HIV/AIDS Clinical Trial
Official title:
HIV Self-Testing to Empower Prevention Choices in Sex Workers
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.
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