Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Harvard School of Public Health

Collaborator
Uganda Health Marketing Group
International Research Consortium
International Initiative for Impact Evaluation

Information provided by (Responsible Party)
Till Barnighausen, Harvard School of Public Health

ClinicalTrials.gov Identifier
NCT02846402

First received: July 20, 2016
Last updated: May 2, 2018
Last Verified: May 2018
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infection

Other : Oral HIV Self-Testing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1:1 cluster randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Causal Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda

Further study details as provided by Till Barnighausen, Harvard School of Public Health:

Primary Outcome Measures

  • HIV testing in the previous month [ Time Frame: One month from first intervention visit ]
  • HIV testing in the previous month [ Time Frame: Four months from first intervention visit ]
Secondary Outcome Measures:
  • Knowledge of own HIV status [ Time Frame: Four months from first intervention visit ]
  • HIV self-test kit use in the two intervention arms [ Time Frame: One month from first intervention visit ]
  • HIV self-test kit use in the two intervention arms [ Time Frame: Four months from first intervention visit ]
Other Outcome Measures:
  • Linkage to HIV care and confirmatory testing [ Time Frame: One month from first intervention visit ]
  • Linkage to HIV care and confirmatory testing [ Time Frame: Four months from first intervention visit ]
  • HIV risk perception and beliefs about acquiring HIV [ Time Frame: One month from first intervention visit ]
  • HIV risk perception and beliefs about acquiring HIV [ Time Frame: Four months from first intervention visit ]
  • HIV disclosure with sexual partners [ Time Frame: One month from first intervention visit ]
  • HIV disclosure with sexual partners [ Time Frame: Four months from first intervention visit ]
  • Condom use with commercial sexual partners since last visit [ Time Frame: One month from first intervention visit ]
  • Condom use with commercial sexual partners since last visit [ Time Frame: Four months from first intervention visit ]
  • Condom use with non-commercial sexual partners since last visit [ Time Frame: One month from first intervention visit ]
  • Condom use with non-commercial sexual partners since last visit [ Time Frame: Four months from first intervention visit ]
  • Average number of commercial sexual partners [ Time Frame: One month from first intervention visit ]
  • Average number of commercial sexual partners [ Time Frame: Four months from first intervention visit ]
  • Average number of non-commercial sexual partners [ Time Frame: One month from first intervention visit ]
  • Average number of non-commercial sexual partners [ Time Frame: Four months from first intervention visit ]
  • Intimate partner violence, including sexual, physical, or verbal [ Time Frame: One month from first intervention visit ]
  • Intimate partner violence, including sexual, physical, or verbal [ Time Frame: Four months from first intervention visit ]
  • HIV fatalism [ Time Frame: One month from first intervention visit ]
  • HIV fatalism [ Time Frame: Four months from first intervention visit ]
  • Self-reported self-efficacy as measured by the General Self Efficacy Scale [ Time Frame: One month from first intervention visit ]
  • Self-reported self-efficacy as measured by the General Self Efficacy Scale [ Time Frame: Four months from first intervention visit ]
  • Female sex worker empowerment as measured by Beattie et al 2014 [ Time Frame: One month from first intervention visit ]
  • Female sex worker empowerment as measured by Beattie et al 2014 [ Time Frame: Four months from first intervention visit ]
  • Pre-exposure prophylaxis preferences [ Time Frame: One month from first intervention visit ]

Enrollment: 960
Study Start Date: September 2016
Study Completion Date: June 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Direct Distribution
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

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 Name: OraQuick HIV Self-Test
Experimental: Fixed Distribution
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

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 Name: OraQuick HIV Self-Test
No Intervention: Referral to Existing Services
Peer educators will not provide HIV self-tests to participants. Peer educators will only provide referral to existing services for HIV testing.

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: Yes  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02846402

Sponsors and Collaborators

Harvard School of Public Health
Uganda Health Marketing Group
International Research Consortium
International Initiative for Impact Evaluation

Investigators

Study Director: Katrina Ortblad, MPH Harvard T.H. Chan School of Public Health
Principal Investigator: Till Barnighausen, MD, ScD Harvard T.H. Chan School of Public Health
More Information

More Information


Responsible Party: Till Barnighausen, Associate Professor, Harvard School of Public Health  
ClinicalTrials.gov Identifier: NCT02846402   History of Changes  
Other Study ID Numbers: 16-0885  
Study First Received: July 20, 2016  
Last Updated: May 2, 2018  

Keywords provided by Till Barnighausen, Harvard School of Public Health:

HIV testing
Female sex workers
HIV self-testing

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on December 10, 2018
This information is provided by ClinicalTrials.gov.