Clinical trial NCT01688167: Increasing Availability and Acceptability of Circumcision in Zambia
Official title: Increasing Availability and Acceptability of Circumcision in Zambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Male circumcision
Sexual risk reduction
Stages of change
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-09-19
Enrollment: 1468
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Change in likelihood of undergoing male circumcision across the study using stages of change model
timeFrame: Baseline, Average of 1 month post-baseline, 6 month and 12 month follow-up
Secondary outcomes:
measure: Uptake of male circumcision
timeFrame: From the date of study enrollment to the date male circumcision is performed or study completion.
Other outcomes:
measure: Male and female condom use post male circumcision
timeFrame: 3 months after undergoing male circumcision
Locations:
city: Lusaka
country: Zambia
facility: University of Zambia Teaching Hospital
Study officials:
affiliation: University of Miami
name: Stephen M Weiss, PhD
role: STUDY_CHAIR
References:
citation: Weiss SM, Zulu R, Jones DL, Redding CA, Cook R, Chitalu N. The Spear and Shield intervention to increase the availability and acceptability of voluntary medical male circumcision in Zambia: a cluster randomised controlled trial. Lancet HIV. 2015 May;2(5):e181-9. doi: 10.1016/S2352-3018(15)00042-9.
citation: Jones DL, Lopez M, Simons H, Diaz-Gloster M, Tobin JN, Weiss SM. Translation of a comprehensive health behavior intervention for women living with HIV: the SMART/EST Women's Program. Transl Behav Med. 2013 Dec;3(4):416-25. doi: 10.1007/s13142-013-0213-4.
citation: Jones D, Weiss S, Chitalu N. HIV Prevention in Resource Limited Settings: A Case Study of Challenges and Opportunities for Implementation. Int J Behav Med. 2015 Jun;22(3):384-92. doi: 10.1007/s12529-014-9397-3.
citation: Cook R, Jones D, Redding CA, Zulu R, Chitalu N, Weiss SM. Female Partner Acceptance as a Predictor of Men's Readiness to Undergo Voluntary Medical Male Circumcision in Zambia: The Spear and Shield Project. AIDS Behav. 2016 Nov;20(11):2503-2513. doi: 10.1007/s10461-015-1079-x.
citation: Redding CA, Jones D, Zulu R, Chitalu N, Cook R, Weiss SM. Stages of Change for Voluntary Medical Male Circumcision and Sexual Risk Behavior in Uncircumcised Zambian Men: The Spear and Shield Project. Int J Behav Med. 2015 Dec;22(6):799-806. doi: 10.1007/s12529-015-9485-z.