Clinical trial NCT02432404: Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity
Official title: Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Vaginosis
Keywords: HSV-2
Contraceptive Vaginal Ring
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2015-05-04
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess potential benefits associated with both intermittent (use for 3 weeks, remove for 1 week, as defined in the package insert) and continuous (use for 4 weeks, then replace) CVR use among women either with BV or at high risk for BV. The investigators will also recruit women who are HSV2-infected.


Eligibility criteria: Inclusion Criteria:

* ≥18-40 year old women
* BV+ by Amsel criteria and Nugent score OR history of BV in the prior 6 months
* Willing to use the NuvaRing as directed
* Not intending or wishing to become pregnant over the course of the study
* Capable of providing written informed consent

Exclusion Criteria:

* Current pregnancy
* Desire/intent to become pregnant over the course of the study
* Women who are less than 6 weeks postpartum
* Contraindications to hormonal contraceptive use per package insert, including history of deep vein thrombosis, smoking in women older than 35 years
* Current IUD
* Unable to comprehend consent material because of language barrier or psychological difficulty

Primary outcomes:
measure: Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests
timeFrame: Up to 8 months
Secondary outcomes:
measure: Number of Visits With BV
timeFrame: Up to 8 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: UW Virology Research Clinic
state: Washington
Study officials:
affiliation: University of Washington
name: Christine Johnston, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Veres S, Miller L, Burington B. A comparison between the vaginal ring and oral contraceptives. Obstet Gynecol. 2004 Sep;104(3):555-63. doi: 10.1097/01.AOG.0000136082.59644.13.
citation: Atashili J, Poole C, Ndumbe PM, Adimora AA, Smith JS. Bacterial vaginosis and HIV acquisition: a meta-analysis of published studies. AIDS. 2008 Jul 31;22(12):1493-501. doi: 10.1097/QAD.0b013e3283021a37.
citation: Cohen CR, Lingappa JR, Baeten JM, Ngayo MO, Spiegel CA, Hong T, Donnell D, Celum C, Kapiga S, Delany S, Bukusi EA. Bacterial vaginosis associated with increased risk of female-to-male HIV-1 transmission: a prospective cohort analysis among African couples. PLoS Med. 2012;9(6):e1001251. doi: 10.1371/journal.pmed.1001251. Epub 2012 Jun 26.
citation: Heffron R, Donnell D, Rees H, Celum C, Mugo N, Were E, de Bruyn G, Nakku-Joloba E, Ngure K, Kiarie J, Coombs RW, Baeten JM; Partners in Prevention HSV/HIV Transmission Study Team. Use of hormonal contraceptives and risk of HIV-1 transmission: a prospective cohort study. Lancet Infect Dis. 2012 Jan;12(1):19-26. doi: 10.1016/S1473-3099(11)70247-X. Epub 2011 Oct 3.
citation: Vodstrcil LA, Hocking JS, Law M, Walker S, Tabrizi SN, Fairley CK, Bradshaw CS. Hormonal contraception is associated with a reduced risk of bacterial vaginosis: a systematic review and meta-analysis. PLoS One. 2013 Sep 4;8(9):e73055. doi: 10.1371/journal.pone.0073055. eCollection 2013.