Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity

NCT02445989 | Completed Phase 4

• 2 other identifiers: 48663R01HD077872
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to explore the hypothesis-supported by limited data-that a contraceptive vaginal ring (CVR) that is commonly used in the United States, the NuvaRing, will enhance women's genital and reproductive health. The investigators propose that this CVR will increase the bacteria that help the vaginal environment protect against infection by HIV and other STIs, and that in women who already have HIV, use of the CVR will lower the quantity of HIV that is shed in the female genital tract.

Conditions

Bacterial Vaginosis; HIV

Keywords

HIV; Contraceptive Vaginal Ring; Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• Quantity of L. crispatus determined by species-specific qPCR assay

  Up to 8 months

Secondary Outcomes (3)

• Rates of bacterial vaginosis during contraceptive ring uses

  Up to 8 months

• Number of adverse events with CVR use

  Up to 8 months

• Acceptability of CVR to male sex partners of study participants assessed by questionnaire

  Up to 1 month

Study Arms (2)

Cyclic NuvaRing CVR Use

ACTIVE COMPARATOR

CVR use for 3 weeks, remove for 1 week, then replace

Drug: NuvaRing

Continuous NuvaRing CVR Use

EXPERIMENTAL

CVR use for 4 weeks, then replace

Drug: NuvaRing

Interventions

NuvaRing DRUG

Provide NuvaRing to women seeking contraception

Also known as: Contraceptive vaginal ring

Continuous NuvaRing CVR Use; Cyclic NuvaRing CVR Use

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BV+ by Amsel Criteria
• Not intending to become pregnant over the course of the study
• If HIV infected, not taking ART
• Capable of providing written informed consent

You may not qualify if:

• Current pregnancy
• Desire/intent to become pregnant over the course of the study
• Contraindications to hormonal contraceptive use
• Current cigarette smoking if age is older than 35 years
• Unable to comprehend consent material because of language barrier or psychological difficulty

Sponsors & Collaborators

• University of Washington: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Thika Clinic

Thika, Kenya

Location

Related Publications (14)

• Polis CB, Curtis KM. Use of hormonal contraceptives and HIV acquisition in women: a systematic review of the epidemiological evidence. Lancet Infect Dis. 2013 Sep;13(9):797-808. doi: 10.1016/S1473-3099(13)70155-5. Epub 2013 Jul 19.

  PMID: 23871397 BACKGROUND

• van der Straten A, Montgomery ET, Cheng H, Wegner L, Masenga G, von Mollendorf C, Bekker L, Ganesh S, Young K, Romano J, Nel A, Woodsong C. High acceptability of a vaginal ring intended as a microbicide delivery method for HIV prevention in African women. AIDS Behav. 2012 Oct;16(7):1775-86. doi: 10.1007/s10461-012-0215-0.

  PMID: 22644068 BACKGROUND

• Kiser PF, Johnson TJ, Clark JT. State of the art in intravaginal ring technology for topical prophylaxis of HIV infection. AIDS Rev. 2012 Jan-Mar;14(1):62-77.

  PMID: 22297505 BACKGROUND

• Marrazzo JM, Martin DH, Watts DH, Schulte J, Sobel JD, Hillier SL, Deal C, Fredricks DN. Bacterial vaginosis: identifying research gaps proceedings of a workshop sponsored by DHHS/NIH/NIAID. Sex Transm Dis. 2010 Dec;37(12):732-44. doi: 10.1097/OLQ.0b013e3181fbbc95.

  PMID: 21068695 BACKGROUND

• 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.

  PMID: 18614873 BACKGROUND

• 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.

  PMID: 22745608 BACKGROUND

• 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.

  PMID: 15339769 BACKGROUND

• Ahrendt HJ, Nisand I, Bastianelli C, Gomez MA, Gemzell-Danielsson K, Urdl W, Karskov B, Oeyen L, Bitzer J, Page G, Milsom I. Efficacy, acceptability and tolerability of the combined contraceptive ring, NuvaRing, compared with an oral contraceptive containing 30 microg of ethinyl estradiol and 3 mg of drospirenone. Contraception. 2006 Dec;74(6):451-7. doi: 10.1016/j.contraception.2006.07.004. Epub 2006 Sep 27.

  PMID: 17157101 BACKGROUND

• Mugo NR, Heffron R, Donnell D, Wald A, Were EO, Rees H, Celum C, Kiarie JN, Cohen CR, Kayintekore K, Baeten JM; Partners in Prevention HSV/HIV Transmission Study Team. Increased risk of HIV-1 transmission in pregnancy: a prospective study among African HIV-1-serodiscordant couples. AIDS. 2011 Sep 24;25(15):1887-95. doi: 10.1097/QAD.0b013e32834a9338.

  PMID: 21785321 BACKGROUND

• Taha TE, James MM, Hoover DR, Sun J, Laeyendecker O, Mullis CE, Kumwenda JJ, Lingappa JR, Auvert B, Morrison CS, Mofensen LM, Taylor A, Fowler MG, Kumenda NI, Eshleman SH. Association of recent HIV infection and in-utero HIV-1 transmission. AIDS. 2011 Jul 17;25(11):1357-64. doi: 10.1097/QAD.0b013e3283489d45.

  PMID: 21572305 BACKGROUND

• 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.

  PMID: 21975269 BACKGROUND

• Mugwanya K, Baeten JM, Mugo NR, Irungu E, Ngure K, Celum C. High-dose valacyclovir HSV-2 suppression results in greater reduction in plasma HIV-1 levels compared with standard dose acyclovir among HIV-1/HSV-2 coinfected persons: a randomized, crossover trial. J Infect Dis. 2011 Dec 15;204(12):1912-7. doi: 10.1093/infdis/jir649. Epub 2011 Oct 12.

  PMID: 21998479 BACKGROUND

• Marrazzo JM, Thomas KK, Fiedler TL, Ringwood K, Fredricks DN. Relationship of specific vaginal bacteria and bacterial vaginosis treatment failure in women who have sex with women. Ann Intern Med. 2008 Jul 1;149(1):20-8. doi: 10.7326/0003-4819-149-1-200807010-00006.

  PMID: 18591634 BACKGROUND

• Baeten JM, Kahle E, Lingappa JR, Coombs RW, Delany-Moretlwe S, Nakku-Joloba E, Mugo NR, Wald A, Corey L, Donnell D, Campbell MS, Mullins JI, Celum C; Partners in Prevention HSV/HIV Transmission Study Team. Genital HIV-1 RNA predicts risk of heterosexual HIV-1 transmission. Sci Transl Med. 2011 Apr 6;3(77):77ra29. doi: 10.1126/scitranslmed.3001888.

  PMID: 21471433 BACKGROUND

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

NuvaRing

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jeanne M Marrazzo, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: May 15, 2015
• Study Start: May 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 10, 2018

Record last verified: 2018-12

Locations

KE (1)