Hormonal Contraception Clinical Trial
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.
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:
1. To assess adherence and utilization patterns for NuvaRing®, behaviourally and
biologically.
2. 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.
3. 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.
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Intervention Model: Single Group Assignment, Masking: Open Label
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