Population-Level Correlation Between Incidence of Curable Sexually Transmitted Infections and Human Immunodeficiency Virus (HIV)-1 Among African Women Participating in HIV-1 Pre-Exposure Prophylaxis Trials

• Published in: The Journal of infectious diseases Vol. 226; no. 6; pp. 1069 - 1074
• Main Authors: Hunidzarira, Portia, Brown, Elizabeth R, Chirenje, Z Mike, Hillier, Sharon L, Marrazzo, Jeanne M, Palanee-Phillips, Thesla, Kiweewa, Flavia M, Baeten, Jared M
• Format: Journal Article
• Language: English
• Published: United States Oxford University Press 21.09.2022
• Subjects: Chlamydia Infections - epidemiology; Chlamydia Infections - prevention & control; Chlamydia trachomatis; Clinical trials; Condoms; Disease prevention; Disease transmission; Female; Gonorrhea; HIV; HIV Infections - epidemiology; HIV Infections - prevention & control; HIV-1; Human immunodeficiency virus; Humans; Immune system; Incidence; Major; Neisseria gonorrhoeae; Pre-Exposure Prophylaxis; Prevalence; Prophylaxis; Sexually transmitted diseases; Sexually Transmitted Diseases - epidemiology; Sexually Transmitted Diseases - prevention & control; Statistical analysis; STD; clinical trial design; HIV incidence; sexually transmitted infections; women
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1093/infdis/jiac269

Abstract Background Highly efficacious oral pre-exposure prophylaxis (PrEP) is the global standard for human immunodeficiency virus (HIV)-1 prevention, including in clinical trials of novel PrEP agents using active-comparator designs. The analysis assessed whether incident sexually transmitted infections (STIs) can serve as a surrogate indicator of HIV-1 incidence that might occur in the absence of PrEP. Methods We analyzed data from 3256 women randomized to placebo groups of oral and vaginal PrEP trials (MTN-003/VOICE and MTN-020/ASPIRE). Regression modeling assessed the correlation between incident individual STIs (Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis, each considered separately) and incident HIV-1. Results Across 18 sites in 4 countries (Malawi, South Africa, Uganda, Zimbabwe), STI and HIV-1 incidences were high: HIV-1 4.9, N gonorrhoeae 5.3, C trachomatis 14.5, and T vaginalis 7.1 per 100 person-years. There was limited correlation between HIV-1 incidence and incidence of individual STIs: N gonorrhoeae (r = 0.02, P = .871), C trachomatis (r = 0.49, P = <.001), and T vaginalis (r = 0.10, P = .481). The modest association with C trachomatis was driven by country-level differences in both C trachomatis and HIV-1, with no statistically significant association within countries. Conclusions Sexually transmitted infection incidence did not reliably predict HIV-1 incidence at the population level among at-risk African women participating in 2 large PrEP trials. New surrogate indicators of HIV-1 incidence are necessary to plan trials of new PrEP agents with active-controlled designs. Among African women in 2 PrEP trials, STI incidence did not reliably predict HIV-1 incidence at the population level.