HIV/AIDS Clinical Trial
Official title:
HIV Self-Testing to Empower Prevention Choices in Sex Workers
Verified date | February 2020 |
Source | Makerere University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | January 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 - 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 Exclusion Criteria: - A physical or mental condition that prohibits informed consent and/or participation in study procedures |
Country | Name | City | State |
---|---|---|---|
Uganda | Infectious Diseases Institute,Makerere University College of Health Sciences | Kampala |
Lead Sponsor | Collaborator |
---|---|
Makerere University | Harvard Medical School, Massachusetts General Hospital, University of Washington |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PrEP adherence as measured by Wisepill electronic adherence monitors and intra-cellular tenofovir drug levels | Comparison of adherence outcomes by randomization arm | 12 months | |
Secondary | 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 | 12 months | |
Secondary | Proportion of sex workers using self-test kits | Proportion of sex workers randomized to HIV self-testing using HIV self test kits | 12 months | |
Secondary | Diagnostic accuracy of HIVST in oral PrEP users | Proportion of false negative HIV self-test tests | 12 months | |
Secondary | Self-reported confidence in PrEP effectiveness as measured by monthly questionnaires | Proportion who believe PrEP is effective in preventing HIV infection | 12 months |
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