API clinical trial sub-analysis dataset

Description

This dataset is derived from a sub-analysis of the data collected during the API clinical trial assessing the impact of antimicrobial treatments on penile ex vivo HIV susceptibility and immunology. Details about the API clinical trial can be found at ClinicalTrials.gov #NCT03412071. This sub-analysis is focused on participants in the control group and those who received topical antimicrobials (Topical clindamycin, topical hydrogen peroxide, and topical metronidazole). Among the particpants receiving topical antimicrobials, we examined whether penile-vaginal sex during the treatment period was associated with differences in the microbial and immunological effects of treatment.

Steps to reproduce

Study Design: This is a sub-analysis of data collected during the registered, open-label, randomized API clinical trial (ClinicalTrials.gov #NCT03412071), which assessed the effects of antimicrobial interventions on penile ex vivo HIV susceptibility, immunology, and microbiolgy in uncircumcized Ugandan men. Study Participants: This analysis only included the 91 participants randomized to immediate circumcision without antimicrobial treatment (controls) and particiapnts who completed 4 weeks of treatment with one of three topical antimicrobial interventions: topical clindamycin, hydrogen peroxide, and metronidazole. Exposure groups: Participants receiving topical antimicrobials were categorized according to whether they reported penile-vaginal sex during the four-week treatment period. Participants reporting at least one episode of penile-vaginal sex were classified as the "Sex" group, while those reporting no penile-vaginal sex were classified as the "No Sex" group. Untreated participants remained as the control group. Analysis: We examined whether penile-vaginal sex during topical antimicrobial treatment was associated with differences in the microbial and immunological effects of treatment. Outcomes included specific penile bacterial abundance, soluble inflammatory and epithelial markers, foreskin T cell subset density, and ex vivo HIV susceptibility. Multivariable linear regression models were adjusted for age, number of sexual parnters in the previous six months, and days since last penile-vaginal sex.

Institutions

• University of Toronto

  Ontario, Toronto

Categories

Funders

• Canadian Institutes of Health Research

  Ontario, Ottawa

  Grant ID: IBC-150412
• Canadian Institutes of Health Research

  Ontario, Ottawa

  Grant ID: PJT-180629
• National Institutes of Health

  United States Department of Health and Human Services

  Maryland, Bethesda

  Grant ID: 5R01DK131936-02

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