Ignite Creation Date:
2025-12-24 @ 11:59 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT02257658
Status:
COMPLETED
Last Update Posted:
2014-10-06
First Post:
2014-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Doxycycline Prophylaxis to Reduce Syphilis in High-Risk, HIV-Positive MSM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013587', 'term': 'Syphilis'}, {'id': 'D006716', 'term': 'Homosexuality'}, {'id': 'D006679', 'term': 'HIV Seropositivity'}], 'ancestors': [{'id': 'D014211', 'term': 'Treponemal Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus 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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-03', 'studyFirstSubmitDate': '2014-10-01', 'studyFirstSubmitQcDate': '2014-10-03', 'lastUpdatePostDateStruct': {'date': '2014-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure changes in the incidence of Syphilis, Gonorrhea and Chlamydia at 12 weeks, 24 weeks, 26 weeks and 48 weeks in the Doxycycline Arm and Contingency Management Arms', 'timeFrame': '12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks'}], 'secondaryOutcomes': [{'measure': 'Measure adherence to study visits in the Doxycycline and Contingency Management Arms at Weeks 12, 24, 36 and 48', 'timeFrame': '12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks'}, {'measure': 'Measure adherence to daily Doxycycline Use using Blood Samples in the Doxycycline Arm at Weeks 12, 24 and 36', 'timeFrame': '12 Weeks, 24 Weeks and 36 Weeks', 'description': 'At Weeks 12, 24 and 36, blood samples were drawn from participants in the Doxycycline arm and sent to a lab to measure doxycyline levels in each participant in the Doxycyline Arm. The purpose of this outcome is to determine if individuals in the Doxycycline Arm are consistently adhering to the daily regimen of the drug.'}, {'measure': 'Measure changes in self-report sexual risk behaviors (e.g., condom use, drug use and number of partners) in the Doxycycline and Contingency Management Arms at Weeks 12, 24 and 36', 'timeFrame': '12 Weeks, 24 Weeks and 36 Weeks', 'description': 'Prior to having labs drawn, participants in both the Doxycycline and Contingency Management Arms were asked about their risk behaviors in the past three months including: meth use, condom use with casual partners, condom use with regular partners, condom use with a main partner, number of casual sexual partners and number of regular sexual partners.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Men who have Sex with Men', 'HIV-positive', 'Syphilis', 'Contingency Management'], 'conditions': ['Syphilis']}, 'referencesModule': {'references': [{'pmid': '21107013', 'type': 'BACKGROUND', 'citation': 'Celum CL. Sexually transmitted infections and HIV: epidemiology and interventions. Top HIV Med. 2010 Oct-Nov;18(4):138-42.'}, {'pmid': '16326843', 'type': 'BACKGROUND', 'citation': 'Goh BT. Syphilis in adults. Sex Transm Infect. 2005 Dec;81(6):448-52. doi: 10.1136/sti.2005.015875.'}, {'pmid': '15219556', 'type': 'BACKGROUND', 'citation': 'Lynn WA, Lightman S. Syphilis and HIV: a dangerous combination. Lancet Infect Dis. 2004 Jul;4(7):456-66. doi: 10.1016/S1473-3099(04)01061-8.'}, {'pmid': '11393490', 'type': 'BACKGROUND', 'citation': 'Centers for Disease Control and Prevention (CDC). Outbreak of syphilis among men who have sex with men--Southern California, 2000. MMWR Morb Mortal Wkly Rep. 2001 Feb 23;50(7):117-20.'}, {'pmid': '19734820', 'type': 'BACKGROUND', 'citation': 'Horberg MA, Ranatunga DK, Quesenberry CP, Klein DB, Silverberg MJ. Syphilis epidemiology and clinical outcomes in HIV-infected and HIV-uninfected patients in Kaiser Permanente Northern California. Sex Transm Dis. 2010 Jan;37(1):53-8. doi: 10.1097/OLQ.0b013e3181b6f0cc.'}, {'pmid': '20679965', 'type': 'BACKGROUND', 'citation': 'Marcus JL, Katz KA, Bernstein KT, Nieri G, Philip SS. Syphilis testing behavior following diagnosis with early syphilis among men who have sex with men--San Francisco, 2005-2008. Sex Transm Dis. 2011 Jan;38(1):24-9. doi: 10.1097/OLQ.0b013e3181ea170b.'}, {'pmid': '10448335', 'type': 'BACKGROUND', 'citation': 'Fleming DT, Wasserheit JN. From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual transmission of HIV infection. Sex Transm Infect. 1999 Feb;75(1):3-17. doi: 10.1136/sti.75.1.3.'}]}, 'descriptionModule': {'briefSummary': 'This pilot study will investigate the feasibility of conducting a large, randomized trial comparing a structural intervention to contingency management to reduce incident syphilis infections in an especially high risk group: HIV+ men who have sex with men (MSM) who have had syphilis twice or more since their HIV diagnosis. Subjects will be randomized to receive either QD doxycycline as syphilis prophylaxis or a financial incentive to remain STI free. The investigators will : 1) measure adherence to study visits in both arms; 2) measure adherence to the prophylaxis regimen; 3) measure any changes in risk behaviors among study participants and 4) to the extent possible in a small pilot study of short duration, compare effectiveness of doxycycline with that of a monetary incentive for remaining STI free.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-infected MSM or transgender women who have sex with men\n* At least two documented and adequately treated episodes of syphilis since HIV diagnosis\n\nExclusion Criteria:\n\n* Had a known allergy or intolerance to doxycycline\n* Abused alcohol or other substances which in the opinion of the investigators would jeopardize adherence to study procedures'}, 'identificationModule': {'nctId': 'NCT02257658', 'acronym': 'DPMSM', 'briefTitle': 'Efficacy of Doxycycline Prophylaxis to Reduce Syphilis in High-Risk, HIV-Positive MSM', 'organization': {'class': 'OTHER', 'fullName': 'Los Angeles LGBT Center'}, 'officialTitle': 'Doxycycline Prophylaxis or Incentive Payments to Reduce Incident Syphilis Among HIV- Infected Men Who Have Sex With Men Who Continue to Engage in High Risk Sex: A Randomized, Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'PHS 398/2590'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Doxycycline', 'description': 'Subjects in the doxycycyline arm will receive Doxycycline, oral, 100 mg, once daily for 36 weeks.', 'interventionNames': ['Drug: Doxycycyline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Incentive', 'description': 'Subjects in the incentive arm will receive escalating payments for remaining STI free at Weeks 12, 24 and 36.', 'interventionNames': ['Behavioral: Incentive']}], 'interventions': [{'name': 'Doxycycyline', 'type': 'DRUG', 'armGroupLabels': ['Doxycycline']}, {'name': 'Incentive', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Incentive']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jeffrey D Klausner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Los Angeles LGBT Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Epidemiologist, Health and Mental Health Services', 'investigatorFullName': 'Matthew Beymer', 'investigatorAffiliation': 'Los Angeles LGBT Center'}}}}