Study of Nuvaring Acceptability, Adherence and Biological Effects Among HIV-negative Women in Kenya
Condition: Hormonal Contraception
Study type: Interventional

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.
    

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:

        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.
    

Intervention name(s): Nuvaring
Intervention type(s): Drug
Intervention description(s): contraceptive vaginal ring with ethinyl estradiol and etonogestrel
Intervention MeSH terms: NuvaRing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Nuvaring; contraceptive vaginal ring; Kenya; adherence; acceptability; immunological effects