| CTRI Number |
CTRI/2020/02/023349 [Registered on: 14/02/2020] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Cervical cancer prevention among HIV-infected women |
|
Scientific Title of Study
|
Evaluation of 2 service delivery algorithms: ‘screen with an HPV test and treat’ or ‘screen with an HPV test followed by VIA and treat’ for prevention of cervical intraepithelial neoplasia in HIV- infected women attending a NACO ART centre in Pune, India: an open label randomized trial |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smita Joshi |
| Designation |
Senior Researcher |
| Affiliation |
Prayas |
| Address |
Department of Preventive Oncology, Prayas, Amrita Clinic, Karve Road Corner, Deccan Gymkhana, Pune
NA
Pune
MAHARASHTRA
411004
India |
| Phone |
9881132506 |
| Fax |
|
| Email |
smitanjoshi18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Joshi |
| Designation |
Senior Researcher |
| Affiliation |
Prayas |
| Address |
Department of Preventive Oncology, Prayas, Amrita Clinic, Karve Road Corner, Deccan Gymkhana, Pune
NA
Pune
MAHARASHTRA
411004
India |
| Phone |
9881132506 |
| Fax |
|
| Email |
smitanjoshi18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita Joshi |
| Designation |
Senior Researcher, |
| Affiliation |
Prayas |
| Address |
Department of Preventive Oncology, Prayas, Amrita Clinic, Karve Road Corner, Deccan Gymkhana, Pune
NA
Pune
MAHARASHTRA
411004
India |
| Phone |
9881132506 |
| Fax |
|
| Email |
smitanjoshi18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Prayas, Amrita Clinic, Karve Road Corner, Athawale Corner, Deccan Gymkhana, Pune 411004 |
|
|
Primary Sponsor
|
| Name |
Prayas |
| Address |
Amrita Clinic, Karve Road Corner, Deccan Gymkhana, Pune 411004 |
| Type of Sponsor |
Other [non-profit organization] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indian Council of Medical Research |
V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smita Joshi |
Prayas |
Amrita Clinic, Athawale Corner, Karve Road Corner, Deccan Gymkhana
Pune
MAHARASHTRA |
919881132506
smitanjoshi18@gmail.com |
| Dr Smita JOshi |
YCM Bajaj ARt Centre |
Sant Tukaram Nagar, Pimpri Colony, Pune, Maharashtra 411018
Pune
MAHARASHTRA |
9881132506
smitanjoshi18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Delayed treatment of HPV infected women |
HPV infected women who have a positive VIA test will be treated. If there is no acetowhite lesion, they will not be treated. |
| Intervention |
Immediate treatment of HPV positive women |
All HPV infected women will be treated either by ablation or excision irrespective of the presence of any aceto-white lesion |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women willing to sign an informed consent form |
|
| ExclusionCriteria |
| Details |
Women who have undergone a hysterectomy,
Pregnant women,
Women with a debilitating health condition,
Women with a prolapsed uterus |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HPV clearance in the 2 treatment arms |
HPV clearance in the 2 treatment arms |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence and predictors of HPV infection in HIV-infected women |
At enrolment |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="2618" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
10/06/2020 |
| Date of Study Completion (India) |
30/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Joshi S, Muwonge R, Bhosale R, Chaudhari P, Kulkarni V, Mandolkar M, Deodhar K, Kand S, Phadke N, Rajan S, Kumar BK, Sankaranarayanan R, Basu P. A randomised controlled non-inferiority trial to compare the efficacy of HPV screen, triage and treat with HPV screen and treat approach for cervical cancer prevention among women living with HIV. Nat Commun. 2025 Feb 22;16(1):1888. doi: 10.1038/s41467-025-56926-3. PMID: 39987163. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
HPV test is the most accurate and reproducible primary test for cervical cancer screening. When an HPV test is used for screening, WHO has suggested 2 algorithms (screen with an HPV test and treat if HPV positive or screen with an HPV test, perform VIA if HPV positive and treat if both tests are positive) for women in the low- and middle-income countries where facilities are limited for triaging with cytology or genotyping or colposcopy. We propose to evaluate the above 2 algorithms in HPV positive HIV-infected women by randomly assigning them to either of the 2 treatment arms and then comparing the HPV clearance rate in the 2 treatment arms. |