An interventional study of OraQuick HIV Self-Test in HIV/AIDS, sponsored by Makerere University. Completed at 1 site in Uganda. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by Makerere University · Not applicable, Interventional, and Prevention
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Among 10 studies in Acquired Immunodeficiency Syndrome by Makerere University — 1 open to participants now, 1 under way, none of them phase 3. Acquired Immunodeficiency Syndrome · Makerere University.
Among the 10 studies in Acquired Immunodeficiency Syndrome by Makerere University, this one is the only one that started in 2018, is one of 5 with no phase, and was the 5th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →1 of the 10 studies in Acquired Immunodeficiency Syndrome by Makerere University is open now, in 1 country. Recruiting first, the newest first:
Makerere University · Sites in Uganda
Ages 18+
By country, each count listing its studies:
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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10 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 110 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 124 across the 9 interventional studies, 200 across the 1 observational. Of the 5 that completed or were terminated, 2 (40%) have results posted.
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Makerere University is the lead sponsor of 144 studies on the registry; 16 are open to participants now.
1 of the studies in Acquired Immunodeficiency Syndrome by Makerere University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07840651Makerere UniversityIntegrating Tuberculosis Treatment Into Community Pharmacies to Improve TB/HIV Outcomes in Uganda | 2027-09 |
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Among the 10 studies in Acquired Immunodeficiency Syndrome by Makerere University, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: OraQuick HIV Self-Test
All study participants will receive quarterly in-clinic HIV testing as standard-of-care.
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.
PrEP adherence as measured by Wisepill electronic adherence monitors and intra-cellular tenofovir drug levels
Comparison of adherence outcomes by randomization arm
Time frame: 12 months
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
Time frame: 12 months
Proportion of sex workers using self-test kits
Proportion of sex workers randomized to HIV self-testing using HIV self test kits
Time frame: 12 months
Diagnostic accuracy of HIVST in oral PrEP users
Proportion of false negative HIV self-test tests
Time frame: 12 months
Self-reported confidence in PrEP effectiveness as measured by monthly questionnaires
Proportion who believe PrEP is effective in preventing HIV infection
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Jan 2020, 20 months.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 20 months is below that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →