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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||Increasing Availability and Acceptability of Circumcision in Zambia|
- 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 ] [ Designated as safety issue: No ]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.
- Uptake of male circumcision [ Time Frame: From the date of study enrollment to the date male circumcision is performed or study completion. ] [ Designated as safety issue: No ]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).
- Male and female condom use post male circumcision [ Time Frame: 3 months after undergoing male circumcision ] [ Designated as safety issue: No ]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
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
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
Four group counselling sessions focused on male circumcision and sexual risk reduction
No Intervention: 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.
No Intervention: Observational
3 CHC sites will be randomly assigned as "observation only;" only aggregated clinic VCT and circumcision data will be collected.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01688167
|University of Zambia Teaching Hospital|
|Study Chair:||Stephen M Weiss, PhD||University of Miami|