Efficacy of Doxycycline Prophylaxis to Reduce Syphilis in High-Risk, HIV-Positive MSM

NCT02257658 | Completed

• 1 other identifier: PHS 398/2590
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Syphilis

Keywords

Men who have Sex with Men; HIV-positive; Syphilis; Contingency Management

Outcome Measures

Primary Outcomes (1)

• 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

  12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks

Secondary Outcomes (3)

• Measure adherence to study visits in the Doxycycline and Contingency Management Arms at Weeks 12, 24, 36 and 48

  12 Weeks, 24 Weeks, 36 Weeks and 48 Weeks

• Measure adherence to daily Doxycycline Use using Blood Samples in the Doxycycline Arm at Weeks 12, 24 and 36

  12 Weeks, 24 Weeks and 36 Weeks

• 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

  12 Weeks, 24 Weeks and 36 Weeks

Study Arms (2)

Doxycycline

EXPERIMENTAL

Subjects in the doxycycyline arm will receive Doxycycline, oral, 100 mg, once daily for 36 weeks.

Drug: Doxycycyline

Incentive

ACTIVE COMPARATOR

Subjects in the incentive arm will receive escalating payments for remaining STI free at Weeks 12, 24 and 36.

Behavioral: Incentive

Interventions

Doxycycyline DRUG

Doxycycline

Incentive BEHAVIORAL

Incentive

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected MSM or transgender women who have sex with men
• At least two documented and adequately treated episodes of syphilis since HIV diagnosis

You may not qualify if:

• Had a known allergy or intolerance to doxycycline
• Abused alcohol or other substances which in the opinion of the investigators would jeopardize adherence to study procedures

Sponsors & Collaborators

• Los Angeles LGBT Center: lead
• University of California, Los Angeles: collaborator

Related Publications (7)

• Celum CL. Sexually transmitted infections and HIV: epidemiology and interventions. Top HIV Med. 2010 Oct-Nov;18(4):138-42.

  PMID: 21107013 BACKGROUND

• Goh BT. Syphilis in adults. Sex Transm Infect. 2005 Dec;81(6):448-52. doi: 10.1136/sti.2005.015875.

  PMID: 16326843 BACKGROUND

• 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: 15219556 BACKGROUND

• 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: 11393490 BACKGROUND

• 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: 19734820 BACKGROUND

• 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: 20679965 BACKGROUND

• 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.

  PMID: 10448335 BACKGROUND

MeSH Terms

Conditions

Syphilis; Homosexuality; HIV Seropositivity

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Sexuality; Sexual Behavior; Behavior; HIV Infections; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jeffrey D Klausner, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Epidemiologist, Health and Mental Health Services

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 6, 2014
• Study Start: September 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 6, 2014

Record last verified: 2014-10