Increasing Availability and Acceptability of Circumcision in Zambia

Study Overview
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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.

Official Title
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Increasing Availability and Acceptability of Circumcision in Zambia

Conditions
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HIV

Intervention / Treatment
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* Behavioral: MC and sexual risk reduction


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Four group counselling sessions focused on male circumcision and sexual risk reduction<br>|
| No Intervention: Standard of Care<br>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<br>3 CHC sites will be randomly assigned as observation only; only aggregated clinic VCT and circumcision data will be collected. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in likelihood of undergoing male circumcision across the study using stages of change model | 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. | Baseline, Average of 1 month post-baseline, 6 month and 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of male circumcision | 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). | From the date of study enrollment to the date male circumcision is performed or study completion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stages of change, HIV, Male circumcision, Sexual risk reduction