Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-06 @ 10:48 AM
Study NCT ID:
NCT02846402
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2016-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1:1 cluster randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 960}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2016-07-20', 'studyFirstSubmitQcDate': '2016-07-22', 'lastUpdatePostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'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'}], 'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV testing', 'Female sex workers', 'HIV self-testing'], 'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '33138623', 'type': 'DERIVED', '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.'}, {'pmid': '30413504', 'type': 'DERIVED', '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.'}, {'pmid': '30286737', 'type': 'DERIVED', '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.'}, {'pmid': '29182634', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nOral 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.\n\nHSPOT 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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older on the enrollment visit date\n* Reports exchanging sex (vaginal, anal, and/or oral) for money or goods at least once in the past month\n* Self-reported HIV negative status and no recent (\\<3 months) HIV testing OR self-reported HIV unknown status\n* Member of the hot spot where recruited for at least one month AND plans on remaining in the area for the next 4 months\n* Have never used an oral HIVST kit\n* Willing to participate in peer education sessions on a monthly basis over the 4-month study period and to participate in study assessments\n* Of sound mind and not under influence of drugs or coercion\n\nExclusion Criteria:\n\n* Less than 18 years of age on the enrollment date\n* Has not exchanged any form of sex in the past one month\n* Self-reported to be living with HIV\n* Self-reported HIV negative status and reports testing within the last 3 months\n* Planning to move out of geographic area within 4 months\n* Concurrently participating in another HIV prevention study\n* Meets criteria but does not wish to participate\n* Not willing or able to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02846402', 'acronym': 'HSPOT', 'briefTitle': 'Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'The Causal Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda', 'orgStudyIdInfo': {'id': '16-0885'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Direct Distribution', 'description': '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.', 'interventionNames': ['Other: Oral HIV Self-Testing']}, {'type': 'EXPERIMENTAL', 'label': 'Fixed Distribution', 'description': '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.', 'interventionNames': ['Other: Oral HIV Self-Testing']}, {'type': 'NO_INTERVENTION', 'label': 'Referral to Existing Services', 'description': 'Peer educators will not provide HIV self-tests to participants. Peer educators will only provide referral to existing services for HIV testing.'}], 'interventions': [{'name': 'Oral HIV Self-Testing', 'type': 'OTHER', 'otherNames': ['OraQuick HIV Self-Test'], 'description': "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.", 'armGroupLabels': ['Direct Distribution', 'Fixed Distribution']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Katrina Ortblad, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}, {'name': 'Till Barnighausen, MD, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uganda Health Marketing Group', 'class': 'UNKNOWN'}, {'name': 'International Research Consortium', 'class': 'UNKNOWN'}, {'name': 'International Initiative for Impact Evaluation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Till Barnighausen', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}