Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

N/ACompletedNCT00542074

University of Washington223 enrolled

Overview

Randomized controlled trial (RCT) to evaluate the effectiveness of applying Purell® (62% ethyl alcohol in emollient gel) to the penis of male partners of women diagnosed with BV for preventing BV recurrence after treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

223

Conditions

Bacterial Vaginosis

Interventions

hygienic information plus 62% ethyl alcohol in emollient gelOTHER

The male partner in each couple was asked to apply Purell® to his penis at least daily, and immediately prior to and following intercourse. Couples received a brochure with information on control of STI and good hygienic practices. Brochures for intervention and control arms were similar except the intervention arm brochure provided information on how to use the study product (Purell®).

hygienic informationOTHER

Couples received a brochure with information on control of STI and good hygienic practices.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Vaginal symptoms * Nugent score \> 6 for vaginal fluid gram stain * Woman and her male partner both interested in study participation * Woman able to return for follow-up visits * Woman able to provide detailed contact information for tracing Exclusion Criteria: * Either male or female partner not recruited within 24 hours of the other

Locations (1)

Nairobi City Council STI referral clinic (Special Treatment Clinic)

Nairobi, Kenya

Outcomes

Primary Outcomes

bacterial vaginosis by Nugent's score

Time frame: up to 2 months following treatment

Secondary Outcomes

presence of lactobacillus by culture

Time frame: 2 months following treatment

Data from ClinicalTrials.gov

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