Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda

NCT02846402 | Completed

• 1 other identifier: 16-0885
• Study Type: interventional
• Target: 960
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Infection

Keywords

HIV testing; Female sex workers; HIV self-testing

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 (3)

• Knowledge of own 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

Other Outcomes (23)

• 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

• HIV risk perception and beliefs about acquiring HIV

  One month 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 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

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 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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Uganda Health Marketing Group: collaborator
• International Research Consortium: collaborator
• International Initiative for Impact Evaluation: collaborator

Related Publications (4)

• 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.

  PMID: 33138623 DERIVED

• 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.

  PMID: 30413504 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

• 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.

  PMID: 29182634 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

• Katrina Ortblad, MPH

  Harvard School of Public Health (HSPH)

  STUDY DIRECTOR

• Till Barnighausen, 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

Model Details: 1:1:1 cluster randomized controlled trial

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 27, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 7, 2018

Record last verified: 2018-05