ZEST 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 Zambian transit towns. 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.
Although Zambia has a generalized HIV epidemic, with approximately 13.3% 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 Zambia. Evidence from Zambia 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 Zambia. 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. ZEST 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. ZEST 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
965
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.
John Snow, Inc
Lusaka, Livingstone, Zambia
John Snow, Inc
Chirundu, Zambia
John Snow, Inc
Kapiri, Zambia
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
Correct knowledge of 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
In the intervention arms
Time frame: Four months from first intervention visit
Linkage to HIV care and confirmatory testing
Time frame: One month from first intervention visit
Linkage to HIV care and confirmatory testing
Time frame: Four months from first intervention visit
HIV risk perception and beliefs about acquiring HIV
Time frame: One month from first intervention visit
HIV risk perception and beliefs about acquiring HIV
Time frame: Four months from first intervention visit
HIV disclosure with sexual partners
Time frame: One month from first intervention visit
HIV disclosure with sexual partners
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Time frame: Four months from first intervention visit
Condom use with commercial sexual partners since last visit
Time frame: One month from first intervention visit
Condom use with commercial sexual partners since last visit
Time frame: Four months from first intervention visit
Condom use with non-commercial sexual partners since last visit
Time frame: One month from first intervention visit
Condom use with non-commercial sexual partners since last visit
Time frame: Four months from first intervention visit
Average number of commercial sexual partners
Time frame: One month from first intervention visit
Average number of commercial sexual partners
Time frame: Four months from first intervention visit
Average number of non-commercial sexual partners
Time frame: One month from first intervention visit
Average number of non-commercial sexual partners
Time frame: Four months from first intervention visit
Intimate partner violence, including sexual, physical, or verbal
Time frame: One month from first intervention visit
Intimate partner violence, including sexual, physical, or verbal
Time frame: Four months from first intervention visit
HIV fatalism
Time frame: One month from first intervention visit
HIV fatalism
Time frame: Four months from first intervention visit
Self-reported self-efficacy as measured by the General Self Efficacy Scale
Time frame: One month from first intervention visit
Self-reported self-efficacy as measured by the General Self Efficacy Scale
Time frame: Four months from first intervention visit
Female sex worker empowerment as measured by Beattie et al 2014
Time frame: One month from first intervention visit
Female sex worker empowerment as measured by Beattie et al 2014
Time frame: Four months from first intervention visit
Pre-exposure prophylaxis preferences
Time frame: One month from first intervention visit