• George F Sawaya, Mike Zvavahera Chirenje, Mildred Tsitsi Magure, Jennifer L Tuveson, Yifei Ma, Stephen C Shiboski, Maria M Da Costa, Joel M Palefsky, Anna-Barbara Moscicki, Rudo Makunike Mutasa, Tsungai Chipato, and Karen K Smith-McCune.
• Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94118, USA. sawayag@obgyn.ucsf.edu
• Obstet Gynecol. 2020 Aug 11; 112 (5): 990-7.

ObjectiveTo estimate the effect of providing women with a latex diaphragm, lubricant gel, and male condoms (intervention) compared with condoms alone (control) on human papillomavirus (HPV) incidence and clearance.MethodsParticipants were 2,040 human immunodeficiency virus (HIV)-negative Zimbabwean women enrolled in a randomized trial estimating the effect of the intervention on HIV acquisition. Clinicians collected cervical samples for HPV testing at baseline, 12 months, and exit. L1 consensus polymerase chain reaction primers were used to determine HPV presence and type.ResultsWe found no differences in the following outcomes: HPV prevalence at the time of the first postenrollment HPV test (intention-to-treat analysis, relative risk [RR] 1.02, 95% confidence interval [CI] 0.90-1.16); HPV incidence at 12 months among women HPV-negative at baseline (RR 0.95, 95% CI 0.80-1.14); and HPV clearance at 12 months among women HPV-positive at baseline (RR 0.80, 95% CI 0.61-1.05). Clearance of HPV type 58 was lower in the intervention group at 12 months (RR 0.67, 95% CI 0.48-0.92), but not at exit (RR 0.93, 95% CI 0.75-1.16); clearance of HPV type 18 was lower in the intervention group at exit (RR 0.55, 95% CI 0.33-0.89), but not at 12 months (RR 0.55, 95% CI 0.29-1.05). Women reporting diaphragm/gel use at 100% of prior sex acts had a lower likelihood of having one or more new HPV types detected at 12 months (RR 0.75, 95% CI 0.58-0.96) and exit (RR 0.77, 95% CI 0.59-0.99).ConclusionAmong women receiving risk reduction counseling and condoms in an HIV prevention program, diaphragm plus lubricant gel provision did not affect HPV incidence or clearance.Clinical Trial RegistrationClinicalTrials.gov, www.clinicaltrials.gov, NCT00121459Level Of EvidenceI.

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