Life Sciences & Biotechnology
Title : | Counseling of Clients for HPV Self Sampling by ASHAs (Accredited Social Health Activists) and by Physicians: A Randomized, Open-Labelled, Non-inferiority Trial (ASHA-CHAPTER Trial) |
Area of research : | Life Sciences & Biotechnology |
Principal Investigator : | Dr. Nilanchali Singh, All India Institute Of Medical Sciences (AIIMS), New Delhi |
Timeline Start Year : | 2023 |
Timeline End Year : | 2025 |
Contact info : | nilanchalisingh@gmail.com |
Equipments : | Desktop Computer |
Details
Executive Summary : | Hr-HPV testing is a very sensitive method of cervical cancer prevention and is now the preferred method of screening recommended by WHO (World Health Organization). Self-sampling for HPV, has emerged as a good option to increase uptake of cervical cancer screening services. Participation rates have reportedly increased 4 to 5-fold with self-sampling as compared to clinician collected sampling. The COVID19 pandemic has affected prevention services severely and it is not clear how they will be resumed over the next two years, as health facilities are already crowded with patients in need of curative services and social distancing will not be easy to maintain when adding the burden of preventive care. Women may be reluctant to take the risk of contracting infection for a preventive check. Also, healthcare workers would also prefer minimum contact with patients during the pandemic. ASHA (Accredited Social Health Activists) workers can fulfill this gap in services as they normally live in the same locality, the women are more comfortable with them, and no special skills are needed to obtain the self-sample. Many women may not have ownership of smart phones to share training material with and may have literacy issues. ASHAs may counsel them as they have basic understanding of health issues. The objective of this study is to evaluate the uptake of cervical cancer screening services by self-sampled HPV testing, in clients counseled by ASHAs in comparison to those counseled by physicians. The study will be a community based non-inferiority, randomized study. It will enroll 500 women, 250 randomized in each group. Group A will be counseled by 25-50 ASHAs. Each ASHA will enroll 5-10 women of the age group 30 to 65 years. The ASHA worker will be trained regarding the method of self-sampling via personal talk, videos, e-pamplets and video conferencing. They will be counselled and motivated about importance of cervical cancer screening. The other 250 women, who will be from same community, will be counseled by physicians. The primary outcome measure is uptake of testing. The secondary outcome measures are feasibility of testing, time taken to counsel each ASHA worker, reason for refusal and percentage of women showing abnormality in testing. The current study compares counseling of clients by ASHA workers with physician counseling. We propose that this strategy of counseling by ASHAs is not inferior to physician counseling. ASHAs may increase compliance to treatment and follow-up. They also aid in patient navigation. There has been no study so far comparing the strategy of HPV self-sampling with utilization of ASHA services versus physicians counseled HPV testing. This study will enhance the scope of preventive cancer care. Results from this pilot study can inform the National Cancer Control Programme in designing cervical cancer prevention strategies utilizing the ASHA services. |
Total Budget (INR): | 17,29,760 |
Organizations involved