Clinical trial NCT02827240: Zambian Peer-Educators for HIV Self-Testing Study
Official title: A Peer Educator-delivered HIV Self-testing Intervention for Female Sex Workers in Zambian Border Towns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Keywords: Female sex workers
HIV testing
HIV self-test
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: John Snow, Inc.
name: International Initiative for Impact Evaluation
First posted: 2016-07-11
Enrollment: 965
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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).

Eligibility 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

Primary outcomes:
measure: HIV testing in the previous month
timeFrame: One month from first intervention visit
measure: HIV testing in the previous month
timeFrame: Four months from first intervention visit
Secondary outcomes:
measure: Correct knowledge of HIV status
timeFrame: Four months from first intervention visit
measure: HIV self-test kit use in the two intervention arms
timeFrame: One month from first intervention visit
measure: HIV self-test kit use in the two intervention arms
timeFrame: Four months from first intervention visit
measure: Linkage to HIV care and confirmatory testing
timeFrame: One month from first intervention visit
measure: Linkage to HIV care and confirmatory testing
timeFrame: Four months from first intervention visit
measure: HIV risk perception and beliefs about acquiring HIV
timeFrame: One month from first intervention visit
measure: HIV risk perception and beliefs about acquiring HIV
timeFrame: Four months from first intervention visit
measure: HIV disclosure with sexual partners
timeFrame: One month from first intervention visit
measure: HIV disclosure with sexual partners
timeFrame: Four months from first intervention visit
measure: Condom use with commercial sexual partners since last visit
timeFrame: One month from first intervention visit
measure: Condom use with commercial sexual partners since last visit
timeFrame: Four months from first intervention visit
measure: Condom use with non-commercial sexual partners since last visit
timeFrame: One month from first intervention visit
measure: Condom use with non-commercial sexual partners since last visit
timeFrame: Four months from first intervention visit
measure: Average number of commercial sexual partners
timeFrame: One month from first intervention visit
measure: Average number of commercial sexual partners
timeFrame: Four months from first intervention visit
measure: Average number of non-commercial sexual partners
timeFrame: One month from first intervention visit
measure: Average number of non-commercial sexual partners
timeFrame: Four months from first intervention visit
measure: Intimate partner violence, including sexual, physical, or verbal
timeFrame: One month from first intervention visit
measure: Intimate partner violence, including sexual, physical, or verbal
timeFrame: Four months from first intervention visit
measure: HIV fatalism
timeFrame: One month from first intervention visit
measure: HIV fatalism
timeFrame: Four months from first intervention visit
measure: Self-reported self-efficacy as measured by the General Self Efficacy Scale
timeFrame: One month from first intervention visit
measure: Self-reported self-efficacy as measured by the General Self Efficacy Scale
timeFrame: Four months from first intervention visit
measure: Female sex worker empowerment as measured by Beattie et al 2014
timeFrame: One month from first intervention visit
measure: Female sex worker empowerment as measured by Beattie et al 2014
timeFrame: Four months from first intervention visit
measure: Pre-exposure prophylaxis preferences
timeFrame: One month from first intervention visit
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: John Snow, Inc
state: Livingstone
city: Chirundu
country: Zambia
facility: John Snow, Inc
city: Kapiri
country: Zambia
facility: John Snow, Inc
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Catherine Oldenburg, ScD, MPH
role: STUDY_DIRECTOR
affiliation: Harvard School of Public Health (HSPH)
name: Till Baernighausen, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.