HIVSTAR ZambiaNCT02793804
HIV Self-Testing Africa Zambia
A study testing Oraquick (made in Thailand) in people with HIV, run by London School of Hygiene and Tropical Medicine at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Oraquick (made in Thailand)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,005 participants
- Where
- 1 siteZambia
- Study dates
- Jun 2016to 1 Feb 2018
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adults (≥ 18 years old)
- Adolescents (16 and 17 years old)
- Able and willing to provide informed consent
- Residing within catchment area of a designated local health unit
- Residing in a randomly selected household
Who cannot join
- Unable and unwilling to provide informed consent
- Residing outside the catchment area.
- Anything that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
1 site in 1 country.
About this study
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
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 (Control).In 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.
Read the 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 in/at the CBDA's/counsellor's 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 CBDA/clinic supervisor. HIVST logbooks will be kept at the CBDA's home in a locked container. Couple's 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 INCLUSION/EXCLUSION CRITERIA
Sample size calculations
Baseline enumeration will include approximately 2400 participants in the intervention communities (400 per community) and 2,400 participants in the control communities (n=~4,800). Within this sample, 20% of participants (~1,000) 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 28.6-57.1% (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 4,800 respondents in total.
- Conditions
- HIV
- Being tested
- Oraquick (made in Thailand)
- Keywords
- HIV self-testing, HIV, Zambia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oraquick (made in Thailand)Device
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | All HIV testing and counselling services will be conducted as currently. |
| HIV Self-Testing | Experimental | Community-based distribution agents (CBDA), including Voluntary Male Medical Circumcision (VMMC) mobilisers, will deliver OraQuick® HIV Self-Tests (Orasure Technologies, Thailand). The kits will also be available at the health facility. Receives: Device: Oraquick (made in Thailand) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between randomisation arms in coverage of recent (within the last 12 months) HIV testing among older adolescents and adults (aged from 16 years) in the clinic catchment areas 12 months after the start of the intervention - by self-report
Recent testing will be measured by self-report and analyzed at the individual level. Respondents will be asked to answer the following question: "Have you tested for HIV within the past 12 months" as part of the baseline, midline, and endline surveys.
Measured: 12 months
Secondary outcomes (1)
Comparison between randomisation arms of antiretroviral therapy (ART) initiation rates for older adolescent and adult (aged from 16 years) cluster residents, during months 1 to 12 of the intervention - measured using clinic data
Linkage to HIV care will be measured using clinic data. Self-testers will receive self-referral forms, and will be asked to bring these to clinics where they receive confirmatory testing and care. Clinic staff will log all clients seeking confirmatory testing following HIV self-testing. Data on linkage will be aggregated to the clinic level for analysis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- None (open label)
- Enrolment
- 5,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Zambart, Society for Family Health, Zambia, Liverpool School of Tropical Medicine, University College, London, Population Services International, World Health Organization, UNITAID
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793804
- Sponsor's protocol ID
- 10660
- Acronym
- STAR Zambia
- Status last verified
- Aug 2017
- First submitted
- 3 Jun 2016
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Neuman M, Hensen B, Mwinga A, Chintu N, Fielding KL, Handima N, Hatzold K, Johnson C, Mulubwa C, Nalubamba M, Otte Im Kampe E, Simwinga M, Smith G, Tsamwa D, Corbett EL, Ayles H. Does community-based distribution of HIV self-tests increase uptake of HIV testing? Results of pair-matched cluster randomised trial in Zambia. BMJ Glob Health. 2021 Jul;6(Suppl 4):e004543. doi: 10.1136/bmjgh-2020-004543.
PubMed 34275868Neuman M, Indravudh P, Chilongosi R, d'Elbee M, Desmond N, Fielding K, Hensen B, Johnson C, Mkandawire P, Mwinga A, Nalubamba M, Ncube G, Nyirenda L, Nyrienda R, Kampe EOI, Taegtmeyer M, Terris-Prestholt F, Weiss HA, Hatzold K, Ayles H, Corbett EL. The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluations. BMC Public Health. 2018 Nov 6;18(1):1234. doi: 10.1186/s12889-018-6120-3.
PubMed 30400959
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02793804
- Acronym / sponsor ID
- STAR Zambia / 10660
- Conditions
- HIV
- Keywords
- HIV self-testing, HIV, Zambia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,005 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Zambart, Society for Family Health, Zambia, Liverpool School of Tropical Medicine, University College, London, Population Services International, World Health Organization, UNITAID
- Study start
- Jun 2016
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 8 Jun 2016 (estimated)
- 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.
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 (Control).In 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 in/at the CBDA's/counsellor's 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 CBDA/clinic supervisor. HIVST logbooks will be kept at the CBDA's home in a locked container. Couple's 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 INCLUSION/EXCLUSION CRITERIA
Sample size calculations
Baseline enumeration will include approximately 2400 participants in the intervention communities (400 per community) and 2,400 participants in the control communities (n=~4,800). Within this sample, 20% of participants (~1,000) 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 28.6-57.1% (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 4,800 respondents in total.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –All HIV testing and counselling services will be conducted as currently. |
| HIV Self-Testing | Experimental | Device: Oraquick (made in Thailand)Community-based distribution agents (CBDA), including Voluntary Male Medical Circumcision (VMMC) mobilisers, will deliver OraQuick® HIV Self-Tests (Orasure Technologies, Thailand). The kits will also be available at the health facility. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (≥ 18 years old)
- Adolescents (16 and 17 years old)
- Able and willing to provide informed consent
- Residing within catchment area of a designated local health unit
- Residing in a randomly selected household
Key exclusion criteria (3 listed)
- Unable and unwilling to provide informed consent
- Residing outside the catchment area.
- Anything that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
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 (made in Thailand) | Device | HIV Self-Testing |
Primary outcome
Comparison between randomisation arms in coverage of recent (within the last 12 months) HIV testing among older adolescents and adults (aged from 16 years) in the clinic catchment areas 12 months after the start of the intervention - by self-report
Time frame: 12 months
Recent testing will be measured by self-report and analyzed at the individual level. Respondents will be asked to answer the following question: "Have you tested for HIV within the past 12 months" as part of the baseline, midline, and endline surveys.
1 secondary outcome
Comparison between randomisation arms of antiretroviral therapy (ART) initiation rates for older adolescent and adult (aged from 16 years) cluster residents, during months 1 to 12 of the intervention - measured using clinic data
Time frame: 12 months
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 14 May 2018.
- Derived from this study: PubMed 34275868Neuman M, Hensen B, Mwinga A, Chintu N, Fielding KL, Handima N, Hatzold K, Johnson C, Mulubwa C, Nalubamba M, Otte Im Kampe E, Simwinga M, Smith G, Tsamwa D, Corbett EL, Ayles H. Does community-based distribution of HIV self-tests increase uptake of HIV testing? Results of pair-matched cluster randomised trial in Zambia. BMJ Glob Health. 2021 Jul;6(Suppl 4):e004543. doi: 10.1136/bmjgh-2020-004543.
- Derived from this study: PubMed 30400959Neuman M, Indravudh P, Chilongosi R, d'Elbee M, Desmond N, Fielding K, Hensen B, Johnson C, Mkandawire P, Mwinga A, Nalubamba M, Ncube G, Nyirenda L, Nyrienda R, Kampe EOI, Taegtmeyer M, Terris-Prestholt F, Weiss HA, Hatzold K, Ayles H, Corbett EL. The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluations. BMC Public Health. 2018 Nov 6;18(1):1234. doi: 10.1186/s12889-018-6120-3.
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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 (made in Thailand) in people with HIV, run by London School of Hygiene and Tropical Medicine at 1 site in Zambia.
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 5 inclusion and 3 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 14 May 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 Zambia. 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?
Comparison between randomisation arms in coverage of recent (within the last 12 months) HIV testing among older adolescents and adults (aged from 16 years) in the clinic catchment areas 12 months after the start of the intervention - by self-report (time frame: 12 months). 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 NCT02793804, which also lists 2 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 14 May 2018.