Increasing Availability and Acceptability of Circumcision in Zambia

University of Miami

Status: Completed

Conditions: HIV

Treatments: Behavioral: MC and sexual risk reduction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01688167

20110290

R01MH095539 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,468 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,468 participants in 3 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: MC and sexual risk reduction

Standard of Care

No Intervention group

Description:

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.

Observational

No Intervention group

Description:

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