skip to content

Clinical Trials

MainTitle

Measurement of HIV Risk to Create Demand for Safe Male Circumcision

This study is ongoing, but not recruiting participants.
Sponsor
Rakai Health Sciences Program

Collaborator
Bill and Melinda Gates Foundation
Johns Hopkins Bloomberg School of Public Health
Makerere University

Information provided by (Responsible Party)
Rakai Health Sciences Program
ClinicalTrials.gov Identifier
NCT02775357

First received: April 7, 2016
Last updated: May 12, 2016
Last Verified: April 2016
History of Changes
Purpose

Purpose

The study is aimed at testing whether use of a new index to measure risk for HIV in the context of HIV testing and counseling will increase demand for safe male circumcision (SMC) services among HIV-negative non-muslim men in Rakai. We will also study whether use of the index leads to positive sexual behavioral modifications among men. The study will also measure acceptability of the index among men.

Condition Intervention
HIV

Behavioral : Measurement and communication of HIV risk
Behavioral : Standard HIV testing and counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Using the Rakai HIV Risk Index to Measure and Communicate HIV Risk to Create Demand for Safe Male Circumcision: A Randomized Controlled Trial

Further study details as provided by Rakai Health Sciences Program:

Primary Outcome Measures

  • Circumcision status as reported on a questionnaire and confirmed by examination [ Time Frame: 6 months ]
    Circumcision status of men ascertained using a questionnaire and confirmed by examination
Secondary Outcome Measures:
  • Condom use at last non-marital relationship as reported on a questionnaire [ Time Frame: 6 months ]
    Condom use at last non-marital sex ascertained using questionnaire self reports

Enrollment: 968
Study Start Date: November 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Enhanced HIV counseling and testing
In addition to standard HIV testing and counseling,men randomized to this arm received Measurement and communication of HIV risk from the HIV counselors using an index developed and validated through the Rakai community cohort study. Their risk was communicated to them and subsequent HIV risk reduction counseling including male circumcision was given.
Behavioral: Measurement and communication of HIV risk

Measurement and communication of HIV risk in the context of HIV testing and counseling to inform HIV risk reduction counseling

Active Comparator: Standard HIV testing and counseling
Men randomized to this arm were given standard HIV testing and counseling following the current Uganda Ministry of Health guidelines. Following the counseling HIV risk reduction counseling including male circumcision was given.
Behavioral: Standard HIV testing and counseling

Participants received HIV testing and counseling following standard Ministry of Health guidelines

Detailed Description:

Three randomized trials, one of which was conducted in Rakai, Uganda, have shown that safe male circumcision (SMC) reduces HIV acquisition in men by approximately 60%. Recommendations from the World Health Organization (WHO) and the Joint United Nations Programme (UNAIDS) emphasize that SMC should be considered an efficacious intervention for HIV prevention in countries and regions with heterosexual epidemics, high HIV and low male circumcision prevalence.
In Sub Saharan Africa, 14 countries including Uganda have been selected to scale up SMC, for these countries the target is to achieve 80% circumcision prevalence by 2015 and maintain it till 2025. The scale up would avert more than 20 percent of new infections among men and women. However SMC programs are faced with the challenge of low uptake of SMC by older sexually active men who might be at higher risk of HIV. The need to increase SMC coverage among men at high risk of HIV requires tools to measure individual HIV risk.
Rakai Health Sciences Program has received funding to carry out an individual randomized, unblinded, two-arm 1:1 trial comprising a total of 968 men (484 men per study arm) from Rakai Community Cohort Study (RCCS) to assess whether HIV Counseling and Testing (HCT), enhanced with measurement and communication of HIV risk (eHCT), increases uptake of SMC and leads to behavior modification among HIV-negative sexually active men aged 15-49 years in Rakai District, Uganda.
The study is using a risk nomogram developed from the Rakai Community Cohort Study data to measure individual HIV risk in the intervention group and standard HCT in the control arm. All men enrolled will be followed at six months to ascertain circumcision status and collect brief information on sexual behaviors such as number of sex partners, use of alcohol with sex, detailed data on their sexual partners etc.The study will also measure acceptability of the index among men.

Eligibility

Eligibility

Ages Eligible for Study: 15 Years to 49 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:

  • Uncircumcised, non-muslim, HIV-negative, sexually active in the previous 12 months


Exclusion Criteria:
  • Refuses HIV testing, not willing to stay in Rakai for at least 6 months following
enrollment or unwilling to be traced

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02775357

Locations

Uganda
Rakai Health Sciences Program
Kalisizo, Rakai, Uganda, 256

Sponsors and Collaborators

Rakai Health Sciences Program
Bill and Melinda Gates Foundation
Johns Hopkins Bloomberg School of Public Health
Makerere University

Investigators

Principal Investigator: Joseph Kagaayi, Ph.D Rakai Health Sciences Program
More Information

More Information


Responsible Party: Rakai Health Sciences Program  
ClinicalTrials.gov Identifier: NCT02775357   History of Changes  
Other Study ID Numbers: OPP1118591  
Study First Received: April 7, 2016  
Last Updated: May 12, 2016  
Individual Participant Data    
Plan to Share IPD: No  

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.