Format

Send to

Choose Destination
PLoS One. 2017 Dec 8;12(12):e0189146. doi: 10.1371/journal.pone.0189146. eCollection 2017.

Safety and efficacy of the PrePex device in HIV-positive men: A single-arm study in Zimbabwe.

Author information

1
Zimbabwe Community Health Intervention Project (ZiCHIRe), Harare, Zimbabwe.
2
International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.
3
Department of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
4
U.S. Centers for Disease Control and Prevention, Harare, Zimbabwe.
5
International Training and Education Center for Health (I-TECH), Seattle, Washington, United States of America.
6
Ministry of Health and Child Care, Harare, Zimbabwe.
7
Zimbabwe National Family Planning Council (ZNFPC), Harare, Zimbabwe.
8
Department of Medicine, University of Washington, Seattle, Washington, United States of America.
9
Department of Global Health, University of Washington, Seattle, Washington, United States of America.

Abstract

METHODS:

We aimed to determine if the adverse event (AE) rate was non-inferior to an AE rate of 2%, a rate considered the global standard of MC safety. Study procedures, AE definitions, and study staff were unchanged from previous PrePex Zimbabwe trials. After PrePex placement and removal, weekly visits assessed wound healing. Men returned on Day 90. Safety was defined as occurrence of moderate and serious clinical AEs. Efficacy was defined as ability to reach the endpoint of complete circumcision.

RESULTS:

Among 400 healthy, HIV-positive, consenting adults, median age was 40 years (IQR: 34, 46); 79.5% in WHO stage 2; median CD4 was 336.5c/μl (IQR: 232, 459); 337 (85%) on anti-retroviral therapy. Among 385 (96%) observed completely healed, median days to complete healing was 42 (IQR: 35-49). There was no association between time to healing and CD4 (p = 0.66). Four study-related severe AEs and no moderate AEs were reported: severe/moderate AE rate of 1.0% (95% CI: 0.27% to 2.5). This was non-inferior to 2% AEs (p = 0.0003). All AEs were device displacements resulting in surgical MC and, subsequently, complete healing.

CONCLUSION:

Male circumcision among healthy, HIV-positive men using PrePex is safe and effective. Reducing the barrier of HIV testing while improving counseling for safer sex practices among all MC clients could increase MC uptake and avert more HIV infections.

PMID:
29220392
PMCID:
PMC5722373
DOI:
10.1371/journal.pone.0189146
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Public Library of Science Icon for PubMed Central
Loading ...
Support Center