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Completed

NCT Number: NCT02827240

Zambian Peer-Educators for HIV Self-Testing Study

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

John Snow, Inc, Lusaka, Livingstone, Zambia

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral HIV Self-Testing

Other

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 names: OraQuick HIV Self-Test

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • International Initiative for Impact Evaluation
  • John Snow, Inc.

Registry information

Official study title

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

Acronym: ZEST

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2016
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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