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Increasing Availability and Acceptability of Circumcision in Zambia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr. Stephen Weiss, University of Miami
ClinicalTrials.gov Identifier:
NCT01688167
First received: September 11, 2012
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

This study proposes to balance supply and demand of male circumcision through a systematic scale-up of coordinated biomedical surgical and behavioral counseling services. The study will compare the combined biobehavioral sexual risk reduction intervention to the standard of care, which focuses exclusively on the provision of circumcision services alone, with the goal of optimizing both local and national HIV prevention efforts.


Condition Intervention
HIV
Behavioral: MC and sexual risk reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Increasing Availability and Acceptability of Circumcision in Zambia

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Change in likelihood of undergoing male circumcision across the study using stages of change model [ Time Frame: Baseline, Average of 1 month post-baseline, 6 month and 12 month follow-up ] [ Designated as safety issue: No ]
    Readiness to undergo male circumcision will be assessed using the stages of change model (pre-contemplation, contemplation, preparation, action, maintenance). Intervention and attention control conditions will be compared at baseline, immediately following intervention, and 6 and 12 months post-intervention.


Secondary Outcome Measures:
  • Uptake of male circumcision [ Time Frame: From the date of study enrollment to the date male circumcision is performed or study completion. ] [ Designated as safety issue: No ]
    To determine if participants in the sexual risk reduction/MC promotion intervention (experimental condition) will be more likely to shift to the "Action" stage (undergo circumcision), in comparison with participants having identical MC services available plus usual care (attention control condition).


Other Outcome Measures:
  • Male and female condom use post male circumcision [ Time Frame: 3 months after undergoing male circumcision ] [ Designated as safety issue: No ]
    To determine whether MC will significantly affect the maintenance of safer sexual practices ("risk compensation") in the experimental group as compared to the attention control group


Enrollment: 1468
Study Start Date: January 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Experimental condition clinics offer the MC and sexual risk reduction intervention: four group counseling sessions focused on male circumcision and sexual risk reduction.
Behavioral: MC and sexual risk reduction
Four group counselling sessions focused on male circumcision and sexual risk reduction
No Intervention: Standard of Care
Male participants in the standard of care control condition CHCs will receive counseling per the VCT protocol guidelines. Participants will attend four video-based time-equivalent "attention-control" group sessions on endemic disease prevention strategies (e.g., TB, malaria, cholera, waterborne diseases). Female partners will be invited to participate in a similar four session program devoted to endemic disease risk reduction.
No Intervention: Observational
3 CHC sites will be randomly assigned as "observation only;" only aggregated clinic VCT and circumcision data will be collected.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV negative
  • Uncircumcised male
  • 18+ years of age
  • Able to understand and sign informed consent in English, Bemba, or Nyanja
  • Have not requested male circumcision services at the time of or following VCT
  • Female partners of enrolled males are invited to participate

Exclusion Criteria:

  • Men seeking circumcision services are not eligible for this study
  • Men with genital abnormalities requiring MC, e.g. balanitis (inflammation of the preputial skin), posthitis (inflammation of the glans penis; common in patients with diabetes), phimosis (scarring of the distal margins of the foreskin) resulting from chronic balanitis, paraphimosis (the inability to pull the retracted foreskin back over the glans) or diseases of the foreskin, including localized carcinoma are not eligible for this study
  • Men with congenital or acquired penile abnormalities that require the preputial skin for generative repair, such as hypospadias (urethra exits from underside of penis) are not eligible to participate
  • Participants unable to provide informed consent will not be eligible.
  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: NCT01688167

Locations
Zambia
University of Zambia Teaching Hospital
Lusaka, Zambia
Sponsors and Collaborators
University of Miami
Investigators
Study Chair: Stephen M Weiss, PhD University of Miami
  More Information

No publications provided

Responsible Party: Dr. Stephen Weiss, Research Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01688167     History of Changes
Other Study ID Numbers: 20110290, R01MH095539
Study First Received: September 11, 2012
Last Updated: April 17, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government
Zambia: Research Ethics Committee

Keywords provided by University of Miami:
HIV
Male circumcision
Sexual risk reduction
Stages of change

ClinicalTrials.gov processed this record on November 20, 2014