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OpenTrials
Completed

NCT Number: NCT01688167

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zambia Teaching Hospital

Lusaka, Zambia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MC and sexual risk reduction

Behavioral

Four group counselling sessions focused on male circumcision and sexual risk reduction

Primary outcomes

  1. 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

    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 outcomes

  1. Uptake of male circumcision

    Time frame: From the date of study enrollment to the date male circumcision is performed or study completion.

    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 outcomes

  1. Male and female condom use post male circumcision

    Time frame: 3 months after undergoing male circumcision

    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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2012
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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