HIV InfectionHSPOTNCT02846402
Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
A study testing Oral HIV Self-Testing in people with HIV Infection, run by Harvard School of Public Health (HSPH).
Trial summary
HSPOT is a cluster-randomized trial designed to determine whether HIV self-tests are acceptable and improve HIV testing rates and HIV status knowledge among female sex workers in Kampala, Uganda. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- Oral HIV Self-Testing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jun 2017
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older on the enrollment visit date
- Reports exchanging sex (vaginal, anal, and/or oral) for money or goods at least once in the past month
- Self-reported HIV negative status and no recent (<3 months) HIV testing OR self-reported HIV unknown status
- Member of the hot spot where recruited for at least one month AND plans on remaining in the area for the next 4 months
- Have never used an oral HIVST kit
- Willing to participate in peer education sessions on a monthly basis over the 4-month study period and to participate in study assessments
- Of sound mind and not under influence of drugs or coercion
Who cannot join
- Less than 18 years of age on the enrollment date
- Has not exchanged any form of sex in the past one month
- Self-reported to be living with HIV
- Self-reported HIV negative status and reports testing within the last 3 months
- Planning to move out of geographic area within 4 months
- Concurrently participating in another HIV prevention study
- Meets criteria but does not wish to participate
- Not willing or able to provide informed consent
About this study
Official title: The Causal Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
HSPOT is a cluster-randomized trial designed to determine whether HIV self-tests are acceptable and improve HIV testing rates and HIV status knowledge among female sex workers in Kampala, Uganda. This study will determine whether directly giving participants an HIV self-test or giving them a coupon to collect a test at a drug store or clinic improves outcomes compared to standard of care.
Read the detailed description
Although Uganda has a generalized HIV epidemic, with approximately 7.4% of adults aged 15 to 49 living with HIV, the epidemic remains even more highly concentrated in key populations, including female sex workers (FSW). A particular concern for FSW is access to healthcare services, including HIV testing services. FSW face significant barriers to accessing healthcare. In other settings, evidence has suggested that stigma is a significant barrier to FSW seeking HIV testing. It is likely that similar mechanisms exist in Uganda. Evidence from Uganda has indicated that complex multilevel factors, such as stigmatization and harassment, contribute to vulnerability among FSW. User-controlled HIV prevention interventions that lead to empowerment of FSW may therefore be a powerful way to address the HIV epidemic in this key population.
Oral HIV self-testing consists of an oral swab kit that allows individuals to test for HIV in the privacy of their own homes whenever they want. The ease of use of HIV self-testing, that it can be done at any time, and that is completely private may make it an attractive alternative to currently-available HIV testing mechanisms for FSW in Uganda. HIV self-testing has generally been shown to be acceptable in a variety of populations, however evidence related to its uptake and acceptability remain sparse, especially among key populations and in Sub-Saharan Africa. This research will provide rigorous evidence of the uptake and efficacy of HIV self-testing for this population.
HSPOT was designed to determine whether either direct distribution of HIV self-test kits via peer educators or distribution of HIV self-tests via coupons that participants can use to collect kits at collection points such as drug stores or health posts leads to better coverage of HIV testing and better awareness of HIV status. HSPOT is a cluster-randomized trial in which peer educators recruit a small group of FSW participants, and the peer educator group is randomized to one of three study arms: 1) direct distribution of test kits, 2) fixed distribution of test kits, or 3) referral to standard of care HIV testing. The primary outcome is HIV testing in the past month measured at one and four months after the first peer educator visit (when the test kits or coupons are distributed in the intervention arms).
- Conditions
- HIV Infection
- Being tested
- Oral HIV Self-Testing
- Keywords
- HIV testing, Female sex workers, HIV self-testing
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral HIV Self-TestingOther
Also called OraQuick HIV Self-Test
The Oral HIV Self-Test is an in-home test that uses an oral swab to collect samples of oral mucosa that is used to detect the presence of HIV antibodies. The test is read after 20 minutes by the user. The test can be done by an individual at any time and place of the user's choosing. The test is read visually.
| Study group | Role | What they receive |
|---|---|---|
| Direct Distribution | Experimental | The direct distribution arm consists of peer educators directly distributing HIV self-test kits to participants. Peer educators will briefly describe HIV self-testing to participants but will not provide extensive training on the use of the test kit. Peer educators also provide referral to existing services for HIV testing. Receives: Other: Oral HIV Self-Testing |
| Fixed Distribution | Experimental | The fixed distribution arm consists of peer educators distributing coupons to participants. The participants can then use the coupon to collect an HIV self-test kit at a participating distribution point, including drug stores, pharmacies, and health posts. Peer educators will briefly describe HIV self-testing to participants but will not provide extensive training on the use of the test kit. Peer educators also provide referral to existing services for HIV testing. Receives: Other: Oral HIV Self-Testing |
| Referral to Existing Services | No intervention | Peer educators will not provide HIV self-tests to participants. Peer educators will only provide referral to existing services for HIV testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV testing in the previous month
Measured: One month from first intervention visit
HIV testing in the previous month
Measured: Four months from first intervention visit
Secondary outcomes (3)
Knowledge of own HIV status
Measured: Four months from first intervention visit
HIV self-test kit use in the two intervention arms
Measured: One month from first intervention visit
HIV self-test kit use in the two intervention arms
Measured: Four months from first intervention visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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 cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 960 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Uganda Health Marketing Group, International Research Consortium, International Initiative for Impact Evaluation
- Responsible party
- Principal investigator, Till Barnighausen, Harvard School of Public Health (HSPH)
- Investigators
- Katrina Ortblad, MPH, Study director, Harvard School of Public Health (HSPH)Till Barnighausen, MD, ScD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846402
- Sponsor's protocol ID
- 16-0885
- Acronym
- HSPOT
- Status last verified
- May 2018
- First submitted
- 20 Jul 2016
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
McMahon SA, Musoke DK, Wachinger J, Nakitende A, Amongin J, Nanyiri E, Turcotte-Tremblay AM, Oldenburg CE, Barnighausen T, Ortblad KF. Unintended uses, meanings, and consequences: HIV self-testing among female sex workers in urban Uganda. AIDS Care. 2021 Oct;33(10):1278-1285. doi: 10.1080/09540121.2020.1837722. Epub 2020 Nov 2.
PubMed 33138623Ortblad KF, Kibuuka Musoke D, Ngabirano T, Nakitende A, Taasi G, Barresi LG, Barnighausen T, Oldenburg CE. HIV self-test performance among female sex workers in Kampala, Uganda: a cross-sectional study. BMJ Open. 2018 Nov 8;8(11):e022652. doi: 10.1136/bmjopen-2018-022652.
PubMed 30413504Ortblad KF, Chanda MM, Musoke DK, Ngabirano T, Mwale M, Nakitende A, Chongo S, Kamungoma N, Kanchele C, Barnighausen T, Oldenburg CE. Acceptability of HIV self-testing to support pre-exposure prophylaxis among female sex workers in Uganda and Zambia: results from two randomized controlled trials. BMC Infect Dis. 2018 Oct 4;18(1):503. doi: 10.1186/s12879-018-3415-z.
PubMed 30286737Ortblad K, Kibuuka Musoke D, Ngabirano T, Nakitende A, Magoola J, Kayiira P, Taasi G, Barresi LG, Haberer JE, McConnell MA, Oldenburg CE, Barnighausen T. Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: A cluster-randomized controlled health systems trial. PLoS Med. 2017 Nov 28;14(11):e1002458. doi: 10.1371/journal.pmed.1002458. eCollection 2017 Nov.
PubMed 29182634
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Causal Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
- ClinicalTrials.gov ID
- NCT02846402
- Acronym / sponsor ID
- HSPOT / 16-0885
- Conditions
- HIV Infection
- Keywords
- HIV testing, Female sex workers, HIV self-testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Uganda Health Marketing Group, International Research Consortium, International Initiative for Impact Evaluation
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 27 Jul 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.
HSPOT is a cluster-randomized trial designed to determine whether HIV self-tests are acceptable and improve HIV testing rates and HIV status knowledge among female sex workers in Kampala, Uganda. This study will determine whether directly giving participants an HIV self-test or giving them a coupon to collect a test at a drug store or clinic improves outcomes compared to standard of care.
Detailed description
Although Uganda has a generalized HIV epidemic, with approximately 7.4% of adults aged 15 to 49 living with HIV, the epidemic remains even more highly concentrated in key populations, including female sex workers (FSW). A particular concern for FSW is access to healthcare services, including HIV testing services. FSW face significant barriers to accessing healthcare. In other settings, evidence has suggested that stigma is a significant barrier to FSW seeking HIV testing. It is likely that similar mechanisms exist in Uganda. Evidence from Uganda has indicated that complex multilevel factors, such as stigmatization and harassment, contribute to vulnerability among FSW. User-controlled HIV prevention interventions that lead to empowerment of FSW may therefore be a powerful way to address the HIV epidemic in this key population.
Oral HIV self-testing consists of an oral swab kit that allows individuals to test for HIV in the privacy of their own homes whenever they want. The ease of use of HIV self-testing, that it can be done at any time, and that is completely private may make it an attractive alternative to currently-available HIV testing mechanisms for FSW in Uganda. HIV self-testing has generally been shown to be acceptable in a variety of populations, however evidence related to its uptake and acceptability remain sparse, especially among key populations and in Sub-Saharan Africa. This research will provide rigorous evidence of the uptake and efficacy of HIV self-testing for this population.
HSPOT was designed to determine whether either direct distribution of HIV self-test kits via peer educators or distribution of HIV self-tests via coupons that participants can use to collect kits at collection points such as drug stores or health posts leads to better coverage of HIV testing and better awareness of HIV status. HSPOT is a cluster-randomized trial in which peer educators recruit a small group of FSW participants, and the peer educator group is randomized to one of three study arms: 1) direct distribution of test kits, 2) fixed distribution of test kits, or 3) referral to standard of care HIV testing. The primary outcome is HIV testing in the past month measured at one and four months after the first peer educator visit (when the test kits or coupons are distributed in the intervention arms).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1:1:1 cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Direct Distribution | Experimental | Other: Oral HIV Self-TestingThe direct distribution arm consists of peer educators directly distributing HIV self-test kits to participants. Peer educators will briefly describe HIV self-testing to participants but will not provide extensive training on the use of the test kit. Peer educators also provide referral to existing services for HIV testing. |
| Fixed Distribution | Experimental | Other: Oral HIV Self-TestingThe fixed distribution arm consists of peer educators distributing coupons to participants. The participants can then use the coupon to collect an HIV self-test kit at a participating distribution point, including drug stores, pharmacies, and health posts. Peer educators will briefly describe HIV self-testing to participants but will not provide extensive training on the use of the test kit. Peer educators also provide referral to existing services for HIV testing. |
| Referral to Existing Services | No intervention | –Peer educators will not provide HIV self-tests to participants. Peer educators will only provide referral to existing services for HIV testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older on the enrollment visit date
- Reports exchanging sex (vaginal, anal, and/or oral) for money or goods at least once in the past month
- Self-reported HIV negative status and no recent (<3 months) HIV testing OR self-reported HIV unknown status
- Member of the hot spot where recruited for at least one month AND plans on remaining in the area for the next 4 months
- Have never used an oral HIVST kit
Key exclusion criteria (8 listed)
- Less than 18 years of age on the enrollment date
- Has not exchanged any form of sex in the past one month
- Self-reported to be living with HIV
- Self-reported HIV negative status and reports testing within the last 3 months
- Planning to move out of geographic area within 4 months
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 |
|---|---|---|
| Oral HIV Self-TestingAlso: OraQuick HIV Self-TestThe Oral HIV Self-Test is an in-home test that uses an oral swab to collect samples of oral mucosa that is used to detect the presence of HIV antibodies. The test is read after 20 minutes by the user. The test can be done by an individual at any time and place of the user's choosing. The test is read visually. | Other | Direct Distribution, Fixed Distribution |
Primary outcome
HIV testing in the previous month
Time frame: One month from first intervention visit
HIV testing in the previous month
Time frame: Four months from first intervention visit
3 secondary outcomes
Knowledge of own HIV status
Time frame: Four months from first intervention visit
HIV self-test kit use in the two intervention arms
Time frame: One month from first intervention visit
HIV self-test kit use in the two intervention arms
Time frame: Four months from first intervention visit
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 7 May 2018.
- Derived from this study: PubMed 33138623McMahon SA, Musoke DK, Wachinger J, Nakitende A, Amongin J, Nanyiri E, Turcotte-Tremblay AM, Oldenburg CE, Barnighausen T, Ortblad KF. Unintended uses, meanings, and consequences: HIV self-testing among female sex workers in urban Uganda. AIDS Care. 2021 Oct;33(10):1278-1285. doi: 10.1080/09540121.2020.1837722. Epub 2020 Nov 2.
- Derived from this study: PubMed 30413504Ortblad KF, Kibuuka Musoke D, Ngabirano T, Nakitende A, Taasi G, Barresi LG, Barnighausen T, Oldenburg CE. HIV self-test performance among female sex workers in Kampala, Uganda: a cross-sectional study. BMJ Open. 2018 Nov 8;8(11):e022652. doi: 10.1136/bmjopen-2018-022652.
- Derived from this study: PubMed 30286737Ortblad KF, Chanda MM, Musoke DK, Ngabirano T, Mwale M, Nakitende A, Chongo S, Kamungoma N, Kanchele C, Barnighausen T, Oldenburg CE. Acceptability of HIV self-testing to support pre-exposure prophylaxis among female sex workers in Uganda and Zambia: results from two randomized controlled trials. BMC Infect Dis. 2018 Oct 4;18(1):503. doi: 10.1186/s12879-018-3415-z.
- Derived from this study: PubMed 29182634Ortblad K, Kibuuka Musoke D, Ngabirano T, Nakitende A, Magoola J, Kayiira P, Taasi G, Barresi LG, Haberer JE, McConnell MA, Oldenburg CE, Barnighausen T. Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: A cluster-randomized controlled health systems trial. PLoS Med. 2017 Nov 28;14(11):e1002458. doi: 10.1371/journal.pmed.1002458. eCollection 2017 Nov.
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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.
Katrina Ortblad, MPH study director
Harvard School of Public Health (HSPH)
Till Barnighausen, MD, ScD principal investigator
Harvard School of Public Health (HSPH)
Questions about this trial
What is this clinical trial studying?
A study testing Oral HIV Self-Testing in people with HIV Infection, run by Harvard School of Public Health (HSPH).
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 7 inclusion and 8 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 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
HIV testing in the previous month (time frame: One month from first intervention visit). 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 NCT02846402, which also lists 4 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 7 May 2018.