Increasing Availability and Acceptability of Circumcision in Zambia

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: MC and sexual risk reduction

• Registration Number: NCT01688167
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-19
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1468

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in likelihood of undergoing male circumcision across the study using stages of change model	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 Outcome Measures

Name	Time	Method
Uptake of male circumcision	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).

Trial Locations

Locations (1)

University of Zambia Teaching Hospital; 🇿🇲 Lusaka, Zambia