Pregnant Women as Research Participants: a Study on HPV Self-Sampling

Cancer-causing infections, such as hepatitis and human papillomavirus (HPV), are responsible for approximately 30% of cancer cases in low- and lower-middle-income countries.¹ The World Health Organization’s (WHO) cervical cancer elimination goal in 2020 aims to achieve 70% global screening coverage using high-performance tests by 2030.² HPV “self-sampling,” a lower vaginal swab that detects viral DNA, is recommended by the WHO to replace the traditional Pap smear, which can present barriers for both patients and providers and is considerably less sensitive.^3,4,5 Self-sampling can be performed by women at home and can identify both cancer-causing strains of HPV (HPV16 and HPV18). Studies have shown that women are more likely to use HPV self-sampling than to see a health care provider for cervical cancer screening.

A researcher in one country in Southeast Asia is interested in exploring ways to create awareness about HPV infection and increase adoption of HPV self-sampling among women. The researcher collaborated with other clinicians from both public and private health care facilities to conduct the first-ever study within this country. They aim to learn about the acceptability of HPV self-sampling among pregnant women as well as the association between HPV and pregnancy outcomes. Positive results would provide supportive evidence for HPV self-sampling to be incorporated into regular antenatal visits and increase screening overall. The research team proposed to recruit pregnant women who attend clinics regularly during pregnancy.

The researchers aimed to recruit 1,500 pregnant women from public and private health care facilities. Women eligible to participate were 30 years or older and at least 27 weeks into pregnancy, based on the fact that although women in this age group may have fewer HPV infections, exposure to high-risk HPV strains raises their risk of cervical cancer.⁶ In addition, pregnancy is said to be comparatively safer when women enter the second trimester.⁷ The research protocol was submitted to a local research ethics committee (REC) for review.

The study included a pretest questionnaire that contained some sensitive questions about sexual health, such as age of having first vaginal sex with men and the number of sexual partners. Research participants were provided with both verbal and written instructions on how to self-collect vaginal samples in the public washroom of a health facility. A posttest questionnaire gauged acceptance of performing the test during pregnancy. Participants were informed about their HPV results via their telecommunication of choice. Those who tested HPV-positive were informed and referred to a colposcopy clinic within 6-12 weeks after childbirth for further management. The researchers chose this time frame because revealing a positive HPV test to a woman who is pregnant may create unnecessary stress and anxiety about getting cancer that could jeopardize the pregnancy.