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Zambian Peer-Educators for HIV Self-Testing Study (ZEST)

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ClinicalTrials.gov Identifier: NCT02827240
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : May 7, 2018
Sponsor:
Collaborators:
John Snow, Inc.
International Initiative for Impact Evaluation
Information provided by (Responsible Party):
Till Barnighausen, Harvard School of Public Health

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infection Other: Oral HIV Self-Testing Not Applicable

Detailed 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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 965 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Peer Educator-delivered HIV Self-testing Intervention for Female Sex Workers in Zambian Border Towns
Actual Study Start Date : August 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Direct Distribution
The direct distribution arm consists of peer educators directly distributing HIV self-test kits to participants. Peer educators will briefly describe HIV self-testing to participants but will not provide extensive training on the use of the test kit. Peer educators also provide referral to existing services for HIV testing.
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.
Other Name: OraQuick HIV Self-Test

Experimental: Fixed Distribution
The fixed distribution arm consists of peer educators distributing coupons to participants. The participants can then use the coupon to collect an HIV self-test kit at a participating distribution point, including drug stores, pharmacies, and health posts. Peer educators will briefly describe HIV self-testing to participants but will not provide extensive training on the use of the test kit. Peer educators also provide referral to existing services for HIV testing.
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.
Other Name: OraQuick HIV Self-Test

No Intervention: Referral to Existing Services
Peer educators will not provide HIV self-tests to participants. Peer educators will only provide referral to existing services for HIV testing.



Primary Outcome Measures :
  1. HIV testing in the previous month [ Time Frame: One month from first intervention visit ]
  2. HIV testing in the previous month [ Time Frame: Four months from first intervention visit ]

Secondary Outcome Measures :
  1. Correct knowledge of HIV status [ Time Frame: Four months from first intervention visit ]
  2. HIV self-test kit use in the two intervention arms [ Time Frame: One month from first intervention visit ]
  3. HIV self-test kit use in the two intervention arms [ Time Frame: Four months from first intervention visit ]
    In the intervention arms

  4. Linkage to HIV care and confirmatory testing [ Time Frame: One month from first intervention visit ]
  5. Linkage to HIV care and confirmatory testing [ Time Frame: Four months from first intervention visit ]
  6. HIV risk perception and beliefs about acquiring HIV [ Time Frame: One month from first intervention visit ]
  7. HIV risk perception and beliefs about acquiring HIV [ Time Frame: Four months from first intervention visit ]
  8. HIV disclosure with sexual partners [ Time Frame: One month from first intervention visit ]
  9. HIV disclosure with sexual partners [ Time Frame: Four months from first intervention visit ]
  10. Condom use with commercial sexual partners since last visit [ Time Frame: One month from first intervention visit ]
  11. Condom use with commercial sexual partners since last visit [ Time Frame: Four months from first intervention visit ]
  12. Condom use with non-commercial sexual partners since last visit [ Time Frame: One month from first intervention visit ]
  13. Condom use with non-commercial sexual partners since last visit [ Time Frame: Four months from first intervention visit ]
  14. Average number of commercial sexual partners [ Time Frame: One month from first intervention visit ]
  15. Average number of commercial sexual partners [ Time Frame: Four months from first intervention visit ]
  16. Average number of non-commercial sexual partners [ Time Frame: One month from first intervention visit ]
  17. Average number of non-commercial sexual partners [ Time Frame: Four months from first intervention visit ]
  18. Intimate partner violence, including sexual, physical, or verbal [ Time Frame: One month from first intervention visit ]
  19. Intimate partner violence, including sexual, physical, or verbal [ Time Frame: Four months from first intervention visit ]
  20. HIV fatalism [ Time Frame: One month from first intervention visit ]
  21. HIV fatalism [ Time Frame: Four months from first intervention visit ]
  22. Self-reported self-efficacy as measured by the General Self Efficacy Scale [ Time Frame: One month from first intervention visit ]
  23. Self-reported self-efficacy as measured by the General Self Efficacy Scale [ Time Frame: Four months from first intervention visit ]
  24. Female sex worker empowerment as measured by Beattie et al 2014 [ Time Frame: One month from first intervention visit ]
  25. Female sex worker empowerment as measured by Beattie et al 2014 [ Time Frame: Four months from first intervention visit ]
  26. Pre-exposure prophylaxis preferences [ Time Frame: One month from first intervention visit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827240


Locations
Zambia
John Snow, Inc
Lusaka, Livingstone, Zambia
John Snow, Inc
Chirundu, Zambia
John Snow, Inc
Kapiri, Zambia
Sponsors and Collaborators
Harvard School of Public Health
John Snow, Inc.
International Initiative for Impact Evaluation
Investigators
Study Director: Catherine Oldenburg, ScD, MPH Harvard T.H. Chan School of Public Health
Principal Investigator: Till Baernighausen, MD, ScD Harvard T.H. Chan School of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Till Barnighausen, Associate Professor, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT02827240     History of Changes
Other Study ID Numbers: 7041968-01
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available via International Initiative for Impact Evaluation's public access data repository.

Keywords provided by Till Barnighausen, Harvard School of Public Health:
Female sex workers
HIV testing
HIV self-test

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases