| CTRI Number |
CTRI/2024/02/062381 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
30/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Identification and Prevention of Cervical Cancer Risk in Women with HIV in India |
|
Scientific Title of Study
|
Secondary Cervical Cancer Prevention of Vulnerable Women with HPV and HIV Co-infection in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Veena A Satyanarayana |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Room No-312
Department of Clinical Psychology
MV Govindaswamy Center 3rd floor
NIMHANS
Hosur Road
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995877 |
| Fax |
|
| Email |
veenas@nimhans.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Veena A Satyanarayana |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Room No-312
Department of Clinical Psychology
MV Govindaswamy Center 3rd floor
NIMHANS
Hosur Road
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995877 |
| Fax |
|
| Email |
veenas@nimhans.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Veena A Satyanarayana |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Room No-312
Department of Clinical Psychology
MV Govindaswamy Center 3rd floor
NIMHANS
Hosur Road
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995877 |
| Fax |
|
| Email |
veenas@nimhans.ac.in |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neuro Sciences (NIMHANS), Hosur Road, Bangalore -560029 |
|
|
Primary Sponsor
|
| Name |
National Institutes of Health, National Cancer Institute |
| Address |
31 Center Drive, Building 31, Bethesda, Maryland 20814, USA |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shetty Dr Vinoda |
Belgaum Institute of Medical Sciences |
ART Centre,
Ground Floor
District hospital building
Dr B R Ambedkar Road, Sadashiv Nagar, Belagavi - 590001, Karnataka
Belgaum
KARNATAKA |
0831-2491071
belgaum.bims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20-B20||Human immunodeficiency virus [HIV] disease, (2) ICD-10 Condition: R878||Other abnormal findings in specimens from female genital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ASHA Health |
ASHA-Health HPV intervention will focus on improving nutrition; social factors (social support); behavioral factors (coping skills, problem-solving skills, barriers to treatment adherence (transportation,
lack of job skills, ART side effects), and mental health factors (depression, stigma)
over 8 bimonthly sessions covering a duration of 4 months |
| Comparator Agent |
Enhanced Standard of Care |
This includes usual care plus
3 sessions on wellness, basic nutrition and HPV and HIV health promotion delivered over a duration of 2 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1 WLH, 25 to 50 years of age per HIV-based guidelines 2 receiving ART for over two months to ensure medication stabilization, validated by an ART card given to all ART patients 3 screened as HPV positive with self sample vaginal collection 4 assessed to have oncogenic HPV and 5 assessed to be VIA negative for cervical lesions, performed by our trained Auxiliary Nurse Midwife (ANM) |
|
| ExclusionCriteria |
| Details |
1 pregnant or lactating women due to hormonal and dietary guideline differences 2 women below 25 years and 3 women determined to be VIA positive as they will be immediately referred to our Gynecology specialist. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HR-HPV persistence or 2 positive tests for the same HR-HPV type, separated by 12 to 18 months. |
12, 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 HIV outcomes HIV
viral load and CD4 count 2 Nutritional indices serum albumin, Vitamin A and
Vitamin D for immune support and Iron 3 Mental health depression, HIV
internalized stigma, and HPV and HIV stigma fears and 4 Engagement in care
HPV and HIV appointment keeping and ART adherence |
6, 12, and 18 months. |
|
|
Target Sample Size
|
Total Sample Size="420"
Sample Size from India="420"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Using qualitative research methods, we plan to first refine a nurse-led, ASHA co- delivered, nutrition-enhanced ASHA-Health HPV intervention, adapted for high-risk group of women co-infected with HIV and HPV, and then conduct a parallel-group cluster randomized control trial, assessing the efficacy of our ASHA-Health HPV intervention, as compared with an enhanced Standard of Care (SOC+) (usual care + 3 sessions [wellness, basic nutrition and HPV/HIV health promotion]) among 420 high-risk co-infected women to prevent cervical cancer while remaining engaged in the HIV treatment cascade, and managing nutritional health. Our Primary outcome is HR-HPV persistence (2 positive tests for the same HR-HPV type separated by 6 or 12 months). Secondary outcomes will be improvement in: 1) HIV outcomes (HIV viral load and CD4 count; 2) Nutritional indices (serum albumin, Vitamin A and Vitamin D - for immune support; and Iron); 3) Mental health (depression, HIV internalized stigma, and HPV/HIV stigma fears); and 4) Engagement in care (HPV/HIV appointment keeping and ART adherence) at 6, 12, and 18 months. |