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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborator: Kenya Medical Research Institute
• Treatments: Contraceptive Agents; Desogestrel; Ethinyl Estradiol; NuvaRing

Criteria

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 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

• Heavy smoking (≥15 cigarettes per day) and over age 35

• Hypersensitivity to any of the components of NuvaRing®

• Current breastfeeding or being within three months of parturition, at the time of screening.

• Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, reproductive, or allergic disease that would compromise the ability of the participant to provide informed consent, or to complete study procedures or study requirements as determined by the principal investigator or designated associate. The clinical significance of any abnormality is to be evaluated in the context of the safety of the patient volunteer and the objectives of this study.