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

September 11, 2012
April 17, 2014
January 2012
January 2015   (final data collection date for primary outcome measure)
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.
Change in likelihood of undergoing male circumcision across the study using stages of change model [ Time Frame: Baseline, Average of 1 month post-baseline, 3 month and 6 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 3 and 6 months post-intervention.
Complete list of historical versions of study NCT01688167 on ClinicalTrials.gov Archive Site
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).
Uptake of male circumcision [ Time Frame: From the date of study enrollment to the date male circumcision is performed or study completion (6 months post-intervention), whichever comes first ] [ 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).
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
Same as current
 
Increasing Availability and Acceptability of Circumcision in Zambia
Increasing Availability and Acceptability of Circumcision in Zambia

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
HIV
Behavioral: MC and sexual risk reduction
Four group counselling sessions focused on male circumcision and sexual risk reduction
  • 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.
    Intervention: Behavioral: MC 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1468
April 2015
January 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Zambia
 
NCT01688167
20110290, R01MH095539
No
Dr. Stephen Weiss, University of Miami
University of Miami
National Institute of Mental Health (NIMH)
Study Chair: Stephen M Weiss, PhD University of Miami
University of Miami
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP