Clinical trial NCT02846402: Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
Official title: The Causal Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Keywords: HIV testing
Female sex workers
HIV self-testing
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Uganda Health Marketing Group
name: International Research Consortium
name: International Initiative for Impact Evaluation
First posted: 2016-07-27
Enrollment: 960
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1:1 cluster randomized controlled trial
Primary purpose: DIAGNOSTIC

Brief summary: HSPOT 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 Kampala, Uganda. 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 Uganda has a generalized HIV epidemic, with approximately 7.4% 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 Uganda. Evidence from Uganda 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 Uganda. 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.

HSPOT 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. HSPOT 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 on the enrollment visit date
* Reports exchanging sex (vaginal, anal, and/or oral) for money or goods at least once in the past month
* Self-reported HIV negative status and no recent (\<3 months) HIV testing OR self-reported HIV unknown status
* Member of the hot spot where recruited for at least one month AND plans on remaining in the area for the next 4 months
* Have never used an oral HIVST kit
* Willing to participate in peer education sessions on a monthly basis over the 4-month study period and to participate in study assessments
* Of sound mind and not under influence of drugs or coercion

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 reports testing within the last 3 months
* Planning to move out of geographic area within 4 months
* Concurrently participating in another HIV prevention study
* Meets criteria but does not wish to participate
* Not willing or able to provide informed consent

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: Knowledge of own 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
Other outcomes:
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
Locations:
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Katrina Ortblad, MPH
role: STUDY_DIRECTOR
affiliation: Harvard School of Public Health (HSPH)
name: Till Barnighausen, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McMahon SA, Musoke DK, Wachinger J, Nakitende A, Amongin J, Nanyiri E, Turcotte-Tremblay AM, Oldenburg CE, Barnighausen T, Ortblad KF. Unintended uses, meanings, and consequences: HIV self-testing among female sex workers in urban Uganda. AIDS Care. 2021 Oct;33(10):1278-1285. doi: 10.1080/09540121.2020.1837722. Epub 2020 Nov 2.
citation: Ortblad KF, Kibuuka Musoke D, Ngabirano T, Nakitende A, Taasi G, Barresi LG, Barnighausen T, Oldenburg CE. HIV self-test performance among female sex workers in Kampala, Uganda: a cross-sectional study. BMJ Open. 2018 Nov 8;8(11):e022652. doi: 10.1136/bmjopen-2018-022652.
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: Ortblad K, Kibuuka Musoke D, Ngabirano T, Nakitende A, Magoola J, Kayiira P, Taasi G, Barresi LG, Haberer JE, McConnell MA, Oldenburg CE, Barnighausen T. Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: A cluster-randomized controlled health systems trial. PLoS Med. 2017 Nov 28;14(11):e1002458. doi: 10.1371/journal.pmed.1002458. eCollection 2017 Nov.