- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)
- 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.
- a)

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