HIV/AIDSNCT03541382
A Cluster Randomised Trial of Community-led Distribution of HIV Self-tests in Rural Malawi (HIV Self-Testing Africa [STAR])
A study testing OraQuick® HIV Self-Test in people with HIV/AIDS, run by London School of Hygiene and Tropical Medicine at 1 site in Malawi.
Trial summary
The aim of this study is to determine the benefits, costs and safety of community-led delivery of HIV self-testing (HIVST) kits in rural Malawi, with a focus on testing and linkage to care and prevention services among defined population sub-groups: men, adolescents aged 15-19 years old, and adults aged 40 years or… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- OraQuick® HIV Self-Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,880 participants
- Where
- 1 siteMalawi
- Study dates
- 8 Oct 2018to 31 Jul 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Aged ≥ 15 years
- Residence in GVH catchment areas included in the intervention arm
Who cannot join
- Aged < 15 years old
- Not resident in GVH catchment areas included in the intervention arm
Trial locations and contacts
1 site in 1 country.
Malawi1 site
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Blantyre
About this study
Official title: Community-led Distribution of HIV Self-tests: a Cluster Randomised Trial Investigating Uptake of HIV Testing and Linkage to Treatment and Prevention, Costs and Safety in Rural Malawi (HIV Self-Testing Africa [STAR])
The aim of this study is to determine the benefits, costs and safety of community-led delivery of HIV self-testing (HIVST) kits in rural Malawi, with a focus on testing and linkage to care and prevention services among defined population sub-groups: men, adolescents aged 15-19 years old, and adults aged 40 years or older.
Read the detailed description
RESEARCH QUESTION
Can community-led delivery of HIV self-tests be used to maximise public health and social benefits and reduce costs without introducing social harms?
RESEARCH AIMS AND OBJECTIVES
The broad aim is to determine the benefits, costs and safety of community-led delivery of HIVST kits in rural Malawi, with a focus on testing and linkage to care and prevention services among defined population sub-groups: men, adolescents aged 15-19 years old, and adults aged 40 years or older.
The specific objectives are to conduct a cluster randomised controlled trial to:
- Establish the effectiveness of community-led HIVST campaigns on lifetime and recent HIV testing in predefined sub-groups.
- Investigate the impact of community-led HIVST campaigns on: (a) population-level initiation of antiretroviral therapy (ART) and uptake of voluntary medical male circumcision (VMMC), (b) knowledge of HIV prevention, (c) stigma reduction
- Explore how differences in community-led HIVST campaigns affect uptake of HIVST and linkage to care and prevention and values, attitudes and behaviours around HIVST.
- Estimate the costs and cost-effectiveness of community-led HIVST campaigns compared to the standard of care (SOC).
RESEARCH DESIGN
The main study consists of a cluster-randomised trial evaluating the effectiveness of community-led HIVST campaigns on coverage of HIV testing and linkage to follow-on services compared to the Ministry of Health (MoH) SOC, facility-based HIV testing services (HTS). We are also interested in understanding the cost-effectiveness of community-led HIVST campaigns, and broader social benefits on stigma reduction.
The unit of randomisation is the Group Village Head (GVH), who are traditionally-appointed leaders that oversee a group of villages, and their catchments areas. Outcomes are measured through (i) household surveys in evaluation villages selected for each study cluster, and (ii) clinic records of patients coming from the study clusters.
For the primary outcome, measured using the households surveys, we assume that lifetime testing rates for adolescents aged 15-19 years old in the SOC arm are 35-50%, based on the recent Demographic and Health Survey. With 16 clusters per arm and 50 adolescents per cluster, we will have at least 90% power to detect a 20% absolute increase in lifetime testing using a coefficient of variation of outcomes (k) of 0.25. If k=0.3, for a 20% increase in lifetime testing, we would have 90% and 80% power with SOC testing rates of 35-40% and 45-55%, respectively. If the absolute increase in lifetime testing is lower at 15%, then for k=0.25 we would have 80% power for SOC testing rates of 35-40%. With adolescents making up 20-25% of the adult population, this will require 250 adults per cluster.
SUB-STUDIES
We will also be conducting a series of sub-studies related to the trial, including:
- Process evaluation to monitor progress of the intervention and adherence to guidelines, and understand how differences in the context-driven intervention affect HIVST uptake and linkage to care and prevention.
- Qualitative evaluation to explore which aspects of the community-led intervention were pivotal in affecting HIV testing and linkage outcomes and values, attitudes and behaviours around HIVST.
- Economic evaluation to estimate costs, cost-effectiveness and cost-benefit per individual tested, newly diagnosed as HIV positive, started on ART and circumcised.
- Conditions
- HIV/AIDS
- Being tested
- OraQuick® HIV Self-Test
- Keywords
- HIV, HIV Self-Testing, Malawi
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraQuick® HIV Self-TestDevice
Community leaders, including GVHs, Village Health Committee members, Village Development Committee members, and members of key community groups will participate in a workshop to facilitate planning of a HIVST campaign. Identified community distributors, who are unpaid volunteers from the community, will also receive a training package in HIVST promotion.
Campaigns will be conducted over a short period (approximately seven days) and under a fixed budget. Community distributors will deliver HIVST kits free of charge to community members, and provide information on how to self-test and access the nearest clinic for linkage to confirmatory HTS, treatment and prevention. Distributors will also provide HIV prevention messages around serodiscordancy, treatment as prevention and VMMC.
| Study group | Role | What they receive |
|---|---|---|
| HIVST campaign arm | Active comparator | Community representatives will be supported to plan and administer an HIVST campaign linked to HIV care and prevention services in their communities. Receives: Device: OraQuick® HIV Self-Test |
| SOC arm | No intervention | Standard HTS will be provided by MoH at health facilities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of self-reported lifetime testing in adolescents aged 15-19 years old
Measured: Measured 8-12 weeks post-intervention
Secondary outcomes (5)
Percentage of self-reported testing in last 3 months in men aged ≥ 15 years
Measured: Measured 8-12 weeks post-intervention
Percentage of self-reported testing in last 3 months in adults aged ≥ 40 years
Measured: Measured 8-12 weeks post-intervention
Cumulative incidence of population-level ART uptake in adults aged ≥ 15 years over 6 months
Measured: Measured 6-months post-intervention
Measure of knowledge of HIV prevention methods
Measured: Measured 8-12 weeks post-intervention
Measure of HIV testing stigma.
Measured: Measured 8-12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start8 Oct 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7,880 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Liverpool School of Tropical Medicine, University College, London, Population Services International, UNITAID
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541382
- Sponsor's protocol ID
- 14761
- Status last verified
- Nov 2019
- First submitted
- 17 May 2018
- Last updated
- 11 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Indravudh PP, Fielding K, Sande LA, Maheswaran H, Mphande S, Kumwenda MK, Chilongosi R, Nyirenda R, Johnson CC, Hatzold K, Corbett EL, Terris-Prestholt F. Pragmatic economic evaluation of community-led delivery of HIV self-testing in Malawi. BMJ Glob Health. 2021 Jul;6(Suppl 4):e004593. doi: 10.1136/bmjgh-2020-004593.
PubMed 34275869Indravudh PP, Fielding K, Kumwenda MK, Nzawa R, Chilongosi R, Desmond N, Nyirenda R, Neuman M, Johnson CC, Baggaley R, Hatzold K, Terris-Prestholt F, Corbett EL. Effect of community-led delivery of HIV self-testing on HIV testing and antiretroviral therapy initiation in Malawi: A cluster-randomised trial. PLoS Med. 2021 May 11;18(5):e1003608. doi: 10.1371/journal.pmed.1003608. eCollection 2021 May.
PubMed 33974621Indravudh PP, Fielding K, Kumwenda MK, Nzawa R, Chilongosi R, Desmond N, Nyirenda R, Johnson CC, Baggaley RC, Hatzold K, Terris-Prestholt F, Corbett EL. Community-led delivery of HIV self-testing to improve HIV testing, ART initiation and broader social outcomes in rural Malawi: study protocol for a cluster-randomised trial. BMC Infect Dis. 2019 Sep 18;19(1):814. doi: 10.1186/s12879-019-4430-4.
PubMed 31533646
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-led Distribution of HIV Self-tests: a Cluster Randomised Trial Investigating Uptake of HIV Testing and Linkage to Treatment and Prevention, Costs and Safety in Rural Malawi (HIV Self-Testing Africa [STAR])
- ClinicalTrials.gov ID
- NCT03541382
- Acronym / sponsor ID
- 14761
- Conditions
- HIV/AIDS
- Keywords
- HIV, HIV Self-Testing, Malawi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,880 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Liverpool School of Tropical Medicine, University College, London, Population Services International, UNITAID
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 30 May 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.
The aim of this study is to determine the benefits, costs and safety of community-led delivery of HIV self-testing (HIVST) kits in rural Malawi, with a focus on testing and linkage to care and prevention services among defined population sub-groups: men, adolescents aged 15-19 years old, and adults aged 40 years or older.
Detailed description
RESEARCH QUESTION
Can community-led delivery of HIV self-tests be used to maximise public health and social benefits and reduce costs without introducing social harms?
RESEARCH AIMS AND OBJECTIVES
The broad aim is to determine the benefits, costs and safety of community-led delivery of HIVST kits in rural Malawi, with a focus on testing and linkage to care and prevention services among defined population sub-groups: men, adolescents aged 15-19 years old, and adults aged 40 years or older.
The specific objectives are to conduct a cluster randomised controlled trial to:
- Establish the effectiveness of community-led HIVST campaigns on lifetime and recent HIV testing in predefined sub-groups.
- Investigate the impact of community-led HIVST campaigns on: (a) population-level initiation of antiretroviral therapy (ART) and uptake of voluntary medical male circumcision (VMMC), (b) knowledge of HIV prevention, (c) stigma reduction
- Explore how differences in community-led HIVST campaigns affect uptake of HIVST and linkage to care and prevention and values, attitudes and behaviours around HIVST.
- Estimate the costs and cost-effectiveness of community-led HIVST campaigns compared to the standard of care (SOC).
RESEARCH DESIGN
The main study consists of a cluster-randomised trial evaluating the effectiveness of community-led HIVST campaigns on coverage of HIV testing and linkage to follow-on services compared to the Ministry of Health (MoH) SOC, facility-based HIV testing services (HTS). We are also interested in understanding the cost-effectiveness of community-led HIVST campaigns, and broader social benefits on stigma reduction.
The unit of randomisation is the Group Village Head (GVH), who are traditionally-appointed leaders that oversee a group of villages, and their catchments areas. Outcomes are measured through (i) household surveys in evaluation villages selected for each study cluster, and (ii) clinic records of patients coming from the study clusters.
For the primary outcome, measured using the households surveys, we assume that lifetime testing rates for adolescents aged 15-19 years old in the SOC arm are 35-50%, based on the recent Demographic and Health Survey. With 16 clusters per arm and 50 adolescents per cluster, we will have at least 90% power to detect a 20% absolute increase in lifetime testing using a coefficient of variation of outcomes (k) of 0.25. If k=0.3, for a 20% increase in lifetime testing, we would have 90% and 80% power with SOC testing rates of 35-40% and 45-55%, respectively. If the absolute increase in lifetime testing is lower at 15%, then for k=0.25 we would have 80% power for SOC testing rates of 35-40%. With adolescents making up 20-25% of the adult population, this will require 250 adults per cluster.
SUB-STUDIES
We will also be conducting a series of sub-studies related to the trial, including:
- Process evaluation to monitor progress of the intervention and adherence to guidelines, and understand how differences in the context-driven intervention affect HIVST uptake and linkage to care and prevention.
- Qualitative evaluation to explore which aspects of the community-led intervention were pivotal in affecting HIV testing and linkage outcomes and values, attitudes and behaviours around HIVST.
- Economic evaluation to estimate costs, cost-effectiveness and cost-benefit per individual tested, newly diagnosed as HIV positive, started on ART and circumcised.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIVST campaign arm | Active comparator | Device: OraQuick® HIV Self-TestCommunity representatives will be supported to plan and administer an HIVST campaign linked to HIV care and prevention services in their communities. |
| SOC arm | No intervention | –Standard HTS will be provided by MoH at health facilities. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Aged ≥ 15 years
- Residence in GVH catchment areas included in the intervention arm
Key exclusion criteria (2 listed)
- Aged < 15 years old
- Not resident in GVH catchment areas included in the intervention arm
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 |
|---|---|---|
| OraQuick® HIV Self-TestCommunity leaders, including GVHs, Village Health Committee members, Village Development Committee members, and members of key community groups will participate in a workshop to facilitate planning of a HIVST campaign. Identified community distributors, who are unpaid volunteers from the community, will also receive a training package in HIVST promotion. Campaigns will be conducted over a short period (approximately seven days) and under a fixed budget. Community distributors will deliver HIVST kits free of charge to community members, and provide information on how to self-test and access the nearest clinic for linkage to confirmatory HTS, treatment and prevention. Distributors will also provide HIV prevention messages around serodiscordancy, treatment as prevention and VMMC. | Device | HIVST campaign arm |
Primary outcome
Percentage of self-reported lifetime testing in adolescents aged 15-19 years old
Time frame: Measured 8-12 weeks post-intervention
5 secondary outcomes
Percentage of self-reported testing in last 3 months in men aged ≥ 15 years
Time frame: Measured 8-12 weeks post-intervention
Percentage of self-reported testing in last 3 months in adults aged ≥ 40 years
Time frame: Measured 8-12 weeks post-intervention
Cumulative incidence of population-level ART uptake in adults aged ≥ 15 years over 6 months
Time frame: Measured 6-months post-intervention
Measure of knowledge of HIV prevention methods
Time frame: Measured 8-12 weeks post-intervention
Measure of HIV testing stigma.
Time frame: Measured 8-12 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Derived from this study: PubMed 34275869Indravudh PP, Fielding K, Sande LA, Maheswaran H, Mphande S, Kumwenda MK, Chilongosi R, Nyirenda R, Johnson CC, Hatzold K, Corbett EL, Terris-Prestholt F. Pragmatic economic evaluation of community-led delivery of HIV self-testing in Malawi. BMJ Glob Health. 2021 Jul;6(Suppl 4):e004593. doi: 10.1136/bmjgh-2020-004593.
- Derived from this study: PubMed 33974621Indravudh PP, Fielding K, Kumwenda MK, Nzawa R, Chilongosi R, Desmond N, Nyirenda R, Neuman M, Johnson CC, Baggaley R, Hatzold K, Terris-Prestholt F, Corbett EL. Effect of community-led delivery of HIV self-testing on HIV testing and antiretroviral therapy initiation in Malawi: A cluster-randomised trial. PLoS Med. 2021 May 11;18(5):e1003608. doi: 10.1371/journal.pmed.1003608. eCollection 2021 May.
- Derived from this study: PubMed 31533646Indravudh PP, Fielding K, Kumwenda MK, Nzawa R, Chilongosi R, Desmond N, Nyirenda R, Johnson CC, Baggaley RC, Hatzold K, Terris-Prestholt F, Corbett EL. Community-led delivery of HIV self-testing to improve HIV testing, ART initiation and broader social outcomes in rural Malawi: study protocol for a cluster-randomised trial. BMC Infect Dis. 2019 Sep 18;19(1):814. doi: 10.1186/s12879-019-4430-4.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OraQuick® HIV Self-Test in people with HIV/AIDS, 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 2 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: finished, as of the sponsor's last update on 11 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of self-reported lifetime testing in adolescents aged 15-19 years old (time frame: Measured 8-12 weeks post-intervention). 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 NCT03541382, which also lists 3 linked publications.
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 11 Aug 2020.