HIV/AIDSANC/FRSNCT03705611
Secondary Distribution of HIV Self-tests Through Antenatal Care Clinic Attendees and Index Clients
A study testing HIV self-testing only and HIV self-testing secondary accuracy in people with HIV/AIDS and HIV Infections, run by London School of Hygiene and Tropical Medicine at 1 site in Malawi.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV/AIDS, HIV Infections
- What is being tested?
- HIV self-testing only and HIV self-testing secondary accuracy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteMalawi
- Study dates
- 12 Sep 2018to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Government primary health clinic or centre
- Provides antenatal care services, HIV testing services and HIV treatment services
Who cannot join
- Not a government health facility
- Does not provide antenatal care services, HIV testing services and HIV treatment services
- Not willing to be part of the trial
- Individual level eligibility screen for antenatal care attendees:
- First antenatal care visit
- Age 18 years or older
Show all 16Show fewer
- Has one main sexual partner (i.e. likely father)
- Main sexual partner not already known to be HIV-positive and on antiretroviral therapy
- Sexual partner likely to remain in clinic catchment area for the next 28 days
- Not already tested together in this pregnancy [e.g. partner has come with her on this visit and has tested today]
- Not already recruited in the study
- Individual level eligibility screen for index clients:
- Age 18 years or older
- At least one sexual partner not already known to be HIV-positive and on antiretroviral therapy
- At least one sexual partner likely to remain in catchment area within the next 28 days
- Not already recruited in the study
Trial locations and contacts
1 site in 1 country.
Elizabeth L Corbett, PhD contact
Malawi1 site, 1 recruiting
- Recruiting
Mulanje District Hopsital
Mulanje
Cecilia Ching'oma, Diploma
About this study
Official title: Secondary Distribution of HIV Self-tests Through Antenatal and HIV Testing Services: a Pragmatic Cluster-randomized Trial (STAR-ANC)
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.
Read more
Two primary outcomes:
- 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
- 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).
Read the 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: Malawi's 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:
- Assess the feasibility of programmatic implementation of secondary distribution of HIV self-test kits from routine Ministry of Health (MoH) clinics.
- Establish the effectiveness of secondary distribution of HIV self-test kits on:
- HIV testing among male partners of antenatal care (ANC) attendees
- Initiation of antiretroviral therapy (ART) and uptake of voluntary medical male circumcision (VMMC) among male partners of antenatal care attendees
- Disclosure and couple testing among male partners of antenatal care attendees
- Identification of HIV-positive contacts among partners of newly diagnosed HIV-positive index clients through routine HIV testing services (HTS).
- Investigate the impact of secondary distribution of HIV self-test kits on the frequency of social harms affecting distributors of HIV self-test kits
- Estimate the costs and cost-effectiveness of adding secondary distribution of HIV self-test kits to the antenatal care and HIV testing service.
- 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 (1:1:1). 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:
- % of women reporting that their partner has tested for HIV within 28 days of ANC appointment.
- 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:
- % 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
- % of partners of antenatal care attendees who attend the clinic for any HIV services within 28 days of enrolling the woman
- % HIV+ index clients who self-report at least one partner tested for HIV as a result of their diagnosis, measured at Day 28
- 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
- Number of partners of HIV+ Index clients who attend the clinic for any HIV services within 28 days of index diagnosis
- Risk of adverse events (e.g. 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 0.25. 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.
- Conditions
- HIV/AIDS, HIV Infections
- Being tested
- HIV self-testing only, HIV self-testing secondary accuracy
- Keywords
- Secondary distribution, HIV self-testing, Malawi
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV self-testing onlyDiagnostic test
Also called OraQuick, OraSure Technologies, USA
Partners will be asked to self-test for HIV following receipt of the test kit from their sexual contact at home or in the community. They will also get information about the partner's clinic -- an HIV testing service room dedicated to providing HIV testing, confirmatory HIV testing, and referral to HIV treatment and prevention services including couples counselling.
HIV self-testing secondary accuracyBehavioural
A monetary incentive provided conditional on clinic attendance and fulfillment of secondary accuracy procedures such as undergoing on spot finger prick rapid HIV testing
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Provide personalised clinic invitation slips (letters) to partners to come for HIV testing, and to access post-test services |
| HIV self-testing only | Experimental | HIV self-testing only Receives: Diagnostic Test: HIV self-testing only |
| HIV self-testing secondary accuracy | Experimental | HIV self-testing secondary accuracy Receives: Diagnostic Test: HIV self-testing only; Behavioral: HIV self-testing secondary accuracy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of partners tested for HIV
For antenatal care clinic attendees, this is as reported by the women during their next antenatal care visit
Measured: 28 days
Number of newly diagnosed HIV positive people
A count of number of sexual contacts of index HIV positive clients attending the clinic for post-test services
Measured: 28 days
Secondary outcomes (2)
Proportion of partners of antenatal care clinic attendees who start HIV treatment, undergo circumcision, or attend discordant couples clinic
Measured: 28 days
Risk of adverse events (e.g. partnership breakdown, intimate partner violence, etc.) related to self-testing reported by antenatal care clinic attendees or HIV-positive index clients
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start12 Sep 2018
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1:1 randomization of primary health clinics (cluster randomized trial)
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Liverpool School of Tropical Medicine, UNITAID
- Responsible party
- Sponsor
- Investigators
- Nicola Desmond, PhD, Principal investigator, Liverpool School of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705611
- Sponsor's protocol ID
- 14916
- Acronym
- ANC/FRS
- Status last verified
- May 2018
- First submitted
- 1 Jun 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data relating to the primary and secondary outcomes will be made publicly available through the London School of Hygiene \& Tropical Medicine Data Campus
Publications
Choko AT, Fielding K, Johnson CC, Kumwenda MK, Chilongosi R, Baggaley RC, Nyirenda R, Sande LA, Desmond N, Hatzold K, Neuman M, Corbett EL. Partner-delivered HIV self-test kits with and without financial incentives in antenatal care and index patients with HIV in Malawi: a three-arm, cluster-randomised controlled trial. Lancet Glob Health. 2021 Jul;9(7):e977-e988. doi: 10.1016/S2214-109X(21)00175-3.
PubMed 34143996
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Distribution of HIV Self-tests Through Antenatal and HIV Testing Services: a Pragmatic Cluster-randomized Trial (STAR-ANC)
- ClinicalTrials.gov ID
- NCT03705611
- Acronym / sponsor ID
- ANC/FRS / 14916
- Conditions
- HIV/AIDS, HIV Infections
- Keywords
- Secondary distribution, HIV self-testing, Malawi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- World Health Organization, Liverpool School of Tropical Medicine, UNITAID
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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: Malawi's 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:
- Assess the feasibility of programmatic implementation of secondary distribution of HIV self-test kits from routine Ministry of Health (MoH) clinics.
- Establish the effectiveness of secondary distribution of HIV self-test kits on:
- HIV testing among male partners of antenatal care (ANC) attendees
- Initiation of antiretroviral therapy (ART) and uptake of voluntary medical male circumcision (VMMC) among male partners of antenatal care attendees
- Disclosure and couple testing among male partners of antenatal care attendees
- Identification of HIV-positive contacts among partners of newly diagnosed HIV-positive index clients through routine HIV testing services (HTS).
- Investigate the impact of secondary distribution of HIV self-test kits on the frequency of social harms affecting distributors of HIV self-test kits
- Estimate the costs and cost-effectiveness of adding secondary distribution of HIV self-test kits to the antenatal care and HIV testing service.
- 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 (1:1:1). 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:
- % of women reporting that their partner has tested for HIV within 28 days of ANC appointment.
- 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:
- % 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
- % of partners of antenatal care attendees who attend the clinic for any HIV services within 28 days of enrolling the woman
- % HIV+ index clients who self-report at least one partner tested for HIV as a result of their diagnosis, measured at Day 28
- 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
- Number of partners of HIV+ Index clients who attend the clinic for any HIV services within 28 days of index diagnosis
- Risk of adverse events (e.g. 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 0.25. 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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1:1:1 randomization of primary health clinics (cluster randomized trial)
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Provide personalised clinic invitation slips (letters) to partners to come for HIV testing, and to access post-test services |
| HIV self-testing only | Experimental | Diagnostic Test: HIV self-testing onlyHIV self-testing only |
| HIV self-testing secondary accuracy | Experimental | Diagnostic Test: HIV self-testing only, Behavioral: HIV self-testing secondary accuracyHIV self-testing secondary accuracy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Government primary health clinic or centre
- Provides antenatal care services, HIV testing services and HIV treatment services
Key exclusion criteria (16 listed)
- Not a government health facility
- Does not provide antenatal care services, HIV testing services and HIV treatment services
- Not willing to be part of the trial
- First antenatal care visit
- Age 18 years or older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV self-testing onlyAlso: OraQuick, OraSure Technologies, USAPartners will be asked to self-test for HIV following receipt of the test kit from their sexual contact at home or in the community. They will also get information about the partner's clinic -- an HIV testing service room dedicated to providing HIV testing, confirmatory HIV testing, and referral to HIV treatment and prevention services including couples counselling. | Diagnostic test | HIV self-testing only, HIV self-testing secondary accuracy |
| HIV self-testing secondary accuracyA monetary incentive provided conditional on clinic attendance and fulfillment of secondary accuracy procedures such as undergoing on spot finger prick rapid HIV testing | Behavioural | HIV self-testing secondary accuracy |
Primary outcome
Proportion of partners tested for HIV
Time frame: 28 days
For antenatal care clinic attendees, this is as reported by the women during their next antenatal care visit
Number of newly diagnosed HIV positive people
Time frame: 28 days
A count of number of sexual contacts of index HIV positive clients attending the clinic for post-test services
2 secondary outcomes
Proportion of partners of antenatal care clinic attendees who start HIV treatment, undergo circumcision, or attend discordant couples clinic
Time frame: 28 days
Risk of adverse events (e.g. partnership breakdown, intimate partner violence, etc.) related to self-testing reported by antenatal care clinic attendees or HIV-positive index clients
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 34143996Choko AT, Fielding K, Johnson CC, Kumwenda MK, Chilongosi R, Baggaley RC, Nyirenda R, Sande LA, Desmond N, Hatzold K, Neuman M, Corbett EL. Partner-delivered HIV self-test kits with and without financial incentives in antenatal care and index patients with HIV in Malawi: a three-arm, cluster-randomised controlled trial. Lancet Glob Health. 2021 Jul;9(7):e977-e988. doi: 10.1016/S2214-109X(21)00175-3.
- Individual participant dataSharing planned: Yes. Anonymised data relating to the primary and secondary outcomes will be made publicly available through the London School of Hygiene \& Tropical Medicine Data Campus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth L Corbett, PhD contact
Nicola Desmond, PhD principal investigator
Liverpool School of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV self-testing only and HIV self-testing secondary accuracy in people with HIV/AIDS and HIV Infections, run by London School of Hygiene and Tropical Medicine at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Augustine T Choko, MSc (+265999577452, augutc@mail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of partners tested for HIV (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03705611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.