HIV
Conditions
Keywords
HIV, Male circumcision, Sexual risk reduction, Stages of change
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.
Interventions
BEHAVIORALMC and sexual risk reduction
Four group counselling sessions focused on male circumcision and sexual risk reduction
Sponsors
National Institute of Mental Health (NIMH)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Male and female condom use post male circumcision | 3 months after undergoing male circumcision | 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 |
Countries
Zambia
Outcome results
None listed