Effect of diaphragm and lubricant gel provision on human papillomavirus infection among women provided with condoms: a randomized controlled trial.
To 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.



Participants 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.



We 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).



Among women receiving risk reduction counseling and condoms in an HIV prevention program, diaphragm plus lubricant gel provision did not affect HPV incidence or clearance.



ClinicalTrials.gov, www.clinicaltrials.gov, NCT00121459



I.
Sawaya
George F
GF
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
Chirenje
Mike Zvavahera
MZ
Magure
Mildred Tsitsi
MT
Tuveson
Jennifer L
JL
Ma
Yifei
Y
Shiboski
Stephen C
SC
Da Costa
Maria M
MM
Palefsky
Joel M
JM
Moscicki
Anna-Barbara
AB
Mutasa
Rudo Makunike
RM
Chipato
Tsungai
T
Smith-McCune
Karen K
KK
D052685:Alphapapillomavirus / Q000302:isolation & purification; D017280:Condoms; D003274:Contraceptive Devices, Female; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D030361:Papillomavirus Infections / Q000517:prevention & control*; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage*; D015030:Zimbabwe
D014622:Vaginal Creams, Foams, and Jellies