Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02793804
Status:
COMPLETED
Last Update Posted:
2018-05-14
First Post:
2016-06-03
Brief Title:
HIV Self-Testing Africa Zambia
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
Self-testing for HIV HIVST Amongst Urban Peri-urban and Rural Communities in Zambia Including a Cluster-randomised Trial of Community-based HIVST Distribution
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR Zambia
Brief Summary:
This study consists of a Cluster Randomised Trial CRT of community and facility-based HIVST distribution by the Society for Family Health SFH in multiple rural and peri-urban settings The study will take place in 6 matched pairs of health facilities and their catchment areas have been selected for study inclusion in collaboration with the district medical office DMO One clinic catchment area from each pair will be randomly allocated to the HIVST arm intervention and the other to the standard of care SOC arm ControlIn the HIVST arm community-based distribution agents CBDA including Voluntary Medical Male Circumcision VMMC mobilisers will deliver HIVST kits The kits will also be available at the health facility In the SOC arm all HIV testing and counseling HTC services will be conducted as currently
Detailed Description:
The study will use the OraQuick HIV Self-Test Orasure Technologies Thailand The kits contain the HIV Oral Fluid Test HIVOFT test kit stand buffer solution locally-translated instructions for use IFUs materials on counselling and linkage to care and primary and secondary packaging The kits will be distributed for free by CBDAs Leaflets will be provided in lieu of patient information sheets but no other consent will be required for HIVST implementation
Following baseline enumeration clinic pairs will be randomly allocated to either the intervention or control arm at a public ceremony An opaque bag containing 2 balls - one for HIVST and one for SOC - will be used to allocate the HIVST arm
It will not be possible to blind participants CBDAs or their supervisors to the cluster intervention allocation but all forms will be managed without reference to the intervention arm Outcome data will not be analysed until completion of the trial with the exception of data analysis by an independent statistician for presentation to the Trial Advisory Group
CBDAs linked to intervention clinics will be provided with training in HIVST and Information Education and Communication IEC materials including flipcharts used kits to show clients how to interpret positive negative and inconclusive results a cotton bud and vial of water to demonstrate the mouth swabbing and development process leaflets and a buffer stock of OraQuick HIV Self-Test to be stored in a locked container in their own home
Older adolescent and adult participants age 15 - 17years or older wishing to know their status will be provided with information on where to obtain further counselling and care together with the kit and an envelope for return of the used kit a self-completed questionnaire SCQ a self-referral slip for the nearest clinic in case of a positive result and information on how to access VMMC for HIV-negative men
Clients will be encouraged to return their used kits confidentially to the CBDA either in person or by posting in the sealed envelope into an opaque locked ballot box container kept inat the CBDAscounsellors house Clients will also be encouraged to seek post-test advice from the CBDA which can be generic or results-based
Kits will be replaced by the clinic supervisors on presentation of used kits and following inspection of an HIV test logbook to confirm recording of names and addresses but not results of clients Numbers of used kits and re-read results will be recorded by the CBDAclinic supervisor HIVST logbooks will be kept at the CBDAs home in a locked container Couples testing will be encouraged In the case of couples wanting to self-test together both partners will be asked to attend the IEC session Clients will be allowed to take up to 2 kits home if the partner cannot attend Testing of children aged 15 years or less will not be permitted as part of this trial but can be arranged through special arrangement with SFH supervisors
There are no sharps or hazardous materials that will be used in this study
BASELINE SURVEY SAMPLING AND INCLUSIONEXCLUSION CRITERIA
Sample size calculations
Baseline enumeration will include approximately 2400 participants in the intervention communities 400 per community and 2400 participants in the control communities n4800 Within this sample 20 of participants 1000 will be randomly selected for the extended baseline survey The sample size justification for the extended questionnaire is detailed below
The sample size was calculated to ensure 80 power to detect a 50 change in the proportion of individual tested for HIV over the last twelve months with 95 confidence Using 2013-2014 Demongraphic and Health Survey DHS data baseline rates for individuals tested in the last 12 months are estimated to be between 286-571 lower in men than women for this sample calculation we have assumed a baseline testing rate of 50 For a two-sample comparison of matched proportions across 6 pairs of matched communities we estimate that it will be necessary to recruit around 400 respondents per community or 4800 respondents in total
Following baseline enumeration clinic pairs will be randomly allocated to either the intervention or control arm at a public ceremony An opaque bag containing 2 balls - one for HIVST and one for SOC - will be used to allocate the HIVST arm
It will not be possible to blind participants CBDAs or their supervisors to the cluster intervention allocation but all forms will be managed without reference to the intervention arm Outcome data will not be analysed until completion of the trial with the exception of data analysis by an independent statistician for presentation to the Trial Advisory Group
CBDAs linked to intervention clinics will be provided with training in HIVST and Information Education and Communication IEC materials including flipcharts used kits to show clients how to interpret positive negative and inconclusive results a cotton bud and vial of water to demonstrate the mouth swabbing and development process leaflets and a buffer stock of OraQuick HIV Self-Test to be stored in a locked container in their own home
Older adolescent and adult participants age 15 - 17years or older wishing to know their status will be provided with information on where to obtain further counselling and care together with the kit and an envelope for return of the used kit a self-completed questionnaire SCQ a self-referral slip for the nearest clinic in case of a positive result and information on how to access VMMC for HIV-negative men
Clients will be encouraged to return their used kits confidentially to the CBDA either in person or by posting in the sealed envelope into an opaque locked ballot box container kept inat the CBDAscounsellors house Clients will also be encouraged to seek post-test advice from the CBDA which can be generic or results-based
Kits will be replaced by the clinic supervisors on presentation of used kits and following inspection of an HIV test logbook to confirm recording of names and addresses but not results of clients Numbers of used kits and re-read results will be recorded by the CBDAclinic supervisor HIVST logbooks will be kept at the CBDAs home in a locked container Couples testing will be encouraged In the case of couples wanting to self-test together both partners will be asked to attend the IEC session Clients will be allowed to take up to 2 kits home if the partner cannot attend Testing of children aged 15 years or less will not be permitted as part of this trial but can be arranged through special arrangement with SFH supervisors
There are no sharps or hazardous materials that will be used in this study
BASELINE SURVEY SAMPLING AND INCLUSIONEXCLUSION CRITERIA
Sample size calculations
Baseline enumeration will include approximately 2400 participants in the intervention communities 400 per community and 2400 participants in the control communities n4800 Within this sample 20 of participants 1000 will be randomly selected for the extended baseline survey The sample size justification for the extended questionnaire is detailed below
The sample size was calculated to ensure 80 power to detect a 50 change in the proportion of individual tested for HIV over the last twelve months with 95 confidence Using 2013-2014 Demongraphic and Health Survey DHS data baseline rates for individuals tested in the last 12 months are estimated to be between 286-571 lower in men than women for this sample calculation we have assumed a baseline testing rate of 50 For a two-sample comparison of matched proportions across 6 pairs of matched communities we estimate that it will be necessary to recruit around 400 respondents per community or 4800 respondents in total
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None