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.
