Zambian Peer-Educators for HIV Self-Testing Study

NCT02827240 | Completed

• 1 other identifier: 7041968-01
• Study Type: interventional
• Target: 965
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV Infection

Keywords

Female sex workers; HIV testing; HIV self-test

Outcome Measures

Primary Outcomes (2)

• HIV testing in the previous month

  One month from first intervention visit

• HIV testing in the previous month

  Four months from first intervention visit

Secondary Outcomes (26)

• Correct knowledge of HIV status

  Four months from first intervention visit

• HIV self-test kit use in the two intervention arms

  One month from first intervention visit

• HIV self-test kit use in the two intervention arms

  Four months from first intervention visit

• Linkage to HIV care and confirmatory testing

  One month from first intervention visit

• Linkage to HIV care and confirmatory testing

  Four months from first intervention visit

Study Arms (3)

Direct Distribution

EXPERIMENTAL

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

Fixed Distribution

EXPERIMENTAL

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

Referral to Existing Services

NO INTERVENTION

Peer educators will not provide HIV self-tests to participants. Peer educators will only provide referral to existing services for HIV testing.

Interventions

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.

Also known as: OraQuick HIV Self-Test

Direct Distribution; Fixed Distribution

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• John Snow, Inc.: collaborator
• International Initiative for Impact Evaluation: collaborator

Study Sites (3)

John Snow, Inc

Lusaka, Livingstone, Zambia

Location

John Snow, Inc

Chirundu, Zambia

Location

John Snow, Inc

Kapiri, Zambia

Location

Related Publications (5)

• Harling G, Chanda MM, Ortblad KF, Mwale M, Chongo S, Kanchele C, Kamungoma N, Barresi LG, Barnighausen T, Oldenburg CE. The influence of interviewers on survey responses among female sex workers in Zambia. BMC Med Res Methodol. 2019 Mar 15;19(1):60. doi: 10.1186/s12874-019-0703-2.

  PMID: 30876402 DERIVED

• Ortblad KF, Chanda MM, Musoke DK, Ngabirano T, Mwale M, Nakitende A, Chongo S, Kamungoma N, Kanchele C, Barnighausen T, Oldenburg CE. Acceptability of HIV self-testing to support pre-exposure prophylaxis among female sex workers in Uganda and Zambia: results from two randomized controlled trials. BMC Infect Dis. 2018 Oct 4;18(1):503. doi: 10.1186/s12879-018-3415-z.

  PMID: 30286737 DERIVED

• Oldenburg CE, Chanda MM, Ortblad KF, Mwale M, Chongo S, Kamungoma N, Kanchele C, Fullem A, Moe C, Barresi LG, Harling GD, Barnighausen T. Effect of HIV self-testing on the number of sexual partners among female sex workers in Zambia. AIDS. 2018 Mar 13;32(5):645-652. doi: 10.1097/QAD.0000000000001740.

  PMID: 29494424 DERIVED

• Chanda MM, Ortblad KF, Mwale M, Chongo S, Kanchele C, Kamungoma N, Fullem A, Dunn C, Barresi LG, Harling G, Barnighausen T, Oldenburg CE. HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial. PLoS Med. 2017 Nov 21;14(11):e1002442. doi: 10.1371/journal.pmed.1002442. eCollection 2017 Nov.

  PMID: 29161260 DERIVED

• Oldenburg CE, Ortblad KF, Chanda MM, Mwanda K, Nicodemus W, Sikaundi R, Fullem A, Barresi LG, Harling G, Barnighausen T. Zambian Peer Educators for HIV Self-Testing (ZEST) study: rationale and design of a cluster randomised trial of HIV self-testing among female sex workers in Zambia. BMJ Open. 2017 Apr 20;7(4):e014780. doi: 10.1136/bmjopen-2016-014780.

  PMID: 28428187 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Catherine Oldenburg, ScD, MPH

  Harvard School of Public Health (HSPH)

  STUDY DIRECTOR

• Till Baernighausen, MD, ScD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 11, 2016
• Study Start: August 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 7, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

ZA (3)