Increasing Availability and Acceptability of Circumcision in Zambia

HIV Clinical Trial

Official title:

Increasing Availability and Acceptability of Circumcision in Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688167
• Other study ID #: 20110290
• Secondary ID: R01MH095539
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: November 2014

Study information

• Verified date: June 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1468
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• MC and sexual risk reduction
Four group counselling sessions focused on male circumcision and sexual risk reduction

Locations

Country	Name	City	State
Zambia	University of Zambia Teaching Hospital	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Zambia, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Male and female condom use post 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	3 months after undergoing male circumcision
Primary	Change in likelihood of undergoing male circumcision across the study using stages of change model	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.	Baseline, Average of 1 month post-baseline, 6 month and 12 month follow-up
Secondary	Uptake of male circumcision	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).	From the date of study enrollment to the date male circumcision is performed or study completion.