| CTRI Number |
CTRI/2021/01/030499 [Registered on: 15/01/2021] Trial Registered Prospectively |
| Last Modified On: |
02/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [HIV self testing kit (oral fluid)] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A Feasibility study of HIV Self Testing Among MSM
|
|
Scientific Title of Study
|
HIV Self Testing as a Mechanism to Increase the
Uptake of HIV Test Among MSM: A Mixed Methods Study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Rai |
| Designation |
Professor & Nodal Person for HIV Sentinel Surveillance, CCM, AIIMS, New Delhi |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 29. Centre for Community Medicine. AIIMS. New Delhi
South
DELHI
110029
India |
| Phone |
9999800806 |
| Fax |
|
| Email |
drsanjay.aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Vashisht |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
c/o Dr. Sanjay Rai. Room No. 29. Centre for Community Medicine. AIIMS. New Delhi
South
DELHI
110029
India |
| Phone |
8412094981 |
| Fax |
|
| Email |
shrutigarg6251@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Vashisht |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
c/o Dr. Sanjay Rai. Room No. 29. Centre for Community Medicine. AIIMS. New Delhi
South
DELHI
110029
India |
| Phone |
8412094981 |
| Fax |
|
| Email |
shrutigarg6251@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Shruti Vashisht |
| Address |
C/o Dr. Sanjay Rai. Room No. 29. CCM . All India Institute of Medical Sciences, New Delhi |
| Type of Sponsor |
Other [Individual (Self)] |
|
|
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 Shruti Vashisht |
AIIMS, New Delhi |
Room No. 29, CCM, AIIMS, New Delhi-110029
South
DELHI |
8412094981
shrutigarg6251@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethics Comittee |
Submittted/Under Review |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HIV negative Men who have sex with Men (MSM) who volunteer for the study, above 18 years of age . |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HIV self testing Kit (oral fluid) |
HIV self testing Kit (oral fluid)which will test HIV antibody from the saliva. Its a non invasive procedure requirig minimal training. |
| Comparator Agent |
Standard of care testing for HIV as per National HIV testing guidelines, India |
Standard of care testing for HIV as per National HIV testing guidelines, India where the people linked to prevention, care, support and treatment services are supposed to be testing for HIV status once in six months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
a. Self-identified MSM
b. Above 18 years of age
c. Male sex at birth
d. Report being HIV-negative
e. Citizen of India
f. Reported having anal sex with at least one man in the past 12 months
|
|
| ExclusionCriteria |
| Details |
a. HIV positive MSM
b. Individuals with known diagnosis of HBV, HCV
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HIV testing frequency among MSM having access to HIV self-testing (oral -fluid) versus those having access to standard HIV testing. |
At the end of one year of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the frequency of HIV testing in men who are registered with the State AIDS Control Society (registered) and in MSM who are not registered with the State AIDS Control Society (unregistered). |
At the end of one year of follow up |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "560"
Final Enrollment numbers achieved (India)="275" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2021 |
| Date of Study Completion (India) |
31/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It will be a cluster RCT with TI partners randomised into two study arms: intervention (HIV self- testing) arm; and control (standard care) arm. Participants in each group will be followed up for one year. |