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

NCT ID: NCT02445989

Last Updated: 2018-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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The investigators objective is to study effects of a contraceptive vaginal ring (CVR) containing estrogen and progesterone (NuvaRing) on vaginal bacteria, HIV shedding, and local immunity in women. The investigators will build on data that support a favorable effect of CVR on vaginal bacteria. Bacterial vaginosis (BV) is found in \>50% of women in sub-Saharan Africa. BV significantly increases risk of HIV acquisition in, and HIV transmission to male partners from, HIV-infected women, genital HIV shedding, and viral set point in infected male partners. Pregnancy is also an independent risk for HIV acquisition and transmission. Contraception comprises critical biomedical prevention for women with or at risk for HIV. Systemic depot progesterone-commonly used throughout Africa-may independently increase risk of HIV acquisition and transmission. Hormonal interventions preventing unintended pregnancy and promoting a protective vaginal microenvironment could synergistically reduce HIV risk especially combined with topical antiretrovirals (ARV). The investigators propose NuvaRing use may contribute to reduction in BV, pregnancy prevention, and decreased rates of HIV shedding in HIV-infected women. Sustained vaginal delivery of contraceptive and ARV PrEP as "multicomponent prevention" is a major focus for scientists but effects on the vaginal environment need careful definition before broad implementation.

Total duration of follow up is no more than 8 months, with 5 months of CVR usage.

Conditions

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Bacterial Vaginosis HIV

Keywords

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HIV Contraceptive Vaginal Ring Bacterial Vaginosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cyclic NuvaRing CVR Use

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

Group Type ACTIVE_COMPARATOR

NuvaRing

Intervention Type DRUG

Provide NuvaRing to women seeking contraception

Continuous NuvaRing CVR Use

CVR use for 4 weeks, then replace

Group Type EXPERIMENTAL

NuvaRing

Intervention Type DRUG

Provide NuvaRing to women seeking contraception

Interventions

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NuvaRing

Provide NuvaRing to women seeking contraception

Intervention Type DRUG

Other Intervention Names

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Contraceptive vaginal ring

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Jeanne Marrazzo

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeanne M Marrazzo, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Thika Clinic

Thika, , Kenya

Site Status

Countries

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Kenya

References

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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.

Reference Type BACKGROUND
PMID: 23871397 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22644068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22297505 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21068695 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18614873 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22745608 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15339769 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17157101 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21785321 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21572305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21975269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21998479 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18591634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21471433 (View on PubMed)

Other Identifiers

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R01HD077872

Identifier Type: NIH

Identifier Source: secondary_id

View Link

48663

Identifier Type: -

Identifier Source: org_study_id