Effect of visual inspection with acetic acid (VIA) screening by primary health workers on cervical cancer mortality: A cluster randomized controlled trial in Mumbai, India

Reporter: J Taylor Whaley, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: June 3, 2013

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Presenter: Surendra S. Shastri, MD
Presenter's Affiliation: Tata Memorial Centre, Mumbai, India

Background

  • Cervical cancer is vastly more common in developing nations than it is in developed nations, and it is fairly rare in the United States.
  • Cervical cancer is the 12th most common cancer that women develop, and the 14th most common cause of cancer death for women in the U.S. However, cervical cancer is the most common cancer in developing nations, with about 370,000 new cases annually having a 50% mortality rate. Cervical cancer is the leading cause of cancer death in Indian women, and 29% of the global burden of cervical cancer is found in India.
  • There has been a 75% decrease in incidence and mortality from cervical cancer in developed nations over the past 50 years. Most of this decrease is attributed to the effective institution of cervical cancer screening programs in developed nations.
    • The Pap test, which relies on cytology to detect abnormalities in cells, has made great strides in catching cervical changes early. If the results of the Pap smear are inconclusive or if the test shows abnormal cells, a colposcopy is typically performed. By using acetic acid on the cervix and examining it with a colposcope, abnormal areas of your cervix can be biopsied.
  • However, cytology-based screening (Pap Smear) is not easily implementable in India for several reasons, including costs, inadequate infrastructure, personal beliefs, and lack of trained professionals. Therefore, there is a need to evolve simpler alternatives.
  • Two large studies evaluated one round of screening and failed to show a reduction in deaths secondary to cervical cancer.
  • Visual inspection with acetic acid (VIA) is a simple test that can be performed without cytology. Its can be performed by trained non-professionals (non-physician or nurse), and the test allows immediate results. To perform the test, acetic acid is applied to the cervix. Abnormalities appear as thick, well-defined, white areas at the transitional zone.
  • The authors present a novel screening strategy for cervix cancer in developing countries.
  • The current randomized trial was undertaken to evaluate the effect of visual inspection with acetic acid screening on cervical cancer mortality in 20 low socioeconomic areas of India.

Materials and Methods

  • The authors initiated a cluster-randomized controlled trial in 1998 to investigate the efficacy of VIA screening by primary health workers (PHWs) in reducing cervical cancer mortality.
  • Women aged 35-64 years with no prior history of cancer were included.
  • The study was designed to randomly include 20 slum clusters (area of low socioeconomic status) with an average of 7,500 eligible women per cluster in Mumbai, India.
  • The trial arms are seen as below.
 

Screening Arm

Control Arm

Cancer Education

4 rounds every 2 years

4 rounds every 2 years

VIA Screening

4 rounds every 2 years

None

Monitoring for Disease Occurrence or Death

4 rounds every 2 years

4 rounds every 2 years

  • Four rounds of cancer education and VIA screening were conducted by PHWs at 24-month intervals in the screening group, while cancer education was offered to both groups every 2 years.
  • To evaluate the soundness of PWH’s screening methods, a gynecology expert independently screened 5% of all women.
  • For any patients with CIN or invasive disease discovered in either group, treatment was provided free.
  • The study was planned for 16 years.

Results

  • Recruitment was completed in March 2002.
  • The investigators recruited 75,360 women from 10 clusters in the screening group and 76,178 women from 10 comparable clusters in the control group.
  • The analysis is on an intention-to-treat basis.
  • The results were analyzed on the advice of the Data Safety Monitoring Committee at 12 years.
  • In the screening group, 89% participation for screening and 79% compliance for post-screening diagnostic confirmation were achieved.
  • The control arm had 91% participation.
  • The quality of screening by PHWs was comparable to that of an expert gynecologist (?=0.84), indicating very good agreement.
  • The incidence of invasive cervical cancer was 26.74 per 100,000 in the screening group and 27.49 per 100,000 in the control group.
  • Compliance to treatment for invasive cancer was 86% in screening group and 72% in the control group.
  • There was a statistically significant downstaging in the stage of cervical cancer that was diagnosed in the screening group.
  • The screening group showed a 31% reduction in cervical cancer mortality (mortality rate ratio RR=0.69; p=0.003) compared to the control group.
  • A 7% reduction was also observed in all-cause mortality (p=0.41).
  • No overdiagnosis was seen after 8 years following the implementation of the screening program.

Author's Conclusions

  • VIA screening conducted by PHWs significantly reduced cervical cancer mortality.
  • VIA screening is easily implementable and effective.
  • Implementation of this screening program would save more than 22,000 cervical cancer deaths in India annually. Globally, in resource poor countries, this would save more than 70,000 deaths annually.

Clinical Implications

  • The authors should be applauded for a very impressive randomized trial evaluating the institution of a simple, inexpensive, yet effective screening method for cervical cancer.
  • Although screening has dramatically decreased the incidence of cervical cancer in the developed nations of the world, cervical cancer remains a huge international problem, particular in poverty stricken countries with poor resources.
  • Annually, 126,000 women are diagnosed with cervical cancer in India and more than 70,000 of those women will die from their disease.
  • Currently, less than 0.006% of women in rural India are screened. Barriers to screening are many, but include complexity of the pap test and its implementation.
  • VIA is a simple, implementable, and effective screening tool.
  • These results are very satisfying and implementation would likely lead to thousands of women being saved from death secondary to this very treatable disease.
  • Future studies will hopefully evaluate VIA versus the recently discovered low-cost HPV test that has shown some promising results.

Patient Summary: What Does This Mean For Me?

In the US and other developed nations, there has been a 75% decrease in cervical cancer rates and deaths from the disease in the 50 years since routine use of the pap test was implemented. However, the pap test has not been successfully implemented in developing nations due to it's cost and complexity. For instance, in India, cervical cancer is the number 1 cause of cancer death in women. This study used trained nurses and other non-professionals to conduct a visual inspection using vinegar to highlight abnormal areas. The examiner uses a speculum to visualize the cervix, applies the acetic acid and looks for abnormal appearing areas. The study found that this inexpensive, simple testing method reduced cervical cancer deaths by 31%. Implementation of this screening program would prevent more than 22,000 cervical cancer deaths in India annually. Worldwide, in resource poor countries, this would save more than 70,000 deaths annually.


News
FDA Approves Avastin for Late-Stage Cervical Cancer

Aug 18, 2014 - The anti-cancer drug Avastin (bevacizumab) has been newly approved to treat aggressive and late-stage cervical cancer, the U.S. Food and Drug Administration said in a news release. The new approval is for use in combination with other anti-cancer drugs, including paclitaxel, cisplatin, and topotecan.



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