Study of Nuvaring Acceptability, Adherence and Biological Effects Among HIV-negative Women in Kenya
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02529683|
Recruitment Status : Completed
First Posted : August 20, 2015
Last Update Posted : August 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hormonal Contraception||Drug: Nuvaring||Not Applicable|
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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial of Acceptability, Adherence and Immune/Microbiologic Effects of a Vaginal Contraceptive Ring Among HIV-negative Women in Western Kenya|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Experimental: Nuvaring (only arm)
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.
contraceptive vaginal ring with ethinyl estradiol and etonogestrel
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529683
|Study Chair:||Mumbi Makanga, MBChB||Kenya Medical Research Institute|
|Study Chair:||Beatrice Nyagol, MN||Kenya Medical Research Institute|
|Principal Investigator:||Eleanor McLellan-Lemal, PhD||US CDC|
|Study Chair:||Mitesh Desai, MD, MPH||US CDC|