HIV/AIDSNCT03426670
HIV Self-Testing to Empower Prevention Choices in Sex Workers
A study testing OraQuick HIV Self-Test in people with HIV/AIDS, run by Makerere University at 1 site in Uganda.
Trial summary
Transgender, male, and female sex workers are 49, 21 and 14 times as likely to be HIV-infected as other adults in the general population. In Uganda, sex workers have high HIV seroprevalence (35-37%) and account for 10% of new HIV infections. Read more about this study
- Who is it for?
- Ages 18 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
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUganda
- Study dates
- 21 May 2018to 31 Jan 2020
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exchanged sex for goods or money at least once in the prior month
- Able and willing to provide written informed consent
- HIV-uninfected based on negative HIV rapid tests according to the national Uganda algorithm
- Adequate renal function (normal creatinine levels; calculated creatinine clearance ≥ 60ml/min)
- Not infected with Hepatitis B virus (negative HBsAg test)
- Not enrolled in HIV prevention trial currently or within the past year
Show all 10Show fewer
- Not currently using PrEP
- Willing to remain in the study for the next 12 months
- Own a mobile phone for personal use
- Have regular access to electricity for charging a mobile phone
Who cannot join
- A physical or mental condition that prohibits informed consent and/or participation in study procedures
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Infectious Diseases Institute,Makerere University College of Health Sciences
Kampala
About this study
Transgender, male, and female sex workers are 49, 21 and 14 times as likely to be HIV-infected as other adults in the general population. In Uganda, sex workers have high HIV seroprevalence (35-37%) and account for 10% of new HIV infections. Two robust, evidence-based, self-controlled HIV prevention tools are available -- HIV self-testing (HIVST) and antiretroviral pre-exposure prophylaxis (PrEP) -- but these are not currently well utilized among sex workers. HIVST and PrEP are complementary tools that could be combined to build self-efficacy and empowerment, increase PrEP adherence and reduce sexual risk behaviors. However, research is needed to show how combination HIVST and PrEP may have a synergistic impact on uptake and use of each prevention intervention. The investigators will conduct a randomized trial among sex workers initiating PrEP in Uganda to test if HIV self-testing increases PrEP adherence among HIV-uninfected sex workers (Aim 1), changes sexual risk behavior in sex workers taking PrEP (Aim 2), and influences prevention choices among sex workers and their partners (Aim 3). The investigators will use novel technologies (real-time electronic monitoring with Wise pill technology and mobile phone surveys) to characterize patterns of PrEP adherence, and assess how use of HIVST and PrEP aligns with sexual risk behaviors. Additionally, the investigators will conduct in-depth qualitative interviews to explore the mechanisms through which combined HIVST and PrEP delivery may be synergistic and empowering. This study will be the first to jointly evaluate HIVST and PrEP in sex workers.
Read the detailed description
This is a randomized clinical trial of HIV-uninfected transgender, female, and male sex workers. The overall goal is to test if HIV self-testing increases PrEP adherence (Aim 1), changes sexual risk behavior (Aim 2), and influences HIV prevention choices (Aim 3) in HIV-uninfected sex workers and their partners. For Aim 1, the investigators will recruit HIV-uninfected sex workers in Kampala, Uganda and randomize them to the intervention (monthly HIVST with quarterly clinic-based testing) or the control arm (quarterly clinic-based testing). Study participants will be trained how to use and interpret HIVST and be provided with 4 kits at enrollment and each quarterly visit: 2 kits for own use and 2 for sexual partners, with additional kits provided as needed. They will be instructed to self-test before opening a new PrEP bottle. The investigators will use Wise pill technology to evaluate patterns of PrEP use, and mobile phone interviews to assess HIVST use and confidence in PrEP effectiveness. The investigators will conduct Aim 2 within the randomized trial in Aim 1 and test whether HIVST changes sexual risk behavior. The investigators will use mobile phone interviews and semi-structured questionnaires to collect the behavioral data. In Aim 3 the investigators will use qualitative methods to assess how HIVST empowers use of HIV prevention interventions among sex workers and their partners.
Aim 1: To test if HIV self-testing versus clinic-based testing increases PrEP adherence among HIV-uninfected sex workers.
Approach: To evaluate the impact of HIVST on PrEP adherence, the investigators will randomize 110 HIV-uninfected transgender, female and male sex workers initiating PrEP in a 1:1 ratio to either monthly HIVST with quarterly in-clinic testing (intervention) or quarterly in-clinic HIV testing (standard of care). PrEP medications will be dispensed quarterly. Sex workers in the intervention arm will be instructed to self-test before starting each monthly course of PrEP. In this study, participants will receive counseling on the importance of strict PrEP adherence for HIV protection.
Hypothesis: Monthly HIVST will empower HIV prevention and motivate PrEP adherence among HIV-uninfected sex workers.
Aim 2: To test the effect of HIV self-testing on sexual risk behavior in sex workers taking PrEP.
Approach: Within the randomized trial in Aim 1, the investigators will provide HIVST kits to sex workers for own use, and with partners (primary and commercial). The investigators will use monthly live phone interviews and semi-structured questionnaires to collect data on high-risk sexual behaviors (e.g. sexual frequency, unprotected sex).
Hypothesis: Use of HIVST will be associated with decreased frequency of unprotected sex and sexually transmitted infections.
Aim 3: To explore how HIV self-testing influences prevention choices among sex workers and partners.
Approach: The investigators will conduct in-depth interviews with sex workers and their primary and commercial partners to assess perceptions and experiences with HIVST, explore how HIVST influences status disclosure, behavior change and PrEP use, and to better understand how mobile technology can be leveraged to motivate repeat testing in individuals at high ongoing risk of HIV.
Hypothesis: HIVST will empower sex workers to adopt protective behaviors, facilitate partner testing, and efficiently identify individuals with undiagnosed HIV infection.
- Conditions
- HIV/AIDS
- Being tested
- OraQuick HIV Self-Test
- Keywords
- HIV self-testing, Pre-exposure prophylaxis, Sex workers
- 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
OraQuick® HIV Self-Test is an in-vitro diagnostic medical device that is used for self-testing of antibodies for HIV-1 and HIV-2 in oral fluid. This test is intended as an aid to detect antibodies to HIV-1 and HIV-2 from infected individuals.
| Study group | Role | What they receive |
|---|---|---|
| OraQuick HIV Self-Test | Active comparator | Sex workers in the intervention arm will be instructed to self-test before starting each monthly course of PrEP. HIV Self-testing will be performed during the months between scheduled quarterly visits. Receives: Device: OraQuick HIV Self-Test |
| In-clinic testing | No intervention | All study participants will receive quarterly in-clinic HIV testing as standard-of-care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP adherence as measured by Wisepill electronic adherence monitors and intra-cellular tenofovir drug levels
Comparison of adherence outcomes by randomization arm
Measured: 12 months
Secondary outcomes (4)
High-risk sexual behaviors as measured by frequency of unprotected sex and sexually transmitted infections
Comparison of self-reported unprotected sex and sexually transmitted infections by randomization arm
Measured: 12 months
Proportion of sex workers using self-test kits
Proportion of sex workers randomized to HIV self-testing using HIV self test kits
Measured: 12 months
Diagnostic accuracy of HIVST in oral PrEP users
Proportion of false negative HIV self-test tests
Measured: 12 months
Self-reported confidence in PrEP effectiveness as measured by monthly questionnaires
Proportion who believe PrEP is effective in preventing HIV infection
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 Feb 2018
- Study start21 May 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization in a 1:1 ratio to either monthly HIVST with quarterly in-clinic testing (intervention) or quarterly in-clinic HIV testing (standard of care).
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Massachusetts General Hospital, Harvard Medical School (HMS and HSDM)
- Responsible party
- Sponsor
- Investigators
- Andrew Mujugira, MBChB, PhD, Principal investigator, Center Head
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426670
- Sponsor's protocol ID
- ST/189/2017
- Status last verified
- Feb 2020
- First submitted
- 10 Jan 2018
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kintu TM, Nnyombi M, Kihumuro RB, Kanyike AM, Mujugira A. Brief Report: Beyond Testing: Exploring the Psychosocial Impact of HIV Self-Testing Among Ugandan Gender-Diverse Sex Workers. J Acquir Immune Defic Syndr. 2026 Oct 1;101(10):1174-1178. doi: 10.1097/QAI.0000000000003907.
PubMed 42156239
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Self-Testing to Empower Prevention Choices in Sex Workers
- ClinicalTrials.gov ID
- NCT03426670
- Acronym / sponsor ID
- ST/189/2017
- Conditions
- HIV/AIDS
- Keywords
- HIV self-testing, Pre-exposure prophylaxis, Sex workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- University of Washington, Massachusetts General Hospital, Harvard Medical School (HMS and HSDM)
- Study start
- 21 May 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 8 Feb 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.
Transgender, male, and female sex workers are 49, 21 and 14 times as likely to be HIV-infected as other adults in the general population. In Uganda, sex workers have high HIV seroprevalence (35-37%) and account for 10% of new HIV infections. Two robust, evidence-based, self-controlled HIV prevention tools are available -- HIV self-testing (HIVST) and antiretroviral pre-exposure prophylaxis (PrEP) -- but these are not currently well utilized among sex workers. HIVST and PrEP are complementary tools that could be combined to build self-efficacy and empowerment, increase PrEP adherence and reduce sexual risk behaviors. However, research is needed to show how combination HIVST and PrEP may have a synergistic impact on uptake and use of each prevention intervention. The investigators will conduct a randomized trial among sex workers initiating PrEP in Uganda to test if HIV self-testing increases PrEP adherence among HIV-uninfected sex workers (Aim 1), changes sexual risk behavior in sex workers taking PrEP (Aim 2), and influences prevention choices among sex workers and their partners (Aim 3). The investigators will use novel technologies (real-time electronic monitoring with Wise pill technology and mobile phone surveys) to characterize patterns of PrEP adherence, and assess how use of HIVST and PrEP aligns with sexual risk behaviors. Additionally, the investigators will conduct in-depth qualitative interviews to explore the mechanisms through which combined HIVST and PrEP delivery may be synergistic and empowering. This study will be the first to jointly evaluate HIVST and PrEP in sex workers.
Detailed description
This is a randomized clinical trial of HIV-uninfected transgender, female, and male sex workers. The overall goal is to test if HIV self-testing increases PrEP adherence (Aim 1), changes sexual risk behavior (Aim 2), and influences HIV prevention choices (Aim 3) in HIV-uninfected sex workers and their partners. For Aim 1, the investigators will recruit HIV-uninfected sex workers in Kampala, Uganda and randomize them to the intervention (monthly HIVST with quarterly clinic-based testing) or the control arm (quarterly clinic-based testing). Study participants will be trained how to use and interpret HIVST and be provided with 4 kits at enrollment and each quarterly visit: 2 kits for own use and 2 for sexual partners, with additional kits provided as needed. They will be instructed to self-test before opening a new PrEP bottle. The investigators will use Wise pill technology to evaluate patterns of PrEP use, and mobile phone interviews to assess HIVST use and confidence in PrEP effectiveness. The investigators will conduct Aim 2 within the randomized trial in Aim 1 and test whether HIVST changes sexual risk behavior. The investigators will use mobile phone interviews and semi-structured questionnaires to collect the behavioral data. In Aim 3 the investigators will use qualitative methods to assess how HIVST empowers use of HIV prevention interventions among sex workers and their partners.
Aim 1: To test if HIV self-testing versus clinic-based testing increases PrEP adherence among HIV-uninfected sex workers.
Approach: To evaluate the impact of HIVST on PrEP adherence, the investigators will randomize 110 HIV-uninfected transgender, female and male sex workers initiating PrEP in a 1:1 ratio to either monthly HIVST with quarterly in-clinic testing (intervention) or quarterly in-clinic HIV testing (standard of care). PrEP medications will be dispensed quarterly. Sex workers in the intervention arm will be instructed to self-test before starting each monthly course of PrEP. In this study, participants will receive counseling on the importance of strict PrEP adherence for HIV protection.
Hypothesis: Monthly HIVST will empower HIV prevention and motivate PrEP adherence among HIV-uninfected sex workers.
Aim 2: To test the effect of HIV self-testing on sexual risk behavior in sex workers taking PrEP.
Approach: Within the randomized trial in Aim 1, the investigators will provide HIVST kits to sex workers for own use, and with partners (primary and commercial). The investigators will use monthly live phone interviews and semi-structured questionnaires to collect data on high-risk sexual behaviors (e.g. sexual frequency, unprotected sex).
Hypothesis: Use of HIVST will be associated with decreased frequency of unprotected sex and sexually transmitted infections.
Aim 3: To explore how HIV self-testing influences prevention choices among sex workers and partners.
Approach: The investigators will conduct in-depth interviews with sex workers and their primary and commercial partners to assess perceptions and experiences with HIVST, explore how HIVST influences status disclosure, behavior change and PrEP use, and to better understand how mobile technology can be leveraged to motivate repeat testing in individuals at high ongoing risk of HIV.
Hypothesis: HIVST will empower sex workers to adopt protective behaviors, facilitate partner testing, and efficiently identify individuals with undiagnosed HIV infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization in a 1:1 ratio to either monthly HIVST with quarterly in-clinic testing (intervention) or quarterly in-clinic HIV testing (standard of care).
| Arm | Type | Receives |
|---|---|---|
| OraQuick HIV Self-Test | Active comparator | Device: OraQuick HIV Self-TestSex workers in the intervention arm will be instructed to self-test before starting each monthly course of PrEP. HIV Self-testing will be performed during the months between scheduled quarterly visits. |
| In-clinic testing | No intervention | –All study participants will receive quarterly in-clinic HIV testing as standard-of-care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Exchanged sex for goods or money at least once in the prior month
- Able and willing to provide written informed consent
- HIV-uninfected based on negative HIV rapid tests according to the national Uganda algorithm
- Adequate renal function (normal creatinine levels; calculated creatinine clearance ≥ 60ml/min)
- Not infected with Hepatitis B virus (negative HBsAg test)
Key exclusion criteria (1 listed)
- A physical or mental condition that prohibits informed consent and/or participation in study procedures
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-TestOraQuick® HIV Self-Test is an in-vitro diagnostic medical device that is used for self-testing of antibodies for HIV-1 and HIV-2 in oral fluid. This test is intended as an aid to detect antibodies to HIV-1 and HIV-2 from infected individuals. | Device | OraQuick HIV Self-Test |
Primary outcome
PrEP adherence as measured by Wisepill electronic adherence monitors and intra-cellular tenofovir drug levels
Time frame: 12 months
Comparison of adherence outcomes by randomization arm
4 secondary outcomes
High-risk sexual behaviors as measured by frequency of unprotected sex and sexually transmitted infections
Time frame: 12 months
Proportion of sex workers using self-test kits
Time frame: 12 months
Diagnostic accuracy of HIVST in oral PrEP users
Time frame: 12 months
Self-reported confidence in PrEP effectiveness as measured by monthly questionnaires
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 26 Feb 2020.
- Derived from this study: PubMed 42156239Kintu TM, Nnyombi M, Kihumuro RB, Kanyike AM, Mujugira A. Brief Report: Beyond Testing: Exploring the Psychosocial Impact of HIV Self-Testing Among Ugandan Gender-Diverse Sex Workers. J Acquir Immune Defic Syndr. 2026 Oct 1;101(10):1174-1178. doi: 10.1097/QAI.0000000000003907.
- Individual participant dataSharing planned: No
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Andrew Mujugira, MBChB, PhD principal investigator
Center Head
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 Makerere University at 1 site in Uganda.
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 10 inclusion and 1 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 26 Feb 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 Uganda. 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?
PrEP adherence as measured by Wisepill electronic adherence monitors and intra-cellular tenofovir drug levels (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 NCT03426670, 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 26 Feb 2020.