala refugee settlement in Zambia. Eligible participants were Congolese refugees and Zambian host community members, aged 15 years and older, with Alcohol Use Identification Test (AUDIT) scores of 8 or more for males and 4 or more for females. Participants were allocated (1:1) to screening, brief intervention, and referral to treatment (SBIRT) or treatment as usual via a computer-generated randomisation scheme with allocation concealment by opaque envelopes. SBIRT included screening, a brief intervention, and indicated referral to psychotherapy for alcohol and other drug use and mental health conditions delivered by trained non-specialists. Treatment as usual comprised referral to primary health centre staff trained in basic management and care for alcohol use problems. The primary outcome was AUDIT score evaluated at 6 months. Linear mixed models and an intention-to-treat approach were used following multiple imputation. Implementation was assessed qualitatively and through cost-effectiveness analysis. Due to the nature of the trial, participants counsellors, and research assistants were unmasked at enrolment, although data analysts remained masked via dummy coding of the study group. The trial was registered on ClinicalTrials.gov (NCT05471921) and is completed.
FINDINGS: Between April 26, 2023, and Feb 29, 2024, 443 participants were screened for eligibility, 43 were excluded, and 400 were enrolled and randomly assigned (199 to the SBIRT group and 201 to the treatment as usual group). 299 (75%) of the 400 participants completed the 6-month assessment and 310 (78%) completed the 12-month assessment. The mean age of participants was 36·9 years (SD 12·1) and 287 (72%) participants were male and 113 (28%) were female. 232 (58%) of the 400 participants were Congolese refugees. AUDIT scores reduced from baseline to 6 months among the SBIRT group (-12·6 [95% CI -14·3 to -11·0]) and the treatment as usual group (-8·1 [-9·8 to -6·3]). The difference in mean change between groups was significantly greater in the SBIRT group than in the treatment as usual group at 6 months (-4·6 [95% CI -6·9 to -2·2]; p<0·0001; d=0·56) and 12 months (-3·5 [95% CI -5·8 to -1·1]; p=0·0030; d=0·43). The incremental cost per improvement in AUDIT at 6 months was US$158. There were no study-related adverse events.
INTERPRETATION: To our knowledge, this is the first known trial in a humanitarian setting of an intervention finding a significant, sustained effect on reduced alcohol use. SBIRT is a feasible and effective strategy to reduce alcohol-related burden in humanitarian and low-resource settings, with potential for integration into national and global health policies and systems.
FUNDING: Elrha's Research for Health in Humanitarian Crises Programme.
Design and feasibility considerations for a phase 3 efficacy trial of the M72/AS01
(2026-Jul-11) Dagnew AF; Noble R; Cinar A; Burhan E; Churchyard G; Fairlie L; Hanekom WA; Muyoyeta M; Mwandumba HC; Nduba V; Curran M; Schmidt AC
BACKGROUND: M72/AS01
METHODS: We conducted event-driven simulations using lower bound (LB) of the two-sided 95% confidence interval (CI) for VE(D). For IGRA-positive participants, assumptions included 1:1 randomization, 9000 participants/arm, 0.4% TB incidence/year, 55% true VE(D), 5% dropout/year, and two-year enrollment. Enrollment irrespective of baseline IGRA status (mixed IGRA-status population) and IGRA-negative-only scenarios were explored to estimate sample sizes and trial duration.
RESULTS: Simulations demonstrated that 110 events rule out a VE(D) 95% CI LB ≤10%, and 185 events rule out ≤25%, assuming ≥90% power and a true VE(D) of 55%. With 18,000 IGRA-positive participants, simulations projected a 90% probability of accruing 110 events within 3.5 to 4 years and 185 within 5.5 to 6 years. In the mixed IGRA-status population, few endpoints occurred among IGRA-negative participants, yielding insufficient power. Standalone VE(D) evaluation in IGRA-negative participants required large sample sizes (approximately 134,800) and prolonged timelines, indicating infeasibility. Accordingly, the selected primary objective of the phase 3 trial was to confirm VE(D) in IGRA-positive HIV-negative participants using LB of 95% CI for VE(D) > 10% after 110 events; secondary objectives include safety and immunogenicity in HIV-negative IGRA-positive; HIV-negative IGRA-negative; and HIV-positive individuals irrespective of IGRA status.
CONCLUSIONS: An IGRA-positive-enriched, event-driven phase 3 trial is feasible to confirm VE(D) of M72/AS01
Corrigendum to "Drivers of decision-making for future adult vaccines: a best-worst scaling among community members and health care workers in Zambia" [Vaccine 70 (2026) 128003].
(2026-Jul-11) Le Tourneau N; Sharma A; Pry JM; Haambokoma M; Shamoya B; Sikombe K; Simbeza SS; Zulu N; Geng EH; Eshun-Wilson I; Kerkhoff AD
'Prevention is better than cure': a mixed methods study of communities' and healthcare workers' perspectives on new adult and adolescent TB vaccines and their implementation in Zambia.
(2026) Kerkhoff AD; Pry JM; Haambokoma M; Le Tourneau N; Simbeza SS; Shamoya B; Zulu N; Nyirenda H; Kunda-Ng'andu E; Sikombe K; Geng EH; Limaye RJ; Sharma A
BACKGROUND: New tuberculosis (TB) vaccines for adults and adolescents are crucial for achieving global control targets, and several candidates may be ready for introduction within 5 years. We conducted a convergent mixed-methods study in Lusaka, Zambia, among community members and healthcare workers (HCWs) to understand preliminary TB vaccine acceptance and potential factors influencing uptake to inform readiness activities critical for successful implementation.
METHODS: Adult community members were enrolled from randomly selected households within four communities with historically low COVID-19 vaccine coverage, and HCWs from 10 public healthcare facilities representing different care levels. Structured surveys evaluated participants' perspectives on new vaccines and mixed-effects Poisson regression was used to estimate the marginal probability of participants' intention to get a new TB vaccine. Qualitative in-depth interviews (IDIs; n=24) and focus group discussions (FGDs; n=9) were conducted and analysed using a hybrid approach to explore acceptable vaccine attributes, preferences and determinants of TB vaccine uptake and recommendations for rollout.
RESULTS: Overall, 499 participants completed surveys (395 community members and 104 HCWs) with 62 additional participants across IDIs and FGDs. 77% of community members and 83% of HCWs expressed intention to get a TB vaccine. Perceived TB risk and severity concerns were the only significant drivers of vaccine intention. Participants pragmatically accepted the WHO's preferred vaccine specifications (50% efficacy, two-dose schedule, transient, mild side effects, at least 2 years' duration) though HCWs preferred higher efficacy thresholds due to occupational risk. Implementation preferences emphasised early community engagement (at least 3-6 months pre-rollout), diverse delivery approaches, including facility-based and community venues for adults, schools for adolescents and door-to-door campaigns, while addressing COVID-19-related scepticism through transparent, clear communication using trusted sources.
CONCLUSIONS: This study reveals strong potential for a successful TB vaccine rollout in Zambia through proactive implementation strategies, including early community engagement, transparent communication and person-centred delivery approaches.
Genetic diversity and trends of influenza A (H3N2) virus in Puducherry, South India: Insights from the 2022–2023 season
(2026-9) Kumaresan Mahalakshmi; P Ferdina Marie Sharmila; Panachikuth Gokul; Agarwal Harshita R; Devanathan Nivedha; Ratchagadasse Vimal Raj; Dhodapkar Rahul