Increasing Availability and Acceptability of Circumcision in Zambia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1468 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-11-30

Brief Summary

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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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Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention

Experimental condition clinics offer the MC and sexual risk reduction intervention: four group counseling sessions focused on male circumcision and sexual risk reduction.

Group Type EXPERIMENTAL

MC and sexual risk reduction

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Observational

3 CHC sites will be randomly assigned as "observation only;" only aggregated clinic VCT and circumcision data will be collected.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MC and sexual risk reduction

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes