Hormonal ContraceptionNCT02529683
Study of Nuvaring Acceptability, Adherence and Biological Effects Among HIV-negative Women in Kenya
A study testing Nuvaring in people with Hormonal Contraception, run by Centers for Disease Control and Prevention.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hormonal Contraception
- What is being tested?
- Nuvaring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
About this study
Official title: Clinical Trial of Acceptability, Adherence and Immune/Microbiologic Effects of a Vaginal Contraceptive Ring Among HIV-negative Women in Western Kenya
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.
Read the detailed description
Background: Adherence to HIV prevention and contraception technologies is imperfect but a key to effectiveness. The options currently available to protect women from HIV infection and unwanted pregnancy (e. g. condom use, abstinence, monogamy) are not consistently available, practical, or under women's control. Intravaginal rings (IVRs) are an important technology that can be long-acting and woman-controlled and are being developed for HIV prevention with and without co-formulated hormonal contraception. Availability of IVRs in sub-Saharan Africa is limited; hence, it is important to evaluate acceptability, utilization, and biologic effects of IVR usage among African women. The NuvaRing® intravaginal combined hormonal contraceptive ring is used successfully in 61 countries worldwide, although not currently in Kenya. NuvaRing is self-inserted for 21 days starting after the last day of menses then removed for seven days to allow menses to occur, and has comparable effectiveness to oral contraceptives. Adherence to HIV prevention and contraception technologies like the IVR is critical to optimizing effectiveness. In preparation for a potential future Phase 2 trial of a combination antiretroviral-contraceptive IVR, KEMRI/CDC proposes to examine adherence, acceptability and biological effects of NuvaRing® among Kenyan women already using a modern method of contraception.
Objectives:
- To assess adherence and utilization patterns for NuvaRing®, behaviourally and biologically.
- To assess acceptability and effect of NuvaRing® on sexual behaviour among women and their sexual partners in a setting where there is no routine IVR use. At the end of the NuvaRing® trial, to additionally assess the hypothetical acceptability of a prototype dual use HIV-prevention and contraceptive IVR among women who had used NuvaRing® and among women who have never used an IVR.
- To assess biologic effects of NuvaRing® including standard safety monitoring and, among a subset of participants, genital compartment immunology and microbiology.
Study Subjects: A total of 220 women and 20 men will be enrolled in different parts of the proposed study. The primary NuvaRing® trial participants (Objectives 1 and 2 above) will be up to 200 young, healthy women recruited from family planning clinics in the Kisumu catchment area. Fifty of these women will form a biomedical subgroup addressing Objective 3. To augment Objective 2, twenty trial participants and their sexual partners will take part in a qualitative in-depth interview, and three focus group discussions will be conducted, one with study participants and the others with 20 women who were not part of the primary NuvaRing® trial.
Design: Single arm clinical trial with up to 3 month pre-product phase (on oral or injectable contraceptives) followed by 6 months of IVR use, ending with an up to 3 month post-product phase during which women return to oral or injectable contraceptives and then exit the study. Monthly and quarterly follow-up will include adherence, acceptability and clinical assessments, and HIV and pregnancy testing. Women in the biomedical subgroup will undergo more frequent visits and collection of genital specimens. In-depth interview and focus group discussions are delineated under 'Study Subjects' above.
Outcome: The study will improve understanding of adherence to biomedical technologies, facilitate the conduct of future HIV microbicide clinical trials relying on IVR technology, and inform public health practice regarding contraception.
- Conditions
- Hormonal Contraception
- Being tested
- Nuvaring
- Keywords
- Nuvaring, contraceptive vaginal ring, Kenya, adherence, acceptability, immunological effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuvaringDrug
contraceptive vaginal ring with ethinyl estradiol and etonogestrel
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nuvaring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant-reported Acceptability
Using computer assisted self-reported questionnaires and focus group discussions
Measured: 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)
Measured: 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
Measured: Six months of product use
Participant-reported Adherence
Using computer assisted self-reported questionnaires and focus group discussions
Measured: Six months of product use
Microbiological effect of vaginally delivered hormonal contraception
Standard Nugent score of cervicovaginal lavage smears.
Measured: Six months of product use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startApr 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormonal ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Kenya Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Mumbi Makanga, MBChB, Study chair, Kenya Medical Research InstituteBeatrice Nyagol, MN, Study chair, Kenya Medical Research InstituteEleanor McLellan-Lemal, PhD, Principal investigator, US CDCMitesh Desai, MD, MPH, Study chair, US CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529683
- Sponsor's protocol ID
- CDC-NCHHSTP-6518
- Other IDs
- SSC Protocol # 2609
- Status last verified
- Aug 2015
- First submitted
- 14 Aug 2015
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Acceptability, Adherence and Immune/Microbiologic Effects of a Vaginal Contraceptive Ring Among HIV-negative Women in Western Kenya
- ClinicalTrials.gov ID
- NCT02529683
- Acronym / sponsor ID
- CDC-NCHHSTP-6518
- Conditions
- Hormonal Contraception
- Keywords
- Nuvaring, contraceptive vaginal ring, Kenya, adherence, acceptability, immunological effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Kenya Medical Research Institute
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Adherence to HIV prevention and contraception technologies is imperfect but a key to effectiveness. The options currently available to protect women from HIV infection and unwanted pregnancy (e. g. condom use, abstinence, monogamy) are not consistently available, practical, or under women's control. Intravaginal rings (IVRs) are an important technology that can be long-acting and woman-controlled and are being developed for HIV prevention with and without co-formulated hormonal contraception. Availability of IVRs in sub-Saharan Africa is limited; hence, it is important to evaluate acceptability, utilization, and biologic effects of IVR usage among African women. The NuvaRing® intravaginal combined hormonal contraceptive ring is used successfully in 61 countries worldwide, although not currently in Kenya. NuvaRing is self-inserted for 21 days starting after the last day of menses then removed for seven days to allow menses to occur, and has comparable effectiveness to oral contraceptives. Adherence to HIV prevention and contraception technologies like the IVR is critical to optimizing effectiveness. In preparation for a potential future Phase 2 trial of a combination antiretroviral-contraceptive IVR, KEMRI/CDC proposes to examine adherence, acceptability and biological effects of NuvaRing® among Kenyan women already using a modern method of contraception.
Objectives:
- To assess adherence and utilization patterns for NuvaRing®, behaviourally and biologically.
- To assess acceptability and effect of NuvaRing® on sexual behaviour among women and their sexual partners in a setting where there is no routine IVR use. At the end of the NuvaRing® trial, to additionally assess the hypothetical acceptability of a prototype dual use HIV-prevention and contraceptive IVR among women who had used NuvaRing® and among women who have never used an IVR.
- To assess biologic effects of NuvaRing® including standard safety monitoring and, among a subset of participants, genital compartment immunology and microbiology.
Study Subjects: A total of 220 women and 20 men will be enrolled in different parts of the proposed study. The primary NuvaRing® trial participants (Objectives 1 and 2 above) will be up to 200 young, healthy women recruited from family planning clinics in the Kisumu catchment area. Fifty of these women will form a biomedical subgroup addressing Objective 3. To augment Objective 2, twenty trial participants and their sexual partners will take part in a qualitative in-depth interview, and three focus group discussions will be conducted, one with study participants and the others with 20 women who were not part of the primary NuvaRing® trial.
Design: Single arm clinical trial with up to 3 month pre-product phase (on oral or injectable contraceptives) followed by 6 months of IVR use, ending with an up to 3 month post-product phase during which women return to oral or injectable contraceptives and then exit the study. Monthly and quarterly follow-up will include adherence, acceptability and clinical assessments, and HIV and pregnancy testing. Women in the biomedical subgroup will undergo more frequent visits and collection of genital specimens. In-depth interview and focus group discussions are delineated under 'Study Subjects' above.
Outcome: The study will improve understanding of adherence to biomedical technologies, facilitate the conduct of future HIV microbicide clinical trials relying on IVR technology, and inform public health practice regarding contraception.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nuvaring (only arm) | Experimental | Drug: NuvaringNuvaring 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (19 listed)
- Participants will be excluded from the study based on:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuvaringcontraceptive vaginal ring with ethinyl estradiol and etonogestrel | Drug | Nuvaring (only arm) |
Primary outcome
Participant-reported Acceptability
Time frame: Six months of product use
Using computer assisted self-reported questionnaires and focus group discussions
Biological (Objective) measures of Adherence
Time frame: Six months of product use
Composite of salivary estradiol assays (instantaneous adherence) and remnant-drug assay of returned used vaginal rings (cumulative adherence over 21 days of use)
Local Immunological effects of vaginally delivered hormonal contraception as measured by immunophenotyping
Time frame: Six months of product use
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
Participant-reported Adherence
Time frame: Six months of product use
Using computer assisted self-reported questionnaires and focus group discussions
Microbiological effect of vaginally delivered hormonal contraception
Time frame: Six months of product use
Standard Nugent score of cervicovaginal lavage smears.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mumbi Makanga, MBChB study chair
Kenya Medical Research Institute
Beatrice Nyagol, MN study chair
Kenya Medical Research Institute
Eleanor McLellan-Lemal, PhD principal investigator
US CDC
Questions about this trial
What is this clinical trial studying?
A study testing Nuvaring in people with Hormonal Contraception, run by Centers for Disease Control and Prevention.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant-reported Acceptability (time frame: Six months of product use). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.