Feasibility of Measuring Immune Resp, Activation in Foreskin/Mucosa in HIV-, Uncircumcised High-HIV-risk MSM, Lima Peru

NCT02630082 | Completed

• 1 other identifier: 11704
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rectal and genital sampling in HIV prevention trials permits assessments at the site of HIV entry. Yet the safety and acceptability of circumcision and sigmoidoscopy (and associated abstinence recommendations) are unknown in uncircumcised men who have sex with men (MSM) at high risk of HIV infection. The purpose of this study is to evaluate the feasibility of methods for assessing baseline characteristics of the mucosa of MSM at risk of HIV infection in Lima, Peru.

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Keywords

HIV Preventive Vaccine; HIV Seronegativity; Immune Response, Mucosal

Outcome Measures

Primary Outcomes (14)

• Pre- and post-procedure retention

  Number of enrolled trial participants that underwent each procedure visit and attended each follow-up visit

  28 weeks

• White blood cell counts

  White blood cells per mm\^3

  28 weeks

• Hematocrit

  Hematocrit values measured as percentage

  28 weeks

• Hemoglobin

  Hemoglobin g/dL

  28 weeks

• Sexual satisfaction

  Sexual satisfaction during receptive, insertive sex, and abstinence periods using a CASI behavioral questionnaire (5 point Likert Scale)

  28 weeks

• HIV risk behaviors

  Sex without a condom according to a CASI behavioral questionnaire (Yes, No)

  28 weeks

• Levels of activation markers associated with vulnerability to HIV infection

  Levels of CCR5, ki67+ Bcl2low, and integrin alpha4beta7 expression on CD4+ CD3+ T cells collected in blood

  28 weeks

• Procedure-related events

  Number of procedure related events such as adverse drug reactions, hermorrage/hematoma, infection, pain, perforation/anatomic injury, and edema assessed for severity (NIH/NIAID DIvision of AIDS table for Grading of Severity of Adult and Pediatric Adverse Experiences).

  28 weeks

• Number of operational protocol deviations per mucosal sample

  Number of deviations per mucosal sample

  through study completion, an average of 7 months

• Proportion of mucosal samples that are evaluable

  Percent of total samples (%)

  through study completion, an average of 7 months

• Inter-person variability in mucosal responses

  Median and range of variables in peripheral blood mononuclear cells, foreskin, and rectosigmoid mucosa

  28 weeks

• Intra-person differences in mucosal responses obtained from the rectosigmoid colon

  Median and range of variables in peripheral blood mononuclear cells, foreskin, and rectosigmoid mucosa

  28 weeks

• Number of clinical protocol deviations per mucosal sample

  Number of deviations per mucosal sample

  through study completion, an average of 7 months

• Number of laboratory protocol deviations per mucosal sample

  Number of deviations per mucosal sample

  through study completion, an average of 7 months

Study Arms (1)

Intervention

OTHER

Circumcision and flexible sigmoidoscopy

Procedure: Circumcision; Procedure: Flexible sigmoidoscopy

Interventions

Circumcision PROCEDURE

Intervention

Flexible sigmoidoscopy PROCEDURE

Intervention

Eligibility Criteria

• Age: 21 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male, age 21 to 30 years, who, in the 6 months prior to screening, experienced 1 or both of the following HIV risk criteria:
• unprotected anal intercourse with 1 or more male or MTF transgender partner(s); or
• anal intercourse with 2 or more male or MTF transgender partners. Note: Volunteers who have been in a monogamous relationship with an HIV-seronegative partner for \> 6 months are excluded.
• Ability and willingness to provide informed consent
• Assessment of understanding: volunteer demonstrates understanding of the procedures and purpose of this study. Participants will complete a questionnaire prior to enrollment with verbal demonstration of understanding of all questionnaire items answered incorrectly.
• Willingness to receive HIV test results
• Willingness to discuss HIV infection risks (including sexual behavior and drug use) and amenable to HIV risk reduction counseling
• Willingness to undergo phlebotomy, rectal swab, sigmoidoscopy, and circumcision
• Willingness to adhere to safety protocols before and after sigmoidoscopy and circumcision
• Agrees not to enroll in another study of an investigational research agent prior to completion of the last required protocol clinic visit
• Hemoglobin ≥ 13.0 g/dL
• White blood cell (WBC) count = 3300 to 12,000 cells/mm3
• Total lymphocyte count ≥ 800 cells/mm3
• Remaining differential either within institutional normal range or with site physician approval
• Platelets = 125,000 to 550,000/mm3

You may not qualify if:

• Volunteers who, in the six months prior to screening, have had sexual partners known to be HIV-infected
• Volunteers who, for the 6 months prior to screening, have been in a monogamous relationship with an HIV-seronegative partner
• History of immunodeficiency
• Foreskin covering less than half the glans
• Absolute medical indication for circumcision (balanitis or phimosis)
• HIV vaccine(s) received in a prior HIV vaccine trial. For potential participants who received control/placebo in an HIV vaccine trial, the HVTN 914 PSRT will determine eligibility on a case-by-case basis
• Untreated clinical signs or symptoms of genitourinary or colonic infection
• Any medical condition contraindicating circumcision or flexible sigmoidoscopy with biopsies
• History of transactional sex (ie, exchange of sex for money, shelter, food, or drugs) in the preceding 6 months
• Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety, or a participant's ability to give informed consent
• History of keloid scarring

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Related Publications (1)

• Lama JR, Karuna ST, Grant SP, Swann EM, Ganoza C, Segura P, Montano SM, Lacherre M, De Rosa SC, Buchbinder S, Sanchez J, McElrath MJ, Lemos MP; HVTN 914 Study Team. Transient Peripheral Immune Activation follows Elective Sigmoidoscopy or Circumcision in a Cohort Study of MSM at Risk of HIV Infection. PLoS One. 2016 Aug 18;11(8):e0160487. doi: 10.1371/journal.pone.0160487. eCollection 2016.

  PMID: 27536938 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Interventions

Circumcision, Male

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Modification, Non-Therapeutic; Cosmetic Techniques; Therapeutics; Surgical Procedures, Operative; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: December 15, 2015
• Study Start: April 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 15, 2015

Record last verified: 2015-12