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Randomized Controlled Trial
. 2025 Mar 7;22(1):30.
doi: 10.1186/s12981-025-00720-0.

A survey weighted analysis of HPTN 071 (PopART) primary outcome of HIV incidence

Timothy M Skalland  1 , Jean de Dieu Tapsoba  2 , Sahar Z Zangeneh  3   4 , Sian Floyd  5 , Helen Ayles  6 , Peter Bock  7 , Sarah Fidler  8 , Susan H Eshleman  9 , Richard J Hayes  5 , Deborah Donnell  2 ; HPTN 071 (PopART) Study Team
Affiliations
Randomized Controlled Trial

A survey weighted analysis of HPTN 071 (PopART) primary outcome of HIV incidence

Timothy M Skalland et al. AIDS Res Ther. .

Abstract

Introduction: HPTN 071 (PopART) implemented a comprehensive HIV prevention package which aimed to reduce HIV incidence within 21 communities of Zambia and South Africa: Arm A, PopART intervention of universal HIV testing and treatment; Arm B, PopART intervention of universal HIV testing with ART provided according to local guidelines; and Arm C, standard of care. Analyses so far have not accounted for the sampling design of the enrolled cohort. We performed a sample-weighted re-analysis of the primary outcome of the PopART trial to derive a population-based estimate of the intervention effect.

Methods: Enrollment used a two-stage sampling design: household and adult participant within each household. We constructed post-stratification weights to match the age and sex distribution of the target population in these communities. Weighted Poisson regression was used to estimate community-level HIV incidence. The PopART intervention effect was estimated using log-transformed community-level incidence estimates in an ANCOVA model.

Results: The analysis based on community-level incidence shows a 25% reduction in incidence for Arm B communities compared to standard of care (RR: 0.75, 95% CI: 0.56-1.02, p = 0.06) while Arm A communities show no difference in HIV incidence compared to standard of care (RR: 1.08, 95% CI: 0.81-1.46, p = 0.56).

Conclusions: Our re-analysis shows 25% reduction in HIV incidence comparing Arm B to Arm C communities. No effect was observed comparing Arm A communities to Arm C communities. These results align with the primary results of the PopART trial.

Clinicaltrials: gov number, NCT01900977, HPTN 071 [PopArt].

Keywords: HIV; Incidence; PopART; Sampling; Survey; UTT; Weighting.

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Conflict of interest statement

Declarations. Ethics approval: Participants in the population cohort provided written informed consent, including when ART was initiated outside of the local guidelines, prior to enrolment in the HPTN 071 (PopART) trial. Competing interests: SE reports grant funding from the NIH, and the study team reports grant funding from the NIH, the international initiative for impact evaluation (3ie), the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and the Bill and Melinda Gates foundation. SF reports membership on the Gilead Scientific advisory board, DSMB CORE HIV vaccine trial (unpaid), DSMB CHAPS EDCTP (unpaid) and the IAS cure scientific advisory board (unpaid). HA reports membership in the technical review panel for the Global Fund.

Figures

Fig. 1
Fig. 1
Log Community-level HIV incidence (analysis period PC12-PC36) compared for each intervention arm (A and B) to standard of care arm (C)
See this image and copyright information in PMC

References

    1. Hayes R, Ayles H, Beyers N, Sabapathy K, Floyd S, Shanaube K, Bock P, Griffith S, Moore A, Watson-Jones D, Fraser C. HPTN 071 (PopART): rationale and design of a cluster-randomised trial of the population impact of an HIV combination prevention intervention including universal testing and treatment–a study protocol for a cluster randomised trial. Trials. 2014;15:1–7. - PMC - PubMed
    1. Hayes RJ, Donnell D, Floyd S, Mandla N, Bwalya J, Sabapathy K, Yang B, Phiri M, Schaap A, Eshleman SH, Piwowar-Manning E. Effect of universal testing and treatment on HIV incidence—HPTN 071 (PopART). N Engl J Med. 2019;381(3):207–18. - PMC - PubMed
    1. Hayes RJ, Moulton LH. Cluster randomised trials. London: Chapman and Hall/CRC; 2017.

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