Increasing Availability and Acceptability of Circumcision in Zambia

NCT01688167 | Completed

• 2 other identifiers: 20110290R01MH095539
• Study Type: interventional
• Target: 1,468
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; Male circumcision; Sexual risk reduction; Stages of change

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Uptake of male circumcision

  From the date of study enrollment to the date male circumcision is performed or study completion.

Other Outcomes (1)

• Male and female condom use post male circumcision

  3 months after undergoing male circumcision

Study Arms (3)

Intervention

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Observational

NO INTERVENTION

3 CHC sites will be randomly assigned as "observation only;" only aggregated clinic VCT and circumcision data will be collected.

Interventions

MC and sexual risk reduction BEHAVIORAL

Four group counselling sessions focused on male circumcision and sexual risk reduction

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV negative
• Uncircumcised male
• + 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Zambia Teaching Hospital

Lusaka, Zambia

Location

Related Publications (5)

• 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.

  PMID: 26120594 BACKGROUND

• 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.

  PMID: 24294330 BACKGROUND

• 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.

  PMID: 24604206 BACKGROUND

• 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.

  PMID: 25931242 BACKGROUND

• 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.

  PMID: 25896876 BACKGROUND

Study Officials

• Stephen M Weiss, PhD

  University of Miami

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 19, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

ZA (1)