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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02445989
Enrollment
120
Registered
2015-05-15
Start date
2016-05-31
Completion date
2018-12-31
Last updated
2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginosis, HIV

Keywords

HIV, Contraceptive Vaginal Ring, Bacterial Vaginosis

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.

Detailed description

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.

Interventions

Provide NuvaRing to women seeking contraception

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Quantity of L. crispatus determined by species-specific qPCR assayUp to 8 months

Secondary

MeasureTime frame
Rates of bacterial vaginosis during contraceptive ring usesUp to 8 months
Number of adverse events with CVR useUp to 8 months
Acceptability of CVR to male sex partners of study participants assessed by questionnaireUp to 1 month

Countries

Kenya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026