Study of Nuvaring Acceptability, Adherence and Biological Effects Among HIV-negative Women in Kenya

NCT02529683 | Completed

• 2 other identifiers: CDC-NCHHSTP-6518SSC Protocol # 2609
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

One arm clinical trial of Nuvaring use for six months among 200 previously contracepting HIV-negative women (COCPs or DMPA) aged 18-35 in Kenya, where no vaginal rings are licensed/available for contraception or other indications. This was meant to be a formative research study to understand the predictors of acceptability and adherence to a contraceptive vaginal ring, and its immunoogical and microbiological effects over six months of product use.

Conditions

Hormonal Contraception

Keywords

Nuvaring; contraceptive vaginal ring; Kenya; adherence; acceptability; immunological effects

Outcome Measures

Primary Outcomes (5)

• Participant-reported Acceptability

  Using computer assisted self-reported questionnaires and focus group discussions

  Six months of product use

• Biological (Objective) measures of Adherence

  Composite of salivary estradiol assays (instantaneous adherence) and remnant-drug assay of returned used vaginal rings (cumulative adherence over 21 days of use)

  Six months of product use

• Local Immunological effects of vaginally delivered hormonal contraception as measured by immunophenotyping

  Immunophenotyping analysis of cervicovaginal lavage collected at each day21 visit in a subset of participants, reported as total CD3, CD38 cell counts and proportions of CD4:CD8 cells

  Six months of product use

• Participant-reported Adherence

  Using computer assisted self-reported questionnaires and focus group discussions

  Six months of product use

• Microbiological effect of vaginally delivered hormonal contraception

  Standard Nugent score of cervicovaginal lavage smears.

  Six months of product use

Study Arms (1)

Nuvaring (only arm)

EXPERIMENTAL

Nuvaring use for six months, with monthly pickup of rings and returning of used rings, and other behavioral/clinical assessments conducted during the visit on day 21 of the menstrual cycle.

Drug: Nuvaring

Interventions

Nuvaring DRUG

contraceptive vaginal ring with ethinyl estradiol and etonogestrel

Nuvaring (only arm)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 34 years of age - Age will be verified using a standard national document e.g. Identity card, birth notification etc., and in case they are missing we will rely on proxy verification. Everyone in Kenya over the age of 18 is required to have a government-issued identification card, which includes their date of birth. There is some likelihood that women who are interested do not have this card and do not know their year of birth. In such, instances the participant will be asked her age and birth month. The day of birth will be defaulted to the 15th and year of birth will be calculated using the available information if not provided by the participant. In instances, where age cannot be verified, participation will not be permitted.
• Fluent in English, Swahili, or DhoLuo
• Resident of the Kisumu catchment area (≈150 kilometres from Kisumu City)
• Able and willing to provide written informed consent
• Willing to provide detailed locator information and not planning to relocate outside the study area for next 12 months
• Engaged in more than one episode of vaginal intercourse on different days in the past 30 days
• Female, not currently pregnant and not intending to get pregnant for the next 12 months
• Demonstrated willingness to prevent conception for the next 12 months, based on:
• o Documented receipt of three on-time monthly oral contraceptive pill (OCP) refills, or one DMPA injection at a FP clinic in the last 3 months prior to enrolling in the study.
• Willing to exclusively use IVR for contraception for the duration of the intervention phase of study. (Proper and consistent condom use will be encouraged and condoms will be provided for STI/HIV prevention)
• HIV negative per Kenya's HIV testing algorithm (using rapid tests)
• Willing to undergo periodic study procedures including pregnancy testing, HIV and STI testing

You may not qualify if:

• Participants will be excluded from the study based on:
• Known medical contraindications:
• Thrombophlebitis or thromboembolic disorders (current or history)
• Cerebral vascular or coronary artery disease (current or history)
• Valvular heart disease with thrombogenic complications
• Severe hypertension
• Diabetes with vascular involvement
• Headaches with focal neurological symptoms
• Major surgery with prolonged immobilization
• Known or suspected carcinoma of the breast or personal history of breast cancer
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
• Undiagnosed abnormal genital bleeding
• Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
• Hepatic tumours (benign or malignant) or active liver disease
• Known or suspected pregnancy

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Kenya Medical Research Institute: collaborator

MeSH Terms

Interventions

NuvaRing

Study Officials

• Mumbi Makanga, MBChB

  Kenya Medical Research Institute

  STUDY CHAIR

• Beatrice Nyagol, MN

  Kenya Medical Research Institute

  STUDY CHAIR

• Eleanor McLellan-Lemal, PhD

  US CDC

  PRINCIPAL INVESTIGATOR

• Mitesh Desai, MD, MPH

  US CDC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 20, 2015
• Study Start: April 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 20, 2015

Record last verified: 2015-08