Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202006666229813 Date of Approval: 19/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title NuvaRing Study
Official scientific title Effects of contraceptive ring on vaginal microbiota, HIV shedding and local immunity
Brief summary describing the background and objectives of the trial Our 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. We 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). We hypothesize 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. To assess potential benefits associated with both cyclic (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 (both HIV-negative and HIV-positive) with BV at enrollment (and thus at high risk for BV persistence and recurrence).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Bacterial Vaginosis,HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 17/02/2016
Actual trial start date 14/06/2016
Anticipated date of last follow up 27/12/2017
Actual Last follow-up date 25/06/2018
Anticipated target sample size (number of participants) 195
Actual target sample size (number of participants) 152
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
SERU SSC 3004 KEMRI SERU
ECCT 15 09 01 PPB
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Cyclic CVR use Non-continuous (cyclic) CVR use involving use for 21 days, then removal for 7 days, with replacement after the 7-day CVR-free period 21 Days Non-continuous (cyclic) CVR use involving use for 21 days, then removal for 7 days, with replacement after the 7-day CVR-free period 60 Active-Treatment of Control Group
Experimental Group Non cyclic CVR use Continuous CVR use for four 28-day cycles, with the replacement of the CVR after each cycle 28 Days Continuous CVR use for four 28-day cycles, with replacement of the CVR after each cycle 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female Eligibility Criteria: ≥18-40-year-old BV+ by Amsel’s criteria Not intending or wishing to become pregnant over the course of the study Capable of providing written informed consent Male Eligibility Criteria: Main sex partner of the randomized female participant Capable of providing written informed consent Female Exclusion Criteria: Current pregnancy Desire/intent to become pregnant over the course of the study Current cigarette smoking if age is older than 35 years Unable to comprehend consent material because of the language barrier or psychological difficulty Male Exclusion Criteria: Unable to comprehend consent material because of the language barrier or psychological difficulty Adult: 19 Year-44 Year 18 Year(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/02/2016 PPB
Ethics Committee Address
Street address City Postal code Country
Lenana Road Nairobi 00100 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/07/2015 KEMRI SERU
Ethics Committee Address
Street address City Postal code Country
Mbagathi way Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Outcome 1: Quantity of L. crispatus determined by species-specific qPCR assay Outcome 2: Local immune parameters, including cytokines, innate mediators, and functional antimicrobial activity in cervicovaginal secretions as assessed by anti-E. coli, anti-HSV, and anti-HIV activity At enrolment and Sixth month of follow up
Secondary Outcome Quantity of genital HIV shedding among HIV-infected participants At enrolment and sixth month of follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Thika Partners Study Clinic located in Thika Kenya OAU Road Thika Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institutes of Health 9000 Rockville Pike Bethesda 20892 Bethesda United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Washington 315 15th Avenue Seattle United States of America University
COLLABORATORS
Name Street address City Postal code Country
Kenya Medical Research Institute Mbagathi way Nairobi Kenya
University of Washington 315 15th Avenue Seattle United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nelly Mugo rwamba@uw.edu +254723914057 Ngong Road
City Postal code Country Position/Affiliation
Nairobi Kenya Local Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Jeanne Marrazzo meigs@uw.edu 2065203833 315 15th Avenue
City Postal code Country Position/Affiliation
Seattle United States of America Principal Investigator
Role Name Email Phone Street address
Public Enquiries Elizabeth Irungu eirungu@pipsthika.org +2540672222561 OAU Road
City Postal code Country Position/Affiliation
Thika Kenya Study Physician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study Investigators commit to sharing the IPD at the end of the study once the analysis is complete. Study Protocol This will be shared once the data analysis is complete. The results of this study will be published in easily journals and will be available on request from the PIs.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information