Zambian Peer-Educators for HIV Self-Testing Study

HIV Infection Clinical Trial

— ZEST  

Official title:

A Peer Educator-delivered HIV Self-testing Intervention for Female Sex Workers in Zambian Border Towns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827240
• Other study ID #: 7041968-01
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: June 2017

Study information

• Verified date: May 2018
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 965
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Female sex

• Reports exchanging sex (including vaginal, anal, and/or oral) for money or goods at least once in the past month

• Self-reported HIV negative with last HIV test at least 3 months OR HIV status unknown

• Permanent residence in the study town of enrollment (Kapiri, Livingstone, or Chirundu)

• Willing to be visited by and meet with assigned peer educator on a monthly basis over the 4-month study period

Exclusion Criteria:

• Less than 18 years of age on the enrollment date

• Has not exchanged any form of sex in the past one month

• Self-reported to be living with HIV

• Self-reported HIV negative status and tested within the past 3 months

• Living in PopART catchment area (Livingstone only)

• Concurrently participating in another HIV prevention study

• Meets criteria but does not wish to participate

• Other

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Other:
• Oral HIV Self-Testing
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.

Locations

Country	Name	City	State
Zambia	John Snow, Inc	Chirundu
Zambia	John Snow, Inc	Kapiri
Zambia	John Snow, Inc	Lusaka	Livingstone

Sponsors (3)

Lead Sponsor	Collaborator
Harvard School of Public Health	International Initiative for Impact Evaluation, John Snow, Inc.

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV testing in the previous month		One month from first intervention visit
Primary	HIV testing in the previous month		Four months from first intervention visit
Secondary	Correct knowledge of HIV status		Four months from first intervention visit
Secondary	HIV self-test kit use in the two intervention arms		One month from first intervention visit
Secondary	HIV self-test kit use in the two intervention arms	In the intervention arms	Four months from first intervention visit
Secondary	Linkage to HIV care and confirmatory testing		One month from first intervention visit
Secondary	Linkage to HIV care and confirmatory testing		Four months from first intervention visit
Secondary	HIV risk perception and beliefs about acquiring HIV		One month from first intervention visit
Secondary	HIV risk perception and beliefs about acquiring HIV		Four months from first intervention visit
Secondary	HIV disclosure with sexual partners		One month from first intervention visit
Secondary	HIV disclosure with sexual partners		Four months from first intervention visit
Secondary	Condom use with commercial sexual partners since last visit		One month from first intervention visit
Secondary	Condom use with commercial sexual partners since last visit		Four months from first intervention visit
Secondary	Condom use with non-commercial sexual partners since last visit		One month from first intervention visit
Secondary	Condom use with non-commercial sexual partners since last visit		Four months from first intervention visit
Secondary	Average number of commercial sexual partners		One month from first intervention visit
Secondary	Average number of commercial sexual partners		Four months from first intervention visit
Secondary	Average number of non-commercial sexual partners		One month from first intervention visit
Secondary	Average number of non-commercial sexual partners		Four months from first intervention visit
Secondary	Intimate partner violence, including sexual, physical, or verbal		One month from first intervention visit
Secondary	Intimate partner violence, including sexual, physical, or verbal		Four months from first intervention visit
Secondary	HIV fatalism		One month from first intervention visit
Secondary	HIV fatalism		Four months from first intervention visit
Secondary	Self-reported self-efficacy as measured by the General Self Efficacy Scale		One month from first intervention visit
Secondary	Self-reported self-efficacy as measured by the General Self Efficacy Scale		Four months from first intervention visit
Secondary	Female sex worker empowerment as measured by Beattie et al 2014		One month from first intervention visit
Secondary	Female sex worker empowerment as measured by Beattie et al 2014		Four months from first intervention visit
Secondary	Pre-exposure prophylaxis preferences		One month from first intervention visit