Microbicides in Obstetrics and Gynaecology – Multiple Choice Questions for Vol. 26, No. 4

  • 1.

    Which of the following statement(s) about research and development of microbicides is/are true:

    • a)

      Microbicides are being developed for women for both vaginal and rectal use.

    • b)

      Although several candidate microbicides have been tested, there is no proof that microbicides can prevent HIV in women.

    • c)

      The only way to demonstrate a vaginal microbicide is effective in preventing HIV is to conduct large efficacy trials involving thousands of HIV-negative women.

    • d)

      Vaginal drug concentrations of the microbicide correlate with protection against HIV infection.

    • e)

      The results of challenge studies in monkeys have correlated closely with protection against HIV in humans.

  • 2.

    Which of the following mechanisms of action have been tested for the effectiveness of candidate microbicides in preventing HIV infection?

    • a)

      Viral integrase enzyme inhibitors.

    • b)

      Vaginal defence enhancers.

    • c)

      Viral entry inhibitors.

    • d)

      Viral DC-sign inhibitors.

    • e)

      Viral replication inhibitors.

  • 3.

    Which of the following is/are reasons why tenofovir is considered a good candidate for development as a microbicide:

    • a)

      Tenofovir is widely used as the drug of choice in first-line treatment regimens to treat acquired immune deficiency syndrome (AIDS).

    • b)

      Tenofovir is a large molecule with poor systemic absorption thereby reducing the risk of systemic side effects from topical use.

    • c)

      Tenofovir has a good safety profile.

    • d)

      Tenofovir has a long half-life.

    • e)

      Tenofovir was effective in preventing simian immunodeficiency (SIV) virus in monkey models.

  • 4.

    The efficiency of HIV transmission from men to women during sexual intercourse is relatively inefficient, although several biological factors have been associated with increased risk of infection. These include:

    • a)

      The presence of ulcerative sexually transmitted infections.

    • b)

      The presence of certain aerobic bacterial species, such as Lactobacilli.

    • c)

      The viral load of the male partner.

    • d)

      The presence of cervico-vaginal mucous.

    • e)

      Bacterial vaginosis.

  • 5.

    Adolescent girls are at increased risk of HIV infection because:

    • a)

      Adolescent girls have cervical ectropion and a larger transformation zone.

    • b)

      Columnar epithelia are more susceptible than stratified squamous ones.

    • c)

      The onset of puberty and higher levels of sex hormones suppress innate and adaptive responses in the genital tract.

    • d)

      They have a greater prevalence of aerobic bacteria.

    • e)

      Protective Lactobacilli only tend to colonise the genital tract with onset of sexual activity.

  • 6.

    The first-generation topical microbicides to prevent HIV infection, nonoxynol-9 (N-9) and cellulose sulfate, were associated with risk of infection because:

    • a)

      They caused microulceration of the vaginal epithelial barrier.

    • b)

      They dampened inflammatory signals in the genital tract, thereby suppressing effective immunity.

    • c)

      They altered protective vaginal microbial flora.

    • d)

      They disrupted the phospholipid membrane of cells, making them less effective at blocking infection.

    • e)

      They made submucosal target cells easier to reach.

  • 7.

    Several combination strategies have been suggested to improve the efficacy of the current anti-retroviral drug containing topical microbicides. These include:

    • a)

      Strategies to reduce genital tract inflammation, such as inclusion of an anti-inflammatory drug together with the microbicidal agent.

    • b)

      Treating the causes of inflammation, such as better management and more intensive treatment of sexually transmitted infections.

    • c)

      Pro-biotic treatment with commensal Lactobacillus species.

    • d)

      Douching agents.

    • e)

      Addition of estrogen containing compounds.

  • 8.

    Which of the following is/are considered an advantage(s) of a topical microbicide formulated as a gel?

    • a)

      Female controlled.

    • b)

      Limited systemic absorption.

    • c)

      Lubricating properties.

    • d)

      They are suitable for drugs that are unstable in aqueous solution.

    • e)

      Low side-effect potential.

  • 9.

    Which of the following prevent(s) HIV by allosterically inhibiting reverse transcription?

    • a)

      Tenofovir.

    • b)

      Dapivirine.

    • c)

      RC-101.

    • d)

      Nonoxynol-9.

    • e)

      Maraviroc.

  • 10.

    When formulating a vaginal microbicide for HIV prevention, which of the following must be taken into consideration?

    • a)

      The pharmaceutically active compound must be stable in the vehicle.

    • b)

      Product must distribute throughout the vaginal or rectal compartment.

    • c)

      pH must be compatible with the mucosal surfaces that the microbicide is intended to be applied to.

    • d)

      Osmolality must be compatible with the mucosal surfaces that the microbicide is intended to be applied to.

    • e)

      Films and solid tablets must have adequate disintegration over time.

  • 11.

    Which factor(s) make(s) designing prevention trials different to treatment trials?

    • a)

      There is essentially no difference.

    • b)

      They require smaller sample sizes.

    • c)

      Identifying the population at risk is often more difficult in prevention trials.

    • d)

      Specific patient groups are more difficult to target.

    • e)

      Many people recruited are not at risk of the disease of interest.

  • 12.

    Which of the following is a key assumption made for the power calculation when designing a microbicide trial?

    • a)

      Human immunodeficiency virus (HIV) incidence.

    • b)

      Adverse reactions to the product.

    • c)

      Adherence to the product.

    • d)

      Acceptability of the product.

    • e)

      Patient drop out rates.

  • 13.

    Why is measuring adherence essential in microbicide trials?

    • a)

      To encourage participants to use the product.

    • b)

      To aid interpretation of product efficacy.

    • c)

      To put the trial result in context with other trials.

    • d)

      To engage participants in the study.

    • e)

      It is a regulatory requirement.

  • 14.

    What is the purpose of the independent data monitoring committee (IDMC)?

    • a)

      To estimate the sample size of the trial.

    • b)

      To provide regulatory guidance and oversight.

    • c)

      To protect the trial sponsors and investigators.

    • d)

      To protect the safety of study participants.

    • e)

      To provide independent review of the unblinded accruing trial data.

  • 15.

    Reproductive health-related exclusion criteria that may be used to screen women out of microbicide trial participation include the following:

    • a)

      Non-pregnant woman.

    • b)

      A woman not planning to fall pregnant over trial duration.

    • c)

      A woman wanting to use contraception.

    • d)

      A woman planning a pregnancy over the trial duration.

    • e)

      None of the above.

  • 16.

    The following microbicides also have contraceptive properties:

    • a)

      Tenofovir.

    • b)

      Savvy.

    • c)

      Cellulose sulfate.

    • d)

      Nonoxynol 9.

    • e)

      Cellulose sulfate and nonoxynol 9 combined.

  • 17.

    Eligible contraceptive methods in CAPRISA 004 included the following:

    • a)

      Female condom.

    • b)

      Depot medroxyprogesterone acetate.

    • c)

      Male condom.

    • d)

      Diaphragm.

    • e)

      Cervical cap.

  • 18.

    A woman who fell pregnant during which of the trials below was removed from the study upon pregnancy diagnosis?

    • a)

      Family Health International (FHI) Savvy/Nigeria trial.

    • b)

      CONRAD Cellulose Sulfate trial.

    • c)

      Population Council Carraguard trial.

    • d)

      Microbicide Development Program (MDP) 301 trial.

    • e)

      Microbicide Trials Network (MTN) 003 trial.

  • 19.

    The following is/are key issues in the HIV prevention research agenda for women:

    • a)

      Developing a microbicide that allows women to have a female-controlled prevention method.

    • b)

      Strengthening infrastructure and social grants.

    • c)

      Combining microbicides with barrier methods.

    • d)

      Including men in HIV prevention efforts to protect women.

    • e)

      Couple counselling to enhance joint responsibility.

  • 20.

    Important sub-populations that require special attention for fighting the HIV epidemic in Sub-Saharan Africa include:

    • a)

      Women aged 24 years and younger.

    • b)

      Men who have sex with men.

    • c)

      Pregnant women.

    • d)

      Intravenous drug users.

    • e)

      Hepatitis B +ve women.

  • 21.

    Critical milestones in the HIV pandemic in relation to women include:

    • a)

      Discovery of the HIV virus in men who have sex with men.

    • b)

      Discovery of HIV in IV drug abusers.

    • c)

      Condoms used as the main means of HIV prevention.

    • d)

      Zena Stein’s commentary in the American Journal of Public Health on the need to increase the HIV prevention strategies available to women.

    • e)

      CAPRISA 004 suggesting that a microbicide product shows efficacy at protecting against HIV infection.

  • 22.

    Important areas to consider in the future of HIV research in women include:

    • a)

      Multi-disciplinary research extending across research fields, including the behavioural and biomedical disciplines.

    • b)

      Placing HIV prevention within the context that women currently find themselves in.

    • c)

      Empowering women and enabling them to use what is currently available.

    • d)

      Looking at interventions that address broader social and political issues of society.

    • e)

      Interventions dealing with structural issues of society.

  • 23.

    The following statement(s) is/are true about the dapivirine vaginal ring:

    • a)

      The ring is designed to work against HIV by preventing the virus from replicating, as it is a non-nucleoside reverse transcriptase inhibitor.

    • b)

      It is designed to protect against both HIV and herpes simplex virus 2 (HSV-2).

    • c)

      The dapivirine vaginal matrix ring is designed to provide sustained release of dapivirine over a minimum of 28 days.

    • d)

      Because of its ability to neutralise pathogens in both semen and vaginal secretions, it is being evaluated as a bi-directional method of protection against HIV for both partners.

    • e)

      Because of the novel ring technology, if found effective, is likely to be a costly HIV prevention method once approved for use.

  • 24.

    Future microbicide product development efforts must continue to focus on multiple formulations and delivery methods (e.g. vaginal ring, tablet, film and gel) because:

    • a)

      Previous safety studies of the ring have shown low participant adherence, indicating that alternative microbicide formulations are needed to improve adherence rates.

    • b)

      Male partners find the dapivirine ring to be an unacceptable form of protection against HIV, as it affects their sexual pleasure during intercourse.

    • c)

      No single HIV prevention option will be appropriate for, or acceptable to, all women.

    • d)

      Long-acting products are expected to improve user adherence and acceptability and result in increased product effectiveness.

    • e)

      Not all drugs can be optimally formulated in specific dosage forms.

  • 25.

    The following statement(s) is/are true about HIV prevention for young women in low-income countries:

    • a)

      Young women are at low risk for HIV infection.

    • b)

      Prevention options that require partner consent are most suitable for young women.

    • c)

      Several prevention methods already exist for these women.

    • d)

      HIV prevention is a serious public health priority, as more than 60% of those infected are aged between 15 and 24 years.

    • e)

      HIV prevention is not necessary in young women.

  • 26.

    Translating positive findings from effectiveness trials into real-life performance in health systems is challenging because:

    • a)

      Microbicides are not yet available.

    • b)

      Health-system performance influences the effectiveness of interventions.

    • c)

      Healthcare workers do not focus on HIV prevention.

    • d)

      Microbicides are expensive.

    • e)

      Quality improvement of the health system has not yet been undertaken.

  • 27.

    Implementation science is defined as:

    • a)

      Scientific study to promote integration of research findings and evidence-based interventions into healthcare policy and practice to improve the quality and effectiveness of health services.

    • b)

      Randomised clinical trials to test microbicide interventions.

    • c)

      Pre-clinical assessment of microbicides.

    • d)

      A research methodology to undertake monitoring and evaluation of programmes.

    • e)

      Post-marketing surveillance of health systems.

  • 28.

    Barriers to implementing microbicides in low-income countries include:

    • a)

      Potential for integration into existing health services.

    • b)

      Lack of confirmation of effectiveness of candidate microbicides.

    • c)

      Low HIV disease burden.

    • d)

      Regulatory approval of an effective microbicide.

    • e)

      Cost of production.

  • 29.

    The following is/are seen as significant challenges to monitoring of microbicide research in low income, high HIV burden countries

    • a)

      Excluding HIV infection pre-recruitment.

    • b)

      Monitoring for HIV conversion during a trial.

    • c)

      Detection of pregnancy.

    • d)

      Unwillingness to report side effects due to not wanting to have the drug stopped.

    • e)

      Detection of coexistent STIs.

  • 30.

    Microbicides are an HIV prevention modality that can potentially be rolled out using existing healthcare infrastructure because:

    • a)

      They are specifically formulated for topical use, which limits systemic toxicities.

    • b)

      Users who may benefit most already use existing infrastructure, such as family planning clinics.

    • c)

      They are formulated as vaginal rings only.

    • d)

      They are already licensed for HIV prevention.

    • e)

      They are available over the counter.

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Nov 9, 2017 | Posted by in OBSTETRICS | Comments Off on Microbicides in Obstetrics and Gynaecology – Multiple Choice Questions for Vol. 26, No. 4

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