NCT01688167

Increasing Availability and Acceptability of Circumcision in Zambia

Completed NA Last updated 22 June 2022

What this trial tests

NA trial testing MC and sexual risk reduction in HIV in 1,468 participants. Completed in 1 November 2014.

Timeline

1 January 2012

Primary endpoint
1 November 2014

1 November 2014

Quick facts

Lead sponsor	University of Miami
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	1,468
Start date	1 January 2012
Primary completion	1 November 2014
Estimated completion	1 November 2014
Sites	1 location across Zambia

Drugs / interventions tested

• MC and sexual risk reduction

Conditions studied

• HIV — all drugs for HIV →

Sponsor

University of Miami

Who can join

18 and older, any sex, with HIV. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in likelihood of undergoing male circumcision across the study using stages of change model
  Time frame: 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.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Spear and Shield intervention to increase the availability and acceptability of voluntary medical male circumcision in Zambia: a cluster randomised controlled trial.
   Weiss SM, Zulu R, Jones DL, Redding CA, et al · · 2015 · cited 42× · PMID 26120594 · DOI 10.1016/s2352-3018(15)00042-9
2. Female Partner Acceptance as a Predictor of Men's Readiness to Undergo Voluntary Medical Male Circumcision in Zambia: The Spear and Shield Project.
   Cook R, Jones D, Redding CA, Zulu R, et al · · 2016 · cited 24× · PMID 25931242 · DOI 10.1007/s10461-015-1079-x
3. Sexual Satisfaction, Performance, and Partner Response Following Voluntary Medical Male Circumcision in Zambia: The Spear and Shield Project.
   Zulu R, Jones D, Chitalu N, Cook R, et al · · 2015 · cited 15× · PMID 26681707 · DOI 10.9745/ghsp-d-15-00163