Increasing Availability and Acceptability of Circumcision in Zambia
This study is currently recruiting participants.
Verified September 2012 by University of Miami
Sponsor:
University of Miami
Collaborator:
Information provided by (Responsible Party):
Dr. Stephen Weiss, University of Miami
ClinicalTrials.gov Identifier:
NCT01688167
First received: September 11, 2012
Last updated: September 14, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV |
Behavioral: MC and sexual risk reduction |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Miami:
Primary Outcome Measures:
- Change in likelihood of undergoing male circumcision across the study using stages of change model [ Time Frame: Baseline, Average of 1 month post-baseline, 3 month and 6 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 3 and 6 months post-intervention.
Secondary Outcome Measures:
- Uptake of male circumcision [ Time Frame: From the date of study enrollment to the date male circumcision is performed or study completion (6 months post-intervention), whichever comes first ] [ 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).
Other Outcome Measures:
- 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
| Estimated Enrollment: | 960 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01688167
Contacts
| Contact: Emeria Pheri | emeriacksonm@yahoo.co.uk |
Locations
| Zambia | |
| University of Zambia Teaching Hospital | Recruiting |
| Lusaka, Zambia | |
Sponsors and Collaborators
University of Miami
Investigators
| Study Chair: | Stephen M Weiss, PhD | University of Miami |
More Information
No publications provided
| Responsible Party: | Dr. Stephen Weiss, Research Professor, University of Miami |
| ClinicalTrials.gov Identifier: | NCT01688167 History of Changes |
| Other Study ID Numbers: | 20110290, R01MH095539 |
| Study First Received: | September 11, 2012 |
| Last Updated: | September 14, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government Zambia: Research Ethics Committee |
Keywords provided by University of Miami:
|
HIV Male circumcision Sexual risk reduction Stages of change |
ClinicalTrials.gov processed this record on March 14, 2013
