Ignite Creation Date:
2024-05-06 @ 12:12 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03705611
Status:
UNKNOWN
Last Update Posted:
2018-10-15
First Post:
2018-06-01
Brief Title:
Secondary Distribution of HIV Self-tests Through Antenatal Care Clinic Attendees and Index Clients
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
Secondary Distribution of HIV Self-tests Through Antenatal and HIV Testing Services a Pragmatic Cluster-randomized Trial STAR-ANC
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
RECRUITING
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:
ANCFRS
Brief Summary:
A three arm cluster randomized trial randomizing government primary health clinics to a standard of care SOC with clinic invitation only b standard of care SOC and one self-test kit to give to sexual partner s c standard of care SOC and self-test kit and monetary incentive given to partner conditional on clinic attendance and completion of pre-set procedures to determine secondary accuracy
Trial to be conducted in four districts Blantyre Zomba Machinga and Chikwawa in Malawi in collaboration with the Ministry of Health
Two primary outcomes
1 proportion of male partners of antenatal care clinic attendees reported by the woman to have tested for human immunodeficiency virus HIV within 28 days of enrolling the woman
2 Number of new HIV positives identified by providing trial services to newly tested HIV positive clients in routine HIV testing service within 28 days of enrolling the index client
Data analysed as intention to treat with all eligible antenatal care ANC attendees and index clients at each health facility as the denominator with unpaired t-test used to compare each intervention arm to the standard of care SOC
Trial to be conducted in four districts Blantyre Zomba Machinga and Chikwawa in Malawi in collaboration with the Ministry of Health
Two primary outcomes
1 proportion of male partners of antenatal care clinic attendees reported by the woman to have tested for human immunodeficiency virus HIV within 28 days of enrolling the woman
2 Number of new HIV positives identified by providing trial services to newly tested HIV positive clients in routine HIV testing service within 28 days of enrolling the index client
Data analysed as intention to treat with all eligible antenatal care ANC attendees and index clients at each health facility as the denominator with unpaired t-test used to compare each intervention arm to the standard of care SOC
Detailed Description:
Type of study This proposal is for a 3-arm pragmatic cluster randomised trial CRT using primary care clinics as the unit of randomisation The three arms are 1 Standard of care SOC with written invitation to the partner and two intervention arms of 2 standard of care SOC HIV self-test kits delivered by the partner and 3 arm 2 plus a monetary incentive for partners who participate in a linked-accuracy study
Problem Malawis Ministry of Health MoH uses a highly decentralized approach for delivery of HIV services that delivers over 3 million HIV tests each year and has taken the country close to The Joint United Nations Programme on HIV and AIDS UNAIDS 90-90-90 targets However a testing gap remains among populations with barriers to accessing facility-based HIV testing services HTS including men The investigators recently showed partner-delivered secondary distribution of HIV self-testing HIVST kits via women attending antenatal care ANC in urban Blantyre to be effective at increasing the uptake of HIV testing and subsequent HIV care and prevention services among male partners However unanswered questions that remain to be addressed include
the accuracy of HIV self-testing HIVST when kits are provided by secondary distribution
how effective secondary distribution is when fully devolved to Ministry of Health MoH providers pragmatic
whether the high safety profile and acceptability of secondary distribution of HIV self-test kits from antenatal care ANC clinics can be generalised to other clinic services
Role of Ministry of Health MoH implementers and researchers HIV self-test kits will be delivered by the HIV Department of Ministry of Health MoH Malawi in partnership with Population Services International PSI-Malawi Ministry of Health MoH aims to routinely scale-up secondary distribution from antenatal care ANC clinics in high HIV prevalence districts and HIV testing services HTS nationally if results are satisfactory
Research Question Can secondary distribution of HIV self-tests through antenatal care and HIV testing services improve coverage of HIV testing in sexual partners of pregnant women and newly-diagnosed people living with HIV PLHIV while maintaining low costs and acceptable linkage safety and accuracy
Objectives The broad objective is to determine the feasibility benefits costs safety and accuracy of secondary distribution of HIV self-test kits from routine antenatal and HIV testing services HTS clinics in Malawi The specific aims are to conduct a pragmatic cluster randomized trial to
1 Assess the feasibility of programmatic implementation of secondary distribution of HIV self-test kits from routine Ministry of Health MoH clinics
2 Establish the effectiveness of secondary distribution of HIV self-test kits on
1 HIV testing among male partners of antenatal care ANC attendees
2 Initiation of antiretroviral therapy ART and uptake of voluntary medical male circumcision VMMC among male partners of antenatal care attendees
3 Disclosure and couple testing among male partners of antenatal care attendees
4 Identification of HIV-positive contacts among partners of newly diagnosed HIV-positive index clients through routine HIV testing services HTS
3 Investigate the impact of secondary distribution of HIV self-test kits on the frequency of social harms affecting distributors of HIV self-test kits
4 Estimate the costs and cost-effectiveness of adding secondary distribution of HIV self-test kits to the antenatal care and HIV testing service
5 Estimate the sensitivity and specificity of OraQuick HIV self-test kits under secondary distribution
Methodology Participants and intervention Pregnant women registering for antenatal care in 27 primary health clinics and newly diagnosed HIV clients from the same 27 clinics in Blantyre Chikwawa Machinga and Zomba Districts Restricted randomisation will be used to allocate clinics to the 3 arms 111 Ministry of Health MoH Clinic staff in the HIV self-testing arms will be trained in use of oral HIVST kits OraQuick HIV self-test kit supply will use Ministry of Health MoH supply chains Information and educational materials will include a tablet with a video clip demonstrating correct use of kits Data capture tools and training materials will be developed with Ministry of Health MoH
A full-time research assistant will support research-data capture at each clinic For the accuracy sub-study this will include a brief questionnaire repeat HIV testing 2 finger-prick HIV rapid diagnostic tests plus repeat OraQuick and dried blood spots DBS for antiretroviral therapy ART drug and HIV viral load testing
Primary and secondary outcomes
The two primary outcomes are comparison between standard of care SOC and HIV self-testing arms of
1 of women reporting that their partner has tested for HIV within 28 days of ANC appointment
2 Number of previously undiagnosed people living with HIV PLHIV identified among partners of HIV-positive index patients by Day 28
The six secondary outcomes are
1 of partners of antenatal care attendees who start antiretroviral therapy ART undergo voluntary medical male circumcision VMMC or attend discordant couples clinic within 28 days of enrolling the woman
2 of partners of antenatal care attendees who attend the clinic for any HIV services within 28 days of enrolling the woman
3 HIV index clients who self-report at least one partner tested for HIV as a result of their diagnosis measured at Day 28
4 Number of partners of HIV testing services HTS index clients who start antiretroviral therapy ART or undergo voluntary medical male circumcision VMMC or attend discordant couples clinic within 28 days of index diagnosis
5 Number of partners of HIV Index clients who attend the clinic for any HIV services within 28 days of index diagnosis
6 Risk of adverse events eg partnership breakdown intimate partner violence etc related to self-testing reported by antenatal care HIV-positive index clients measured at Day 28
Sample size
9 clinics per arm each recruiting 350 antenatal care clients and 135 newly diagnosed people living with HIV PLHIV will provide 90 power to detect a 12 absolute difference in the primary outcome assuming 20 of standard of care SOC partners and a coefficient of variation k of 025 Cluster-level summaries with a t-test applied to the mean of clinic proportions will be compared to the standard of care SOC for the primary outcome
Ethical considerations The investigators request a waiver of informed consent for HIV self-testing as this is now international best practice and delivery will be by Ministry of Health MoH routine systems Written informed consent witnessed thumb-print if illiterate will be taken from all participants in the accuracy sub-study
Dissemination The results will be used to inform Ministry of Health MoH on HIV self-testing scale-up plans and will also be disseminated through College of Medicine in Blantyre including College of Medicine Research Ethics Committee COMREC and through conference presentations and publication in peer-reviewed journal
Problem Malawis Ministry of Health MoH uses a highly decentralized approach for delivery of HIV services that delivers over 3 million HIV tests each year and has taken the country close to The Joint United Nations Programme on HIV and AIDS UNAIDS 90-90-90 targets However a testing gap remains among populations with barriers to accessing facility-based HIV testing services HTS including men The investigators recently showed partner-delivered secondary distribution of HIV self-testing HIVST kits via women attending antenatal care ANC in urban Blantyre to be effective at increasing the uptake of HIV testing and subsequent HIV care and prevention services among male partners However unanswered questions that remain to be addressed include
the accuracy of HIV self-testing HIVST when kits are provided by secondary distribution
how effective secondary distribution is when fully devolved to Ministry of Health MoH providers pragmatic
whether the high safety profile and acceptability of secondary distribution of HIV self-test kits from antenatal care ANC clinics can be generalised to other clinic services
Role of Ministry of Health MoH implementers and researchers HIV self-test kits will be delivered by the HIV Department of Ministry of Health MoH Malawi in partnership with Population Services International PSI-Malawi Ministry of Health MoH aims to routinely scale-up secondary distribution from antenatal care ANC clinics in high HIV prevalence districts and HIV testing services HTS nationally if results are satisfactory
Research Question Can secondary distribution of HIV self-tests through antenatal care and HIV testing services improve coverage of HIV testing in sexual partners of pregnant women and newly-diagnosed people living with HIV PLHIV while maintaining low costs and acceptable linkage safety and accuracy
Objectives The broad objective is to determine the feasibility benefits costs safety and accuracy of secondary distribution of HIV self-test kits from routine antenatal and HIV testing services HTS clinics in Malawi The specific aims are to conduct a pragmatic cluster randomized trial to
1 Assess the feasibility of programmatic implementation of secondary distribution of HIV self-test kits from routine Ministry of Health MoH clinics
2 Establish the effectiveness of secondary distribution of HIV self-test kits on
1 HIV testing among male partners of antenatal care ANC attendees
2 Initiation of antiretroviral therapy ART and uptake of voluntary medical male circumcision VMMC among male partners of antenatal care attendees
3 Disclosure and couple testing among male partners of antenatal care attendees
4 Identification of HIV-positive contacts among partners of newly diagnosed HIV-positive index clients through routine HIV testing services HTS
3 Investigate the impact of secondary distribution of HIV self-test kits on the frequency of social harms affecting distributors of HIV self-test kits
4 Estimate the costs and cost-effectiveness of adding secondary distribution of HIV self-test kits to the antenatal care and HIV testing service
5 Estimate the sensitivity and specificity of OraQuick HIV self-test kits under secondary distribution
Methodology Participants and intervention Pregnant women registering for antenatal care in 27 primary health clinics and newly diagnosed HIV clients from the same 27 clinics in Blantyre Chikwawa Machinga and Zomba Districts Restricted randomisation will be used to allocate clinics to the 3 arms 111 Ministry of Health MoH Clinic staff in the HIV self-testing arms will be trained in use of oral HIVST kits OraQuick HIV self-test kit supply will use Ministry of Health MoH supply chains Information and educational materials will include a tablet with a video clip demonstrating correct use of kits Data capture tools and training materials will be developed with Ministry of Health MoH
A full-time research assistant will support research-data capture at each clinic For the accuracy sub-study this will include a brief questionnaire repeat HIV testing 2 finger-prick HIV rapid diagnostic tests plus repeat OraQuick and dried blood spots DBS for antiretroviral therapy ART drug and HIV viral load testing
Primary and secondary outcomes
The two primary outcomes are comparison between standard of care SOC and HIV self-testing arms of
1 of women reporting that their partner has tested for HIV within 28 days of ANC appointment
2 Number of previously undiagnosed people living with HIV PLHIV identified among partners of HIV-positive index patients by Day 28
The six secondary outcomes are
1 of partners of antenatal care attendees who start antiretroviral therapy ART undergo voluntary medical male circumcision VMMC or attend discordant couples clinic within 28 days of enrolling the woman
2 of partners of antenatal care attendees who attend the clinic for any HIV services within 28 days of enrolling the woman
3 HIV index clients who self-report at least one partner tested for HIV as a result of their diagnosis measured at Day 28
4 Number of partners of HIV testing services HTS index clients who start antiretroviral therapy ART or undergo voluntary medical male circumcision VMMC or attend discordant couples clinic within 28 days of index diagnosis
5 Number of partners of HIV Index clients who attend the clinic for any HIV services within 28 days of index diagnosis
6 Risk of adverse events eg partnership breakdown intimate partner violence etc related to self-testing reported by antenatal care HIV-positive index clients measured at Day 28
Sample size
9 clinics per arm each recruiting 350 antenatal care clients and 135 newly diagnosed people living with HIV PLHIV will provide 90 power to detect a 12 absolute difference in the primary outcome assuming 20 of standard of care SOC partners and a coefficient of variation k of 025 Cluster-level summaries with a t-test applied to the mean of clinic proportions will be compared to the standard of care SOC for the primary outcome
Ethical considerations The investigators request a waiver of informed consent for HIV self-testing as this is now international best practice and delivery will be by Ministry of Health MoH routine systems Written informed consent witnessed thumb-print if illiterate will be taken from all participants in the accuracy sub-study
Dissemination The results will be used to inform Ministry of Health MoH on HIV self-testing scale-up plans and will also be disseminated through College of Medicine in Blantyre including College of Medicine Research Ethics Committee COMREC and through conference presentations and publication in peer-reviewed journal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None